Form F-3 - Registration statement by foreign private issuers

As filed with the Securities and Exchange Commission on August 16, 2024

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM F-3

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

CASI Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Cayman Islands		58-1959440
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

1701-1702, China Central Office Tower 1

No. 81 Jianguo Road Chaoyang District

Beijing, 100025

People’s Republic of China

+86 (10) 6508 6063

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Rui Zhang

CASI Pharmaceuticals, Inc.

9620 Medical Center Drive, Suite 300

Rockville, MD 20850

240-864-2600

(Name, address, including zip code, and telephone number, including area code, of agent for service)

With a Copy to:

Yuting Wu, Esq.

Skadden, Arps, Slate, Meagher & Flom LLP

JingAn Kerry Center, Tower II, 46/F

1539 Nanjing West Road

Shanghai 200040

People’s Republic of China

+86 21-6193-8200

Approximate date of commencement of proposed sale to the public: From time to time after this Registration Statement becomes effective.

If only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ¨

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. x

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨

If this Form is a registration statement pursuant to General Instruction I.C. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ¨

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.C. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ¨

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

Emerging growth company ¨

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ¨

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until this registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this prospectus is not complete and may be changed. The selling shareholders named in this prospectus may not sell these securities until the registration statement filed with the Securities and Exchange Commission is declared effective. This prospectus is not an offer to sell these securities and the selling shareholders named in this prospectus are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to completion, dated August 16, 2024

PROSPECTUS

CASI Pharmaceuticals, Inc.

3,000,000 Ordinary Shares

This prospectus relates to 3,000,000 ordinary shares of the Company, par value $0.0001 per share (“Offered Shares”), including 1,980,000 ordinary shares issuable upon exercise of certain warrants issued to the selling shareholders, that may be sold from time to time by the selling shareholders named in this prospectus or their transferees, pledgees, donees or other successors in interest, issued pursuant to certain Subscription Agreements and Subscription and Purchase Agreements by and between us and the selling shareholders, dated as of June 26, 2024.

We will not receive any of the proceeds from the sale of the Offered Shares by the selling shareholders.

The selling shareholders named in this prospectus, may sell all or a portion of the Offered Shares held by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. The names of any underwriters may be stated in the applicable prospectus supplement, if any such prospectus supplement is prepared. If the Offered Shares are sold through underwriters or broker-dealers, the selling shareholders will be responsible for underwriting discounts or commissions or agent’s commissions. The Offered Shares may be sold in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale or at negotiated prices. For additional information on the methods of sale that may be used by the selling shareholders, see “Plan of Distribution” beginning on page 14 of this prospectus.

We will bear all costs, expenses and fees in connection with the registration of the Offered Shares offered hereby.

Our ordinary shares are traded on the Nasdaq Capital Market under the symbol “CASI.” On August 15, 2024 the last reported sale price of our ordinary shares on Nasdaq Capital Market was $6.56 per ordinary share.

Investing in our securities involves a high degree of risk. We may be subject to various legal and operational risks as a result of doing business in the PRC, risks relating to our auditor, risks relating to cash and asset transfers among CASI and its subsidiaries, and risks relating to permission and filing procedures required from the governmental authorities of the PRC with respect to the operation of our PRC subsidiaries and future offerings in the United States. You should carefully review the risks and uncertainties described under the section titled “Risk Factors” on page 7 of this prospectus and, if applicable, any risk factors described in any applicable prospectus supplement and in our filings with the U.S. Securities and Exchange Commission, or SEC, that are incorporated by reference in this prospectus.

We are a “foreign private issuer” as defined in Rule 405 under the Securities Act of 1933, as amended, and, as such, we have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings. Please see “Implications of Being a Foreign Private Issuer.”

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus or any prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.

INTRODUCTORY COMMENTS

We are not a Chinese operating company but a Cayman Islands holding company with business operations primarily conducted by our Chinese subsidiaries. This holding company structure and our operation in China may involve risks. We currently conduct our business through the following consolidated subsidiaries: CASI Pharmaceuticals (China) Co., Ltd., referred to as CASI China; CASI Pharmaceuticals (Wuxi) Co., Ltd., referred to as CASI Wuxi; CASI Biopharmaceuticals (WUXI) Co., Ltd, referred to as CASI Biopharmaceuticals; and CASI Pharmaceuticals Co., Limited, referred to as CASI Hong Kong.

We face various risks and uncertainties related to doing business in China. Our business operations are primarily conducted in China, and we are subject to complex and evolving PRC laws and regulations. The PRC government’s significant authority in regulating our operations and its oversight and control over offerings conducted overseas by, and foreign investment in, China-based issuers could significantly limit or completely hinder our ability to offer or continue to offer securities to investors and cause the value of our securities to significantly decline or become worthless. Implementation of industry-wide regulations, including data security or anti-monopoly related regulations, could result in a material change in our operations and may cause the value of our securities to significantly decline or become worthless. Risks and uncertainties arising from the legal system in China, including risks and uncertainties regarding the enforcement of laws and quickly evolving rules and regulations in China, could result in a material adverse change in our operations and the value of our ordinary shares. For example, China’s government has in recent years issued statements and regulatory actions to regulate certain market players or to improve its supervision of the market in general, such as those related to data security or anti-monopoly concerns. While we currently do not believe such regulatory actions have materially impacted our business operations, our ability to accept foreign investments, or our ability to maintain listing with the Nasdaq Stock Market, there is no assurance that any new rules or regulations promulgated in the future will not impose additional requirements on us. If any such rules or regulations are adopted, we may be subject to more stringent regulatory scrutiny for our operation and financing efforts, which may in turn result in us incurring additional compliance costs and expenses, delay our investment and financing activities, or otherwise impact our ability to conduct our business, accept foreign investments, or list on a U.S. or other foreign exchange.

Risks Relating to Our Auditor

Our auditor, the independent registered public accounting firm that issues the audit report contained in our annual report, as an auditor of companies that are traded publicly in the United States and a firm registered with the Public Company Accounting Oversight Board, or PCAOB, is subject to laws in the United States pursuant to which the PCAOB conducts regular inspections to assess its compliance with applicable professional standards. Our auditor is located in mainland China, a jurisdiction where the PCAOB was historically unable to conduct inspections and investigations completely before 2022. As a result, we and investors in CASI Pharmaceuticals, Inc., a Delaware corporation, our predecessor prior to the redomicile merger and referred to hereinafter as CASI Delaware, were deprived of the benefits of such PCAOB inspections. Pursuant to the Holding Foreign Companies Accountable Act, or the HFCAA, if the SEC determines that we have filed audit reports issued by a registered public accounting firm that has not been subject to inspections by the PCAOB for two consecutive years, the SEC will prohibit our securities from being traded on a national securities exchange or in the over-the-counter trading market in the United States.

On December 16, 2021, the PCAOB issued a report to notify the SEC of its determination that the PCAOB was unable to inspect or investigate completely registered public accounting firms headquartered in mainland China and Hong Kong and CASI Delaware’s auditor was subject to that determination. In April 2022, the SEC conclusively listed CASI Delaware as a Commission-Identified Issuer under the HFCAA following the filing of its annual report on Form 10-K for the fiscal year ended December 31, 2021. On December 15, 2022, the PCAOB issued a report that vacated its December 16, 2021 determination and removed mainland China and Hong Kong from the list of jurisdictions where it is unable to inspect or investigate completely registered public accounting firms. For this reason, we do not expect we will be identified as a Commission-Identified Issuer under the HFCAA for the fiscal year ended December 31, 2023.

Each year in the future, the PCAOB will determine whether it can inspect and investigate completely audit firms in mainland China and Hong Kong, among other jurisdictions. If the PCAOB determines in the future that it no longer has full access to inspect and investigate completely accounting firms in mainland China and Hong Kong and we use an accounting firm headquartered in one of these jurisdictions to issue an audit report on our financial statements filed with the SEC, we would be identified as a Commission-Identified Issuer following the filing of the annual report for the relevant fiscal year. In accordance with the HFCAA, our ordinary shares would be prohibited from being traded on a national securities exchange or in the over-the-counter trading market in the United States if we are identified as a Commission-Identified Issuer for two consecutive years in the future. If our ordinary shares are prohibited from trading in the United States, there is no certainty that we will be able to list on a non-U.S. exchange or that a market for our ordinary shares will develop outside of the United States. A prohibition of being able to trade in the United States would substantially impair your ability to sell or purchase our ordinary shares when you wish to do so, and the risk and uncertainty associated with delisting would have a negative impact on the price of such shares. Also, such a prohibition would significantly affect our ability to raise capital on terms acceptable to us, or at all, which would have a material adverse impact on our business, financial condition, and prospects.

Cash and Asset Transfer among CASI and its Subsidiaries

We provide funding to our subsidiaries from time to time through capital contributions or loans, subject to satisfaction of applicable government registration and approval requirements. For the year ended December 31, 2023, we provided funding of US$1.0 million through capital contributions to CASI Hong Kong, our newly incorporated Hong Kong subsidiary.

Our subsidiaries may pay dividends and make other distributions to us subject to satisfaction of applicable government filing and approval requirements. Such dividend or other distributions may be subject to limitations and certain tax consequences, a discussion on which is set forth below. For the year ended December 31, 2023, no dividends or other distributions were made by our subsidiaries.

We also pay service fees to our PRC subsidiaries pursuant to certain sales support service agreements and research and development support service agreements. For the year ended December 31, 2023, we paid service fees of US$1.1 million to CASI China, one of our PRC subsidiaries. Under PRC tax laws and regulations, the earnings of our subsidiaries under such agreements are subject to a statutory tax rate of 25%.

In the year ended December 31, 2023, no assets other than cash were transferred through our organization.

All cash transfers among us and our subsidiaries have been eliminated in our consolidated statement of cash flows.

The existing PRC foreign exchange regulations may limit our ability to initiate and complete cash transfers within our group. Approval from the State Administration of Foreign Exchange, or SAFE, and the People’s Bank of China, or PBOC, may be required where RMB are to be converted into foreign currencies, including U.S. dollars, and approval from SAFE and PBOC or their branches may be required where RMB are to be remitted out of China.

We have never declared or paid dividends on our ordinary shares or any other securities and we do not anticipate paying any dividends on our ordinary shares in the foreseeable future. We may rely on dividends from our subsidiaries in China to pay dividend and other distributions on our ordinary shares. PRC regulations may restrict the ability of our PRC subsidiaries to pay dividends to us. In addition to applicable foreign exchange limitations, under the current regulatory regime in China, a PRC company may pay dividends only out of its accumulated profit, if any, determined in accordance with PRC accounting standards and regulations, and is required to set aside as general reserves at least 10% of its after-tax profit, until the cumulative amount of such reserves reaches 50% of its registered capital, prior to any dividend distribution. In addition, a PRC company shall not distribute any profits in a given year until any losses from prior fiscal years have been offset.

Permission and Filing Procedures Required from the PRC Authorities with respect to the Operations of Our PRC Subsidiaries and Future offering in the US

As the date hereof, our PRC subsidiaries have obtained the requisite licenses and permits from the PRC government authorities that are material for our business operations, including, among others, the Business License, the Drug Distribution License, the Drug Manufacturing Permit, the Clinical Trial Application with the PRC National Medical Products Administration, or NMPA, and the notification filing for international collaborative clinical trial or the application for international collaborative scientific research with the China Human Genetic Resources Administrative Office, or HGRAO. We also work with our business partners which have obtained the requisite licenses and permits for their business collaboration with us, including, among others, the Import Drug Registration for product(s) we promote and distribute in China. Given the uncertainties of interpretation and implementation of relevant laws and regulations and the enforcement practices of the relevant government authorities, we may be required to obtain additional permissions or approvals for our business operations.

As the date hereof, we and our PRC subsidiaries (i) are not required to obtain permissions from the China Securities Regulatory Commission, or the CSRC, (ii) are not required to go through cybersecurity review by the Cyberspace Administration of China, or the CAC, and (iii) have not been asked to obtain or denied such permissions by any PRC authority. On July 7, 2022, the CAC published the Guidelines for Data Export Security Assessment (《数据出境安全评估办法》) (the “Guidelines”), which took effect on September 1, 2022. Pursuant to the Guidelines, the data processor who intends to transfer certain important data or large volumes of personal information outside of China shall complete a prior CAC-led data outbound transfer security assessment. However, there is no specific enforcement guidelines or interpretation for such security assessment, including what constitutes “important data”, or how to define “outbound transfer”, which results in uncertainties whether our business will be subject to such CAC-led assessment. For the data we accessed through or obtained from clinical trials, we have complied with the laws and regulations then-in-effect, and completed the registration with HGRAO, but it is unclear if we will be required to go through the CAC-led or CAC-involved security assessment or if the current HGRAO registration procedure will be changed in the future. We will closely monitor and review any regulatory developments and comply with any new approval or license requirement when necessary. If (i) we have erroneously concluded that such permissions or approvals are not required, or (ii) applicable laws, regulations, or interpretations change and we are required to obtain such permissions or approvals in the future, we may have to expend significant time and costs to procure them. If we are unable to do so, on commercially reasonable terms, in a timely manner or otherwise, we may become subject to sanctions imposed by the PRC regulatory authorities, which could include fines and penalties, proceedings against us, and other forms of sanctions, and our ability to conduct our business, invest into China as foreign investments or accept foreign investments, or be listed on a U.S. or other overseas exchange may be restricted, and our business, reputation, financial condition, and results of operations may be materially and adversely affected.

On February 17, 2023, the CSRC released the Trial Administrative Measures of the Overseas Securities Offering and Listing by Domestic Companies (《境内企业境外发行证券和上市管理试行办法》) and five ancillary interpretive guidelines (collectively, the “Overseas Listing Trial Measures”), which apply to overseas offerings and listing by PRC-based companies, or domestic companies, of equity shares, depository receipts, corporate bonds convertible to equity shares, and other equity securities, and came into effect on March 31, 2023. According to the Overseas Listing Trial Measures, (1) domestic companies that seek to offer or list securities overseas, both directly and indirectly, should fulfill the filing procedure and report relevant information to the CSRC, and if an overseas-listed PRC-based issuer issues new securities in the same overseas market after the overseas offering and listing, it is also required to file with the CSRC within three business days after the completion of the issuance; if a domestic company fails to complete the filing procedure or conceals any material fact or falsifies any major content in its filing documents, such domestic company may be subject to administrative penalties, such as order to rectify, warnings, fines, and its controlling shareholders, actual controllers, the person directly in charge and other directly liable persons may also be subject to administrative penalties, such as warnings and fines; (2) if a foreign-incorporated issuer meets both of the following conditions, its overseas offering and listing shall be determined as an indirect overseas offering and listing by a domestic company of the PRC: (i) any of the total assets, net assets, revenues or profits of the domestic operating entities of the issuer in the most recent accounting year accounts for more than 50% of the corresponding line items in the issuer’s audited consolidated financial statements for the same period; and (ii) its major operational activities are carried out in China or its main places of business are located in China, or the senior managers in charge of operation and management of the issuer are mostly Chinese citizens or are domiciled in China; and (3) where a domestic company seeks to indirectly offer and list securities in an overseas market (including issuance of new securities after its overseas offering and listing), the issuer shall designate a major domestic operating entity responsible for all filing procedures with the CSRC.

Furthermore, in case any of the following major events occurs after the overseas offering and listing, the issuer is also required to report the relevant information to the CSRC within three business days of the occurrence and the announcement of the relevant events: (1) change of control; (2) the foreign securities regulatory body or the relevant competent authority has taken such measures as investigation and punishment; (3) conversion of listing status or listing board; and (4) voluntary of compulsory termination of listing. Where there is any material change in the major business and operation of the issuer after overseas offering and listing, and such change does not fall within the scope of filing, the issuer shall, within three business days of the occurrence of such change, submit a special report and a legal opinion issued by a domestic law firm to the CSRC to explain the relevant situation.

As substantially all of our operations are currently based in the PRC, our future offerings and major changes shall be subject to the foregoing filing procedures under the Overseas Listing Trial Measures. We cannot assure you that we can meet such requirements, obtain the requisite permits from the relevant government authorities, or complete such filing in a timely manner or at all. Any failure may significantly limit or completely hinder our ability to continue to offer securities to investors and cause the value of our securities to significantly decline or be worthless. In addition, as the Overseas Listing Trial Measures was recently promulgated, there remains substantial uncertainty as to its interpretation and implementation and how it may impact our ability to raise or utilize funds and our business operations.

The date of this prospectus is     , 2024.

TABLE OF CONTENTS

ABOUT THIS PROSPECTUS	i
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS	ii
INDUSTRY AND MARKET DATA	iii
TRADEMARKS AND TRADENAMES	iii
OUR COMPANY	1
RISK FACTORS	7
OFFER STATISTICS AND EXPECTED TIMETABLE	8
CAPITALIZATION	9
USE OF PROCEEDS	10
DESCRIPTION OF SHARE CAPITAL	10
DESCRIPTION OF SECURITIES	10
ENFORCEABILITY OF CIVIL LIABILITIES	11
SELLING SHAREHOLDERS	12
PLAN OF DISTRIBUTION	14
TAXATION	16
LEGAL MATTERS	16
EXPERTS	16
EXPENSES OF ISSUANCE AND DISTRIBUTION	17
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE	18
WHERE YOU CAN GET MORE INFORMATION	19

ABOUT THIS PROSPECTUS

This prospectus describes the general manner in which the selling shareholders identified in this prospectus may offer from time to time up to 3,000,000 Offered Shares, including 1,980,000 ordinary shares issuable upon exercise of certain warrants issued to the selling shareholders.

You should rely only on the information contained in this prospectus and the related exhibits, any prospectus supplement or amendment thereto and the documents incorporated by reference, or to which we have referred you, before making your investment decision. We have not, and the selling shareholders have not, authorized any other person to provide you with different or additional information. If anyone provides you with different or inconsistent information, you should not rely on it. This prospectus is not an offer to sell, nor are the selling shareholders seeking an offer to buy, the Offered Shares offered by this prospectus in any jurisdiction where the offer or sale is not permitted. You should assume that the information contained in this prospectus or in any applicable prospectus supplement is accurate only as of the date on the front cover thereof or the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any applicable prospectus supplement or any sales of the Offered Shares offered hereby or thereby.

If necessary, the specific manner in which the Offered Shares may be offered and sold will be described in a supplement to this prospectus, which supplement may also add, update or change any of the information contained in this prospectus. To the extent there is a conflict between the information contained in this prospectus and any prospectus supplement, you should rely on the information in such prospectus supplement, provided that if any statement in one of these documents is inconsistent with a statement in another document having a later date—for example, a document incorporated by reference in this prospectus or any prospectus supplement—the statement in the document having the later date modifies or supersedes the earlier statement.

Neither the delivery of this prospectus nor any distribution of Offered Shares pursuant to this prospectus shall, under any circumstances, create any implication that there has been no change in the information set forth or incorporated by reference into this prospectus or in our affairs since the date of this prospectus. Our business, financial condition, results of operations and prospects may have changed since such date.

Throughout this prospectus, references to the “Company,” “we,” “our,” “us,” “registrant” or similar terms used in this prospectus refer to CASI Pharmaceuticals, Inc., an exempted company with limited liability incorporated under the laws of the Cayman Islands, including its consolidated subsidiaries, unless the context otherwise indicates, which is also referred to as “CASI.”

“PRC” or “China” refers to the People’s Republic of China, excluding, for the purpose of this prospectus, Taiwan, Hong Kong and Macau, “RMB” or “Renminbi” refers to the legal currency of China, and “$”, “US$” or “U.S. Dollars” refers to the legal currency of the United States.

This prospectus may contain translations of Renminbi amounts into U.S. dollars at specified rates solely for the convenience of the reader. We make no representation that the Renminbi or U.S. dollar amounts referred to in this prospectus could have been or could be converted into U.S. dollars or Renminbi, as the case may be, at any particular rate or at all.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This prospectus and the documents we have filed with the SEC that are incorporated by reference contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. The statements contained in this prospectus or incorporated by reference herein that are not purely historical are forward-looking statements. Our forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.

You can identify some of these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue” or other similar expressions. These forward-looking statements include, among others, statements regarding the timing of our commercial launch of products, clinical trials, our cash position and future expenses, and our future revenues. We have based these forward-looking statements largely on our current expectations and projections about future events that we believe may affect our financial condition, results of operations, business strategy and financial needs.

Actual results could differ materially from those currently anticipated due to a number of factors, including: uncertainties related to the non-binding proposal to acquire the Company’s certain business operations in China; the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. FDA, EMA, NMPA, or other regulatory authorities; our inability to receive approval for renewal of license of our existing products; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products and our dependence on third parties; the risks related to our dependence on Juventas to partner with us to co-market CNCT19; risks related to the uncertainty in connection with the ongoing arbitration proceedings between us and Juventas with respect to Juventas’ purported termination of certain CNCT19 license agreements; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; the risk related to the Company’s ongoing development of and regulatory application for CID-103 with respect to the treatment of antibody-mediated rejection for organ transplant and the license arrangements of CID-103; risks relating to the interests of our largest shareholder and our Chairman and Chief Executive Officer that differ from our other shareholders; and risks related to the success of a new manufacturing facility operated by CASI Wuxi. Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition.

The forward-looking statements contained in this prospectus are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those described in the section titled “Risk Factors” and elsewhere in this prospectus. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We discuss in greater detail many of these risks under the section titled “Risk Factors” in our most recent annual report on Form 20-F, as well as any amendments thereto reflected in subsequent filings with the SEC, as well as our reports on 6-K, which are incorporated by reference into this prospectus in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of the date of the document containing the applicable statement. Unless required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information or future events or developments. You should read this prospectus, any applicable prospectus supplement, together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus in connection with a specific offering completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in the foregoing documents by these cautionary statements.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

INDUSTRY AND MARKET DATA

In this prospectus and the documents incorporated by reference in this prospectus, we present industry data, information and statistics regarding the markets in which CASI and its subsidiaries compete as well as publicly available information, industry and general publications and research and studies conducted by third parties. This information is supplemented where necessary with the Company’s own internal estimates and information obtained from discussions with its customers, taking into account publicly available information about other industry participants and CASI’s management’s judgment where information is not publicly available.

Industry publications, research, studies and forecasts generally state that the information they contain has been obtained from sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and uncertainties as the other forward-looking statements in this prospectus or any document incorporated by reference into this prospectus. These forecasts and forward-looking information are subject to uncertainty and risk due to a variety of factors, including those described under the section entitled “Risk Factors.” These and other factors could cause results to differ materially from those expressed in any forecasts or estimates.

TRADEMARKS AND TRADENAMES

This prospectus and the information incorporated herein by reference include trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included or incorporated by reference into this prospectus, any applicable prospectus supplement or any related free writing prospectus are the property of their respective owners.

iii

OUR COMPANY

Company Overview

This summary highlights information contained in the documents incorporated herein by reference. Before making an investment decision, you should read the entire prospectus, and our other filings with the SEC, including those filings incorporated herein by reference, carefully, including the sections entitled “Risk Factors” and “Special Note Regarding Forward-Looking Statements.”

We are a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world.

Holding Company Structure

CASI is not a Chinese operating company but a Cayman Islands holding company with a significant portion of the business operations expected to be conducted by its Chinese subsidiaries. This holding company structure and our operation in China may involve risks. We currently conduct our business through the following consolidated subsidiaries:

CASI Pharmaceuticals (China) Co., Ltd., referred to as CASI China;

CASI Pharmaceuticals (Wuxi) Co., Ltd., referred to as CASI Wuxi;

CASI Biopharmaceuticals (WUXI) Co., Ltd, referred to as CASI Biopharmaceuticals; and

CASI Pharmaceuticals Co., Limited, referred to as CASI Hong Kong.

We do not have any variable interest in any unconsolidated entity that provides financing, liquidity, market risk or credit support to us or engages in leasing, hedging or product development services with us. The organizational chart of CASI as of July 31, 2024 is set forth below:

Note: Currently CASI Hong Kong has no meaningful operations.

Nasdaq Capital Market Listing; Redomiciliation

Our ordinary shares are traded on The Nasdaq Capital Market under the symbol “CASI.” In March 2023, we completed a redomicile merger, with CASI surviving the merger as the surviving company and successor issuer, and CASI’s ordinary shares continued trading on The Nasdaq Capital Market under the symbol “CASI.” CASI is treated for U.S. federal income tax purposes as a U.S. corporation, including with respect to any dividends paid by it, which dividends may be subject to U.S. withholding taxes.

Corporate Information

Our principal executive offices are located at 1701-1702, China Central Office Tower 1, No. 81 Jianguo Road Chaoyang District, Beijing, 100025, People’s Republic of China. Our telephone number at this address is +86 (10) 6508 6063. Our registered office in the Cayman Islands is located at Maples Corporate Services Limited, P.O. Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands.

Our agent for service of process in the United States is located at 9620 Medical Center Drive, Suite 300, Rockville, MD 20850, 240-864-2600.

Implications of Being a Foreign Private Issuer

As a “foreign private issuer,” CASI is subject to different U.S. securities laws than domestic U.S. issuers. The rules governing the information that CASI must disclose differ from those governing U.S. corporations pursuant to the Securities Exchange Act of 1934, as amended, or the Exchange Act. Because we qualify as a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the securities rules and regulations in the United States that are applicable to U.S. domestic issuers, including:

the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q or current reports on Form 8-K;

the sections of the Exchange Act regulating the solicitation of proxies, consents, or authorizations in respect of a security registered under the Exchange Act;

the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and

the selective disclosure rules by issuers of material nonpublic information under Regulation FD.

We are required to file an annual report on Form 20-F within four months of the end of each fiscal year. In addition, we intend to publish our results on a quarterly basis as press releases, distributed pursuant to the rules and regulations of the Nasdaq Stock Market. Press releases relating to financial results and material events will also be furnished to the SEC on Form 6-K. However, the information we are required to file with or furnish to the SEC will be less extensive and less timely compared to that required to be filed with the SEC by U.S. domestic issuers. As a result, you may not be afforded the same protections or information that would be made available to you were you investing in a U.S. domestic issuer.

In addition, as a foreign private issuer, CASI’s officers and directors and holders of more than 10% of the issued and outstanding ordinary shares are exempt from the rules under the Exchange Act requiring insiders to report purchases and sales of ordinary shares as well as from Section 16 short swing profit reporting and liability. A company will lose its foreign private issuer status if more than 50% of its outstanding voting securities are owned by U.S. residents and any of the following three circumstances applies: (i) the majority of its executive officers or directors are U.S. citizens or residents, (ii) more than 50% of its assets are located in the United States or (iii) its business is administered principally in the United States.

Risks Associated with our Business

Our business is subject to numerous risks, as described under the heading “Risk Factors” contained in the applicable prospectus and under similar headings that are incorporated by reference into this prospectus, including, without limitation, the further risks discussed below.

Risks and Uncertainties Relating to Doing Business in China

Risks Relating to Our Auditor

Our auditor, the independent registered public accounting firm that issues the audit report contained in our annual report, as an auditor of companies that are traded publicly in the United States and a firm registered with the Public Company Accounting Oversight Board, or PCAOB, is subject to laws in the United States pursuant to which the PCAOB conducts regular inspections to assess its compliance with applicable professional standards. Our auditor is located in mainland China, a jurisdiction where the PCAOB was historically unable to conduct inspections and investigations completely before 2022. As a result, we and investors in CASI Delaware were deprived of the benefits of such PCAOB inspections. Pursuant to the Holding Foreign Companies Accountable Act, or the HFCAA, if the SEC determines that we have filed audit reports issued by a registered public accounting firm that has not been subject to inspections by the PCAOB for two consecutive years, the SEC will prohibit our securities from being traded on a national securities exchange or in the over-the-counter trading market in the United States.

Cash and Asset Transfer among CASI and its Subsidiaries

In the year ended December 31, 2023, no assets other than cash were transferred through our organization.

All cash transfers among us and our subsidiaries have been eliminated in our consolidated statement of cash flows.

Permission and Filing Procedures Required from the PRC Authorities with respect to the Operations of Our PRC Subsidiaries and Future offering in the US

Recent Development

The Company’s board of directors received a preliminary non-binding proposal letter (the “Proposal Letter”) dated June 21, 2024, from Dr. Wei-Wu He, Chairman of the Board and CEO of the Company, to acquire the entire business operations of the Company in China and all license-in, distribution and related rights in Asia (excluding Japan) related to all of the Company’s pipeline products, including but not limited to EVOMELA®, FOLOTYN®, CNCT19, BI-1206, CB-5339,CID-103 and Thiotepa, for an aggregate purchase price of $40.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company (the “Proposed Transaction”). On June 25, the Board has formed a special committee comprised solely of incumbent independent directors (the “Special Committee”) to evaluate the transaction contemplated under the Proposal Letter and such other strategic and business alternatives available to the Company in respect of the Company’s business operations in China. As of the date hereof, no decisions have been made by the Special Committee with respect to the Proposed Transaction or any alternative strategic option that the Company may pursue.

On June 26, 2024, the Company entered into Subscription Agreements and Subscription and Purchase Agreements with selling shareholders. On July 15, 2024, the transaction contemplated under such agreements closed, pursuant to which the Company issued 1,020,000 ordinary shares and Warrants to purchase 1,980,000 ordinary shares to the selling shareholders.

RISK FACTORS

Investing in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks and uncertainties discussed under the section titled “Risk Factors” contained in our most recent annual report on Form 20-F and in our current reports on Form 6-K, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this prospectus in their entirety, together with other information in this prospectus, the documents incorporated by reference and any prospectus supplement or free writing prospectus used in connection with a specific offering. See “Where You Can Find More Information.”

The risks described in these documents are not the only ones we face, but those that we consider to be material. There may be other unknown or unpredictable economic, business, competitive, regulatory or other factors that could have material adverse effects on our future results. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. If any of these risks actually occur, our business, financial condition, results of operations or cash flow could be harmed. This could cause the trading price of our securities to decline, resulting in a loss of all or part of your investment. Please also read carefully the section below titled “Forward-Looking Statements.”

OFFER STATISTICS AND EXPECTED TIMETABLE

This prospectus relates to the proposed resale from time to time by the selling shareholders of up to 3,000,000 ordinary shares, consisting of (i) up to 1,020,000 ordinary shares, or the Purchased Shares and (ii) up to 1,980,000 ordinary shares issuable upon exercise of certain pre-funded warrants, or the Warrants, which are held by certain selling shareholders. The selling shareholders acquired Purchased Shares and the Warrants pursuant to certain Subscription Agreements and certain Subscription and Purchase Agreements, each dated June 26, 2024, by and among our company and the selling shareholders.

Pursuant to the Subscription Agreements and the Subscription and Purchase Agreements, we issued the Purchased Shares and the Warrants to the Selling Shareholders on July 15, 2024, and agreed to register the Purchased Shares and ordinary shares issuable upon exercise of the Warrants on a registration statement, and use our best efforts to cause such registration statement to be declared effective by the SEC as promptly as possible after the initial filing. We are registering such shares in the registration statement which includes this prospectus.

We shall keep the shelf registration statement current and cause it to remain effective to permit the prospectus under the shelf registration statement or any subsequent registration statement to be usable by the selling shareholders. The selling shareholders may sell all or a portion of the Offered Shares held by them and offered hereby from time to time. See “Plan of Distribution.”

CAPITALIZATION

The following table sets forth our capitalization as of June 30, 2024:

on an actual basis;

on an adjusted basis to reflect the issuance of 1,020,000 Purchased Shares on July 15, 2024; and

on a further adjusted basis to give effect to 1) the issuance of 1,020,000 Purchased Shares on July 15, 2024, and 2) the issuance of 1,980,000 ordinary shares upon exercise of the Warrants issued on July 15, 2024.

The information in this table should be read in conjunction with the financial statements and the notes thereto incorporated by reference into this prospectus.

(In USD thousands, except share and per share data)	Actual			Adjusted			Further Adjusted
Long term borrowing	$	18,465		$	18,465		$	18,465

Shareholders’ equity:
Ordinary shares, $0.0001 par value; 500,000,000 shares authorized, 14,439,124 shares issued and outstanding on an actual basis, 15,459,124 shares issued and outstanding on an adjusted basis, 17,439,124 shares issued and outstanding on a further adjusted basis	$	1		$	2		$	2
Treasury shares, at cost: 411,952 shares	$	(9,604	)	$	(9,604	)	$	(9,604	)
Subscription receivable	$	(2,019	)	$	(2,019	)	$	(2,019	)
Additional paid-in capital	$	699,373		$	704,473		$	714,373
Accumulated other comprehensive loss	$	(1,420	)	$	(1,420	)	$	(1,420	)
Accumulated deficit	$	(677,310	)	$	(677,310	)	$	(677,310	)
Total shareholders’ equity	$	9,021		$	14,122		$	24,022
Total capitalization	$	27,486		$	32,587		$	42,487

USE OF PROCEEDS

We will not receive any proceeds from the sale of Offered Shares by the selling shareholders.

The selling shareholders will pay any underwriting discounts and commissions and expenses incurred by them for brokerage, accounting, tax or legal services or any other expenses incurred by them in disposing of the Offered Shares. We will bear all other costs, fees and expenses incurred in effecting the registration of the Offered Shares covered by this prospectus, including, without limitation, all registration and filing fees and fees and expenses of our counsel and our accountants.

See “Plan of Distribution” elsewhere in this prospectus for more information.

DESCRIPTION OF SHARE CAPITAL

Information relating to our share capital and certain provisions of our Memorandum and Articles of Association is incorporated by reference from our annual report for the fiscal year ended December 31, 2023 filed on Form 20-F (our “2023 Annual Report”), under the caption “ITEM 10, ADDITIONAL INFORMATION – B. MEMORANDUM AND ARTICLES OF ASSOCIATION.” Such information does not purport to be complete and is qualified in its entirety by the provisions of our Updated Amended and Restated Memorandum and Articles of Association and applicable provisions of the laws of the Cayman Islands.

See “Where You Can Find More Information” elsewhere in this prospectus for information on where you can obtain copies of our articles of incorporation and our bylaws, which have been filed with and are publicly available from the SEC.

DESCRIPTION OF SECURITIES

Information relating to our securities, including our ordinary shares, is incorporated by reference to Exhibit 2.2 filed to our 2023 Annual Report.

As of August 16, 2024, the Company had 15,461,057 outstanding ordinary shares and 411,952 treasury shares. Our ordinary shares are currently traded on the NASDAQ Capital Market under the symbol “CASI.”

ENFORCEABILITY OF CIVIL LIABILITIES

CASI is incorporated in the Cayman Islands because of certain benefits associated with being a Cayman Islands company, such as political and economic stability, an effective judicial system, a favorable tax system, the absence of foreign exchange control or currency restrictions and the availability of professional and support services. However, the Cayman Islands has a less developed body of securities laws as compared to the United States and provides less protection for investors. In addition, Cayman Islands companies do not have standing to sue before the federal courts of the United States.

A majority portion of CASI’s assets are located outside the United States. In addition, half of CASI’s directors and officers are nationals or residents of jurisdictions other than the United States and all or a majority portion of their assets are located outside the United States. As a result, it may be difficult for investors to effect service of process within the United States upon CASI or these persons, or to bring an action against CASI or against these persons in the United States, in the event that you believe that your rights have been infringed under the securities laws of the United States or any state in the United States. It may also be difficult for you to enforce in U.S. courts judgments obtained in U.S. courts based on the civil liability provisions of the U.S. federal securities laws against CASI and its officers and directors.

Maples and Calder (Hong Kong) LLP, our counsel as to Cayman Islands law, has advised us that there is uncertainty as to whether the courts of the Cayman Islands would (1) recognize or enforce judgments of U.S. courts obtained against CASI or its directors or officers, predicated upon the civil liability provisions of the securities laws of the United States or any state in the United States, or (2) entertain original actions brought in the Cayman Islands against CASI or its directors or officers, predicated upon the securities laws of the United States or any state in the United States.

Maples and Calder (Hong Kong) LLP has informed us that although there is no statutory enforcement in the Cayman Islands of judgments obtained in the federal or state courts of the United States (and the Cayman Islands are not a party to any treaties for the reciprocal enforcement or recognition of such judgments), a judgment obtained in such jurisdiction will be recognized and enforced in the courts of the Cayman Islands at common law, without any re-examination of the merits of the underlying dispute, by an action commenced on the foreign judgment debt in the Grand Court of the Cayman Islands, provided such judgment (a) is given by a foreign court of competent jurisdiction, (b) imposes on the judgment debtor a liability to pay a liquidated sum for which the judgment has been given, (c) is final, (d) is not in respect of taxes, a fine or a penalty, and (e) was not obtained in a manner and is not of a kind the enforcement of which is contrary to natural justice or the public policy of the Cayman Islands. However, the Cayman Islands courts are unlikely to enforce a judgment obtained from the U.S. courts under civil liability provisions of the U.S. federal securities law if such judgment is determined by the courts of the Cayman Islands to give rise to obligations to make payments that are penal or punitive in nature. Because such a determination has not yet been made by a court of the Cayman Islands, it is uncertain whether such civil liability judgments from U.S. courts would be enforceable in the Cayman Islands.

It is our understanding that the PRC does not have treaties with the United States and many other countries providing for the reciprocal recognition and enforcement of judgments of courts and that there is uncertainty as to whether the courts of the PRC would recognize or enforce judgments of United States courts against CASI or the directors or officers of CASI predicated upon the civil liability provisions of the securities laws of the United States or any state in the United States.

Additionally, it is our understanding that it may be difficult for you to bring an original action against CASI or against its directors and officers who are nationals or residents of countries other than the United States in a PRC court in the event that you believe that your rights have been infringed under the U.S. federal securities laws, PRC laws, Cayman Islands laws or otherwise because we are incorporated under the laws of the Cayman Islands and it may be difficult for U.S. shareholders, by virtue only of holding CASI ordinary shares, to establish a connection to the PRC as required by the PRC Civil Procedures Law in order for a PRC court to have jurisdiction.

SELLING SHAREHOLDERS

This prospectus covers an aggregate of up to 1,020,000 Purchased Shares that previously issued to the selling shareholders and 1,980,000 ordinary shares issuable upon exercise of certain Warrants, in each case issued to the selling shareholders in a private placement transaction as described below.

Private Placement of Purchased Shares and Warrants

The Purchased Shares and Warrants were issued in reliance upon the exemption from the registration requirements provided in the Securities Act of 1933, as amended (the “Securities Act”) promulgated thereunder. We are registering the offer and resale of the Offered Shares issued pursuant to certain Subscription Agreements and certain Subscription and Purchase Agreements and Offered Shares issuable upon exercise of certain Warrants issued under such Subscription and Purchase Agreements.

The Warrants are exercisable immediately upon the date of issuance at an initial exercise price of $0.0001, for cash. The Warrants may also be exercised cashlessly pursuant to the terms thereunder. The Warrants are subject to customary anti-dilution provisions reflecting stock dividends and splits or other similar transactions.

The information with respect to the Purchased Shares and Warrants above does not purport to be complete and is qualified in its entirety by the provisions of Subscription Agreements and Subscription and Purchase Agreements.

Information About the Selling Shareholders

We are registering the Offered Shares in order to permit the selling shareholders to offer such shares for resale from time to time. Except for the ownership of the ordinary shares, the selling shareholders, other than Dr. Wei-Wu He, HE Family GRAT and Panacea Venture Healthcare Fund II, L.P., have not had any material relationship with us within the past three years. Dr. Wei-Wu He has served as chairman of the board of directors and CEO of CASI since April 2, 2019, and HE Family GRAT is a grantor retained annuity trust organized under the law of Nevada under control of Dr. Wei-Wu He. James Huang, who served as a director of CASI Delaware prior to the redomicile merger, is the sole owner of Panacea Innovation Limited, which is the sole owner of Panacea Venture Healthcare Fund II GP Company, Ltd., which is the general partner of Panacea Venture Healthcare Fund II, L.P.

The table below is based on information supplied to us by the selling shareholders and lists the selling shareholders and other information regarding the beneficial ownership (as determined under Section 13(d) of the Exchange Act, and the rules and regulations thereunder) of the Offered Shares held by each of the selling shareholders. Please refer to footnotes with respect to the limitations to the exercise of Warrants.

The number of ordinary shares owned and the percentage of beneficial ownership before this offering set forth in these columns are based on 15,461,057 ordinary shares outstanding as of the date of this prospectus. This prospectus generally covers the resale of 100% of the maximum number of Offered Shares issued. For purposes of computing the number of ordinary shares beneficially owned after this offering and computing percentage ownership after this offering, we have assumed that all Offered Shares held by the selling shareholders will be sold in this offering. The selling shareholders may only sell some or none of their Offered Shares in this offering. See “Plan of Distribution” below.

Name of Selling Shareholder	Number of Ordinary Shares Owned Prior to this Offering⁽¹⁾		Percentage Owned Prior to this Offering⁽²⁾			Maximum Number of Ordinary Shares to be Sold Pursuant to this Prospectus⁽³⁾		Number of Ordinary Shares Owned After this Offering⁽³⁾		Percentage of Outstanding Ordinary Shares Owned Following this Offering⁽²⁾⁽³⁾
Entities Affiliated with Venrock Healthcare Capital Partners⁽⁴⁾		1,617,575		9.99	%		1,500,000		386,090		2.50	%
Foresite Capital Fund VI LP⁽⁵⁾		1,568,374		9.99	%		1,000,000		1,309,383		8.47	%
Panacea Venture Healthcare Fund II, L.P. ⁽⁶⁾		1,318,429		8.53	%		200,000		1,118,429		7.23	%
Dr. Wei-Wu He⁽⁷⁾		3,257,891		20.94	%		300,000		2,957,891		19.01	%

*	Less than 1%

(1)

The selling shareholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”

(2)

As of the date of this prospectus, a total of 15,461,057 ordinary shares are considered to be outstanding pursuant to SEC Rule 13d-3(d)(1). For each beneficial owner above, any securities that are exercisable or convertible within 60 days have been included in the denominator.

(3)

We have assumed that all Offered Shares held by the selling shareholders will be sold in this offering, including ordinary shares issuable upon exercise of Warrants.

(4)

Consists of (i)(a) 1,237,500 Offered Shares held by Venrock Healthcare Capital Partners EG, L.P. (“VHCP EG”), including 412,500 ordinary shares held by VHCP EG and 825,000 ordinary shares issuable upon the exercise of Warrants held by VHCP EG and (b) 318,526 ordinary shares held by VHCP EG not offered hereunder; (ii)(a) 238,650 Offered Shares held by Venrock Healthcare Capital Partners III, L.P. (“VHCP III”), including 79,550 ordinary shares held by VHCP III and 159,100 ordinary shares issuable upon the exercise of Warrants held by VHCP III and (b) 61,427 ordinary shares held by VHCP III not offered hereunder; and (iii)(a) 23,850 Offered Shares held by VHCP Co-Investment Holdings III, LLC (“VHCP Co-Invest III”), including 7,950 ordinary shares held by VHCP Co-Invest III and 15,900 ordinary shares issuable upon the exercise of Warrants held by VHCP Co-Invest III and (b) 6,137 ordinary shares held by VHCP Co-Invest III not offered hereunder. Pursuant to the terms of the Warrants, no Warrant may be exercised if and to the extent that, as a result of the exercise, the holder, together with its affiliates and any other persons acting as a group together with the holder or its affiliates, would beneficially own greater than 9.99% (the “Maximum Percentage”) of the total number of ordinary shares outstanding immediately following the exercise of such Warrant; provided that the holder of a Warrant may increase the Maximum Percentage to 14.99% upon 61 days’ written notice. As a result of such limitation, an aggregate of 268,515 of the ordinary shares underlying the Warrants held by VHCP EG, VHCP III and VHCP Co-Invest III may not be exercised as of the date hereof and have been excluded from “Number of Ordinary Shares Owned Prior to this Offering.” VHCP Management III, LLC (“VHCPM”) is the sole general partner of VHCP III and the sole manager of VHCP Co-Invest III. VHCP Management EG, LLC (“VHCPM EG”) is the sole general partner of VHCP EG. Dr. Bong Koh and Nimish Shah are the voting members of VHCPM and VHCPM EG. The business address of each of these persons and entities is 7 Bryant Park, 23rd Floor, New York, NY 10018.

(5)

Consists of (i) 1,000,000 Offered Shares owned by Foresite Capital Fund VI L.P. (“FCF VI”), including 20,000 ordinary shares owned by FCF VI and 980,000 ordinary shares issuable upon the exercise of Warrants owned by FCF VI and (ii) 1,309,383 ordinary shares owned by FCF VI not offered hereunder. Pursuant to the terms of the Warrants, no Warrant may be exercised if and to the extent that, as a result of the exercise, the holder, together with its affiliates and any other persons acting as a group together with the holder or its affiliates, would beneficially own greater than 9.99% (the “Maximum Percentage”) of the total number of ordinary shares outstanding immediately following the exercise of such Warrant; provided that the holder of a Warrant may increase the Maximum Percentage to 14.99% upon 61 days’ written notice. As a result of such limitation, 741,009 of the ordinary shares underlying the Warrant held by FCF VI may not be exercised as of the date hereof and have been excluded from “Number of Ordinary Shares Owned Prior to this Offering.” Foresite Capital Management VI, LLC (“FCM VI”) is the general partner of FCF VI. FCF VI may be deemed to have sole voting and dispositive power over the securities owned by FCF VI. James Tananbaum is the sole managing member of FCM VI and may be deemed to have sole voting and dispositive power over these securities. Each of FCM VI and Dr. Tananbaum disclaim beneficial ownership of securities beneficially owned by the selling shareholder, except to the extent of such person’s pecuniary interests in such securities. The business address of each of FCF VI, FCM VI and Dr. Tananbaum is c/o Foresite Capital Management, 900 Larkspur Landing Circle, Suite 150, Larkspur, CA 94939.

(6)

Consists of (i) 200,000 Offered Shares owned by Panacea Venture Healthcare Fund II, L.P. and (ii) 1,118,429 ordinary shares owned by Panacea Venture Healthcare Fund II, L.P. not offered hereunder. James Huang is the sole owner of Panacea Innovation Limited, which is the sole owner of Panacea Venture Healthcare Fund II GP Company, Ltd., which is the general partner of Panacea Venture Healthcare Fund II, L.P. As a result, Mr. Huang and the foregoing entities may be deemed to share beneficial ownership of the Ordinary Shares held of record by Panacea Venture Healthcare Fund II, L.P. The business address of Panacea Venture Healthcare Fund II, L.P. is c/o Maples Corporate Services Limited, Ugland House, Grand Cayman KY1-1104, Cayman Islands.

(7)

Consists of (i) 1,910,550 ordinary shares held by Dr. Wei-Wu He, (ii) 44,107 ordinary shares directly held by Emerging Technology Partners, LLC, (iii) 753,234 ordinary shares beneficially held by ETP Global Fund. L.P., (iv) 300,000 ordinary shares beneficially held by ETP BioHealth III Fund, L.P., (v) 50,000 ordinary shares beneficially owned by Huiying Memorial Foundation, (vi) 100,000 ordinary shares owned by HE Family GRAT, and (vii) 100,000 ordinary shares issuable upon exercise of options which are exercisable within 60 days as of the date hereof. Emerging Technology Partners, LLC (“ETP”), a Delaware limited liability company, is the general partner of ETP Global Fund L.P. (“ETP Global”), a Delaware limited partnership. ETP also is the general partner of ETP BioHealth III Fund, L.P., a Delaware limited partnership. Dr. Wei-Wu He is founder and managing partner of each of ETP and ETP Global. Huiying Memorial Foundation is a 501(c)(3) private family foundation incorporated in the District of Columbia and Dr. Wei-Wu He is a member of the board of trustees and an officer of the Huiying Memorial Foundation. Dr. Wei-Wu He does not participate in the investment decisions of the Foundation with respect to the Company’s ordinary shares and disclaims beneficial ownership of the Company’s ordinary shares held by Huiying Memorial Foundation. HE Family GRAT is a grantor retained annuity trust organized under the law of Nevada for the benefit of Dr. Wei-Wu He’s family members, and Dr. Wei-Wu He is the trustee of HE Family GRAT. The business address of HE Family GRAT is 100 W. Liberty St. STE. 100, Reno, NV, 89501-1927, and the business address of Dr. Wei-Wu He is 1701-1702, China Central Office Tower 1, No. 81 Jianguo Road Chaoyang District, Beijing, 100025, People’s Republic of China.

PLAN OF DISTRIBUTION

We are registering our Offered Shares issued to permit the resale of these Offered Shares by the selling shareholders from time to time after the date of this prospectus. As used in this section, the term “selling shareholders” includes donees, pledgees, transferees or other successors-in-interest selling ordinary shares or interests in ordinary shares received after the date of this prospectus from a registered selling shareholder as a gift, pledge, partnership, limited liability company or other entity distribution or other transfer, and may, or may not, elect to sell or transfer their ordinary shares or interests in such shares covered by this prospectus, as and to the extent they may determine. We will not receive any of the proceeds from the sale by the selling shareholders of these Offered Shares. We will bear all fees and expenses incident to our obligation to register these shares Offered Shares.

The selling shareholders may sell all or a portion of the Offered Shares held by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. If the Offered Shares are sold through underwriters or broker-dealers, the selling shareholders will be responsible for underwriting discounts or commissions or agent’s commissions. The Offered Shares may be sold in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions, pursuant to one or more of the following methods:

on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;

in the over-the-counter market;

in transactions otherwise than on these exchanges or systems or in the over-the-counter market;

through the writing or settlement of options, whether such options are listed on an options exchange or otherwise;

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;

purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

an exchange distribution in accordance with the rules of the applicable exchange;

privately negotiated transactions;

short sales made after the date this registration statement is declared effective by the SEC;

broker-dealers may agree with a selling security holder to sell a specified number of such shares at a stipulated price per share;

a combination of any such methods of sale; and

any other method permitted pursuant to applicable law.

In addition, a selling shareholder that is an entity may elect to make an in-kind distribution of securities to its members, partners or stockholders pursuant to the registration statement of which this prospectus is a part by delivering a prospectus with a plan of distribution. Such members, partners or stockholders would thereby receive freely tradeable securities pursuant to the distribution through a registration statement. To the extent a distributee is an affiliate of ours (or to the extent otherwise required by law), we may file a prospectus supplement in order to permit the distributees to use the prospectus to resell the securities acquired in the distribution.

The selling shareholders may also sell Offered Shares under Rule 144 promulgated under the Securities Act, if available, rather than under this prospectus. In addition, the selling shareholders may transfer the Offered Shares by other means not described in this prospectus. If the selling shareholders effect such transactions by selling Offered Shares to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling shareholders or commissions from purchasers of the Offered Shares for whom they may act as agent or to whom they may sell as principal (which discounts, concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types of transactions involved). In connection with sales of the Offered Shares or otherwise, the selling shareholders may enter into hedging transactions with broker-dealers, which may in turn engage in short sales of the Offered Shares in the course of hedging in positions they assume. The selling shareholders may also sell Offered Shares short and deliver Offered Shares covered by this prospectus to close out short positions and to return borrowed shares in connection with such short sales. The selling shareholders may also loan or pledge Offered Shares to broker-dealers that in turn may sell such shares.

The selling shareholders may pledge or grant a security interest in some or all of the Offered Shares owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the Offered Shares from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending, if necessary, the list of selling shareholders to include the pledgee, transferee or other successors in interest as selling shareholders under this prospectus. The selling shareholders also may transfer and donate the Offered Shares in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

To the extent required by the Securities Act and the rules and regulations thereunder, the selling shareholders and any broker-dealer participating in the distribution of the Offered Shares may be deemed to be “underwriters” within the meaning of the Securities Act, and any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be deemed to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the Offered Shares is made, a prospectus supplement, if required, will be distributed, which will set forth the aggregate amount of Offered Shares being offered and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constituting compensation from the selling shareholders and any discounts, commissions or concessions allowed or re-allowed or paid to broker-dealers.

Under the securities laws of some states, the Offered Shares may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the Offered Shares may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.

There can be no assurance that any selling shareholder will sell any or all of the Offered Shares registered pursuant to the registration statement, of which this prospectus forms a part.

The selling shareholders and any other person participating in such distribution will be subject to applicable provisions of the Exchange Act, and the rules and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of the Offered Shares by the selling shareholders and any other participating person. To the extent applicable, Regulation M may also restrict the ability of any person engaged in the distribution of the Offered Shares to engage in market-making activities with respect to the Offered Shares. All of the foregoing may affect the marketability of the Offered Shares and the ability of any person or entity to engage in market-making activities with respect to the Offered Shares.

We will pay all expenses of the registration of the Offered Shares, including, without limitation, SEC filing fees and expenses of compliance with state securities or “blue sky” laws; provided, however, a selling shareholder will pay all underwriting discounts and selling commissions, if any. We will indemnify the selling shareholders against liabilities, including some liabilities under the Securities Act. We may be indemnified by the selling shareholders against civil liabilities, including liabilities under the Securities Act that may arise from any written information furnished to us by the selling shareholders specifically for use in this prospectus.

Once sold under the registration statement, of which this prospectus forms a part, the Offered Shares will be freely tradable in the hands of persons other than our affiliates.

TAXATION

Information regarding taxation is set forth under the heading “Item 10.E. Taxation” in our 2023 Annual Report, which is incorporated in this prospectus by reference, as updated by our subsequent filings under the Exchange Act.

LEGAL MATTERS

We are being represented by Skadden, Arps, Slate, Meagher & Flom LLP with respect to legal matters of United States federal securities and New York State law. The validity of the ordinary shares in this offering and legal matters as to Cayman Islands law will be passed on for us by Maples and Calder (Hong Kong) LLP. Skadden, Arps, Slate, Meagher & Flom LLP may rely upon Maples and Calder (Hong Kong) LLP with respect to matters governed by Cayman Islands law.

EXPERTS

The consolidated financial statements of CASI Pharmaceuticals, Inc. as of December 31, 2023 and 2022, and for each of the years in the three-year period ended December 31, 2023, have been incorporated by reference herein in reliance upon the report of KPMG Huazhen LLP, independent registered public accounting firm, incorporated by reference herein, and upon the authority of said firm as experts in accounting and auditing.

Expenses of Issuance and Distribution

The following is a statement of the expenses to be incurred by us in connection with the registration of the securities under this registration statement, all of which will be borne by us. All amounts shown are estimates except for the SEC registration fee.

SEC registration fee	$	2,850
Legal fees and expenses		180,000
Accounting fees and expenses		28,000
Miscellaneous		1,000
Total	$	211,850

INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE

The SEC allows us to “incorporate by reference” the information we file with them into this prospectus. This means that we can disclose important information about us and our financial condition to you by referring you to another document filed separately with the SEC instead of having to repeat the information in this prospectus. The information incorporated by reference is considered to be part of this prospectus and later information that we file with the SEC will automatically update and supersede this information. We incorporate by reference the documents listed below and any future filings made with the SEC under the Exchange Act, except for information “furnished” to the SEC which is not deemed filed and not incorporated in this prospectus, after the date hereof but before the completion or termination of this offering:

	·	the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, filed with the SEC on March 28, 2024;
	·	the Company’s Reports on Form 6-K furnished to the SEC on April 8, 2024, May 15, 2024, June 27, 2024, July 8, 2024, July 19, 2024 and August 16, 2024; and
	·	the description of the Company’s ordinary shares contained in the Company’s Registration Statement on Form 8A-12B (File No. 001-41666) filed with the SEC on March 27, 2023, pursuant to Section 12(b) of the Exchange Act, including any amendment or report filed for the purpose of updating such description.

We also incorporate by reference any future annual reports on Form 20-F we file with the SEC under the Exchange Act after the date of this prospectus and prior to the termination of the offering of securities by means of this prospectus, and any future reports of foreign private issuer on Form 6-K we furnish to the SEC during such period that are identified in such reports as being incorporated by reference in this prospectus.

Any statement contained in a document that we incorporate by reference herein will be modified or superseded for all purposes to the extent that a statement contained in this prospectus (or in any other document that is subsequently filed with the SEC and incorporated by reference herein prior to the termination of this offering) modifies or is contrary to that previous statement. Any statement so modified or superseded will not be deemed a part of this prospectus except as so modified or superseded.

We will provide to each person, including any beneficial owner, to whom a prospectus is delivered, without charge upon written or oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus but not delivered with the prospectus, including exhibits that are specifically incorporated by reference into such documents. You may request a copy of such documents at no cost, by writing or telephoning us at the following address or telephone number:

CASI Pharmaceuticals, Inc.

9620 Medical Center Drive, Suite 300

Rockville, MD 20850

240-864-2600

WHERE YOU CAN GET MORE INFORMATION

We have filed with the SEC a registration statement on Form F-3 under the Securities Act with respect to the securities described in this prospectus and any accompanying prospectus supplement, as applicable. This prospectus and any accompanying prospectus supplement, which constitute a part of that registration statement, do not contain all of the information set forth in that registration statement and its exhibits. For further information with respect to us and our securities, you should consult the registration statement and its exhibits.

We are subject to the informational requirements of the Exchange Act, and, in accordance with the Exchange Act, we also must file reports with, and furnish other information to, the SEC. As a foreign private issuer, we are exempt from the rules under the Exchange Act prescribing the furnishing and content of proxy statements, and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required to publish financial statements as promptly as U.S. companies. However, we file with the SEC an annual report on Form 20-F containing financial statements audited by an independent registered public accounting firm, and we submit to the SEC, on Form 6-K, unaudited quarterly financial information.

The SEC maintains an internet site (www.sec.gov) that makes available reports and other information that we file or furnish electronically with it.

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 8. Indemnification of Directors and Officers.

The laws of the Cayman Islands do not limit the extent to which a company’s memorandum and articles of association may provide for indemnification of officers and directors, except to the extent any such provision may be held by the Cayman Islands courts to be contrary to public policy, such as to provide indemnification against willful default, willful neglect, civil fraud or the consequences of committing a crime.

CASI’s Articles of Association provides that every director (including alternate director), secretary, assistant secretary, or other officer for the time being and from time to time of CASI (but not including CASI’s auditors) and the personal representatives of the same (each an “Indemnified Person”) shall be indemnified and secured harmless against all actions, proceedings, costs, charges, expenses, losses, damages or liabilities incurred or sustained by such Indemnified Person, other than by reason of such Indemnified Person’s own dishonesty, willful default or fraud, in or about the conduct of CASI’s business or affairs (including as a result of any mistake of judgment) or in the execution or discharge of his duties, powers, authorities or discretions, including without prejudice to the generality of the foregoing, any costs, expenses, losses or liabilities incurred by such Indemnified Person in defending (whether successfully or otherwise) any civil proceedings concerning CASI or its affairs in any court whether in the Cayman Islands or elsewhere.

CASI also entered into indemnification agreements with its directors and officers under the laws of the Cayman Islands, pursuant to which we have agreed to indemnify each such person and hold him harmless against expenses, judgments, fines and amounts payable under settlement agreements in connection with any threatened, pending or completed action, suit or proceeding to which he or she has been made a party or in which he became involved by reason of the fact that he or she is or was our director or officer. Except with respect to expenses to be reimbursed by CASI in the event that the indemnified person has been successful on the merits or otherwise in defense of the action, suit or proceeding, CASI’s obligations under the indemnification agreements are subject to certain customary restrictions and exceptions.

In addition, CASI maintains standard policies of insurance under which coverage is provided to its directors and officers against loss rising from claims made by reason of breach of duty or other wrongful act, and to CASI with respect to payments which may be made by CASI to such directors and officers pursuant to the above indemnification provision or otherwise as a matter of law.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling CASI pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is theretofore unenforceable.

Item 9. Exhibits

The exhibits to this registration statement are listed in the Index to Exhibits below.

Item 10. Undertakings.

(a)       The undersigned registrant hereby undertakes:

(1)

To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement;

(i)

To include any prospectus required by Section 10(a)(3) of the Securities Act;

(ii)

To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

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(iii)

To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;

provided, however, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports filed with or furnished to the SEC by the registrant pursuant to section 13 or section 15(d) of the Exchange Act that are incorporated by reference in the registration statement or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

(2)

That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(3)

To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4)

To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Securities Act need not be furnished, provided that the registrant includes in the prospectus, by means of a post-effective amendment, financial statements required pursuant to this paragraph (a) (4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements. Notwithstanding the foregoing, a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Securities Act or Item 8.A of Form 20-F if such financial statements and information are contained in periodic reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference in this registration statement.

(5)

That, for the purpose of determining liability under the Securities Act to any purchaser:

(i)

Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

(ii)

Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof; provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

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(6)

That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

(i)

Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

(ii)

Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

(iii)

The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

(iv)

Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

(b)

The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(c)

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act, as amended, and will be governed by the final adjudication of such issue.

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INDEX TO EXHIBITS

Exhibit Number		Title

3.1		Updated Amended and Restated Memorandum and Articles of Association of the Registrant (incorporated by reference to Exhibit 1.1 to the Annual Report on Form 20-F (File No. 001-41666), filed with the SEC on March 28, 2024).
4.1		Registrant’s Updated Specimen Ordinary Share Certificate (incorporated by reference to Exhibit 2.1 to the Annual Report on Form 20-F (File No. 001-41666), filed with the SEC on March 28, 2024).
4.2*		Subscription and Purchase Agreement between and between the Registrant, Venrock Healthcare Capital Partners EG, L.P., Venrock Healthcare Capital Partners III, L.P. and VHCP Co-Investment Holdings III, LLC, dated June 26, 2024, including Warrants issued thereunder.
4.3*		Subscription and Purchase Agreement between and between the Registrant and Foresite Capital Fund VI LP, dated June 26, 2024, including Warrant issued thereunder.
4.4*		Subscription and Purchase Agreement between and between the Registrant and PANACEA VENTURE HEALTHCARE FUND II, L.P., dated June 26, 2024
4.5*		Subscription and Purchase Agreement between and between the Registrant, Dr. Wei-Wu He and P HE Family GRAT, dated June 26, 2024
5.1*		Opinion of Maples and Calder (Hong Kong) LLP
23.1*		Consent of KPMG Huazhen LLP
23.2*		Consent of Maples and Calder (Hong Kong) LLP (included in Exhibit 5.1)
24.1*		Power of Attorney (contained on the signature page to this registration statement)
107		Filing Fee Table

*	Filed herewith

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the city of Beijing, the Peoples Republic of China, on August 16, 2024.

	CASI Pharmaceuticals, Inc.

By:	/s/ Wei-Wu He
	Name:	Dr. Wei-Wu He
	Title:	Chief Executive Officer and Chairman of the Board of Directors

Power of Attorney

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Dr. Wei-Wu He, acting alone, as his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for such person and in his or her name, place and stead in any and all capacities, in connection with this registration statement, including to sign in the name and on behalf of the undersigned, this registration statement and any and all amendments thereto, including post-effective amendments and registrations filed pursuant to Rule 462 under the Securities Act of 1933, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto such attorneys-in-fact and agents, each acting alone, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or her substitute, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated:

Signature	Title	Date

/s/ Dr. Wei-Wu He	Chief Executive Officer and Director (Principal Executive Officer)	August 16, 2024
Dr. Wei-Wu He		August 16, 2024

/s/ Dan Lang	Chief Financial Officer (Principal Financial Officer)	August 16, 2024
Dan Lang	Chief Financial Officer (Principal Financial Officer)

/s/ Y. Alexander Wu	Independent Director	August 16, 2024
Y. Alexander Wu	Independent Director

/s/ Zhenbo Su	Independent Director	August 16, 2024
Zhenbo Su	Independent Director

/s/ Thomas Folinsbee	Independent Director	August 16, 2024
Thomas Folinsbee	Independent Director

/s/ Xuebo Zeng	Independent Director	August 16, 2024
Xuebo Zeng	Independent Director

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SIGNATURE OF AUTHORIZED UNITED STATES REPRESENTATIVE

Pursuant to the requirement of the Securities Act, the undersigned, the duly undersigned representative in the United States of CASI Pharmaceuticals, Inc., has signed this registration statement in the United States, on August 16, 2024.


CASI Pharmaceuticals, Inc.

By:	/s/ Rui Zhang
	Name: Rui Zhang
	Title: Authorized Officer

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Exhibit 4.2

Execution Version

SUBSCRIPTION AND PURCHASE AGREEMENT

This Subscription and Purchase Agreement (this “Agreement”) is made as of June 26, 2024 by and between:

(1)

CASI Pharmaceuticals, Inc., an exempted company incorporated in the Cayman Islands with address of principal business office at 1701-1702, China Central Office Tower 1, No. 81 Jianguo Road Chaoyang District, Beijing, 100025, People’s Republic of China (the “Company”); and

(2)

Venrock Healthcare Capital Partners EG, L.P., a DE limited partnership with address of principal business office at 7 Bryant Park, 23rd Floor, New York, NY 10018.

(3)

Venrock Healthcare Capital Partners III, L.P., a DE limited partnership with address of principal business office at 7 Bryant Park, 23rd Floor, New York, NY 10018.

(4)

VHCP Co-Investment Holdings III, LLC, a DE limited liability company with address of principal business office at 7 Bryant Park, 23rd Floor, New York, NY 10018. (each person under (2), (3) and (4), a “Purchaser”).

The Company, on the one hand, and each Purchaser, on the other hand, are hereinafter each referred to as a “Party” and collectively as the “Parties”.

W I T N E S S E T H:

WHEREAS, upon the terms and subject to the conditions of this Agreement, the Company desires to issue and sell to each Purchaser, and each Purchaser wishes to purchase from the Company, ordinary shares of the Company, par value US$0.0001 per share (“Ordinary Shares”) and a warrant that is exercisable for a certain number of Ordinary Shares in a private placement exempt from securities registration afforded by Section 4(a)(2) under the U.S. Securities Act of 1933, as amended (the “Securities Act”);

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises hereinafter set forth, the Parties hereto agree as follows:

Article I

PURCHASE AND SALE

Section 1.1      Issuance, Sale and Purchase of Ordinary Shares and the Warrant. Upon the terms and subject to the conditions of this Agreement, each Purchaser hereby agrees to purchase from the Company, and the Company hereby agrees to issue, sell and deliver to each Purchaser, at the Closing (as defined below), (i) that number of Ordinary Shares and (ii) a pre-funded warrant (in the form of Exhibit A attached hereto) that is exercisable for that number of Ordinary Shares (the “Warrant”), in each case, for the amount of consideration set forth opposite such Purchaser’s name on Schedule I hereto (the “Purchase Price”), free and clear of all liens or encumbrances (except for restrictions arising under the Securities Act or created by virtue of this Agreement). The Ordinary Shares issued to the Purchasers pursuant to this Agreement at the Closing pursuant to Schedule I shall be referred to herein as the “Purchased Ordinary Shares”, and the Ordinary Shares to be issued to the Purchaser upon the exercise of the Warrant pursuant the Warrant shall be referred to herein as the “Warrant Shares”, and together with Purchased Ordinary Shares, the “Purchased Shares”.

Section 1.2      Closing.

(a)            Closing. The closing (the “Closing”) of the sale and purchase of the Purchased Ordinary Shares and the Warrant pursuant to Section 1.1 shall take place remotely via the electronic exchange of the closing documents and signatures on the third Business Day following the satisfaction or, to the extent permitted by applicable Law, waiver of the conditions precedent specified in Section 1.3 or such other time as the Parties may mutually agree upon. The date and time of the Closing are referred to herein as the “Closing Date”.

(b)           Payment and Delivery. At the Closing, each Purchaser shall pay and deliver the Purchase Price to the Company in U.S. dollars by wire transfer, or by such other method mutually agreeable to the Parties, of immediately available funds to such bank account(s) designated in writing by the Company, and the Company shall have the Purchased Ordinary Shares issued and registered in the name of such Purchaser or in such nominee name as it may designate and shall deliver to such Purchaser (i) a copy of duly executed share certificate(s) registered in the name of such Purchaser (the original copies of which shall be delivered to such Purchaser as soon as commercially practicable following the Closing), together with a certified true copy of the relevant extract of the register of members of the Company, evidencing the Purchased Ordinary Shares being issued and sold to such Purchaser, and (ii) a PDF copy of duly executed Warrant registered in the name of the Purchaser (the original copies of which shall be delivered to such Purchaser as soon as commercially practicable following the Closing).

(c)            Restrictive Legend and Transfer Restrictions. Each certificate representing the Purchased Shares shall be endorsed with the following legend:

THIS SECURITY HAS BEEN ACQUIRED FOR INVESTMENT AND WITHOUT A VIEW TO DISTRIBUTION AND HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE “ACT”), OR UNDER STATE SECURITIES LAWS. NO TRANSFER, SALE, ASSIGNMENT, PLEDGE, HYPOTHECATION OR OTHER DISPOSITION OF THIS SECURITY OR ANY INTEREST OR PARTICIPATION THEREIN MAY BE MADE EXCEPT (A) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR (B) PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS AND, IN THE CASE OF CLAUSE (B), UNLESS THE ISSUER RECEIVES AN OPINION OF COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER TO THE EFFECT THAT REGISTRATION IS NOT REQUIRED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS. IN ADDITION, ANY SUCH TRANSFER OR OTHER DISPOSITION IS SUBJECT TO THE CONDITIONS CONTAINED IN A PURCHASE AGREEMENT, DATED JUNE 26, 2024. A COPY OF SUCH CONDITIONS WILL BE PROVIDED TO THE HOLDER HEREOF UPON REQUEST. ANY ATTEMPT TO TRANSFER, SELL, PLEDGE OR HYPOTHECATE THIS SECURITY IN VIOLATION OF THESE RESTRICTIONS SHALL BE VOID.

Unless made pursuant to an effective registration statement under the Securities Act or pursuant to Rule 144 thereunder, any transferee of the Purchased Shares, the Warrants or any interest therein, by its acceptance thereof, shall be deemed to have made the representations set forth in Section 2.2 of this Agreement. Unless made pursuant to an effective registration statement under the Securities Act or pursuant to Rule 144 thereunder, the Company shall not be required to register the transfer of any Purchased Shares or Warrant to any person unless the Company receives from the proposed transferee a written instrument in form and substance reasonably satisfactory to the Company in which such transferee makes the representations and warranties set forth in Section 2.2 of this Agreement and, if the Company so requests, an opinion of counsel in form and substance reasonably satisfactory to the Company to the effect that registration under the Securities Act is not required in connection with such transfer.

Section 1.3      Closing Conditions.

(a)            Conditions to the Purchaser’s Obligations to Effect the Closing. The obligation of each Purchaser to purchase and pay for the Purchased Ordinary Shares and the Warrant as contemplated by this Agreement is subject to the satisfaction, on or before the Closing Date of the following conditions, any of which may only be waived in writing by such Purchaser in its sole discretion:

(i)            All corporate and other actions required to be taken by the Company in connection with the issuance and sale of the Purchased Ordinary Shares and the Warrant hereunder and any other transactions contemplated under this Agreement and all the agreements and other documents required in connection with implementing the transactions contemplated hereby (together, the “Transaction Documents”) shall have been completed.

(ii)           The representations and warranties of the Company contained in Section 2.1 of this Agreement shall have been true and correct in all material respects (or if qualified by materiality or a Material Adverse Effect, true and correct in all respects) on the date of this Agreement and on and as of the Closing Date; and the Company shall have performed and complied in all material respects with all, and not be in breach or default in any material respects under any, agreements, covenants, conditions and obligations contained in this Agreement or any other Transaction Document that are required to be performed or complied with on or before the Closing Date.

(iii)          No governmental authority of competent jurisdiction shall have enacted, issued, promulgated, enforced or entered any law (whether temporary, preliminary or permanent) that is in effect and restrains, enjoins, prevents, prohibits or otherwise makes illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company; and no action, suit, proceeding or investigation shall have been instituted by a governmental authority of competent jurisdiction or threatened that seeks to restrain, enjoin, prevent, prohibit or otherwise make illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company.

(iv)          Since the date hereof, no event or series of events shall have occurred that has had or would reasonably be expected to have a Material Adverse Effect.

(v)           The listing and trading of the Ordinary Shares on the Nasdaq Capital Market shall not have been suspended, by the SEC or the Nasdaq Capital Market from trading thereon, nor shall any suspension by the SEC or the Nasdaq Capital Market have been threatened, either (A) in writing by the SEC or the Nasdaq Capital Market or (B) by falling below the minimum listing maintenance requirements of the Nasdaq Capital Market (with a reasonable prospect of delisting occurring after giving effect to all applicable notice, appeal, compliance and hearing periods); and the Company shall have submitted with The Nasdaq Stock Market, LLC a Notification Form: Listing of Additional Shares for the listing of the Purchased Ordinary Shares and the Warrant Shares.

(vi)          The Company shall have delivered to the Purchaser and the Placement Agent the opinion of Skadden Arps, Slate, Meagher & Flom LLP, dated as of the Closing Date, which such opinion shall include a valid private placement opinion, in customary form and substance to be reasonably agreed upon with the Purchaser and the Placement Agent and addressing such legal matters as the Purchaser, the Placement Agent and the Company reasonably agree.

(vii)         An authorized officer of the Company shall have delivered to the Purchaser at the Closing Date a certificate certifying that the conditions specified in Sections 1.3(a)(i), (ii), (iii), (iv) and (v) of this Agreement have been fulfilled.

(b)            Conditions to the Company’s Obligations to Effect the Closing. The obligation of the Company to issue, sell and deliver the Purchased Ordinary Shares and the Warrant to each Purchaser as contemplated by this Agreement is subject to the satisfaction, on or before the Closing Date of each of the following conditions, any of which may only be waived in writing by the Company in its sole discretion:

(i)            All corporate and other actions, as applicable, required to be taken by such Purchaser in connection with the purchase of the Purchased Ordinary Shares and the Warrant hereunder and any other transactions contemplated under the Transaction Documents shall have been completed.

(ii)           The representations and warranties of such Purchaser contained in Section 2.2 of this Agreement shall have been true and correct in all material respects (or if qualified by materiality or a Material Adverse Effect, true and correct in all respects) on the date of this Agreement and on and as of the Closing Date; and such Purchaser shall have performed and complied in all material respects with all, and not be in breach or default in any material respect under any, agreements, covenants, conditions and obligations contained in this Agreement or any other Transaction Document that are required to be performed or complied with on or before the Closing Date.

Article II

REPRESENTATIONS AND WARRANTIES

Section 2.1      Representations and Warranties of the Company. The Company hereby represents and warrants to each Purchaser and Jefferies LLC (the “Placement Agent”), whom the Company has engaged as its exclusive placement agent in connection with the private placement of the Ordinary Shares and the Warrant, as of the date hereof and as of the Closing Date as follows:

(a)            Due Formation. The Company is a company duly incorporated as an exempted company with limited liability, validly existing and in good standing under the laws of the Cayman Islands. The Company has all requisite power and authority to carry on its business as it is currently being conducted.

(b)           Authority. The Company has full power and authority to enter into, execute and deliver this Agreement and other Transaction Documents and each agreement, certificate, document and instrument to be executed and delivered by the Company pursuant to this Agreement and other Transaction Documents and to perform its obligations hereunder and thereunder. The execution and delivery by the Company of this Agreement and other Transaction Documents and the performance by the Company of its obligations hereunder and thereunder have been duly authorized by all requisite actions on its part.

(c)            Valid Agreement. The Transaction Documents have all been duly executed and delivered by the Company and, assuming the due and valid execution and delivery hereof by the Purchasers, constitute the legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by the availability of specific performance, injunctive relief, or other equitable remedies.

(d)           Capitalization.

(i)            The authorized share capital of the Company is US$50,000 divided into 500,000,000 shares of a par value of US$0.0001 each. All outstanding Ordinary Shares of the Company and all outstanding shares of each of the Company’s subsidiaries and consolidated Affiliates (each a “Subsidiary” and collectively “Subsidiaries”) have been issued and granted in compliance with (x) all applicable Securities Laws and other applicable laws, and (y) all requirements set forth in applicable plans or contracts, without violation of any preemptive rights, rights of first refusal or other similar rights. “Securities Laws” means the Securities Act, the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the listing rules of, or any listing agreement with, the Nasdaq Capital Market (“NASDAQ”) and any other applicable law regulating securities or takeover matters.

(ii)           The rights of the Ordinary Shares to be issued to each Purchaser as Purchased Shares shall be as stated in the Amended and Restated Memorandum and Articles of Association of the Company.

(e)            Due Issuance of the Purchased Shares. The Purchased Shares have been duly authorized and, when issued and delivered to and paid for by each Purchaser pursuant to this Agreement, will be validly issued, fully paid and non-assessable and free and clear of any pledge, mortgage, security interest, encumbrance, lien, charge, assessment, right of first refusal, right of pre-emption, third party right or interest, claim or restriction of any kind or nature, except for restrictions arising under the Securities Act or created by virtue of this Agreement, and upon delivery and entry into the register of members of the Company will transfer to such Purchaser good and valid title to the Purchased Shares.

(f)            Noncontravention. Neither the execution and the delivery of this Agreement or any other Transaction Document, nor the consummation of the transactions contemplated hereby and thereby, will (i) violate any provision of the organizational documents of the Company or its Subsidiaries or violate any constitution, statute, regulation, rule, injunction, judgment, order, decree, ruling, charge, or other restriction of any government, governmental entity or court to which the Company or its Subsidiaries is subject, or (ii) except in each case as do not and would not have a Material Adverse Effect, conflict with, result in a breach of, constitute a default under, result in the acceleration of or creation of an encumbrance under, or create in any party the right to accelerate, terminate, modify, or cancel, any agreement, contract, lease, license, instrument, or other arrangement to which the Company or its Subsidiaries is a party or by which the Company or its Subsidiaries is bound or to which any of the Company’s or its Subsidiaries’ assets are subject. There is no action, suit or proceeding, pending or threatened against the Company or its Subsidiaries that questions the validity of this Agreement or any other Transaction Document or the right of the Company to enter into this Agreement or any other Transaction Document or to consummate the transactions contemplated hereby, and is reasonably expected to be determined adversely against the Company or its Subsidiaries, and if so determined, would have a Material Adverse Effect. As used herein, “Material Adverse Effect” shall mean any event, fact, circumstance or occurrence that, individually or in the aggregate with any other events, facts, circumstances or occurrences, results in or would reasonably be expected to result in a material adverse change in or a material adverse effect on any of (A) the financial condition, assets, liabilities, results of operations, business, or operations of the Company and its Subsidiaries taken as a whole, except to the extent that any such Material Adverse Effect results from (x) the public disclosure of the transactions contemplated under the Transaction Documents in accordance with the terms of such documents, (y) changes in generally accepted accounting principles that are generally applicable to comparable companies, or (z) changes in general economic and market conditions; or (B) the ability of the Company to consummate the transactions contemplated by the Transaction Documents and to timely perform its material obligations under the Transaction Documents.

(g)            Consents and Approvals. Assuming the accuracy of the representations and warranties of the Purchasers under this Agreement and other Transaction Documents, neither the execution and delivery by the Company of this Agreement or any other Transaction Document, nor the consummation by the Company of any of the transactions contemplated hereby and thereby, nor the performance by the Company of this Agreement or any other Transaction Document in accordance with its terms requires the consent, approval, order or authorization of, or registration with, or the giving notice to, any governmental or public body or authority or any third party, other than such as have been or will have been obtained, made or given on or prior to the Closing Date, except for (x) any required filing or notifications regarding the issuance or listing of additional securities with NASDAQ or other regulatory authorities, or (y) such consent, authorization, order, filing or registration which, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Effect.

(h)           SEC Documents. Since January 1, 2023, the Company has timely filed or furnished (including following any extensions of time for filing provided by Rule 12b-25 promulgated under the Exchange Act), as applicable, all reports, schedules, forms, statements and other documents required to be filed or furnished by it with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the Securities Act or the Exchange Act and the rules and regulations promulgated thereunder (all of the foregoing documents filed with or furnished to the SEC and all exhibits included therein and financial statements, notes and schedules thereto and documents incorporated by reference therein being hereinafter referred to as the “SEC Documents”). Each of SEC Documents complied in all material respects with the requirements of the Securities Laws and the rules and regulations of the SEC promulgated thereunder. Since January 1, 2023, none of the SEC Documents, at the time they were filed or furnished, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. As of the date of this Agreement, the Company’s Ordinary Shares are listed on Nasdaq, and the Company has not received any notification that the Commission or Nasdaq is contemplating suspending or terminating such listings (or the applicable registration under the Exchange Act related thereto).

(i)            Foreign Private Issuer. The Company is a “foreign private issuer,” within the meaning of Rule 3b-4 under the Exchange Act. The Company has taken all actions required pursuant to Nasdaq Rule 5615(a)(3) to duly and validly rely on the exemption for foreign private issuers from applicable rules and regulations of the Nasdaq by adopting the home country practice as disclosed in the SEC Documents.

(j)            Legal Proceeding. Except as disclosed in the Company’s SEC Documents, there are no actions by or against the Company or its Subsidiaries or affecting the business or any of the assets of the Company or its Subsidiaries pending before any governmental authority, or, to the Company’s knowledge, threatened to be brought by or before any governmental authority, that would have a Material Adverse Effect.

(k)            Financial Statements. Except as disclosed in the SEC Documents, the financial statements (including any related notes) contained in the SEC Documents (collectively, the “Financial Statements”): (A) were prepared in accordance with U.S. GAAP applied on a consistent basis throughout the periods covered thereby (except (a) as may be otherwise indicated in such Financial Statements or the notes thereto, or (b) in the case of unaudited interim statements, to the extent they may exclude footnotes or may be condensed to summary statements) and (B) fairly present in all material respects the consolidated financial position of the Company and the Subsidiaries as of the respective dates thereof and the consolidated results of operations and cash flows of the Company and the Subsidiaries for the periods covered thereby, in each case except as disclosed therein or in the SEC Documents and as permitted under the Exchange Act.

(l)             Intellectual Property. In each case except as otherwise disclosed in the SEC Documents, (1) the Company and each of its Subsidiaries owns or has obtained valid and enforceable licenses for the inventions, patents, patent applications, trademarks, trade names, service names, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information) and other intellectual property described in the SEC Documents as being owned or licensed by it or which are necessary for the conduct of its business as currently conducted or as currently proposed to be conducted (with respect to the development and commercialization of the product candidates described in the SEC Documents, except where the failure to own or license such rights would not, individually or in the aggregate, have a Material Adverse Effect) (collectively, “Intellectual Property”), and to the Company’s knowledge the conduct of its business does not infringe, misappropriate, or otherwise conflict in any material respect with any such rights of others; (2) the Intellectual Property of the Company is subsisting, free and clear of all material liens, and has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part and the Company has no knowledge of any facts which would form a reasonable basis for any such adjudication except where such adjudication or material liens would not, individually or in the aggregate, have a Material Adverse Effect; (3) to the Company’s knowledge, there are no third parties who have rights to any Intellectual Property, except for any customary reversionary rights of third-party licensors with respect to Intellectual Property that is disclosed in the SEC Documents as licensed to the Company or a Subsidiary; and, to the Company’s knowledge, there is no infringement by third parties of any Intellectual Property; and (4) the Company and each Subsidiary has complied in all material respects with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or a Subsidiary, and all such agreements are in full force and effect except as would not have a Material Adverse Effect. The Company and each Subsidiary has taken commercially reasonable steps to protect, maintain, and safeguard its Intellectual Property, including the execution of appropriate nondisclosure, confidentiality agreements, and invention assignment agreements and invention assignments with its employees or consultants, and, to the Company’s knowledge, no employee of the Company or consultant is in or has been in violation of any material term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement, or any restrictive covenant to or with a former employer where the basis of such violation relates to Intellectual Property except as would not have a Material Adverse Effect.

(m)           Regulatory Matters. Except as disclosed in the SEC Documents: (1) All material franchises, permits, licenses, consents and other permissions, authorizations, orders, filings, registrations, notifications, certificates, clearances, qualifications and approvals (“Permits”), for carrying on the business of the Company described in the SEC Documents, including all Permits required therefor by any applicable Regulatory Agency, have been obtained and are in full force and effect, except as would not have a Material Adverse Effect. The Company has not been notified in writing that any such Permits will be revoked or is incapable of renewal, except for any approvals required from the applicable Regulatory Agencies for the clinical development or marketing of any of the Company’s product candidates that has not yet been initiated or where the failure to obtain any such Permit would not have a Material Adverse Effect. (2) As to each drug product candidate subject to the jurisdiction of any U.S. federal, state, local or foreign regulatory body that regulates the types of matters subject to the jurisdiction of the FDA (each, a “Health Authority”) that is manufactured, packaged, labeled, tested by the Company (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested by or on behalf of the Company in compliance in all material respects with all applicable requirements under any applicable laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company, and the Company has not received any written notice, warning letter or other communication from any Health Authority, which (A) imposes a hold on or requires or threatens the termination, suspension or modification of any pre-clinical or clinical investigation or study being conducted on any Pharmaceutical Product by or on behalf of the Company or in which the Company has participated, (B) enjoins production at any facility of or utilized by the Company, (C) enters or proposes to enter into a consent decree of permanent injunction with the Company, or (D) otherwise alleges any material violation of any laws, rules or regulations by the Company. The currently pending clinical trials, studies and other preclinical tests of the Pharmaceutical Products conducted by or on behalf of the Company are being conducted in all material respects in compliance with all applicable requirements of Health Authorities, including, but not limited to, the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder, and in accordance with experimental protocols, procedures and with controls generally used by qualified experts in the preclinical or clinical study of new drugs. The Company has not been informed in writing by any Health Authority that such Health Authority will prohibit the marketing, sale, license or use in any jurisdiction in which the Company operates of any Pharmaceutical Product proposed to such Health Authority to be developed, produced or marketed by the Company nor, to the Company’s knowledge, has any Health Authority expressed in any meeting with the Company or written communication to the Company any concern as to approving or clearing for marketing any Pharmaceutical Product being developed or proposed to be developed by the Company. To the Company’s knowledge, there are no serious adverse events that have resulted from any of such studies, tests or trials that were not disclosed as required to any Health Authority. (3) The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the SEC Documents were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and to the Company’s knowledge no other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the SEC Documents; the Company and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any other Regulatory Agency; neither the Company nor any of its Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials or preclinical tests that are described or referred to in the SEC Documents; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies. As used herein, “Regulatory Agency” means all applicable statutes, rules, regulations and policies of applicable regulatory authorities, including but are not limited to the United States Food and Drug Administration (“FDA”) and the National Medial Product Administration of the People’s Republic of China, in each case that is responsible for registrations necessary for, or otherwise governs, the manufacture, handling, use, storage, import, transport, distribution or sale of any pharmaceutical product.

(n)           No Registration. Assuming the accuracy of each Purchaser’s representations and warranties set forth in Section 2.2 of this Agreement, no registration under the Securities Act is required for the offer and sale by the Company of the Purchased Shares and the Warrant to such Purchaser as contemplated hereby nor under the Transaction Documents.

(o)           Offering.

(i)            Neither the Company nor anyone acting on its behalf has offered the Purchased Ordinary Shares or Warrants or any similar securities for sale to, or solicited any offer to buy any of the same from, or otherwise approached or negotiated in respect thereof with, any person other than the Purchasers and such other purchasers pursuant to certain subscription agreements and subscription and purchaser agreements entered into on the date hereof (collectively, the “PIPE Purchasers”), each of which has been offered the Purchased Ordinary Shares or Warrants at a private sale for investment. “Institutional Accredited Investor” means an institutional accredited investor as defined in Rule 501(a)(1), (2), (3) or (7) under the Securities Act.

(ii)           None of the Company nor any of its affiliates has offered the Purchased Ordinary Shares, the Warrant or any similar securities during the six months prior to the date hereof to anyone other than the PIPE Purchasers. The Company has no intention to offer the Purchased Ordinary Shares or Warrants or any similar security during the six months from the date hereof.

(iii)            Neither the Company nor any person acting on its behalf has offered or sold the Purchased Ordinary Shares or Warrants by any form of general solicitation or general advertising, including, but not limited to, the following: (1) any advertisement, article, notice or other communication published in any newspaper, magazine, or similar media or broadcast over television or radio; (2) any website posting or widely distributed email; or (3) any seminar or meeting whose attendees have been invited by any general solicitation or general advertising.

(iv)          Other than the Placement Agent, the Company has not dealt with any broker, finder, commission agent, placement agent or arranger in connection with the sale of the Purchased Ordinary Shares and Warrants and the transactions contemplated by this Agreement, and the Company is not under any obligation to pay any broker’s fee or commission in connection with such transactions other than to the Placement Agent. Neither the Company nor any of its affiliates nor any other person acting on its behalf (other than its officers acting in such capacity) has solicited offers for, or offered or sold, the Purchased Ordinary Shares and Warrants other than through the Placement Agent.

(v)           The Company shall exercise reasonable care to assure that the Purchasers and any subsequent transferees are not underwriters within the meaning of the Securities Act.

(p)           No Additional Representations. The Company makes no representations or warranties as to any matter whatsoever except as expressly set forth in the Transaction Documents or in any certificate delivered by the Company to each Purchaser and the Placement Agent in accordance with the terms thereof.

Section 2.2      Representations and Warranties of the Purchaser. Each Purchaser hereby, severally but not jointly, represents and warrants to the Company and the Placement Agent as of the date hereof and as of the Closing Date as follows:

(a)            Due Formation. The Purchaser is duly formed, validly existing and in good standing in the jurisdiction of its organization. The Purchaser has all requisite power and authority to carry on its business as it is currently being conducted.

(b)           Authority. The Purchaser has full power and authority to enter into, execute and deliver the Transaction Documents and each agreement, certificate, document and instrument to be executed and delivered by it pursuant to the Transaction Documents and to perform its obligations hereunder and thereunder. The execution and delivery by the Purchaser of the Transaction Documents and the performance by it of its obligations hereunder and thereunder have been duly authorized by all requisite actions on its part.

(c)            Valid Agreement. The Transaction Documents have been duly executed and delivered by the Purchaser and constitutes its legal, valid and binding obligation, enforceable against the Purchaser in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by the availability of specific performance, injunctive relief, or other equitable remedies.

(d)           Noncontravention. Neither the execution and the delivery of this Agreement, nor the consummation of the transactions contemplated hereby, will (i) where applicable, violate any provision of the organizational documents of the Purchaser or violate any constitution, statute, regulation, rule, injunction, judgment, order, decree, ruling, charge, or other restriction of any government, governmental entity or court to which the Purchaser is subject, or (ii) conflict with, result in a breach of, constitute a default under, result in the acceleration of or creation of an encumbrance under, or create in any party the right to accelerate, terminate, modify, or cancel, any agreement, contract, lease, license, instrument, or other arrangement to which the Purchaser is a party or by which the Purchaser is bound or to which any of the Purchaser’s assets are subject. There is no action, suit or proceeding, pending or, threatened against the Purchaser that questions the validity of this Agreement or other Transaction Documents or the right of the Purchaser to enter into this Agreement or other Transaction Documents or to consummate the transactions contemplated hereby and thereby.

(e)            Consents and Approvals. Neither the execution and delivery by the Purchaser of this Agreement or other Transaction Documents, nor the consummation by the Purchaser of any of the transactions contemplated hereby or thereby, nor the performance by the Purchaser of this Agreement or any other Transaction Documents in accordance with its terms requires the consent, approval, order or authorization of, or registration with, or the giving notice to, any governmental or public body or authority or any third party, except such as have been or will have been obtained, made or given on or prior to the Closing Date.

(f)            Status and Investment Intent

(i)            Experience. The Purchaser is a sophisticated investor with knowledge and experience in financial and business matters such that the Purchaser is capable of evaluating the merits and risks of the investment in the Warrant and the Purchased Shares. The Purchaser is able to bear the economic risks of an investment in the Warrant and the Purchased Shares.

(ii)           Purchase Entirely for Own Account. The Purchaser is acquiring the Warrant and the Purchased Shares for its own account for investment purposes only and not with the view to, or with any intention of, resale, distribution or other disposition thereof. The Purchaser does not have any direct or indirect arrangement, or understanding with any other person to distribute, or regarding the distribution of the Warrant or Purchased Shares in violation of the Securities Act or any other applicable state securities law. The Purchaser is not a broker-dealer registered with the SEC under the Exchange Act or an entity engaged in a business that would require it to be so registered as a broker-dealer.

(iii)          Restricted Securities. The Purchaser acknowledges that the Purchased Shares and the Warrant are “restricted securities” that have not been registered under the Securities Act or any applicable state securities law, and the Purchased Shares will bear a restrictive legend substantially in the form set forth in Section 1.2(c). The Purchaser further acknowledges that, absent an effective registration under the Securities Act, the Purchased Shares may only be offered, sold or otherwise transferred (A) to the Company, (B) outside the United States in accordance with Rule 904 of Regulation S under the Securities Act, or (C) pursuant to an exemption from registration under the Securities Act, including the exemption provided by Rule 144 of the Securities Act. Assuming the validity of the representations of the Company, the Purchaser further acknowledges that the Company is not required to register the Purchased Shares and the Warrant. The Purchaser represents and warrants that such Purchaser will not sell, transfer or otherwise dispose of the Purchased Shares or the Warrant or any interest therein except in a registered transaction or in a transaction exempt from or not subject to the registration requirements of the Securities Act.

(iv)          Information. The Purchaser has carefully reviewed all documents relating to the transactions contemplated by this Agreement and has been provided with all other materials that it considers relevant to the transactions contemplated by this Agreement, has had a full opportunity to ask questions of and receive answers from the Company or any person acting on behalf of the Company concerning the terms and conditions of transactions contemplated by this Agreement. The Purchaser was given the opportunity to ask questions and receive answers concerning the terms and conditions of the offering and to obtain any additional information which the Company possesses or can acquire without unreasonable effort or expense. In making its decision to invest in the Company, the Purchaser is not relying upon, and has not relied upon, any statement, representation or warranty made by any person, except for the statements, representations and warranties contained in this Agreement. The Purchaser is relying solely on its own counsel and other advisors as to the financial, tax, legal and related matters concerning an investment in the Warrant and the Purchased Shares. The Purchaser understands that the Placement Agent has acted solely as the agent of the Company in this private placement of the Purchased Ordinary Shares and the Warrant and the Purchaser has not relied on the business or legal advice of the Placement Agent or any of its agents, representatives, counsel or Affiliates in making its investment decision hereunder, and confirms that none of such persons has made any representations or warranties to the Purchaser in connection with the transactions contemplated by this Agreement. Neither the Placement Agent nor any of its agents, representatives, counsel or Affiliates has any responsibility with respect to the completeness or accuracy or any information or materials furnished to the Purchaser in connection with the transactions contemplated by this Agreement. The purchase of Purchased Ordinary Shares and the Warrants by the Purchaser has not been solicited by or through anyone other than the Issuer or the Placement Agent.

(v)           Status. The Purchaser is either (x) a non-U.S. person located outside of the United States, as such terms are defined in Rule 902 of Regulation S under the Securities Act or (y) both an “accredited investor”, as that term is defined in Rule 501 of Regulation D under the Securities Act and a “qualified institutional buyer” as defined in Rule 144A promulgated under the Securities Act acting for its own account (and not for the account of others). The Purchaser has not been subject to any “directed selling efforts” within the meaning of Rule 903 of Regulation S under the Securities Act in connection with its execution of this Agreement.

(vi)          FINRA. The Purchaser does not, directly or indirectly, own more than five per cent of the outstanding common stock (or other voting securities) of any member of the Financial Industry Regulatory Authority, Inc. (“FINRA”) or a holding company for a FINRA member, and is not otherwise a “restricted person” for the purposes of FINRA Rule 5130.

(g)            Sufficient Funding. The Purchaser has at its disposal sufficient funding to pay the Purchase Price and consummate the transactions contemplated hereby and under the Transaction Documents.

(h)            Potential Transaction of the Company. The Purchaser acknowledges that the Company is currently reviewing and considering a preliminary non-binding proposal with respect to the acquisition of certain of the Company’s business operations in China (the “Proposal”), and agrees that (i) the Company shall have full power to, pursuant to the applicable laws and its Amended and Restated Memorandum and Articles of Association, review, negotiate and enter into transactions in connection with the Proposal or such other alternative transactions available to the Company, and (ii) the Company may sell, transfer, license, assign or otherwise dispose of its assets and/or all the license-in, distribution and related rights in Asia (excluding Japan) related to all the Company’s pipeline products including but not limited to EVOMELA^®, FOLOTYN^®, CNCT19, BI-1206, CB-5339, CID-103 and Thiotepa, in connection with such transactions.

(i)            No Additional Representations. The Purchaser makes no representations or warranties as to any matter whatsoever except as expressly set forth in the Transaction Documents or in any certificate delivered by the Purchaser to the Company in accordance with the terms thereof.

Article III

Post-Closing COVENANTS

Section 3.1      Further Assurances. Each of the Purchasers and the Company shall use all reasonable efforts to fulfill or obtain the fulfillment of the conditions precedent to the consummation of the transactions contemplated by this Agreement on a timely basis, including the execution and delivery of any documents, certificates, instruments or other papers that are reasonably required for the consummation of such transactions, and will cooperate and consult with the other and use reasonable efforts to prepare and file all necessary documentation, to effect all necessary applications, notices, petitions, filings and other documents, and to obtain all necessary permits, consents, orders, approvals and authorizations of, or any exemption by, all governmental entities, necessary or advisable to consummate the transactions contemplated by this Agreement.

Section 3.2      Listing. The Company shall use commercially reasonable efforts to maintain the listing and trading of its Ordinary Shares on the Nasdaq Capital Market and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the rules and regulations of NASDAQ.

Section 3.3      Disclosure. The Company shall, not later than 6:00 p.m., New York City time, on the trading day immediately after the date of this Agreement, disseminate a public announcement disclosing the execution of this Agreement and the material terms of the Transaction Documents pursuant to the applicable rules and regulations (the “Public Announcement”). After each of the furnishing of the Public Announcement and the Closing, the Company shall have publicly disclosed all material, nonpublic information delivered to the Purchaser (or the Purchaser’s representatives or agents) by the Company, or any of its officers, directors, employees, agents or representatives (if any) in connection with the transactions contemplated by the Transaction Documents. The Company shall provide the Purchaser a reasonable opportunity to comment on a draft of the Public Announcement prior to its dissemination and shall give reasonable consideration to all such comments. The Purchaser covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed by the Company as described in this Section 3.3, the Purchaser shall maintain the confidentiality of all disclosures made to it in connection with the transactions contemplated by the Transaction Documents (including the existence and terms of the transactions contemplated thereby), except that the Purchaser may disclose the terms of such transactions to its financial, accounting, legal and other advisors (provided that the Purchaser directs such persons to maintain the confidentiality of such information).

Section 3.4      Reservation. As of the date hereof, the Company has available and, as long as the Purchased Warrant remains outstanding, the Company shall authorize, reserve and keep available at all times, free of preemptive and other similar rights of shareholders, the requisite aggregate number of authorized but unissued Ordinary Shares to enable the Company to timely effect the exercise of the Purchased Warrant, assuming the Purchased Warrant is exercisable in full and without regard to any limitations on the exercise of the Purchased Warrant set forth therein.

Section 3.5      [Reserved]

Section 3.6      Registration of Purchased Shares.

(a)           The Company shall prepare and file with the SEC a registration statement on appropriate form pursuant to the Securities Act (the “Registration Statement”) with respect to all Purchased Shares owned by the Purchasers as promptly as reasonably practicable and in any event no later than sixty (60) days after the Closing to cover the sale of such Purchased Shares pursuant to such Registration Statement, and shall use its best efforts to cause such Registration Statement to be declared effective by the SEC as soon as practicable.

(b)           All fees and expenses incurred in connection with the preparation and filing of the Registration Statement (excluding any underwriting discounts and selling commissions, stock transfer taxes and fees and all legal fees and expenses of legal counsel for the Purchasers) shall be borne by the Company.

(c)            Each Purchaser shall use commercially reasonable efforts to assist the Company in the preparation and filing of the Registration Statement and such other matters in relation thereto, including without limitation to provide such information reasonably requested by the Company in relation thereto.

(d)           Each Purchaser shall indemnify and hold harmless the Company, its officers, directors, agents, partners, members, managers, stockholders, advisors, Affiliates and employees of each of them, to the fullest extent permitted by applicable law, from and against all losses or reasonable and documented expenses, as incurred, arising out of or are based solely upon any actual or alleged untrue statement of a material fact contained in the Registration Statement, any Prospectus, or any form of prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any actual or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, or any form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading (i) to the extent that such untrue statements or omissions are based solely upon information regarding such Purchaser furnished in writing to the Company by such Purchaser expressly for use therein, (ii) to the extent that such information relates to such Purchaser or such Purchaser’s proposed method of distribution of Purchased Shares and was supplied by such Purchaser expressly for use in the Registration Statement, such Prospectus or such form of Prospectus or in any amendment or supplement thereto, or (iii) in the case of an occurrence of an event of (x) the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement covering any or all of the Purchased Shares or the initiation of any proceedings for that purpose; or (y) the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Purchased Shares for sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose, to the extent related to the use by such Purchaser of an outdated or defective Prospectus after the Company has notified such Purchaser in writing that the Prospectus is outdated or defective and prior to the receipt by such Purchaser of an advice in writing by the Company that the use of the applicable Prospectus (as it may have been supplemented or amended) may be resumed. In no event shall the liability of such Purchaser under this Agreement be greater in amount than the dollar amount of the net proceeds received by such Purchaser upon the sale of the Purchased Shares giving rise to such indemnification obligation. For the purpose of this Section 3.6(d)6, Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Purchased Shares covered by a Registration Statement, and all other amendments and supplements to the Prospectus, including post effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.

(e)            The Company shall indemnify and hold harmless each Purchaser, its officers, directors, agents, partners, members, managers, stockholders, advisors, Affiliates and employees of each of them, to the fullest extent permitted by applicable law, from and against all losses or reasonable and documented expenses, as incurred, arising out of or are based solely upon any actual or alleged untrue statement of a material fact contained in the Registration Statement, any Prospectus, or any form of prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any actual or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, or any form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading, except to the extent that (A) such untrue statements or omissions are based solely upon information regarding such Purchaser furnished in writing to the Company by such Purchaser expressly for use therein, or to the extent that such information relates to such Purchaser or such Purchaser’ proposed method of distribution of Purchased Shares and was supplied by such Purchaser expressly for use in the Registration Statement, such Prospectus or such form of Prospectus or in any amendment or supplement thereto, or (B) in the case of an occurrence of an event of (x) the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement covering any or all of the Purchased Shares or the initiation of any proceedings for that purpose; or (y) the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Purchased Shares for sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose, related to the use by such Purchaser of an outdated or defective Prospectus after the Company has notified such Purchaser in writing that the Prospectus is outdated or defective, or (C) to the extent that any such losses arise out of such Purchaser’s (or any other indemnified Person’s) failure to send or give a copy of the Prospectus or supplement (as then amended or supplemented), if required, pursuant to Rule 172 under the Securities Act (or any successor rule) to the Persons asserting an untrue statement or omission at or prior to the written confirmation of the sale of Purchased Shares to such Person if such statement or omission was corrected in such Prospectus or supplement.

Section 3.7      CSRC Filing.

(a)           The Company undertakes to file or cause to be filed with the China Securities Regulatory Commission (the “CSRC”) the requisite information and documents within three (3) Business Days or other timeframe prescribed by the CSRC following the Closing in accordance with the Trial Administrative Measures of Overseas Securities Offering and Listing by Domestic Companies (境内企业境外发行证券和上市管理试行办法) and supporting guidelines issued by the CSRC on February 17, 2023, as amended, supplemented or otherwise modified from time to time (the “CSRC Filing”).

(b)            Each Purchaser shall provide the Company with reasonable assistance it may require in connection with the CSRC Filing, including without limitation to provide such information relating to such Purchaser as may be necessary for the purposes of submitting such filings, or may otherwise be required in order for the Company to satisfy the regulatory requirements in respect of the CSRC Filing.

Article IV

MISCELLANEOUS

Section 4.1      Governing Law; Arbitration. This Agreement shall be governed and interpreted in accordance with the laws of the State of New York. Any dispute, controversy or claim arising out of or relating to this Agreement, or the interpretation, breach, termination or validity hereof, shall be submitted to arbitration upon the request of any party with notice to the other party. The arbitration shall be conducted in Hong Kong under the auspices of the Hong Kong International Arbitration Centre (“HKIAC”) in accordance with the HKIAC Administered Arbitration Rules then in effect, which rules are deemed to be incorporated by reference into this Section 4.1. There shall be three (3) arbitrators. The complainant and the respondent to such dispute shall each select one arbitrator within thirty (30) days after giving or receiving the demand for arbitration. The Chairman of the HKIAC shall select the third arbitrator. If either party to the arbitration does not appoint an arbitrator who has consented to participate within 30 days after selection of the first arbitrator, the relevant appointment shall be made by the Chairman of the HKIAC. The arbitration proceedings shall be conducted in English. Each party irrevocably waives, to the fullest extent it may effectively do so, any objection which it may now or hereafter have to the laying of venue of any such arbitration in Hong Kong and the HKIAC, and hereby submits to the exclusive jurisdiction of HKIAC in any such arbitration. The award of the arbitration tribunal shall be conclusive and binding upon the disputing parties, and any party to the dispute may apply to a court of competent jurisdiction for enforcement of such award. Any party to the dispute shall be entitled to seek preliminary injunctive relief, if possible, from any court of competent jurisdiction pending the constitution of the arbitral tribunal.

Section 4.2      Amendment. This Agreement shall not be amended, changed or modified, except by another agreement in writing executed by the Parties.

Section 4.3      Binding Effect. This Agreement shall inure to the benefit of, and be binding upon, each of the Parties and their respective heirs, successors and permitted assigns and legal representatives.

Section 4.4      Assignment. Neither this Agreement nor any of the rights, duties or obligations hereunder may be assigned by a Party without the express written consent of the other Parties, except that each Purchaser may assign all or any part of its rights and obligations hereunder to any Affiliate of such Purchaser without the consent of the Company; provided that no such assignment shall relieve such Purchaser of its obligations hereunder if such assignee does not perform such obligations. Any purported assignment in violation of the foregoing sentence shall be null and void. For purposes of this Agreement, “Affiliate” of a person means any other person that directly or indirectly Controls, is Controlled by or is under common Control with such person, where “Control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management of a person, whether through the ownership of voting securities, by contract, credit arrangement or proxy, as trustee, executor or agent or otherwise.

Section 4.5      Notices. All notices, requests, demands and other communications that are required or may be given pursuant to the terms of this Agreement shall be in writing, and delivery shall be deemed sufficient in all respects and to have been duly given as follows: (a) on the actual date of service if delivered personally, (b) at the time of receipt if given by electronic mail to the email addresses set forth in this Section 4.5, (c) on the third Business Day after mailing if mailed by first-class mail return receipt requested, postage prepaid and properly addressed as set forth in this Section 4.5, or (d) on the day after delivery to a nationally recognized overnight courier service during its business hours for overnight delivery against receipt, and properly addressed as set forth in this Section 4.5:

If to the Purchasers, at:	***

	Email: ***

If to the Company, at:	9620 Medical Center Drive, Suite 300 Rockville, MD 20850

	Attn: Rui Zhang

Any Party may change its address for purposes of this Section 4.5 by giving the other Parties hereto written notice of the new address in the manner set forth above. For purposes of this Agreement, “Business Day” means any day other than Saturday, Sunday or another day on which commercial banks located in the Cayman Islands, New York City, mainland China or Hong Kong are authorized or required by law or executive order to be closed.

Section 4.6      Entire Agreement. This Agreement and the other Transaction Documents together constitute the entire understanding and agreement between the Parties with respect to the matters covered hereby, and all prior agreements and understandings, oral or in writing, if any, between the Parties with respect to the matters covered hereby are merged and superseded by this Agreement and the other Transaction Documents.

Section 4.7      Severability. If any provisions of this Agreement shall be adjudicated to be illegal, invalid or unenforceable in any action or proceeding whether in its entirety or in any portion, then such provision shall be deemed amended, if possible, or deleted, as the case may be, from the Agreement in order to render the remainder of the Agreement and any provision thereof both valid and enforceable, and all other provisions hereof shall be given effect separately therefrom and shall not be affected thereby.

Section 4.8      Fees and Expenses. Except as otherwise provided in this Agreement, each of the Parties will bear its own costs and expenses incurred in connection with the negotiation, preparation and execution of this Agreement and the transactions contemplated hereby, including fees and expenses of attorneys, accountants, consultants and financial advisors.

Section 4.9      Announcement. Without limiting any other provision of this Agreement, the Company and Purchasers, to the extent permitted by applicable law, will consult with each other before issuance of, and provide each other the opportunity to review, comment upon and concur with, and use all reasonable efforts to agree on, any press release or public statement with respect to the Transaction Documents and the transactions contemplated hereby and thereby, and will not (to the extent practicable) issue any such press release or make any such public statement prior to such consultation and agreement, except as may be required by law, rules, regulations or any listing agreement with or requirement of NASDAQ or any other applicable securities exchange, provided that the disclosing Party shall, to the extent permitted by applicable law, rules, regulations or any listing agreement with or requirement of NASDAQ or any other applicable securities exchange and if reasonably practicable, inform the other Parties about the disclosure to be made pursuant to such requirements prior to the disclosure.

Section 4.10    Specific Performance. The Parties agree that irreparable damage would occur in the event any provision of this Agreement is not performed in accordance with the terms hereof and that the Parties shall be entitled to specific performance of the terms hereof, in addition to any other remedy at law or equity.

Section 4.11    Termination. This Agreement may be terminated and the transactions contemplated by this Agreement abandoned at any time prior to the Closing:

(a)

by mutual agreement of the Company and the Purchasers;

(b)

by the Company or the Purchasers if any legislative body, court, administrative agency or commission or other governmental authority, instrumentality, agency or commission shall have enacted, issued, promulgated, enforced or entered any law or governmental regulation or order which has the effect of prohibiting the sale and issuance of the Purchased Shares; provided, however, that the right to terminate this Agreement pursuant to this Section 4.11(b) shall not be available to a Party if the issuance of such law, regulation or order was initiated by, or primarily due to a breach by, such party of this Agreement;

(c)

by the Purchasers if there has been a material breach of any representation or warranty by the Company under any Transaction Document or any material breach of any covenant or agreement by the Company under any Transaction Document that would give rise to failure of the conditions set forth in Section 1.3(a) to be satisfied, which breach is not cured within ten (10) Business Days following the Purchasers’ delivery of a written notice thereof to the Company; provided, however, that the Purchasers shall not have the right to terminate this Agreement pursuant to this Section 4.11(c) if the Purchasers shall have materially breached or failed to perform any of its representation or warrant or covenant or agreement under any Transaction Document which breach or failure to perform would give rise to the failure of the condition set forth in Section 1.3; or

(d)

by the Company if there has been a material breach of any representation or warranty by the Purchasers under any Transaction Document or any material breach of any covenant or agreement by the Purchasers under any Transaction Document that would give rise to failure of the conditions set forth in Section 1.3(b) to be satisfied, which breach is not cured within ten (10) Business Days following the Company’s delivery of a written notice thereof to the Purchasers; provided, however, that the Company shall not have the right to terminate this Agreement pursuant to this Section 4.11(d) if the Company shall have materially breached or failed to perform any of its representation or warrant or covenant or agreement under any Transaction Document which breach or failure to perform would give rise to the failure of the condition set forth in Section 1.3,

(e)

by the Company in the event that the Closing shall not have occurred by September 25, 2024,

in each case this Agreement shall forthwith become void and there shall be no liability or obligation on the part of the Parties, except that the provisions of Section 4 hereof shall remain in full force and effect; provided that nothing herein shall relieve any Party hereto from liability for any breach of this Agreement that occurred prior to such termination.

Section 4.12    Acknowledgements Regarding Placement Agent.

(a)

Each Purchaser acknowledges that the Placement Agent is acting as a placement agent on a “best efforts” basis for the Ordinary Shares and the Warrant being offered hereby and will be compensated by the Company for acting in such capacity. Each Purchaser represents that such Purchaser was contacted regarding the sale of the Ordinary Shares and the Warrant by the Placement Agent or the Company (or an authorized agent or representative thereof) with whom such Purchaser entered into a verbal or written confidentiality agreement.

(b)

Each Purchaser represents that it is making this investment based on the results of its own due diligence investigation of the Company, and has not relied on any information or advice furnished by or on behalf of the Placement Agent in connection with the transactions contemplated hereby. Each Purchaser acknowledges that the Placement Agent has not made, and will not make, any representations and warranties with respect to the Company or the transactions contemplated hereby, and such Purchaser will not rely on any statements made by the Placement Agent, orally or in writing, to the contrary.

Section 4.13    Exculpation of the Placement Agent. Each Party hereto agrees for the express benefit of the Placement Agent and its Affiliates and representatives that:

(a)

The Placement Agent and its Affiliates and representatives (i) have no duties or obligations other than those specifically set forth herein or in that certain Engagement Letter by and between the Company and the Placement Agent, dated June 26, 2024 (the “Engagement Letter”); (ii) shall not be liable for any improper payment made in accordance with the information provided by the Company; (iii) make no representation or warranty, and have no responsibilities as to the validity, accuracy, value or genuineness of any information, certificates or documentation delivered by or on behalf of the Company pursuant to this Agreement or in connection with any of the transactions contemplated hereby, including any offering or marketing materials; and (iv) shall not be liable (A) for any action taken, suffered or omitted by any of them in good faith and reasonably believed to be authorized or within the discretion or rights or powers conferred upon them by this Agreement or any Transaction Document, or (B) for anything which any of them may do or refrain from doing in connection with this Agreement or any Transaction Document, except in each case for such person’s own gross negligence, willful misconduct or bad faith.

(b)

The Placement Agent and its Affiliates and representatives shall be entitled to (1) rely on, and shall be protected in acting upon, any certificate, instrument, notice, letter or any other document or security delivered to any of them by or on behalf of the Company, and (2) be indemnified by the Company for acting as a Placement Agent hereunder pursuant to the indemnification provisions set forth in the Engagement Letter.

Section 4.14    Headings. The headings of the various articles and sections of this Agreement are inserted merely for the purpose of convenience and do not expressly or by implication limit, define or extend the specific terms of the section so designated.

Section 4.15    Third-Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto, their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other person, except as set forth in Sections 3.6(d), 3.6(e), 4.12, 4.13 and 4.15 of this Agreement. The Placement Agent shall be the third-party beneficiary of the representations and warranties of the Company and the Purchasers in Article II.

Section 4.16    Execution in Counterparts. For the convenience of the Parties and to facilitate execution, this Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, but all of which together shall constitute but one and the same instrument.

Section 4.17    Remedies and Waivers.  No delay or omission by any Party in exercising any right, power or remedy provided by law or under this Agreement or any other documents referred to in it shall: (i) affect that right, power or remedy; or (ii) operate as a waiver thereof. The single or partial exercise of any right, power or remedy provided by law or under this Agreement shall not preclude any other or further exercise or any other right, power or remedy. Except as otherwise expressly provided in this Agreement, the rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by law.

[signature pages follow]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

	CASI Pharmaceuticals, Inc.

	By:	/s/ Wei-Wu He
	Name: Wei-Wu He
	Title: Chairman and Chief Executive Officer

[Signature Page to Subscription and Purchase Agreement]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

	VENROCK HEALTHCARE CAPITAL PARTNERS EG, L.P.
	By: VHCP Management EG, LLC, its general partner

	By:	/s/ Sherman Souther
		Authorized Signatory

	VENROCK HEALTHCARE CAPITAL PARTNERS III, L.P.
	By:	VHCP Management III, LLC, its general partner
	By:	VR Adviser, LLC, its manager

	VHCP CO-INVESTMENT HOLDINGS III, LLC
	By:	VHCP Management III, LLC, its manager
	By:	VR Adviser, LLC, its manager

	By:	/s/ Sherman Souther
		Authorized Signatory

[Signature Page to Subscription and Purchase Agreement]

Schedule I

Purchaser	Purchase Price for Ordinary Shares	Purchased Ordinary Shares
Venrock Healthcare Capital Partners EG, L.P.	US$2,062,500	412,500
Venrock Healthcare Capital Partners III, L.P.	US$397,750	79,550
VHCP Co- Investment Holdings III, LLC	US$39,750	7,950

	Purchase Price for Warrant	Warrant Shares
Venrock Healthcare Capital Partners EG, L.P.	US$4,124,917.50  (a nominal exercise price of $0.0001 per ordinary share will be paid upon exercise of the warrant)	825,000
Venrock Healthcare Capital Partners III, L.P.	US$795,484.09  (a nominal exercise price of $0.0001 per ordinary share will be paid upon exercise of the warrant)	159,100
VHCP Co- Investment Holdings III, LLC	US$79,498.41 (a nominal exercise price of $0.0001 per ordinary share will be paid upon exercise of the warrant)	15,900

Exhibit A

Form of Warrant

PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT

CASI PHARMACEUTICALS, INC.

Warrant Shares: 825,000

Issue Date: July 15, 2024

THIS PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, Venrock Healthcare Capital Partners EG, L.P. or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Issue Date (the “Initial Exercise Date”) until this Warrant is exercised in full (the “Termination Date”) but not thereafter, to subscribe for and purchase from CASI PHARMACEUTICALS, INC., a company incorporated with limited liability under the laws of the Cayman Islands (the “Company”), up to 825,000 Ordinary Shares, par value $0.0001 per share, of the Company (as subject to adjustment hereunder, the “Warrant Shares”). The purchase price of one Ordinary Share, par value $0.0001 per share, of the Company (each, an “Ordinary Share”), under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).

1.            Definitions. Capitalized terms used and not otherwise defined herein shall have the meanings set forth in that certain Subscription and Purchase Agreement (the “Purchase Agreement”), dated June 26, 2024, by and between the Company and the Holder.

2.            Exercise.

(a)            Exercise of Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date and on or prior to the Termination Date by delivery to the Company of a duly executed PDF copy submitted by email (or email attachment) of the Notice of Exercise in the form annexed hereto (the “Notice of Exercise”). Prior to the Warrant Share Delivery Date, the Holder shall deliver the aggregate Exercise Price for the Warrant Shares specified in the applicable Notice of Exercise by wire transfer unless the net exercise procedure specified in Section 2(c) below is specified in the applicable Notice of Exercise. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Business Days after the date on which the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within three (3) Business Days of receipt of such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof. Notwithstanding anything to the contrary in this Warrant, no purchase or other rights pursuant to this Warrant shall be exercised after the Termination Date.

(b)            Exercise Price. The aggregate exercise price of this Warrant, except for a nominal exercise price of US$0.0001 per Warrant Share, was pre-funded to the Company on or prior to the Initial Exercise Date and, consequently, no additional consideration (other than the nominal exercise price of US$0.0001 per Warrant Share) shall be required to be paid by the Holder to any Person to effect any exercise of this Warrant. Notwithstanding anything herein to the contrary, the Holder shall not be entitled to the return or refund of all or any portion of such pre-funded aggregate exercise price under any circumstance or for any reason whatsoever, including in the event that this Warrant shall not have been exercised on or prior to the Termination Date. The remaining unpaid exercise price per Ordinary Share under this Warrant shall be US$0.0001, subject to adjustment hereunder (such remaining unpaid exercise price, the “Exercise Price”). For purposes of this Warrant, “Person” means any natural person, firm, partnership, association, corporation, company, trust, public body or government or other entity of any kind or nature.

(c)            Net Exercise. This Warrant may also be exercised, in whole or in part, at such time by means of a “net exercise”. In the case where this Warrant is exercised in whole, the Holder shall be entitled to receive a number of Warrant Shares in an exchange of securities effected pursuant to Section 3(a)(9) of the Securities Act as determined as follows:

X = Y [(A-B)/A]

“X” equals the number of Warrant Shares to be issued to the Holder;

“Y” equals the total number of Warrant Shares with respect to which this Warrant is then being exercised;

“A” equals he last VWAP immediately preceding the time of delivery of the Exercise Notice giving rise to the applicable “cashless exercise,” as set forth in the applicable Exercise Notice (to clarify, the “last VWAP” will be the last VWAP as calculated over an entire Trading Day such that, in the event that this Warrant is exercised at a time that the Principal Trading Market is open, the prior Trading Day’s VWAP shall be used in this calculation); and

“B” equals the Exercise Price per Warrant Share then in effect on the Exercise Date.

For the purposes of this Section 2:

“Principal Trading Market” means the national securities exchange or other trading market on which the Ordinary Shares primarily listed and quoted for trading, which, as of the Issue Date, shall be The Nasdaq Capital Market.

“Trading Day” means any weekday on which the Principal Trading Market is open for trading. If the Ordinary Shares are not listed or admitted for trading, “Trading Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in New York City are authorized or required by law or other governmental action to close.

“VWAP” means, for any date, the price determined by the first of the following clauses that applies: (i) if the Ordinary Shares are then listed or quoted on a national securities exchange or other trading market, the daily volume weighted average price of the Ordinary Shares for such date (or the nearest preceding date) on the Principal Trading Market as reported by Bloomberg L.P. (based on a trading day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (ii) if Ordinary Shares are then listed or quoted for trading and neither OTCQB nor OTCQX is the Principal Trading Market, the volume weighted average price of the Ordinary Shares for such date (or the nearest preceding date) on OTCQB or OTCQX, as applicable, (iii) if the Ordinary Shares are not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Ordinary Shares are then reported in the “Pink Sheets” published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Ordinary Shares so reported, or (iv) in all other cases, the fair market value of a share of Ordinary Shares as determined by an independent appraiser selected in good faith by the Holder and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.

(d)            Mechanics of Exercise.

(i)              Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company (“DTC”) through its Deposit Withdrawal Agent Commission system, or if the Company’s transfer agent is not participating in the Fast Automated Securities Transfer Program, by delivering of scanned copies of (a) share certificate(s) or a book entry position and (b) a true copy of the register of members of the Company or an extract therefrom duly certified by the registered agent or a director of the Company, evidencing that the Holder or its designee has been registered as the holder for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise through email to the email address specified by the Holder in the Notice of Exercise by the date that is the earlier of (i) two (2) Business Days after the delivery to the Company of the Notice of Exercise and (ii) the number of trading days that comprises the standard settlement period following delivery of the Notice of Exercise (such date, the “Warrant Share Delivery Date”), with original copies of such documents delivered to the address specified by the Holder in the Notice of Exercise as soon as practicable thereafter, but in no event later than ten (10) Business Days after the Warrant Share Delivery Date. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of Ordinary Shares on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered or Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Ordinary Shares as in effect on the date of delivery of the Notice of Exercise. The Holder, or any Person so designated by the Holder to receive Warrant Shares, shall be deemed to have become the holder of record of such Warrant Shares as of the Exercise Date, irrespective of the date such Warrant Shares are credited to the Holder’s DTC account or the date of delivery of the certificates or book entry position evidencing such Warrant Shares, as the case may be.

(ii)            Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.

(iii)            Rescission Rights. If the Company fails to cause its transfer agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i) hereof by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise by delivering written notice to the Company at any time prior to the delivery of such Warrant Shares.

(iv)            Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder, if the Company fails to cause its transfer agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(d)(i) above pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases for the Holder, Ordinary Shares to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including reasonable and customary brokerage commissions, if any) for the Ordinary Shares so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue times (2) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of Ordinary Shares that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Ordinary Shares having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of Ordinary Shares with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and evidence of the amount of such loss. Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver Ordinary Shares upon exercise of the Warrant as required pursuant to the terms hereof.

(v)            No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share.

(vi)            Charges, Taxes and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto.

(e)             Holder’s Exercise Limitations. Notwithstanding anything to the contrary contained herein, the Company shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that prior to and after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates (such Persons, “Attribution Parties”)), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of Ordinary Shares beneficially owned by the Holder and its Affiliates and Attribution Parties shall include the number of Warrant Shares issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of Warrant Shares which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates or Attribution Parties and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates or Attribution Parties. Except as set forth in the preceding sentence, for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this Section 2(e), in determining the number of outstanding Ordinary Shares, a Holder may rely on the number of outstanding Ordinary Shares as reflected in (A) the Company’s most recent annual report on Form 20-F, Report on Form 6-K or other public filings filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company setting forth the number of Ordinary Shares outstanding. Upon the written request of a Holder, the Company shall within one (1) Business Day confirm in writing to the Holder the number of Ordinary Shares then outstanding. In any case, the number of outstanding Ordinary Shares shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates or Attribution Parties since the date as of which such number of outstanding Ordinary Shares was reported. The “Beneficial Ownership Limitation” shall be 9.99% of the number of Ordinary Shares outstanding immediately after giving effect to the issuance of the Ordinary Shares issuable upon exercise of this Warrant. The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 2(e), provided that the Beneficial Ownership Limitation in no event exceeds 14.99% of the number of the Ordinary Shares outstanding immediately after giving effect to the issuance of Ordinary Shares upon exercise of this Warrant held by the Holder and the provisions of this Section 2(e) shall continue to apply. Any increase in the Beneficial Ownership Limitation will not be effective until the 61^st day after such notice is delivered to the Company. The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant.

3.            Certain Adjustments.

(a)            Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a dividend or otherwise makes a distribution or distributions on its Ordinary Shares or any other equity or equity equivalent securities payable in Ordinary Shares (which, for avoidance of doubt, shall not include any Ordinary Shares issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding Ordinary Shares into a larger number of shares, (iii) combines (including by way of reverse share split) outstanding Ordinary Shares into a smaller number of shares, or (iv) issues by reclassification of the Ordinary Shares any share capital of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of Ordinary Shares (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of Ordinary Shares outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of shareholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification.

(b)            Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 3(a) above, if at any time the Company grants, issues or sells any Ordinary Shares or rights to purchase shares, warrants, securities or other property pro rata to the record holders of any class of share capital of the Company (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of Ordinary Shares acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of the share capital of the Company are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, that to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such Ordinary Shares as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

(c)            Pro Rata Distributions. During such time as this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of Ordinary Shares, by way of return of capital or otherwise (including, without limitation, any distribution of cash, shares or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of Ordinary Shares acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of Ordinary Shares are to be determined for the participation in such Distribution (provided, however, that to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any Ordinary Shares as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

(d)            Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company (and all of the Company’s subsidiaries, taken as a whole), directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Ordinary Shares are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of fifty percent (50%) or more of the outstanding Ordinary Shares, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Ordinary Shares or any compulsory share exchange pursuant to which the Ordinary Shares is effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off, merger or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than fifty percent (50%) of the outstanding Ordinary Shares (except for any such transaction in which the stockholders of the Company immediately prior to such transaction maintain, in substantially the same proportions, the voting power of such Person immediately after the transaction) (each a “Fundamental Transaction”), then, upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the option of the Holder (without regard to any limitation in Section 2(e) on the exercise of this Warrant), the number of Ordinary Shares of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration receivable as a result of such Fundamental Transaction (the “Alternate Consideration”) by a holder of the number of Ordinary Shares for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one Ordinary Share in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Ordinary Shares are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Warrant and the other Transaction Documents in accordance with the provisions of this Section 3(d) pursuant to written agreements in form and substance reasonably satisfactory to the Holder (without unreasonable delay) prior to such Fundamental Transaction and shall, at the request of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant that is exercisable for a corresponding number of shares of such Successor Entity (or its parent entity) equivalent to the Ordinary Shares acquirable and receivable upon exercise of this Warrant prior to such Fundamental Transaction. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Warrant and the other Transaction Documents referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company under this Warrant and the other Transaction Documents with the same effect as if such Successor Entity had been named as the Company herein. The Company shall not effect any Fundamental Transaction in which the Company is not the surviving entity or the Alternate Consideration includes securities of another Person unless (i) the Alternate Consideration is solely cash and the Company provides for the simultaneous “cashless exercise” of this Warrant pursuant to the terms of this Warrant or (ii) prior to or simultaneously with the consummation thereof, any successor to the Company, surviving entity or other Person (including any purchaser of assets of the Company) shall assume the obligation to deliver to the Holder such Alternate Consideration as, in accordance with the foregoing provisions, the Holder may be entitled to receive, and the other obligations under this Warrant, provided the Company and the Holder shall negotiate in good faith the treatment of this Warrant in the transactions contemplated by the Proposal or such alternative transactions in relation thereto. The provisions of this paragraph (d) shall similarly apply to subsequent transactions analogous of a Fundamental Transaction type. No Fundamental Transaction shall have the effect of extending the Termination Date.

(e)            Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of Ordinary Shares deemed to be issued and outstanding as of a given date shall be the sum of the number of Ordinary Shares (excluding treasury shares, if any) issued and outstanding.

(f)            Notice to Holder.

(i)              Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

(ii)             Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Ordinary Shares, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Ordinary Shares, (C) the Company shall authorize the granting to all holders of the Ordinary Shares rights or warrants to subscribe for or purchase any shares of any class or of any rights, (D) the approval of any shareholders of the Company shall be required in connection with any reclassification of the Ordinary Shares, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange, in each case whereby the Ordinary Share is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by email to the Holder at its last email address as it shall appear upon the Warrant Register of the Company, at least three (3) days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Ordinary Shares of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Ordinary Shares of record shall be entitled to exchange their Ordinary Shares for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

4.            Transfer of Warrant.

(a)            Transferability. Subject to applicable securities laws, this Warrant and all rights hereunder are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder and funds sufficient to pay any transfer taxes payable upon the making of such transfer; provided that any transfer to a Person that is not an Affiliate of the Holder shall be subject to the Company’s prior written consent. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Business Days of the date on which the Holder delivers an assignment form to the Company assigning this Warrant in full. The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.

(b)            New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the Issue Date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.

(c)            Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

5.            Miscellaneous.

(a)            No Rights as Shareholder Until Exercise; No Settlement in Cash. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a shareholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i). Except as expressly provided in Section 2(d)(i) and Section 2(d)(iv), in no event will the Company be required to net cash settle an exercise of this Warrant.

(b)            Loss, Theft, Destruction or Mutilation of Warrant. Within ten (10) Business Days of receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any share certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to the Company (which, in the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or share certificate, if mutilated, the Company will make and deliver a new Warrant or share certificate of like tenor, in lieu of such Warrant or share certificate. The Company hereby agrees that in case of loss, theft or destruction of this Warrant or any share certificate relating to the Warrant Shares, the Company shall find as reasonably satisfactory evidence, indemnity and security a customary affidavit and indemnity from Holder certifying to such loss, theft or destruction.

(c)            Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business Day, then, such action may be taken or such right may be exercised on the next succeeding Business Day.

(d)            Authorized Shares. The Company agrees that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Ordinary Shares a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable. The Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.

(e)            Interpretation. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be determined in accordance with the provisions of the Purchase Agreement.

(f)            Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, may be subject to restrictions relating to resale imposed by state and federal securities laws.

(g)            Waiver. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies.

(h)            Notices. Any notice, request or other document required or permitted to be given or delivered to the Holder by the Company shall be delivered in accordance with the notice provisions of the Purchase Agreement.

(i)            Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to seek specific performance of its rights under this Warrant.

(j)            Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.

(k)            Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company, on the one hand, and the Holder, on the other hand.

(l)            Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.

(m)            Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

(n)            Governing Law; Arbitration. This Warrant shall be governed and interpreted in accordance with the laws of the State of New York. Any dispute, controversy or claim arising out of or relating to this Agreement, or the interpretation, breach, termination or validity hereof, shall be submitted to arbitration upon the request of any party with notice to the other party. The arbitration shall be conducted in Hong Kong under the auspices of the Hong Kong International Arbitration Centre (“HKIAC”) in accordance with the HKIAC Administered Arbitration Rules then in effect, which rules are deemed to be incorporated by reference into this Section 4.1. There shall be three (3) arbitrators. The complainant and the respondent to such dispute shall each select one arbitrator within thirty (30) days after giving or receiving the demand for arbitration. The Chairman of the HKIAC shall select the third arbitrator. If either party to the arbitration does not appoint an arbitrator who has consented to participate within 30 days after selection of the first arbitrator, the relevant appointment shall be made by the Chairman of the HKIAC. The arbitration proceedings shall be conducted in English. Each party irrevocably waives, to the fullest extent it may effectively do so, any objection which it may now or hereafter have to the laying of venue of any such arbitration in Hong Kong and the HKIAC, and hereby submits to the exclusive jurisdiction of HKIAC in any such arbitration. The award of the arbitration tribunal shall be conclusive and binding upon the disputing parties, and any party to the dispute may apply to a court of competent jurisdiction for enforcement of such award. Any party to the dispute shall be entitled to seek preliminary injunctive relief, if possible, from any court of competent jurisdiction pending the constitution of the arbitral tribunal.

[Signature page follows]

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

CASI PHARMACEUTICALS, INC.

By:	/s/ Wei-Wu He
Name:	Wei-Wu He
Title:	Chairman and Chief Executive Officer

Exhibit A

NOTICE OF EXERCISE

TO: CASI PHARMACEUTICALS, INC.

(1)            The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.

(2)            Payment shall take the form of (check applicable box):

[ ]            in lawful money of the United States; or

[ ]            if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with subsection 2(c), to exercise this Warrant with respect to the number of Warrant Shares purchasable pursuant to the net exercise procedure set forth in subsection 2(c).

(3)            Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

___________________________________

The share certificate(s) and the certified register of members evidencing the Warrant Shares shall be delivered to the following address and email address:

_______________________________

[SIGNATURE OF HOLDER]

Name of Investing Entity:
Signature of Authorized Signatory of Investing Entity:
Name of Authorized Signatory:
Title of Authorized Signatory:
Date:

Exhibit B

ASSIGNMENT FORM

(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to exercise the Warrant to purchase shares.)

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to

Name:

Address:

Phone Number:

Email Address:

Dated:

Holder’s Signature:

Holder’s Address:

PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT

CASI PHARMACEUTICALS, INC.

Warrant Shares: 159,100

Issue Date: July 15, 2024

THIS PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, Venrock Healthcare Capital Partners III, L.P. or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Issue Date (the “Initial Exercise Date”) until this Warrant is exercised in full (the “Termination Date”) but not thereafter, to subscribe for and purchase from CASI PHARMACEUTICALS, INC., a company incorporated with limited liability under the laws of the Cayman Islands (the “Company”), up to 159,100 Ordinary Shares, par value $0.0001 per share, of the Company (as subject to adjustment hereunder, the “Warrant Shares”). The purchase price of one Ordinary Share, par value $0.0001 per share, of the Company (each, an “Ordinary Share”), under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).

2.            Exercise.

X = Y [(A-B)/A]

“X” equals the number of Warrant Shares to be issued to the Holder;

“Y” equals the total number of Warrant Shares with respect to which this Warrant is then being exercised;

“B” equals the Exercise Price per Warrant Share then in effect on the Exercise Date.

For the purposes of this Section 2:

(d)            Mechanics of Exercise.

(i)            Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company (“DTC”) through its Deposit Withdrawal Agent Commission system, or if the Company’s transfer agent is not participating in the Fast Automated Securities Transfer Program, by delivering of scanned copies of (a) share certificate(s) or a book entry position and (b) a true copy of the register of members of the Company or an extract therefrom duly certified by the registered agent or a director of the Company, evidencing that the Holder or its designee has been registered as the holder for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise through email to the email address specified by the Holder in the Notice of Exercise by the date that is the earlier of (i) two (2) Business Days after the delivery to the Company of the Notice of Exercise and (ii) the number of trading days that comprises the standard settlement period following delivery of the Notice of Exercise (such date, the “Warrant Share Delivery Date”), with original copies of such documents delivered to the address specified by the Holder in the Notice of Exercise as soon as practicable thereafter, but in no event later than ten (10) Business Days after the Warrant Share Delivery Date. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of Ordinary Shares on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered or Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Ordinary Shares as in effect on the date of delivery of the Notice of Exercise. The Holder, or any Person so designated by the Holder to receive Warrant Shares, shall be deemed to have become the holder of record of such Warrant Shares as of the Exercise Date, irrespective of the date such Warrant Shares are credited to the Holder’s DTC account or the date of delivery of the certificates or book entry position evidencing such Warrant Shares, as the case may be.

3.            Certain Adjustments.

(f)            Notice to Holder.

(i)            Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

(ii)            Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Ordinary Shares, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Ordinary Shares, (C) the Company shall authorize the granting to all holders of the Ordinary Shares rights or warrants to subscribe for or purchase any shares of any class or of any rights, (D) the approval of any shareholders of the Company shall be required in connection with any reclassification of the Ordinary Shares, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange, in each case whereby the Ordinary Share is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by email to the Holder at its last email address as it shall appear upon the Warrant Register of the Company, at least three (3) days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Ordinary Shares of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Ordinary Shares of record shall be entitled to exchange their Ordinary Shares for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

4.            Transfer of Warrant.

5.            Miscellaneous.

(m)            Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

[Signature page follows]

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

CASI PHARMACEUTICALS, INC.

By:	/s/ Wei-Wu He
Name:	Wei-Wu He
Title:	Chairman and Chief Executive Officer

Exhibit A

NOTICE OF EXERCISE

TO: CASI PHARMACEUTICALS, INC.

(2)            Payment shall take the form of (check applicable box):

[ ]            in lawful money of the United States; or

(3)            Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

The share certificate(s) and the certified register of members evidencing the Warrant Shares shall be delivered to the following address and email address:

[SIGNATURE OF HOLDER]

Name of Investing Entity:
Signature of Authorized Signatory of Investing Entity:
Name of Authorized Signatory:
Title of Authorized Signatory:
Date:

Exhibit B

 ASSIGNMENT FORM

(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to exercise the Warrant to purchase shares.)

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to

Name:

Address:

Phone Number:

Email Address:

Dated:

Holder’s Signature:

Holder’s Address:

PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT

CASI PHARMACEUTICALS, INC.

Warrant Shares: 15,900

Issue Date: July 15, 2024

THIS PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, VHCP Co-Investment Holdings III, LLC or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Issue Date (the “Initial Exercise Date”) until this Warrant is exercised in full (the “Termination Date”) but not thereafter, to subscribe for and purchase from CASI PHARMACEUTICALS, INC., a company incorporated with limited liability under the laws of the Cayman Islands (the “Company”), up to 15,900 Ordinary Shares, par value $0.0001 per share, of the Company (as subject to adjustment hereunder, the “Warrant Shares”). The purchase price of one Ordinary Share, par value $0.0001 per share, of the Company (each, an “Ordinary Share”), under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).

2.            Exercise.

X = Y [(A-B)/A]

“X” equals the number of Warrant Shares to be issued to the Holder;

“Y” equals the total number of Warrant Shares with respect to which this Warrant is then being exercised;

“B” equals the Exercise Price per Warrant Share then in effect on the Exercise Date.

For the purposes of this Section 2:

(d)            Mechanics of Exercise.

(i)            Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company (“DTC”) through its Deposit Withdrawal Agent Commission system, or if the Company’s transfer agent is not participating in the Fast Automated Securities Transfer Program, by delivering of scanned copies of (a) share certificate(s) or a book entry position and (b) a true copy of the register of members of the Company or an extract therefrom duly certified by the registered agent or a director of the Company, evidencing that the Holder or its designee has been registered as the holder for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise through email to the email address specified by the Holder in the Notice of Exercise by the date that is the earlier of (i) two (2) Business Days after the delivery to the Company of the Notice of Exercise and (ii) the number of trading days that comprises the standard settlement period following delivery of the Notice of Exercise (such date, the “Warrant Share Delivery Date”), with original copies of such documents delivered to the address specified by the Holder in the Notice of Exercise as soon as practicable thereafter, but in no event later than ten (10) Business Days after the Warrant Share Delivery Date. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of Ordinary Shares on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered or Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Ordinary Shares as in effect on the date of delivery of the Notice of Exercise. The Holder, or any Person so designated by the Holder to receive Warrant Shares, shall be deemed to have become the holder of record of such Warrant Shares as of the Exercise Date, irrespective of the date such Warrant Shares are credited to the Holder’s DTC account or the date of delivery of the certificates or book entry position evidencing such Warrant Shares, as the case may be.

3.            Certain Adjustments.

(f)            Notice to Holder.

(i)            Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

(ii)            Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Ordinary Shares, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Ordinary Shares, (C) the Company shall authorize the granting to all holders of the Ordinary Shares rights or warrants to subscribe for or purchase any shares of any class or of any rights, (D) the approval of any shareholders of the Company shall be required in connection with any reclassification of the Ordinary Shares, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange, in each case whereby the Ordinary Share is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by email to the Holder at its last email address as it shall appear upon the Warrant Register of the Company, at least three (3) days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Ordinary Shares of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Ordinary Shares of record shall be entitled to exchange their Ordinary Shares for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

4.            Transfer of Warrant.

5.            Miscellaneous.

(m)            Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

[Signature page follows]

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

CASI PHARMACEUTICALS, INC.

By:	/s/ Wei-Wu He
Name:	Wei-Wu He
Title:	Chairman and Chief Executive Officer

Exhibit A

NOTICE OF EXERCISE

TO: CASI PHARMACEUTICALS, INC.

(2)            Payment shall take the form of (check applicable box):

[ ]            in lawful money of the United States; or

(3)            Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

The share certificate(s) and the certified register of members evidencing the Warrant Shares shall be delivered to the following address and email address:

[SIGNATURE OF HOLDER]

Name of Investing Entity:
Signature of Authorized Signatory of Investing Entity:
Name of Authorized Signatory:
Title of Authorized Signatory:
Date:

Exhibit B

ASSIGNMENT FORM

(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to exercise the Warrant to purchase shares.)

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to

Name:

Address:

Phone Number:

Email Address:

Dated:

Holder’s Signature:

Holder’s Address:

Exhibit 4.3

Execution Version

SUBSCRIPTION AND PURCHASE AGREEMENT

This Subscription and Purchase Agreement (this “Agreement”) is made as of June 26, 2024 by and between:

(1)

CASI Pharmaceuticals, Inc., an exempted company incorporated in the Cayman Islands with address of principal business office at 1701-1702, China Central Office Tower 1, No. 81 Jianguo Road Chaoyang District, Beijing, 100025, People’s Republic of China (the “Company”); and

(2)

Foresite Capital Fund VI LP, a limited partnership duly organized under the laws of the State of Delaware with address of principal business office at 900 Larkspur Landing Circle, Suite 150, Larkspur, California 94939 (“Purchaser”).

The Company, on the one hand, and the Purchaser, on the other hand, are hereinafter each referred to as a “Party” and collectively as the “Parties”.

W I T N E S S E T H:

WHEREAS, upon the terms and subject to the conditions of this Agreement, the Company desires to issue and sell to the Purchaser, and the Purchaser wishes to purchase from the Company, ordinary shares of the Company, par value US$0.0001 per share (“Ordinary Shares”) and a warrant that is exercisable for a certain number of Ordinary Shares in a private placement exempt from securities registration afforded by Section 4(a)(2) under the U.S. Securities Act of 1933, as amended (the “Securities Act”);

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises hereinafter set forth, the Parties hereto agree as follows:

Article I

PURCHASE AND SALE

Section 1.1      Issuance, Sale and Purchase of Ordinary Shares and the Warrant. Upon the terms and subject to the conditions of this Agreement, the Purchaser hereby agrees to purchase from the Company, and the Company hereby agrees to issue, sell and deliver to the Purchaser, at the Closing (as defined below), (i) that number of Ordinary Shares and (ii) a pre-funded warrant (in the form of Exhibit A attached hereto) that is exercisable for that number of Ordinary Shares (the “Warrant”), in each case, for the amount of consideration set forth opposite the Purchaser’s name on Schedule I hereto (the “Purchase Price”), free and clear of all liens or encumbrances (except for restrictions arising under the Securities Act or created by virtue of this Agreement). The Ordinary Shares issued to the Purchaser pursuant to this Agreement at the Closing pursuant to Schedule I shall be referred to herein as the “Purchased Ordinary Shares”, and the Ordinary Shares to be issued to the Purchaser upon the exercise of the Warrant pursuant the Warrant shall be referred to herein as the “Warrant Shares”, and together with Purchased Ordinary Shares, the “Purchased Shares”.

Section 1.2      Closing.

(a)            Closing. The closing (the “Closing”) of the sale and purchase of the Purchased Ordinary Shares and the Warrant pursuant to Section 1.1 shall take place remotely via the electronic exchange of the closing documents and signatures on the third Business Day following the satisfaction or, to the extent permitted by applicable Law, waiver of the conditions precedent specified in Section 1.3 or such other time as the Parties may mutually agree upon. The date and time of the Closing are referred to herein as the “Closing Date”.

(b)            Payment and Delivery. At the Closing, the Purchaser shall pay and deliver the Purchase Price to the Company in U.S. dollars by wire transfer, or by such other method mutually agreeable to the Parties, of immediately available funds to such bank account(s) designated in writing by the Company, and the Company shall have the Purchased Ordinary Shares issued and registered in the name of the Purchaser or in such nominee name as it may designate and shall deliver to the Purchaser (i) a copy of duly executed share certificate(s) registered in the name of the Purchaser (the original copies of which shall be delivered to the Purchaser as soon as commercially practicable following the Closing), together with a certified true copy of the relevant extract of the register of members of the Company, evidencing the Purchased Ordinary Shares being issued and sold to the Purchaser, and (ii) a PDF copy of duly executed Warrant registered in the name of the Purchaser (the original copies of which shall be delivered to the Purchaser as soon as commercially practicable following the Closing).

(c)            Restrictive Legend and Transfer Restrictions. Each certificate representing the Purchased Shares shall be endorsed with the following legend:

THIS SECURITY HAS BEEN ACQUIRED FOR INVESTMENT AND WITHOUT A VIEW TO DISTRIBUTION AND HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE “ACT”), OR UNDER STATE SECURITIES LAWS. NO TRANSFER, SALE, ASSIGNMENT, PLEDGE, HYPOTHECATION OR OTHER DISPOSITION OF THIS SECURITY OR ANY INTEREST OR PARTICIPATION THEREIN MAY BE MADE EXCEPT (A) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR (B) PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS AND, IN THE CASE OF CLAUSE (B), UNLESS THE ISSUER RECEIVES AN OPINION OF COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER TO THE EFFECT THAT REGISTRATION IS NOT REQUIRED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS. IN ADDITION, ANY SUCH TRANSFER OR OTHER DISPOSITION IS SUBJECT TO THE CONDITIONS CONTAINED IN A PURCHASE AGREEMENT, DATED JUNE 26, 2024. A COPY OF SUCH CONDITIONS WILL BE PROVIDED TO THE HOLDER HEREOF UPON REQUEST. ANY ATTEMPT TO TRANSFER, SELL, PLEDGE OR HYPOTHECATE THIS SECURITY IN VIOLATION OF THESE RESTRICTIONS SHALL BE VOID.

Unless made pursuant to an effective registration statement under the Securities Act or pursuant to Rule 144 thereunder, any transferee of the Purchased Shares, the Warrants or any interest therein, by its acceptance thereof, shall be deemed to have made the representations set forth in Section 2.2 of this Agreement. Unless made pursuant to an effective registration statement under the Securities Act or pursuant to Rule 144 thereunder, the Company shall not be required to register the transfer of any Purchased Shares or Warrant to any person unless the Company receives from the proposed transferee a written instrument in form and substance reasonably satisfactory to the Company in which such transferee makes the representations and warranties set forth in Section 2.2 of this Agreement and, if the Company so requests, an opinion of counsel in form and substance reasonably satisfactory to the Company to the effect that registration under the Securities Act is not required in connection with such transfer.

Section 1.3      Closing Conditions.

(a)            Conditions to the Purchaser’s Obligations to Effect the Closing. The obligation of the Purchaser to purchase and pay for the Purchased Ordinary Shares and the Warrant as contemplated by this Agreement is subject to the satisfaction, on or before the Closing Date of the following conditions, any of which may only be waived in writing by the Purchaser in its sole discretion:

(ii)           The representations and warranties of the Company contained in Section 2.1 of this Agreement shall have been true and correct in all material respects (or if qualified by materiality or a Material Adverse Effect, true and correct in all respects) on the date of this Agreement and on and as of the Closing Date; and the Company shall have performed and complied in all material respects with all, and not be in breach or default in any material respects under any, agreements, covenants, conditions and obligations contained in this Agreement or any other Transaction Document that are required to be performed or complied with on or before the Closing Date.

(iv)          Since the date hereof, no event or series of events shall have occurred that has had or would reasonably be expected to have a Material Adverse Effect.

(v)            The listing and trading of the Ordinary Shares on the Nasdaq Capital Market shall not have been suspended, by the SEC or the Nasdaq Capital Market from trading thereon, nor shall any suspension by the SEC or the Nasdaq Capital Market have been threatened, either (A) in writing by the SEC or the Nasdaq Capital Market or (B) by falling below the minimum listing maintenance requirements of the Nasdaq Capital Market (with a reasonable prospect of delisting occurring after giving effect to all applicable notice, appeal, compliance and hearing periods); and the Company shall have submitted with The Nasdaq Stock Market, LLC a Notification Form: Listing of Additional Shares for the listing of the Purchased Ordinary Shares and the Warrant Shares.

(vi)            The Company shall have delivered to the Purchaser and the Placement Agent the opinion of Skadden Arps, Slate, Meagher & Flom LLP, dated as of the Closing Date, which such opinion shall include a valid private placement opinion, in customary form and substance to be reasonably agreed upon with the Purchaser and the Placement Agent and addressing such legal matters as the Purchaser, the Placement Agent and the Company reasonably agree.

(vii)            An authorized officer of the Company shall have delivered to the Purchaser at the Closing Date a certificate certifying that the conditions specified in Sections 1.3(a)(i), (ii), (iii), (iv) and (v) of this Agreement have been fulfilled.

(b)            Conditions to the Company’s Obligations to Effect the Closing. The obligation of the Company to issue, sell and deliver the Purchased Ordinary Shares and the Warrant to the Purchaser as contemplated by this Agreement is subject to the satisfaction, on or before the Closing Date of each of the following conditions, any of which may only be waived in writing by the Company in its sole discretion:

(i)            All corporate and other actions, as applicable, required to be taken by the Purchaser in connection with the purchase of the Purchased Ordinary Shares and the Warrant hereunder and any other transactions contemplated under the Transaction Documents shall have been completed.

(ii)            The representations and warranties of the Purchaser contained in Section 2.2 of this Agreement shall have been true and correct in all material respects (or if qualified by materiality or a Material Adverse Effect, true and correct in all respects) on the date of this Agreement and on and as of the Closing Date; and the Purchaser shall have performed and complied in all material respects with all, and not be in breach or default in any material respect under any, agreements, covenants, conditions and obligations contained in this Agreement or any other Transaction Document that are required to be performed or complied with on or before the Closing Date.

(iii)           No governmental authority of competent jurisdiction shall have enacted, issued, promulgated, enforced or entered any law (whether temporary, preliminary or permanent) that is in effect and restrains, enjoins, prevents, prohibits or otherwise makes illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company; and no action, suit, proceeding or investigation shall have been instituted by a governmental authority of competent jurisdiction or threatened that seeks to restrain, enjoin, prevent, prohibit or otherwise make illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company.

Article II

REPRESENTATIONS AND WARRANTIES

Section 2.1      Representations and Warranties of the Company. The Company hereby represents and warrants to the Purchaser and Jefferies LLC (the “Placement Agent”), whom the Company has engaged as its exclusive placement agent in connection with the private placement of the Ordinary Shares and the Warrant, as of the date hereof and as of the Closing Date as follows:

(b)            Authority. The Company has full power and authority to enter into, execute and deliver this Agreement and other Transaction Documents and each agreement, certificate, document and instrument to be executed and delivered by the Company pursuant to this Agreement and other Transaction Documents and to perform its obligations hereunder and thereunder. The execution and delivery by the Company of this Agreement and other Transaction Documents and the performance by the Company of its obligations hereunder and thereunder have been duly authorized by all requisite actions on its part.

(c)            Valid Agreement. The Transaction Documents have all been duly executed and delivered by the Company and, assuming the due and valid execution and delivery hereof by the Purchaser, constitute the legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by the availability of specific performance, injunctive relief, or other equitable remedies.

(d)            Capitalization.

(i)            The authorized share capital of the Company is US$50,000 divided into 500,000,000 shares of a par value of US$0.0001 each. All outstanding Ordinary Shares of the Company and all outstanding shares of each of the Company’s subsidiaries and consolidated Affiliates (each a “Subsidiary” and collectively “Subsidiaries”) have been issued and granted in compliance with (x) all applicable Securities Laws and other applicable laws, and (y) all requirements set forth in applicable plans or contracts, without violation of any preemptive rights, rights of first refusal or other similar rights. “Securities Laws” means the Securities Act, the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the listing rules of, or any listing agreement with, the Nasdaq Capital Market (“NASDAQ”) and any other applicable law regulating securities or takeover matters.

(ii)           The rights of the Ordinary Shares to be issued to the Purchaser as Purchased Shares shall be as stated in the Amended and Restated Memorandum and Articles of Association of the Company.

(e)            Due Issuance of the Purchased Shares. The Purchased Shares have been duly authorized and, when issued and delivered to and paid for by the Purchaser pursuant to this Agreement, will be validly issued, fully paid and non-assessable and free and clear of any pledge, mortgage, security interest, encumbrance, lien, charge, assessment, right of first refusal, right of pre-emption, third party right or interest, claim or restriction of any kind or nature, except for restrictions arising under the Securities Act or created by virtue of this Agreement, and upon delivery and entry into the register of members of the Company will transfer to the Purchaser good and valid title to the Purchased Shares.

(f)            Noncontravention. Neither the execution and the delivery of this Agreement or any other Transaction Document, nor the consummation of the transactions contemplated hereby and thereby, will (i) violate any provision of the organizational documents of the Company or its Subsidiaries or violate any constitution, statute, regulation, rule, injunction, judgment, order, decree, ruling, charge, or other restriction of any government, governmental entity or court to which the Company or its Subsidiaries is subject, or (ii) except in each case as do not and would not have a Material Adverse Effect, conflict with, result in a breach of, constitute a default under, result in the acceleration of or creation of an encumbrance under, or create in any party the right to accelerate, terminate, modify, or cancel, any agreement, contract, lease, license, instrument, or other arrangement to which the Company or its Subsidiaries is a party or by which the Company or its Subsidiaries is bound or to which any of the Company’s or its Subsidiaries’ assets are subject. There is no action, suit or proceeding, pending or threatened against the Company or its Subsidiaries that questions the validity of this Agreement or any other Transaction Document or the right of the Company to enter into this Agreement or any other Transaction Document or to consummate the transactions contemplated hereby, and is reasonably expected to be determined adversely against the Company or its Subsidiaries, and if so determined, would have a Material Adverse Effect. As used herein, “Material Adverse Effect” shall mean any event, fact, circumstance or occurrence that, individually or in the aggregate with any other events, facts, circumstances or occurrences, results in or would reasonably be expected to result in a material adverse change in or a material adverse effect on any of (A) the financial condition, assets, liabilities, results of operations, business, or operations of the Company and its Subsidiaries taken as a whole, except to the extent that any such Material Adverse Effect results from (x) the public disclosure of the transactions contemplated under the Transaction Documents in accordance with the terms of such documents, (y) changes in generally accepted accounting principles that are generally applicable to comparable companies, or (z) changes in general economic and market conditions; or (B) the ability of the Company to consummate the transactions contemplated by the Transaction Documents and to timely perform its material obligations under the Transaction Documents.

(g)           Consents and Approvals. Assuming the accuracy of the representations and warranties of the Purchaser under this Agreement and other Transaction Documents, neither the execution and delivery by the Company of this Agreement or any other Transaction Document, nor the consummation by the Company of any of the transactions contemplated hereby and thereby, nor the performance by the Company of this Agreement or any other Transaction Document in accordance with its terms requires the consent, approval, order or authorization of, or registration with, or the giving notice to, any governmental or public body or authority or any third party, other than such as have been or will have been obtained, made or given on or prior to the Closing Date, except for (x) any required filing or notifications regarding the issuance or listing of additional securities with NASDAQ or other regulatory authorities, or (y) such consent, authorization, order, filing or registration which, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Effect.

(h)            SEC Documents. Since January 1, 2023, the Company has timely filed or furnished (including following any extensions of time for filing provided by Rule 12b-25 promulgated under the Exchange Act), as applicable, all reports, schedules, forms, statements and other documents required to be filed or furnished by it with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the Securities Act or the Exchange Act and the rules and regulations promulgated thereunder (all of the foregoing documents filed with or furnished to the SEC and all exhibits included therein and financial statements, notes and schedules thereto and documents incorporated by reference therein being hereinafter referred to as the “SEC Documents”). Each of SEC Documents complied in all material respects with the requirements of the Securities Laws and the rules and regulations of the SEC promulgated thereunder. Since January 1, 2023, none of the SEC Documents, at the time they were filed or furnished, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. As of the date of this Agreement, the Company’s Ordinary Shares are listed on Nasdaq, and the Company has not received any notification that the Commission or Nasdaq is contemplating suspending or terminating such listings (or the applicable registration under the Exchange Act related thereto).

(i)            Foreign Private Issuer. The Company is a “foreign private issuer,” within the meaning of Rule 3b-4 under the Exchange Act. The Company has taken all actions required pursuant to Nasdaq Rule 5615(a)(3) to duly and validly rely on the exemption for foreign private issuers from applicable rules and regulations of the Nasdaq by adopting the home country practice as disclosed in the SEC Documents.

(k)            Financial Statements. Except as disclosed in the SEC Documents, the financial statements (including any related notes) contained in the SEC Documents (collectively, the “Financial Statements”): (A) were prepared in accordance with U.S. GAAP applied on a consistent basis throughout the periods covered thereby (except (a) as may be otherwise indicated in such Financial Statements or the notes thereto, or (b) in the case of unaudited interim statements, to the extent they may exclude footnotes or may be condensed to summary statements) and (B) fairly present in all material respects the consolidated financial position of the Company and the Subsidiaries as of the respective dates thereof and the consolidated results of operations and cash flows of the Company and the Subsidiaries for the periods covered thereby, in each case except as disclosed therein or in the SEC Documents and as permitted under the Exchange Act.

(l)            Intellectual Property. In each case except as otherwise disclosed in the SEC Documents, (1) the Company and each of its Subsidiaries owns or has obtained valid and enforceable licenses for the inventions, patents, patent applications, trademarks, trade names, service names, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information) and other intellectual property described in the SEC Documents as being owned or licensed by it or which are necessary for the conduct of its business as currently conducted or as currently proposed to be conducted (with respect to the development and commercialization of the product candidates described in the SEC Documents, except where the failure to own or license such rights would not, individually or in the aggregate, have a Material Adverse Effect) (collectively, “Intellectual Property”), and to the Company’s knowledge the conduct of its business does not infringe, misappropriate, or otherwise conflict in any material respect with any such rights of others; (2) the Intellectual Property of the Company is subsisting, free and clear of all material liens, and has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part and the Company has no knowledge of any facts which would form a reasonable basis for any such adjudication except where such adjudication or material liens would not, individually or in the aggregate, have a Material Adverse Effect; (3) to the Company’s knowledge, there are no third parties who have rights to any Intellectual Property, except for any customary reversionary rights of third-party licensors with respect to Intellectual Property that is disclosed in the SEC Documents as licensed to the Company or a Subsidiary; and, to the Company’s knowledge, there is no infringement by third parties of any Intellectual Property; and (4) the Company and each Subsidiary has complied in all material respects with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or a Subsidiary, and all such agreements are in full force and effect except as would not have a Material Adverse Effect. The Company and each Subsidiary has taken commercially reasonable steps to protect, maintain, and safeguard its Intellectual Property, including the execution of appropriate nondisclosure, confidentiality agreements, and invention assignment agreements and invention assignments with its employees or consultants, and, to the Company’s knowledge, no employee of the Company or consultant is in or has been in violation of any material term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement, or any restrictive covenant to or with a former employer where the basis of such violation relates to Intellectual Property except as would not have a Material Adverse Effect.

(m)            Regulatory Matters. Except as disclosed in the SEC Documents: (1) All material franchises, permits, licenses, consents and other permissions, authorizations, orders, filings, registrations, notifications, certificates, clearances, qualifications and approvals (“Permits”), for carrying on the business of the Company described in the SEC Documents, including all Permits required therefor by any applicable Regulatory Agency, have been obtained and are in full force and effect, except as would not have a Material Adverse Effect. The Company has not been notified in writing that any such Permits will be revoked or is incapable of renewal, except for any approvals required from the applicable Regulatory Agencies for the clinical development or marketing of any of the Company’s product candidates that has not yet been initiated or where the failure to obtain any such Permit would not have a Material Adverse Effect. (2) As to each drug product candidate subject to the jurisdiction of any U.S. federal, state, local or foreign regulatory body that regulates the types of matters subject to the jurisdiction of the FDA (each, a “Health Authority”) that is manufactured, packaged, labeled, tested by the Company (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested by or on behalf of the Company in compliance in all material respects with all applicable requirements under any applicable laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company, and the Company has not received any written notice, warning letter or other communication from any Health Authority, which (A) imposes a hold on or requires or threatens the termination, suspension or modification of any pre-clinical or clinical investigation or study being conducted on any Pharmaceutical Product by or on behalf of the Company or in which the Company has participated, (B) enjoins production at any facility of or utilized by the Company, (C) enters or proposes to enter into a consent decree of permanent injunction with the Company, or (D) otherwise alleges any material violation of any laws, rules or regulations by the Company. The currently pending clinical trials, studies and other preclinical tests of the Pharmaceutical Products conducted by or on behalf of the Company are being conducted in all material respects in compliance with all applicable requirements of Health Authorities, including, but not limited to, the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder, and in accordance with experimental protocols, procedures and with controls generally used by qualified experts in the preclinical or clinical study of new drugs. The Company has not been informed in writing by any Health Authority that such Health Authority will prohibit the marketing, sale, license or use in any jurisdiction in which the Company operates of any Pharmaceutical Product proposed to such Health Authority to be developed, produced or marketed by the Company nor, to the Company’s knowledge, has any Health Authority expressed in any meeting with the Company or written communication to the Company any concern as to approving or clearing for marketing any Pharmaceutical Product being developed or proposed to be developed by the Company. To the Company’s knowledge, there are no serious adverse events that have resulted from any of such studies, tests or trials that were not disclosed as required to any Health Authority. (3) The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the SEC Documents were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and to the Company’s knowledge no other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the SEC Documents; the Company and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any other Regulatory Agency; neither the Company nor any of its Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials or preclinical tests that are described or referred to in the SEC Documents; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies. As used herein, “Regulatory Agency” means all applicable statutes, rules, regulations and policies of applicable regulatory authorities, including but are not limited to the United States Food and Drug Administration (“FDA”) and the National Medial Product Administration of the People’s Republic of China, in each case that is responsible for registrations necessary for, or otherwise governs, the manufacture, handling, use, storage, import, transport, distribution or sale of any pharmaceutical product.

(n)            No Registration. Assuming the accuracy of the Purchaser’s representations and warranties set forth in Section 2.2 of this Agreement, no registration under the Securities Act is required for the offer and sale by the Company of the Purchased Shares and the Warrant to the Purchaser as contemplated hereby nor under the Transaction Documents.

(o)            Offering.

(i)            Neither the Company nor anyone acting on its behalf has offered the Purchased Ordinary Shares or Warrants or any similar securities for sale to, or solicited any offer to buy any of the same from, or otherwise approached or negotiated in respect thereof with, any person other than the Purchaser and such other purchasers pursuant to certain subscription agreements and subscription and purchaser agreements entered into on the date hereof (collectively, the “PIPE Purchasers”), each of which has been offered the Purchased Ordinary Shares or Warrants at a private sale for investment. “Institutional Accredited Investor” means an institutional accredited investor as defined in Rule 501(a)(1), (2), (3) or (7) under the Securities Act.

(ii)            None of the Company nor any of its affiliates has offered the Purchased Ordinary Shares, the Warrant or any similar securities during the six months prior to the date hereof to anyone other than the PIPE Purchasers. The Company has no intention to offer the Purchased Ordinary Shares or Warrants or any similar security during the six months from the date hereof.

(iii)           Neither the Company nor any person acting on its behalf has offered or sold the Purchased Ordinary Shares or Warrants by any form of general solicitation or general advertising, including, but not limited to, the following: (1) any advertisement, article, notice or other communication published in any newspaper, magazine, or similar media or broadcast over television or radio; (2) any website posting or widely distributed email; or (3) any seminar or meeting whose attendees have been invited by any general solicitation or general advertising.

(iv)           Other than the Placement Agent, the Company has not dealt with any broker, finder, commission agent, placement agent or arranger in connection with the sale of the Purchased Ordinary Shares and Warrants and the transactions contemplated by this Agreement, and the Company is not under any obligation to pay any broker’s fee or commission in connection with such transactions other than to the Placement Agent. Neither the Company nor any of its affiliates nor any other person acting on its behalf (other than its officers acting in such capacity) has solicited offers for, or offered or sold, the Purchased Ordinary Shares and Warrants other than through the Placement Agent.

(v)           The Company shall exercise reasonable care to assure that the Purchaser and any subsequent transferees are not underwriters within the meaning of the Securities Act.

(p)            No Additional Representations. The Company makes no representations or warranties as to any matter whatsoever except as expressly set forth in the Transaction Documents or in any certificate delivered by the Company to the Purchaser and the Placement Agent in accordance with the terms thereof.

Section 2.2      Representations and Warranties of the Purchaser. The Purchaser hereby represents and warrants to the Company and the Placement Agent as of the date hereof and as of the Closing Date as follows:

(b)            Authority. The Purchaser has full power and authority to enter into, execute and deliver the Transaction Documents and each agreement, certificate, document and instrument to be executed and delivered by it pursuant to the Transaction Documents and to perform its obligations hereunder and thereunder. The execution and delivery by the Purchaser of the Transaction Documents and the performance by it of its obligations hereunder and thereunder have been duly authorized by all requisite actions on its part.

(c)            Valid Agreement. The Transaction Documents have been duly executed and delivered by the Purchaser and constitutes its legal, valid and binding obligation, enforceable against the Purchaser in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by the availability of specific performance, injunctive relief, or other equitable remedies.

(d)            Noncontravention. Neither the execution and the delivery of this Agreement, nor the consummation of the transactions contemplated hereby, will (i) where applicable, violate any provision of the organizational documents of the Purchaser or violate any constitution, statute, regulation, rule, injunction, judgment, order, decree, ruling, charge, or other restriction of any government, governmental entity or court to which the Purchaser is subject, or (ii) conflict with, result in a breach of, constitute a default under, result in the acceleration of or creation of an encumbrance under, or create in any party the right to accelerate, terminate, modify, or cancel, any agreement, contract, lease, license, instrument, or other arrangement to which the Purchaser is a party or by which the Purchaser is bound or to which any of the Purchaser’s assets are subject. There is no action, suit or proceeding, pending or, threatened against the Purchaser that questions the validity of this Agreement or other Transaction Documents or the right of the Purchaser to enter into this Agreement or other Transaction Documents or to consummate the transactions contemplated hereby and thereby.

(f)            Status and Investment Intent

(ii)            Purchase Entirely for Own Account. The Purchaser is acquiring the Warrant and the Purchased Shares for its own account for investment purposes only and not with the view to, or with any intention of, resale, distribution or other disposition thereof. The Purchaser does not have any direct or indirect arrangement, or understanding with any other person to distribute, or regarding the distribution of the Warrant or Purchased Shares in violation of the Securities Act or any other applicable state securities law. The Purchaser is not a broker-dealer registered with the SEC under the Exchange Act or an entity engaged in a business that would require it to be so registered as a broker-dealer.

(iii)           Restricted Securities. The Purchaser acknowledges that the Purchased Shares and the Warrant are “restricted securities” that have not been registered under the Securities Act or any applicable state securities law, and the Purchased Shares will bear a restrictive legend substantially in the form set forth in Section 1.2(c). The Purchaser further acknowledges that, absent an effective registration under the Securities Act, the Purchased Shares may only be offered, sold or otherwise transferred (A) to the Company, (B) outside the United States in accordance with Rule 904 of Regulation S under the Securities Act, or (C) pursuant to an exemption from registration under the Securities Act, including the exemption provided by Rule 144 of the Securities Act. Assuming the validity of the representations of the Company, the Purchaser further acknowledges that the Company is not required to register the Purchased Shares and the Warrant. The Purchaser represents and warrants that such Purchaser will not sell, transfer or otherwise dispose of the Purchased Shares or the Warrant or any interest therein except in a registered transaction or in a transaction exempt from or not subject to the registration requirements of the Securities Act.

(iv)           Information. The Purchaser has carefully reviewed all documents relating to the transactions contemplated by this Agreement and has been provided with all other materials that it considers relevant to the transactions contemplated by this Agreement, has had a full opportunity to ask questions of and receive answers from the Company or any person acting on behalf of the Company concerning the terms and conditions of transactions contemplated by this Agreement. The Purchaser was given the opportunity to ask questions and receive answers concerning the terms and conditions of the offering and to obtain any additional information which the Company possesses or can acquire without unreasonable effort or expense. In making its decision to invest in the Company, the Purchaser is not relying upon, and has not relied upon, any statement, representation or warranty made by any person, except for the statements, representations and warranties contained in this Agreement. The Purchaser is relying solely on its own counsel and other advisors as to the financial, tax, legal and related matters concerning an investment in the Warrant and the Purchased Shares. The Purchaser understands that the Placement Agent has acted solely as the agent of the Company in this private placement of the Purchased Ordinary Shares and the Warrant and the Purchaser has not relied on the business or legal advice of the Placement Agent or any of its agents, representatives, counsel or Affiliates in making its investment decision hereunder, and confirms that none of such persons has made any representations or warranties to the Purchaser in connection with the transactions contemplated by this Agreement. Neither the Placement Agent nor any of its agents, representatives, counsel or Affiliates has any responsibility with respect to the completeness or accuracy or any information or materials furnished to the Purchaser in connection with the transactions contemplated by this Agreement. The purchase of Purchased Ordinary Shares and the Warrants by the Purchaser has not been solicited by or through anyone other than the Issuer or the Placement Agent.

(v)            Status. The Purchaser is either (x) a non-U.S. person located outside of the United States, as such terms are defined in Rule 902 of Regulation S under the Securities Act or (y) both an “accredited investor”, as that term is defined in Rule 501 of Regulation D under the Securities Act and a “qualified institutional buyer” as defined in Rule 144A promulgated under the Securities Act acting for its own account (and not for the account of others). The Purchaser has not been subject to any “directed selling efforts” within the meaning of Rule 903 of Regulation S under the Securities Act in connection with its execution of this Agreement.

(vi)           FINRA. The Purchaser does not, directly or indirectly, own more than five per cent of the outstanding common stock (or other voting securities) of any member of the Financial Industry Regulatory Authority, Inc. (“FINRA”) or a holding company for a FINRA member, and is not otherwise a “restricted person” for the purposes of FINRA Rule 5130.

(h)            Potential Transaction of the Company. The Purchaser acknowledges that the Company is currently reviewing and considering a preliminary non-binding proposal with respect to the acquisition of certain of the Company’s business operations in China (the “Proposal”), and agrees that (i) the Company shall have full power to, pursuant to the applicable laws and its Amended and Restated Memorandum and Articles of Association, review, negotiate and enter into transactions in connection with the Proposal or such other alternative transactions available to the Company, and (ii) the Company may sell, transfer, license, assign or otherwise dispose of its assets and/or all the license-in, distribution and related rights in Asia (excluding Japan) related to all the Company’s pipeline products including but not limited to EVOMELA^®, FOLOTYN^®, CNCT19, BI-1206, CB-5339, CID-103 and Thiotepa, in connection with such transactions.

Article III

Post-Closing COVENANTS

Section 3.1      Further Assurances. Each of the Purchaser and the Company shall use all reasonable efforts to fulfill or obtain the fulfillment of the conditions precedent to the consummation of the transactions contemplated by this Agreement on a timely basis, including the execution and delivery of any documents, certificates, instruments or other papers that are reasonably required for the consummation of such transactions, and will cooperate and consult with the other and use reasonable efforts to prepare and file all necessary documentation, to effect all necessary applications, notices, petitions, filings and other documents, and to obtain all necessary permits, consents, orders, approvals and authorizations of, or any exemption by, all governmental entities, necessary or advisable to consummate the transactions contemplated by this Agreement.

Section 3.2      Listing. The Company shall use commercially reasonable efforts to maintain the listing and trading of its Ordinary Shares on the Nasdaq Capital Market and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the rules and regulations of NASDAQ.

Section 3.3      Disclosure. The Company shall, not later than 6:00 p.m., New York City time, on the trading day immediately after the date of this Agreement, disseminate a public announcement disclosing the execution of this Agreement and the material terms of the Transaction Documents pursuant to the applicable rules and regulations (the “Public Announcement”). After each of the furnishing of the Public Announcement and the Closing, the Company shall have publicly disclosed all material, nonpublic information delivered to the Purchaser (or the Purchaser’s representatives or agents) by the Company, or any of its officers, directors, employees, agents or representatives (if any) in connection with the transactions contemplated by the Transaction Documents. The Company shall provide the Purchaser a reasonable opportunity to comment on a draft of the Public Announcement prior to its dissemination and shall give reasonable consideration to all such comments. The Purchaser covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed by the Company as described in this Section 3.3, the Purchaser shall maintain the confidentiality of all disclosures made to it in connection with the transactions contemplated by the Transaction Documents (including the existence and terms of the transactions contemplated thereby), except that the Purchaser may disclose the terms of such transactions to its financial, accounting, legal and other advisors (provided that the Purchaser directs such persons to maintain the confidentiality of such information).

Section 3.4      Reservation. As of the date hereof, the Company has available and, as long as the Purchased Warrant remains outstanding, the Company shall authorize, reserve and keep available at all times, free of preemptive and other similar rights of shareholders, the requisite aggregate number of authorized but unissued Ordinary Shares to enable the Company to timely effect the exercise of the Purchased Warrant, assuming the Purchased Warrant is exercisable in full and without regard to any limitations on the exercise of the Purchased Warrant set forth therein.

Section 3.5      [Reserved]

Section 3.6      Registration of Purchased Shares.

(a)            The Company shall prepare and file with the SEC a registration statement on appropriate form pursuant to the Securities Act (the “Registration Statement”) with respect to all Purchased Shares owned by the Purchaser as promptly as reasonably practicable and in any event no later than sixty (60) days after the Closing to cover the sale of such Purchased Shares pursuant to such Registration Statement, and shall use its best efforts to cause such Registration Statement to be declared effective by the SEC as soon as practicable.

(b)            All fees and expenses incurred in connection with the preparation and filing of the Registration Statement (excluding any underwriting discounts and selling commissions, stock transfer taxes and fees and all legal fees and expenses of legal counsel for the Purchaser) shall be borne by the Company.

(c)            The Purchaser shall use commercially reasonable efforts to assist the Company in the preparation and filing of the Registration Statement and such other matters in relation thereto, including without limitation to provide such information reasonably requested by the Company in relation thereto.

(d)            The Purchaser shall indemnify and hold harmless the Company, its officers, directors, agents, partners, members, managers, stockholders, advisors, Affiliates and employees of each of them, to the fullest extent permitted by applicable law, from and against all losses or reasonable and documented expenses, as incurred, arising out of or are based solely upon any actual or alleged untrue statement of a material fact contained in the Registration Statement, any Prospectus, or any form of prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any actual or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, or any form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading (i) to the extent that such untrue statements or omissions are based solely upon information regarding the Purchaser furnished in writing to the Company by the Purchaser expressly for use therein, (ii) to the extent that such information relates to the Purchaser or the Purchaser’s proposed method of distribution of Purchased Shares and was supplied by the Purchaser expressly for use in the Registration Statement, such Prospectus or such form of Prospectus or in any amendment or supplement thereto, or (iii) in the case of an occurrence of an event of (x) the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement covering any or all of the Purchased Shares or the initiation of any proceedings for that purpose; or (y) the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Purchased Shares for sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose, to the extent related to the use by the Purchaser of an outdated or defective Prospectus after the Company has notified the Purchaser in writing that the Prospectus is outdated or defective and prior to the receipt by the Purchaser of an advice in writing by the Company that the use of the applicable Prospectus (as it may have been supplemented or amended) may be resumed. In no event shall the liability of the Purchaser under this Agreement be greater in amount than the dollar amount of the net proceeds received by the Purchaser upon the sale of the Purchased Shares giving rise to such indemnification obligation. For the purpose of this Section 3.6(d), Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Purchased Shares covered by a Registration Statement, and all other amendments and supplements to the Prospectus, including post effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.

(e)            The Company shall indemnify and hold harmless the Purchaser, its officers, directors, agents, partners, members, managers, stockholders, advisors, Affiliates and employees of each of them, to the fullest extent permitted by applicable law, from and against all losses or reasonable and documented expenses, as incurred, arising out of or are based solely upon any actual or alleged untrue statement of a material fact contained in the Registration Statement, any Prospectus, or any form of prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any actual or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, or any form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading, except to the extent that (A) such untrue statements or omissions are based solely upon information regarding the Purchaser furnished in writing to the Company by the Purchaser expressly for use therein, or to the extent that such information relates to the Purchaser or the Purchaser’ proposed method of distribution of Purchased Shares and was supplied by the Purchaser expressly for use in the Registration Statement, such Prospectus or such form of Prospectus or in any amendment or supplement thereto, or (B) in the case of an occurrence of an event of (x) the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement covering any or all of the Purchased Shares or the initiation of any proceedings for that purpose; or (y) the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Purchased Shares for sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose, related to the use by the Purchaser of an outdated or defective Prospectus after the Company has notified the Purchaser in writing that the Prospectus is outdated or defective, or (C) to the extent that any such losses arise out of the Purchaser’s (or any other indemnified Person’s) failure to send or give a copy of the Prospectus or supplement (as then amended or supplemented), if required, pursuant to Rule 172 under the Securities Act (or any successor rule) to the Persons asserting an untrue statement or omission at or prior to the written confirmation of the sale of Purchased Shares to such Person if such statement or omission was corrected in such Prospectus or supplement.

Section 3.7      CSRC Filing.

(a)            The Company undertakes to file or cause to be filed with the China Securities Regulatory Commission (the “CSRC”) the requisite information and documents within three (3) Business Days or other timeframe prescribed by the CSRC following the Closing in accordance with the Trial Administrative Measures of Overseas Securities Offering and Listing by Domestic Companies (境内企业境外发行证券和上市管理试行办法) and supporting guidelines issued by the CSRC on February 17, 2023, as amended, supplemented or otherwise modified from time to time (the “CSRC Filing”).

(b)            The Purchaser shall provide the Company with reasonable assistance it may require in connection with the CSRC Filing, including without limitation to provide such information relating to the Purchaser as may be necessary for the purposes of submitting such filings, or may otherwise be required in order for the Company to satisfy the regulatory requirements in respect of the CSRC Filing.

Article IV

MISCELLANEOUS

Section 4.1      Governing Law; Arbitration. This Agreement shall be governed and interpreted in accordance with the laws of the State of New York. Any dispute, controversy or claim arising out of or relating to this Agreement, or the interpretation, breach, termination or validity hereof, shall be submitted to arbitration upon the request of any party with notice to the other party. The arbitration shall be conducted in Hong Kong under the auspices of the Hong Kong International Arbitration Centre (“HKIAC”) in accordance with the HKIAC Administered Arbitration Rules then in effect, which rules are deemed to be incorporated by reference into this Section 4.1. There shall be three (3) arbitrators. The complainant and the respondent to such dispute shall each select one arbitrator within thirty (30) days after giving or receiving the demand for arbitration. The Chairman of the HKIAC shall select the third arbitrator. If either party to the arbitration does not appoint an arbitrator who has consented to participate within 30 days after selection of the first arbitrator, the relevant appointment shall be made by the Chairman of the HKIAC. The arbitration proceedings shall be conducted in English. Each party irrevocably waives, to the fullest extent it may effectively do so, any objection which it may now or hereafter have to the laying of venue of any such arbitration in Hong Kong and the HKIAC, and hereby submits to the exclusive jurisdiction of HKIAC in any such arbitration. The award of the arbitration tribunal shall be conclusive and binding upon the disputing parties, and any party to the dispute may apply to a court of competent jurisdiction for enforcement of such award. Any party to the dispute shall be entitled to seek preliminary injunctive relief, if possible, from any court of competent jurisdiction pending the constitution of the arbitral tribunal.

Section 4.2      Amendment. This Agreement shall not be amended, changed or modified, except by another agreement in writing executed by the Parties.

Section 4.3      Binding Effect. This Agreement shall inure to the benefit of, and be binding upon, each of the Parties and their respective heirs, successors and permitted assigns and legal representatives.

Section 4.4      Assignment. Neither this Agreement nor any of the rights, duties or obligations hereunder may be assigned by a Party without the express written consent of the other Parties, except that the Purchaser may assign all or any part of its rights and obligations hereunder to any Affiliate of the Purchaser without the consent of the Company; provided that no such assignment shall relieve the Purchaser of its obligations hereunder if such assignee does not perform such obligations. Any purported assignment in violation of the foregoing sentence shall be null and void. For purposes of this Agreement, “Affiliate” of a person means any other person that directly or indirectly Controls, is Controlled by or is under common Control with such person, where “Control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management of a person, whether through the ownership of voting securities, by contract, credit arrangement or proxy, as trustee, executor or agent or otherwise.

Section 4.5      Notices. All notices, requests, demands and other communications that are required or may be given pursuant to the terms of this Agreement shall be in writing, and delivery shall be deemed sufficient in all respects and to have been duly given as follows: (a) on the actual date of service if delivered personally, (b) at the time of receipt if given by electronic mail to the email addresses set forth in this Section 4.5, (c) on the third Business Day after mailing if mailed by first-class mail return receipt requested, postage prepaid and properly addressed as set forth in this Section 4.5, or (d) on the day after delivery to a nationally recognized overnight courier service during its business hours for overnight delivery against receipt, and properly addressed as set forth in this Section 4.5:

	If to the Purchaser, at:	* Attn: *

	If to the Company, at:	9620 Medical Center Drive, Suite 300 Rockville, MD 20850 Attn: Rui Zhang

Any Party may change its address for purposes of this Section 4.5 by giving the other Parties hereto written notice of the new address in the manner set forth above. For purposes of this Agreement, “Business Day” means any day other than Saturday, Sunday or another day on which commercial banks located in the Cayman Islands, New York City, mainland China or Hong Kong are authorized or required by law or executive order to be closed.

Section 4.6      Entire Agreement. This Agreement and the other Transaction Documents together constitute the entire understanding and agreement between the Parties with respect to the matters covered hereby, and all prior agreements and understandings, oral or in writing, if any, between the Parties with respect to the matters covered hereby are merged and superseded by this Agreement and the other Transaction Documents.

Section 4.7      Severability. If any provisions of this Agreement shall be adjudicated to be illegal, invalid or unenforceable in any action or proceeding whether in its entirety or in any portion, then such provision shall be deemed amended, if possible, or deleted, as the case may be, from the Agreement in order to render the remainder of the Agreement and any provision thereof both valid and enforceable, and all other provisions hereof shall be given effect separately therefrom and shall not be affected thereby.

Section 4.8      Fees and Expenses. Except as otherwise provided in this Agreement, each of the Parties will bear its own costs and expenses incurred in connection with the negotiation, preparation and execution of this Agreement and the transactions contemplated hereby, including fees and expenses of attorneys, accountants, consultants and financial advisors.

Section 4.9      Announcement. Without limiting any other provision of this Agreement, the Company and Purchaser, to the extent permitted by applicable law, will consult with each other before issuance of, and provide each other the opportunity to review, comment upon and concur with, and use all reasonable efforts to agree on, any press release or public statement with respect to the Transaction Documents and the transactions contemplated hereby and thereby, and will not (to the extent practicable) issue any such press release or make any such public statement prior to such consultation and agreement, except as may be required by law, rules, regulations or any listing agreement with or requirement of NASDAQ or any other applicable securities exchange, provided that the disclosing Party shall, to the extent permitted by applicable law, rules, regulations or any listing agreement with or requirement of NASDAQ or any other applicable securities exchange and if reasonably practicable, inform the other Parties about the disclosure to be made pursuant to such requirements prior to the disclosure.

Section 4.10      Specific Performance. The Parties agree that irreparable damage would occur in the event any provision of this Agreement is not performed in accordance with the terms hereof and that the Parties shall be entitled to specific performance of the terms hereof, in addition to any other remedy at law or equity.

Section 4.11      Termination. This Agreement may be terminated and the transactions contemplated by this Agreement abandoned at any time prior to the Closing:

(a)

by mutual agreement of the Company and the Purchaser;

(b)

by the Company or the Purchaser if any legislative body, court, administrative agency or commission or other governmental authority, instrumentality, agency or commission shall have enacted, issued, promulgated, enforced or entered any law or governmental regulation or order which has the effect of prohibiting the sale and issuance of the Purchased Shares; provided, however, that the right to terminate this Agreement pursuant to this Section 4.11(b) shall not be available to a Party if the issuance of such law, regulation or order was initiated by, or primarily due to a breach by, such party of this Agreement;

(c)

by the Purchaser if there has been a material breach of any representation or warranty by the Company under any Transaction Document or any material breach of any covenant or agreement by the Company under any Transaction Document that would give rise to failure of the conditions set forth in Section 1.3(a) to be satisfied, which breach is not cured within ten (10) Business Days following the Purchaser’s delivery of a written notice thereof to the Company; provided, however, that the Purchaser shall not have the right to terminate this Agreement pursuant to this Section 4.11(c) if the Purchaser shall have materially breached or failed to perform any of its representation or warrant or covenant or agreement under any Transaction Document which breach or failure to perform would give rise to the failure of the condition set forth in Section 1.3; or

(d)

by the Company if there has been a material breach of any representation or warranty by the Purchaser under any Transaction Document or any material breach of any covenant or agreement by the Purchaser under any Transaction Document that would give rise to failure of the conditions set forth in Section 1.3(b) to be satisfied, which breach is not cured within ten (10) Business Days following the Company’s delivery of a written notice thereof to the Purchaser; provided, however, that the Company shall not have the right to terminate this Agreement pursuant to this Section 4.11(d) if the Company shall have materially breached or failed to perform any of its representation or warrant or covenant or agreement under any Transaction Document which breach or failure to perform would give rise to the failure of the condition set forth in Section 1.3,

(e)

by the Company in the event that the Closing shall not have occurred by September 25, 2024,

in each case this Agreement shall forthwith become void and there shall be no liability or obligation on the part of the Parties, except that the provisions of Section 4 hereof shall remain in full force and effect; provided that nothing herein shall relieve any Party hereto from liability for any breach of this Agreement that occurred prior to such termination.

Section 4.12      Acknowledgements Regarding Placement Agent.

(a)

The Purchaser acknowledges that the Placement Agent is acting as a placement agent on a “best efforts” basis for the Ordinary Shares and the Warrant being offered hereby and will be compensated by the Company for acting in such capacity. The Purchaser represents that the Purchaser was contacted regarding the sale of the Ordinary Shares and the Warrant by the Placement Agent or the Company (or an authorized agent or representative thereof) with whom the Purchaser entered into a verbal or written confidentiality agreement.

(b)

The Purchaser represents that it is making this investment based on the results of its own due diligence investigation of the Company, and has not relied on any information or advice furnished by or on behalf of the Placement Agent in connection with the transactions contemplated hereby. The Purchaser acknowledges that the Placement Agent has not made, and will not make, any representations and warranties with respect to the Company or the transactions contemplated hereby, and the Purchaser will not rely on any statements made by the Placement Agent, orally or in writing, to the contrary.

Section 4.13      Exculpation of the Placement Agent. Each Party hereto agrees for the express benefit of the Placement Agent and its Affiliates and representatives that:

(a)

The Placement Agent and its Affiliates and representatives (i) have no duties or obligations other than those specifically set forth herein or in that certain Engagement Letter by and between the Company and the Placement Agent, dated June 26, 2024 (the “Engagement Letter”); (ii) shall not be liable for any improper payment made in accordance with the information provided by the Company; (iii) make no representation or warranty, and have no responsibilities as to the validity, accuracy, value or genuineness of any information, certificates or documentation delivered by or on behalf of the Company pursuant to this Agreement or in connection with any of the transactions contemplated hereby, including any offering or marketing materials; and (iv) shall not be liable (A) for any action taken, suffered or omitted by any of them in good faith and reasonably believed to be authorized or within the discretion or rights or powers conferred upon them by this Agreement or any Transaction Document, or (B) for anything which any of them may do or refrain from doing in connection with this Agreement or any Transaction Document, except in each case for such person’s own gross negligence, willful misconduct or bad faith.

(b)

The Placement Agent and its Affiliates and representatives shall be entitled to (1) rely on, and shall be protected in acting upon, any certificate, instrument, notice, letter or any other document or security delivered to any of them by or on behalf of the Company, and (2) be indemnified by the Company for acting as a Placement Agent hereunder pursuant to the indemnification provisions set forth in the Engagement Letter.

Section 4.14      Headings. The headings of the various articles and sections of this Agreement are inserted merely for the purpose of convenience and do not expressly or by implication limit, define or extend the specific terms of the section so designated.

Section 4.15      Third-Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto, their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other person, except as set forth in Sections 3.6(d), 3.6(e), 4.12, 4.13 and 4.15 of this Agreement. The Placement Agent shall be the third-party beneficiary of the representations and warranties of the Company and the Purchaser in Article II.

Section 4.16      Execution in Counterparts. For the convenience of the Parties and to facilitate execution, this Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, but all of which together shall constitute but one and the same instrument.

Section 4.17      Remedies and Waivers. No delay or omission by any Party in exercising any right, power or remedy provided by law or under this Agreement or any other documents referred to in it shall: (i) affect that right, power or remedy; or (ii) operate as a waiver thereof. The single or partial exercise of any right, power or remedy provided by law or under this Agreement shall not preclude any other or further exercise or any other right, power or remedy. Except as otherwise expressly provided in this Agreement, the rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by law.

[signature pages follow]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

	CASI Pharmaceuticals, Inc.

	By:	/s/ Wei-Wu He
	Name: Wei-Wu He
	Title: Chairman and Chief Executive Officer

[Signature Page to Subscription and Purchase Agreement]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

	Foresite Capital Fund VI LP

	By:  Foresite Capital Management VI LLC
	Its:  General Partner

	By:	/s/ Dennis D. Ryan
	Name: Dennis D. Ryan
	Title:   Chief Financial Officer

[Signature Page to Subscription and Purchase Agreement]

Schedule I

Purchaser		Purchase Price for Ordinary Shares		Purchased Ordinary Shares
Foresite Capital Fund VI LP		US$100,000		20,000

		Purchase Price for Warrant		Warrant Shares
		US$4,899,902 (a nominal exercise price of $0.0001 per ordinary share will be paid upon exercise of the warrant)		980,000

Exhibit A

Form of Warrant

PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT

CASI PHARMACEUTICALS, INC.

Warrant Shares: 980,000

Issue Date: July 15, 2024

THIS PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, Foresite Capital Fund VI LP or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Issue Date (the “Initial Exercise Date”) until this Warrant is exercised in full (the “Termination Date”) but not thereafter, to subscribe for and purchase from CASI PHARMACEUTICALS, INC., a company incorporated with limited liability under the laws of the Cayman Islands (the “Company”), up to 980,000 Ordinary Shares, par value $0.0001 per share, of the Company (as subject to adjustment hereunder, the “Warrant Shares”). The purchase price of one Ordinary Share, par value $0.0001 per share, of the Company (each, an “Ordinary Share”), under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).

1.             Definitions. Capitalized terms used and not otherwise defined herein shall have the meanings set forth in that certain Subscription and Purchase Agreement (the “Purchase Agreement”), dated June 26, 2024, by and between the Company and the Holder.

2.             Exercise.

X = Y [(A-B)/A]

“X” equals the number of Warrant Shares to be issued to the Holder;

“Y” equals the total number of Warrant Shares with respect to which this Warrant is then being exercised;

“B” equals the Exercise Price per Warrant Share then in effect on the Exercise Date.

For the purposes of this Section 2:

(d)            Mechanics of Exercise.

(i)            Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company (“DTC”) through its Deposit Withdrawal Agent Commission system, or if the Company’s transfer agent is not participating in the Fast Automated Securities Transfer Program, by delivering of scanned copies of (a) share certificate(s) or a book entry position and (b) a true copy of the register of members of the Company or an extract therefrom duly certified by the registered agent or a director of the Company, evidencing that the Holder or its designee has been registered as the holder for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise through email to the email address specified by the Holder in the Notice of Exercise by the date that is the earlier of (i) two (2) Business Days after the delivery to the Company of the Notice of Exercise and (ii) the number of trading days that comprises the standard settlement period following delivery of the Notice of Exercise (such date, the “Warrant Share Delivery Date”), with original copies of such documents delivered to the address specified by the Holder in the Notice of Exercise as soon as practicable thereafter, but in no event later than ten (10) Business Days after the Warrant Share Delivery Date. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of Ordinary Shares on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered or Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Ordinary Shares as in effect on the date of delivery of the Notice of Exercise. The Holder, or any Person so designated by the Holder to receive Warrant Shares, shall be deemed to have become the holder of record of such Warrant Shares as of the Exercise Date, irrespective of the date such Warrant Shares are credited to the Holder’s DTC account or the date of delivery of the certificates or book entry position evidencing such Warrant Shares, as the case may be.

(iii)           Rescission Rights. If the Company fails to cause its transfer agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i) hereof by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise by delivering written notice to the Company at any time prior to the delivery of such Warrant Shares.

(iv)          Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder, if the Company fails to cause its transfer agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(d)(i) above pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases for the Holder, Ordinary Shares to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including reasonable and customary brokerage commissions, if any) for the Ordinary Shares so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue times (2) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of Ordinary Shares that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Ordinary Shares having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of Ordinary Shares with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and evidence of the amount of such loss. Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver Ordinary Shares upon exercise of the Warrant as required pursuant to the terms hereof.

3.            Certain Adjustments.

(f)            Notice to Holder.

(i)            Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

(ii)            Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Ordinary Shares, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Ordinary Shares, (C) the Company shall authorize the granting to all holders of the Ordinary Shares rights or warrants to subscribe for or purchase any shares of any class or of any rights, (D) the approval of any shareholders of the Company shall be required in connection with any reclassification of the Ordinary Shares, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange, in each case whereby the Ordinary Share is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by email to the Holder at its last email address as it shall appear upon the Warrant Register of the Company, at least three (3) days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Ordinary Shares of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Ordinary Shares of record shall be entitled to exchange their Ordinary Shares for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

4.            Transfer of Warrant.

5.            Miscellaneous.

(d)           Authorized Shares. The Company agrees that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Ordinary Shares a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable. The Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.

(g)           Waiver. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies.

(h)           Notices. Any notice, request or other document required or permitted to be given or delivered to the Holder by the Company shall be delivered in accordance with the notice provisions of the Purchase Agreement.

(k)           Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company, on the one hand, and the Holder, on the other hand.

(m)            Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

[Signature page follows]

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

CASI PHARMACEUTICALS, INC.

By:	/s/ Wei-Wu He
Name: Wei-Wu He
Title: Chairman and Chief Executive Officer

Exhibit A

NOTICE OF EXERCISE

TO: CASI PHARMACEUTICALS, INC.

(1)           The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.

(2)           Payment shall take the form of (check applicable box):

[ ]            in lawful money of the United States; or

[ ]           if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with subsection 2(c), to exercise this Warrant with respect to the number of Warrant Shares purchasable pursuant to the net exercise procedure set forth in subsection 2(c).

(3)            Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

___________________________________

The share certificate(s) and the certified register of members evidencing the Warrant Shares shall be delivered to the following address and email address:

_______________________________

[SIGNATURE OF HOLDER]

Name of Investing Entity: 

Signature of Authorized Signatory of Investing Entity:

Name of Authorized Signatory:

Title of Authorized Signatory:

Date:

Exhibit B

ASSIGNMENT FORM

(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to exercise the Warrant to purchase shares.)

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to

Name:

Address:

Phone Number:

Email Address:

Dated:

Holder’s Signature:

Holder’s Address:

Exhibit 4.4

Execution Version

SUBSCRIPTION AGREEMENT

This Subscription Agreement (this “Agreement”) is made as of June 26, 2024 by and between:

(1)

CASI Pharmaceuticals, Inc., an exempted company incorporated in the Cayman Islands with address of principal business office at 1701-1702, China Central Office Tower 1, No. 81 Jianguo Road Chaoyang District, Beijing, 100025, People’s Republic of China (the “Company”); and

(2)

PANACEA VENTURE HEALTHCARE FUND II, L.P., a limited partnership duly organized under the laws of Cayman Islands with address of principal business office at Maples Corporate Services Limited, Ugland House, Grand Cayman KY1-1104, Cayman Islands (“Purchaser”).

The Company, on the one hand, and the Purchaser, on the other hand, are hereinafter each referred to as a “Party” and collectively as the “Parties”.

W I T N E S S E T H:

WHEREAS, upon the terms and subject to the conditions of this Agreement, the Company desires to issue and sell to the Purchaser, and the Purchaser wishes to purchase from the Company, ordinary shares of the Company, par value US$0.0001 per share (“Ordinary Shares”) in a private placement exempt from securities registration afforded by Section 4(a)(2) under the U.S. Securities Act of 1933, as amended (the “Securities Act”);

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises hereinafter set forth, the Parties hereto agree as follows:

Article I

PURCHASE AND SALE

Section 1.1      Issuance, Sale and Purchase of Ordinary Shares. Upon the terms and subject to the conditions of this Agreement, the Purchaser hereby agrees to purchase from the Company, and the Company hereby agrees to issue, sell and deliver to the Purchaser, at the Closing (as defined below), that number of Ordinary Shares for the amount of consideration set forth opposite the Purchaser’s name on Schedule I hereto (the “Purchase Price”), free and clear of all liens or encumbrances (except for restrictions arising under the Securities Act or created by virtue of this Agreement). The Ordinary Shares issued to the Purchaser pursuant to this Agreement at the Closing pursuant to Schedule I shall be referred to herein as the “Purchased Shares”.

Section 1.2      Closing.

(a)            Closing. The closing (the “Closing”) of the sale and purchase of the Purchased Shares pursuant to Section 1.1 shall take place remotely via the electronic exchange of the closing documents and signatures on the third Business Day following the satisfaction or, to the extent permitted by applicable Law, waiver of the conditions precedent specified in Section 1.3 or such other time as the Parties may mutually agree upon. The date and time of the Closing are referred to herein as the “Closing Date”.

(b)            Payment and Delivery. At the Closing, the Purchaser shall pay and deliver the Purchase Price to the Company in U.S. dollars by wire transfer, or by such other method mutually agreeable to the Parties, of immediately available funds to such bank account(s) designated in writing by the Company, and the Company shall have the Purchased Shares issued and registered in the name of the Purchaser or in such nominee name as it may designate and shall deliver to the Purchaser a copy of duly executed share certificate(s) registered in the name of the Purchaser (the original copies of which shall be delivered to the Purchaser as soon as commercially practicable following the Closing), together with a certified true copy of the relevant extract of the register of members of the Company, evidencing the Purchased Shares being issued and sold to the Purchaser.

(c)            Restrictive Legend and Transfer Restrictions. Each certificate representing the Purchased Shares shall be endorsed with the following legend:

THIS SECURITY HAS BEEN ACQUIRED FOR INVESTMENT AND WITHOUT A VIEW TO DISTRIBUTION AND HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE “ACT”), OR UNDER STATE SECURITIES LAWS. NO TRANSFER, SALE, ASSIGNMENT, PLEDGE, HYPOTHECATION OR OTHER DISPOSITION OF THIS SECURITY OR ANY INTEREST OR PARTICIPATION THEREIN MAY BE MADE EXCEPT (A) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR (B) PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS AND, IN THE CASE OF CLAUSE (B), UNLESS THE ISSUER RECEIVES AN OPINION OF COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER TO THE EFFECT THAT REGISTRATION IS NOT REQUIRED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS. IN ADDITION, ANY SUCH TRANSFER OR OTHER DISPOSITION IS SUBJECT TO THE CONDITIONS CONTAINED IN A PURCHASE AGREEMENT, DATED JUNE 26, 2024. A COPY OF SUCH CONDITIONS WILL BE PROVIDED TO THE HOLDER HEREOF UPON REQUEST. ANY ATTEMPT TO TRANSFER, SELL, PLEDGE OR HYPOTHECATE THIS SECURITY IN VIOLATION OF THESE RESTRICTIONS SHALL BE VOID.

Unless made pursuant to an effective registration statement under the Securities Act or pursuant to Rule 144 thereunder, any transferee of the Purchased Shares, the Warrants or any interest therein, by its acceptance thereof, shall be deemed to have made the representations set forth in Section 2.2 of this Agreement. Unless made pursuant to an effective registration statement under the Securities Act or pursuant to Rule 144 thereunder, the Company shall not be required to register the transfer of any Purchased Shares or Warrant to any person unless the Company receives from the proposed transferee a written instrument in form and substance reasonably satisfactory to the Company in which such transferee makes the representations and warranties set forth in Section 2.2 of this Agreement and, if the Company so requests, an opinion of counsel in form and substance reasonably satisfactory to the Company to the effect that registration under the Securities Act is not required in connection with such transfer.

Section 1.3      Closing Conditions.

(a)            Conditions to the Purchaser’s Obligations to Effect the Closing. The obligation of the Purchaser to purchase and pay for the Purchased Shares as contemplated by this Agreement is subject to the satisfaction, on or before the Closing Date of the following conditions, any of which may only be waived in writing by the Purchaser in its sole discretion:

(i)          All corporate and other actions required to be taken by the Company in connection with the issuance and sale of the Purchased Shares hereunder and any other transactions contemplated under this Agreement and all the agreements and other documents required in connection with implementing the transactions contemplated hereby (together, the “Transaction Documents”) shall have been completed.

(ii)         The representations and warranties of the Company contained in Section 2.1 of this Agreement shall have been true and correct in all material respects (or if qualified by materiality or a Material Adverse Effect, true and correct in all respects) on the date of this Agreement and on and as of the Closing Date; and the Company shall have performed and complied in all material respects with all, and not be in breach or default in any material respects under any, agreements, covenants, conditions and obligations contained in this Agreement or any other Transaction Document that are required to be performed or complied with on or before the Closing Date.

(iii)        No governmental authority of competent jurisdiction shall have enacted, issued, promulgated, enforced or entered any law (whether temporary, preliminary or permanent) that is in effect and restrains, enjoins, prevents, prohibits or otherwise makes illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company; and no action, suit, proceeding or investigation shall have been instituted by a governmental authority of competent jurisdiction or threatened that seeks to restrain, enjoin, prevent, prohibit or otherwise make illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company.

(iv)       Since the date hereof, no event or series of events shall have occurred that has had or would reasonably be expected to have a Material Adverse Effect.

(v)        The listing and trading of the Ordinary Shares on the Nasdaq Capital Market shall not have been suspended, by the SEC or the Nasdaq Capital Market from trading thereon, nor shall any suspension by the SEC or the Nasdaq Capital Market have been threatened, either (A) in writing by the SEC or the Nasdaq Capital Market or (B) by falling below the minimum listing maintenance requirements of the Nasdaq Capital Market (with a reasonable prospect of delisting occurring after giving effect to all applicable notice, appeal, compliance and hearing periods); and the Company shall have submitted with The Nasdaq Stock Market, LLC a Notification Form: Listing of Additional Shares for the listing of the Purchased Shares.

(vi)       The Company shall have delivered to the Purchaser and the Placement Agent the opinion of Skadden Arps, Slate, Meagher & Flom LLP, dated as of the Closing Date, which such opinion shall include a valid private placement opinion, in customary form and substance to be reasonably agreed upon with the Purchaser and the Placement Agent and addressing such legal matters as the Purchaser, the Placement Agent and the Company reasonably agree.

(vii)      An authorized officer of the Company shall have delivered to the Purchaser at the Closing Date a certificate certifying that the conditions specified in Sections 1.3(a)(i), (ii), (iii), (iv) and (v) of this Agreement have been fulfilled.

(b)            Conditions to the Company’s Obligations to Effect the Closing. The obligation of the Company to issue, sell and deliver the Purchased Shares to the Purchaser as contemplated by this Agreement is subject to the satisfaction, on or before the Closing Date of each of the following conditions, any of which may only be waived in writing by the Company in its sole discretion:

(i)          All corporate and other actions, as applicable, required to be taken by the Purchaser in connection with the purchase of the Purchased Shares hereunder and any other transactions contemplated under the Transaction Documents shall have been completed.

(ii)         The representations and warranties of the Purchaser contained in Section 2.2 of this Agreement shall have been true and correct in all material respects (or if qualified by materiality or a Material Adverse Effect, true and correct in all respects) on the date of this Agreement and on and as of the Closing Date; and the Purchaser shall have performed and complied in all material respects with all, and not be in breach or default in any material respect under any, agreements, covenants, conditions and obligations contained in this Agreement or any other Transaction Document that are required to be performed or complied with on or before the Closing Date.

(iii)        No governmental authority of competent jurisdiction shall have enacted, issued, promulgated, enforced or entered any law (whether temporary, preliminary or permanent) that is in effect and restrains, enjoins, prevents, prohibits or otherwise makes illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company; and no action, suit, proceeding or investigation shall have been instituted by a governmental authority of competent jurisdiction or threatened that seeks to restrain, enjoin, prevent, prohibit or otherwise make illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company.

Article II

REPRESENTATIONS AND WARRANTIES

Section 2.1      Representations and Warranties of the Company. The Company hereby represents and warrants to the Purchaser and Jefferies LLC (the “Placement Agent”), whom the Company has engaged as its exclusive placement agent in connection with the private placement of the Ordinary Shares, as of the date hereof and as of the Closing Date as follows:

(b)            Authority. The Company has full power and authority to enter into, execute and deliver this Agreement and other Transaction Documents and each agreement, certificate, document and instrument to be executed and delivered by the Company pursuant to this Agreement and other Transaction Documents and to perform its obligations hereunder and thereunder. The execution and delivery by the Company of this Agreement and other Transaction Documents and the performance by the Company of its obligations hereunder and thereunder have been duly authorized by all requisite actions on its part.

(c)            Valid Agreement. The Transaction Documents have all been duly executed and delivered by the Company and, assuming the due and valid execution and delivery hereof by the Purchaser, constitute the legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by the availability of specific performance, injunctive relief, or other equitable remedies.

(d)            Capitalization.

(i)          The authorized share capital of the Company is US$50,000 divided into 500,000,000 shares of a par value of US$0.0001 each. All outstanding Ordinary Shares of the Company and all outstanding shares of each of the Company’s subsidiaries and consolidated Affiliates (each a “Subsidiary” and collectively “Subsidiaries”) have been issued and granted in compliance with (x) all applicable Securities Laws and other applicable laws, and (y) all requirements set forth in applicable plans or contracts, without violation of any preemptive rights, rights of first refusal or other similar rights. “Securities Laws” means the Securities Act, the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the listing rules of, or any listing agreement with, the Nasdaq Capital Market (“NASDAQ”) and any other applicable law regulating securities or takeover matters.

(ii)         The rights of the Ordinary Shares to be issued to the Purchaser as Purchased Shares shall be as stated in the Amended and Restated Memorandum and Articles of Association of the Company.

(f)             Noncontravention. Neither the execution and the delivery of this Agreement or any other Transaction Document, nor the consummation of the transactions contemplated hereby and thereby, will (i) violate any provision of the organizational documents of the Company or its Subsidiaries or violate any constitution, statute, regulation, rule, injunction, judgment, order, decree, ruling, charge, or other restriction of any government, governmental entity or court to which the Company or its Subsidiaries is subject, or (ii) except in each case as do not and would not have a Material Adverse Effect, conflict with, result in a breach of, constitute a default under, result in the acceleration of or creation of an encumbrance under, or create in any party the right to accelerate, terminate, modify, or cancel, any agreement, contract, lease, license, instrument, or other arrangement to which the Company or its Subsidiaries is a party or by which the Company or its Subsidiaries is bound or to which any of the Company’s or its Subsidiaries’ assets are subject. There is no action, suit or proceeding, pending or threatened against the Company or its Subsidiaries that questions the validity of this Agreement or any other Transaction Document or the right of the Company to enter into this Agreement or any other Transaction Document or to consummate the transactions contemplated hereby, and is reasonably expected to be determined adversely against the Company or its Subsidiaries, and if so determined, would have a Material Adverse Effect. As used herein, “Material Adverse Effect” shall mean any event, fact, circumstance or occurrence that, individually or in the aggregate with any other events, facts, circumstances or occurrences, results in or would reasonably be expected to result in a material adverse change in or a material adverse effect on any of (A) the financial condition, assets, liabilities, results of operations, business, or operations of the Company and its Subsidiaries taken as a whole, except to the extent that any such Material Adverse Effect results from (x) the public disclosure of the transactions contemplated under the Transaction Documents in accordance with the terms of such documents, (y) changes in generally accepted accounting principles that are generally applicable to comparable companies, or (z) changes in general economic and market conditions; or (B) the ability of the Company to consummate the transactions contemplated by the Transaction Documents and to timely perform its material obligations under the Transaction Documents.

(g)            Consents and Approvals. Assuming the accuracy of the representations and warranties of the Purchaser under this Agreement and other Transaction Documents, neither the execution and delivery by the Company of this Agreement or any other Transaction Document, nor the consummation by the Company of any of the transactions contemplated hereby and thereby, nor the performance by the Company of this Agreement or any other Transaction Document in accordance with its terms requires the consent, approval, order or authorization of, or registration with, or the giving notice to, any governmental or public body or authority or any third party, other than such as have been or will have been obtained, made or given on or prior to the Closing Date, except for (x) any required filing or notifications regarding the issuance or listing of additional securities with NASDAQ or other regulatory authorities, or (y) such consent, authorization, order, filing or registration which, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Effect.

(h)            SEC Documents. Since January 1, 2023, the Company has timely filed or furnished (including following any extensions of time for filing provided by Rule 12b-25 promulgated under the Exchange Act), as applicable, all reports, schedules, forms, statements and other documents required to be filed or furnished by it with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the Securities Act or the Exchange Act and the rules and regulations promulgated thereunder (all of the foregoing documents filed with or furnished to the SEC and all exhibits included therein and financial statements, notes and schedules thereto and documents incorporated by reference therein being hereinafter referred to as the “SEC Documents”). Each of SEC Documents complied in all material respects with the requirements of the Securities Laws and the rules and regulations of the SEC promulgated thereunder. Since January 1, 2023, none of the SEC Documents, at the time they were filed or furnished, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. As of the date of this Agreement, the Company’s Ordinary Shares are listed on Nasdaq, and the Company has not received any notification that the Commission or Nasdaq is contemplating suspending or terminating such listings (or the applicable registration under the Exchange Act related thereto).

(i)             Foreign Private Issuer. The Company is a “foreign private issuer,” within the meaning of Rule 3b-4 under the Exchange Act. The Company has taken all actions required pursuant to Nasdaq Rule 5615(a)(3) to duly and validly rely on the exemption for foreign private issuers from applicable rules and regulations of the Nasdaq by adopting the home country practice as disclosed in the SEC Documents.

(j)             Legal Proceeding. Except as disclosed in the Company’s SEC Documents, there are no actions by or against the Company or its Subsidiaries or affecting the business or any of the assets of the Company or its Subsidiaries pending before any governmental authority, or, to the Company’s knowledge, threatened to be brought by or before any governmental authority, that would have a Material Adverse Effect.

(k)            Financial Statements. Except as disclosed in the SEC Documents, the financial statements (including any related notes) contained in the SEC Documents (collectively, the “Financial Statements”): (A) were prepared in accordance with U.S. GAAP applied on a consistent basis throughout the periods covered thereby (except (a) as may be otherwise indicated in such Financial Statements or the notes thereto, or (b) in the case of unaudited interim statements, to the extent they may exclude footnotes or may be condensed to summary statements) and (B) fairly present in all material respects the consolidated financial position of the Company and the Subsidiaries as of the respective dates thereof and the consolidated results of operations and cash flows of the Company and the Subsidiaries for the periods covered thereby, in each case except as disclosed therein or in the SEC Documents and as permitted under the Exchange Act.

(l)             Intellectual Property. In each case except as otherwise disclosed in the SEC Documents, (1) the Company and each of its Subsidiaries owns or has obtained valid and enforceable licenses for the inventions, patents, patent applications, trademarks, trade names, service names, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information) and other intellectual property described in the SEC Documents as being owned or licensed by it or which are necessary for the conduct of its business as currently conducted or as currently proposed to be conducted (with respect to the development and commercialization of the product candidates described in the SEC Documents, except where the failure to own or license such rights would not, individually or in the aggregate, have a Material Adverse Effect) (collectively, “Intellectual Property”), and to the Company’s knowledge the conduct of its business does not infringe, misappropriate, or otherwise conflict in any material respect with any such rights of others; (2) the Intellectual Property of the Company is subsisting, free and clear of all material liens, and has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part and the Company has no knowledge of any facts which would form a reasonable basis for any such adjudication except where such adjudication or material liens would not, individually or in the aggregate, have a Material Adverse Effect; (3) to the Company’s knowledge, there are no third parties who have rights to any Intellectual Property, except for any customary reversionary rights of third-party licensors with respect to Intellectual Property that is disclosed in the SEC Documents as licensed to the Company or a Subsidiary; and, to the Company’s knowledge, there is no infringement by third parties of any Intellectual Property; and (4) the Company and each Subsidiary has complied in all material respects with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or a Subsidiary, and all such agreements are in full force and effect except as would not have a Material Adverse Effect. The Company and each Subsidiary has taken commercially reasonable steps to protect, maintain, and safeguard its Intellectual Property, including the execution of appropriate nondisclosure, confidentiality agreements, and invention assignment agreements and invention assignments with its employees or consultants, and, to the Company’s knowledge, no employee of the Company or consultant is in or has been in violation of any material term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement, or any restrictive covenant to or with a former employer where the basis of such violation relates to Intellectual Property except as would not have a Material Adverse Effect.

(m)           Regulatory Matters. Except as disclosed in the SEC Documents: (1) All material franchises, permits, licenses, consents and other permissions, authorizations, orders, filings, registrations, notifications, certificates, clearances, qualifications and approvals (“Permits”), for carrying on the business of the Company described in the SEC Documents, including all Permits required therefor by any applicable Regulatory Agency, have been obtained and are in full force and effect, except as would not have a Material Adverse Effect. The Company has not been notified in writing that any such Permits will be revoked or is incapable of renewal, except for any approvals required from the applicable Regulatory Agencies for the clinical development or marketing of any of the Company’s product candidates that has not yet been initiated or where the failure to obtain any such Permit would not have a Material Adverse Effect. (2) As to each drug product candidate subject to the jurisdiction of any U.S. federal, state, local or foreign regulatory body that regulates the types of matters subject to the jurisdiction of the FDA (each, a “Health Authority”) that is manufactured, packaged, labeled, tested by the Company (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested by or on behalf of the Company in compliance in all material respects with all applicable requirements under any applicable laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company, and the Company has not received any written notice, warning letter or other communication from any Health Authority, which (A) imposes a hold on or requires or threatens the termination, suspension or modification of any pre-clinical or clinical investigation or study being conducted on any Pharmaceutical Product by or on behalf of the Company or in which the Company has participated, (B) enjoins production at any facility of or utilized by the Company, (C) enters or proposes to enter into a consent decree of permanent injunction with the Company, or (D) otherwise alleges any material violation of any laws, rules or regulations by the Company. The currently pending clinical trials, studies and other preclinical tests of the Pharmaceutical Products conducted by or on behalf of the Company are being conducted in all material respects in compliance with all applicable requirements of Health Authorities, including, but not limited to, the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder, and in accordance with experimental protocols, procedures and with controls generally used by qualified experts in the preclinical or clinical study of new drugs. The Company has not been informed in writing by any Health Authority that such Health Authority will prohibit the marketing, sale, license or use in any jurisdiction in which the Company operates of any Pharmaceutical Product proposed to such Health Authority to be developed, produced or marketed by the Company nor, to the Company’s knowledge, has any Health Authority expressed in any meeting with the Company or written communication to the Company any concern as to approving or clearing for marketing any Pharmaceutical Product being developed or proposed to be developed by the Company. To the Company’s knowledge, there are no serious adverse events that have resulted from any of such studies, tests or trials that were not disclosed as required to any Health Authority. (3) The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the SEC Documents were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and to the Company’s knowledge no other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the SEC Documents; the Company and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any other Regulatory Agency; neither the Company nor any of its Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials or preclinical tests that are described or referred to in the SEC Documents; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies. As used herein, “Regulatory Agency” means all applicable statutes, rules, regulations and policies of applicable regulatory authorities, including but are not limited to the United States Food and Drug Administration (“FDA”) and the National Medial Product Administration of the People’s Republic of China, in each case that is responsible for registrations necessary for, or otherwise governs, the manufacture, handling, use, storage, import, transport, distribution or sale of any pharmaceutical product.

(n)            No Registration. Assuming the accuracy of the Purchaser’s representations and warranties set forth in Section 2.2 of this Agreement, no registration under the Securities Act is required for the offer and sale by the Company of the Purchased Shares to the Purchaser as contemplated hereby nor under the Transaction Documents.

(o)            Offering.

(i)          Neither the Company nor anyone acting on its behalf has offered the Purchased Shares or any similar securities for sale to, or solicited any offer to buy any of the same from, or otherwise approached or negotiated in respect thereof with, any person other than the Purchaser and such other purchasers pursuant to certain subscription agreements and subscription and purchaser agreements entered into on the date hereof (collectively, the “PIPE Purchasers”), each of which has been offered the Purchased Shares at a private sale for investment. “Institutional Accredited Investor” means an institutional accredited investor as defined in Rule 501(a)(1), (2), (3) or (7) under the Securities Act.

(ii)         None of the Company nor any of its affiliates has offered the Purchased Shares or any similar securities during the six months prior to the date hereof to anyone other than the PIPE Purchasers. The Company has no intention to offer the Purchased Shares or any similar security during the six months from the date hereof.

(iii)        Neither the Company nor any person acting on its behalf has offered or sold the Purchased Shares by any form of general solicitation or general advertising, including, but not limited to, the following: (1) any advertisement, article, notice or other communication published in any newspaper, magazine, or similar media or broadcast over television or radio; (2) any website posting or widely distributed email; or (3) any seminar or meeting whose attendees have been invited by any general solicitation or general advertising.

(iv)        Other than the Placement Agent, the Company has not dealt with any broker, finder, commission agent, placement agent or arranger in connection with the sale of the Purchased Shares and the transactions contemplated by this Agreement, and the Company is not under any obligation to pay any broker’s fee or commission in connection with such transactions other than to the Placement Agent. Neither the Company nor any of its affiliates nor any other person acting on its behalf (other than its officers acting in such capacity) has solicited offers for, or offered or sold, the Purchased Shares other than through the Placement Agent.

(v)         The Company shall exercise reasonable care to assure that the Purchaser and any subsequent transferees are not underwriters within the meaning of the Securities Act.

(p)            No Additional Representations. The Company makes no representations or warranties as to any matter whatsoever except as expressly set forth in the Transaction Documents or in any certificate delivered by the Company to the Purchaser and the Placement Agent in accordance with the terms thereof.

(b)            Authority. The Purchaser has full power and authority to enter into, execute and deliver the Transaction Documents and each agreement, certificate, document and instrument to be executed and delivered by it pursuant to the Transaction Documents and to perform its obligations hereunder and thereunder. The execution and delivery by the Purchaser of the Transaction Documents and the performance by it of its obligations hereunder and thereunder have been duly authorized by all requisite actions on its part.

(c)            Valid Agreement. The Transaction Documents have been duly executed and delivered by the Purchaser and constitutes its legal, valid and binding obligation, enforceable against the Purchaser in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by the availability of specific performance, injunctive relief, or other equitable remedies.

(d)            Noncontravention. Neither the execution and the delivery of this Agreement, nor the consummation of the transactions contemplated hereby, will (i) where applicable, violate any provision of the organizational documents of the Purchaser or violate any constitution, statute, regulation, rule, injunction, judgment, order, decree, ruling, charge, or other restriction of any government, governmental entity or court to which the Purchaser is subject, or (ii) conflict with, result in a breach of, constitute a default under, result in the acceleration of or creation of an encumbrance under, or create in any party the right to accelerate, terminate, modify, or cancel, any agreement, contract, lease, license, instrument, or other arrangement to which the Purchaser is a party or by which the Purchaser is bound or to which any of the Purchaser’s assets are subject. There is no action, suit or proceeding, pending or, threatened against the Purchaser that questions the validity of this Agreement or other Transaction Documents or the right of the Purchaser to enter into this Agreement or other Transaction Documents or to consummate the transactions contemplated hereby and thereby.

(f)            Status and Investment Intent

(i)          Experience. The Purchaser is a sophisticated investor with knowledge and experience in financial and business matters such that the Purchaser is capable of evaluating the merits and risks of the investment in the Purchased Shares. The Purchaser is able to bear the economic risks of an investment in the Purchased Shares.

(ii)         Purchase Entirely for Own Account. The Purchaser is acquiring the Purchased Shares for its own account for investment purposes only and not with the view to, or with any intention of, resale, distribution or other disposition thereof. The Purchaser does not have any direct or indirect arrangement, or understanding with any other person to distribute, or regarding the distribution of the Purchased Shares in violation of the Securities Act or any other applicable state securities law. The Purchaser is not a broker-dealer registered with the SEC under the Exchange Act or an entity engaged in a business that would require it to be so registered as a broker-dealer.

(iii)        Restricted Securities. The Purchaser acknowledges that the Purchased Shares are “restricted securities” that have not been registered under the Securities Act or any applicable state securities law, and the Purchased Shares will bear a restrictive legend substantially in the form set forth in Section 1.2(c). The Purchaser further acknowledges that, absent an effective registration under the Securities Act, the Purchased Shares may only be offered, sold or otherwise transferred (A) to the Company, (B) outside the United States in accordance with Rule 904 of Regulation S under the Securities Act, or (C) pursuant to an exemption from registration under the Securities Act, including the exemption provided by Rule 144 of the Securities Act. Assuming the validity of the representations of the Company, the Purchaser further acknowledges that the Company is not required to register the Purchased Shares and the Warrant. The Purchaser represents and warrants that such Purchaser will not sell, transfer or otherwise dispose of the Purchased Shares or the Warrant or any interest therein except in a registered transaction or in a transaction exempt from or not subject to the registration requirements of the Securities Act.

(iv)        Information. The Purchaser has carefully reviewed all documents relating to the transactions contemplated by this Agreement and has been provided with all other materials that it considers relevant to the transactions contemplated by this Agreement, has had a full opportunity to ask questions of and receive answers from the Company or any person acting on behalf of the Company concerning the terms and conditions of transactions contemplated by this Agreement. The Purchaser was given the opportunity to ask questions and receive answers concerning the terms and conditions of the offering and to obtain any additional information which the Company possesses or can acquire without unreasonable effort or expense. In making its decision to invest in the Company, the Purchaser is not relying upon, and has not relied upon, any statement, representation or warranty made by any person, except for the statements, representations and warranties contained in this Agreement. The Purchaser is relying solely on its own counsel and other advisors as to the financial, tax, legal and related matters concerning an investment in the Purchased Shares. The Purchaser understands that the Placement Agent has acted solely as the agent of the Company in this private placement of the Purchased Shares and the Purchaser has not relied on the business or legal advice of the Placement Agent or any of its agents, representatives, counsel or Affiliates in making its investment decision hereunder, and confirms that none of such persons has made any representations or warranties to the Purchaser in connection with the transactions contemplated by this Agreement. Neither the Placement Agent nor any of its agents, representatives, counsel or Affiliates has any responsibility with respect to the completeness or accuracy or any information or materials furnished to the Purchaser in connection with the transactions contemplated by this Agreement. The purchase of Purchased Shares by the Purchaser has not been solicited by or through anyone other than the Issuer or the Placement Agent.

(v)         Status. The Purchaser is either (x) a non-U.S. person located outside of the United States, as such terms are defined in Rule 902 of Regulation S under the Securities Act or (y) both an “accredited investor”, as that term is defined in Rule 501 of Regulation D under the Securities Act and a “qualified institutional buyer” as defined in Rule 144A promulgated under the Securities Act acting for its own account (and not for the account of others). The Purchaser has not been subject to any “directed selling efforts” within the meaning of Rule 903 of Regulation S under the Securities Act in connection with its execution of this Agreement.

(vi)        FINRA. The Purchaser does not, directly or indirectly, own more than five per cent of the outstanding common stock (or other voting securities) of any member of the Financial Industry Regulatory Authority, Inc. (“FINRA”) or a holding company for a FINRA member, and is not otherwise a “restricted person” for the purposes of FINRA Rule 5130.

(h)            Potential Transaction of the Company. The Purchaser acknowledges that the Company is currently reviewing and considering a preliminary non-binding proposal with respect to the acquisition of certain of the Company’s business operations in China (the “Proposal”), and agrees that (i) the Company shall have full power to, pursuant to the applicable laws and its Amended and Restated Memorandum and Articles of Association, review, negotiate and enter into transactions in connection with the Proposal or such other alternative transactions available to the Company, and (ii) the Company may sell, transfer, license, assign or otherwise dispose of its assets and/or all the license-in, distribution and related rights in Asia (excluding Japan) related to all the Company’s pipeline products including but not limited to EVOMELA^®, FOLOTYN^®, CNCT19, BI-1206, CB-5339, CID-103 and Thiotepa, in connection with such transactions.

(i)             No Additional Representations. The Purchaser makes no representations or warranties as to any matter whatsoever except as expressly set forth in the Transaction Documents or in any certificate delivered by the Purchaser to the Company in accordance with the terms thereof.

Article III

Post-Closing COVENANTS

Section 3.2      Listing. The Company shall use commercially reasonable efforts to maintain the listing and trading of its Ordinary Shares on the Nasdaq Capital Market and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the rules and regulations of NASDAQ.

Section 3.3      Disclosure. The Company shall, not later than 6:00 p.m., New York City time, on the trading day immediately after the date of this Agreement, disseminate a public announcement disclosing the execution of this Agreement and the material terms of the Transaction Documents pursuant to the applicable rules and regulations (the “Public Announcement”). After each of the furnishing of the Public Announcement and the Closing, the Company shall have publicly disclosed all material, nonpublic information delivered to the Purchaser (or the Purchaser’s representatives or agents) by the Company, or any of its officers, directors, employees, agents or representatives (if any) in connection with the transactions contemplated by the Transaction Documents. The Company shall provide the Purchaser a reasonable opportunity to comment on a draft of the Public Announcement prior to its dissemination and shall give reasonable consideration to all such comments. The Purchaser covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed by the Company as described in this Section 3.3, the Purchaser shall maintain the confidentiality of all disclosures made to it in connection with the transactions contemplated by the Transaction Documents (including the existence and terms of the transactions contemplated thereby), except that the Purchaser may disclose the terms of such transactions to its financial, accounting, legal and other advisors (provided that the Purchaser directs such persons to maintain the confidentiality of such information).

Section 3.4      Reservation. As of the date hereof, the Company has available and, as long as the Purchased Warrant remains outstanding, the Company shall authorize, reserve and keep available at all times, free of preemptive and other similar rights of shareholders, the requisite aggregate number of authorized but unissued Ordinary Shares to enable the Company to timely effect the exercise of the Purchased Warrant, assuming the Purchased Warrant is exercisable in full and without regard to any limitations on the exercise of the Purchased Warrant set forth therein.

Section 3.5      [Reserved]

Section 3.6      Registration of Purchased Shares.

(a)            The Company shall prepare and file with the SEC a registration statement on appropriate form pursuant to the Securities Act (the “Registration Statement”) with respect to all Purchased Shares owned by the Purchaser as promptly as reasonably practicable and in any event no later than sixty (60) days after the Closing to cover the sale of such Purchased Shares pursuant to such Registration Statement, and shall use its best efforts to cause such Registration Statement to be declared effective by the SEC as soon as practicable.

(b)            All fees and expenses incurred in connection with the preparation and filing of the Registration Statement (excluding any underwriting discounts and selling commissions, stock transfer taxes and fees and all legal fees and expenses of legal counsel for the Purchaser) shall be borne by the Company.

(d)           The Purchaser shall indemnify and hold harmless the Company, its officers, directors, agents, partners, members, managers, stockholders, advisors, Affiliates and employees of each of them, to the fullest extent permitted by applicable law, from and against all losses or reasonable and documented expenses, as incurred, arising out of or are based solely upon any actual or alleged untrue statement of a material fact contained in the Registration Statement, any Prospectus, or any form of prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any actual or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, or any form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading (i) to the extent that such untrue statements or omissions are based solely upon information regarding the Purchaser furnished in writing to the Company by the Purchaser expressly for use therein, (ii) to the extent that such information relates to the Purchaser or the Purchaser’s proposed method of distribution of Purchased Shares and was supplied by the Purchaser expressly for use in the Registration Statement, such Prospectus or such form of Prospectus or in any amendment or supplement thereto, or (iii) in the case of an occurrence of an event of (x) the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement covering any or all of the Purchased Shares or the initiation of any proceedings for that purpose; or (y) the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Purchased Shares for sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose, to the extent related to the use by the Purchaser of an outdated or defective Prospectus after the Company has notified the Purchaser in writing that the Prospectus is outdated or defective and prior to the receipt by the Purchaser of an advice in writing by the Company that the use of the applicable Prospectus (as it may have been supplemented or amended) may be resumed. In no event shall the liability of the Purchaser under this Agreement be greater in amount than the dollar amount of the net proceeds received by the Purchaser upon the sale of the Purchased Shares giving rise to such indemnification obligation. For the purpose of this Section 3.6(d), Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Purchased Shares covered by a Registration Statement, and all other amendments and supplements to the Prospectus, including post effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.

Section 3.7      CSRC Filing.

(a)            The Company undertakes to file or cause to be filed with the China Securities Regulatory Commission (the “CSRC”) the requisite information and documents within three (3) Business Days or other timeframe prescribed by the CSRC following the Closing in accordance with the Trial Administrative Measures of Overseas Securities Offering and Listing by Domestic Companies (境内企业境外发行证券和上市管理试行办法) and supporting guidelines issued by the CSRC on February 17, 2023, as amended, supplemented or otherwise modified from time to time (the “CSRC Filing”).

(b)           The Purchaser shall provide the Company with reasonable assistance it may require in connection with the CSRC Filing, including without limitation to provide such information relating to the Purchaser as may be necessary for the purposes of submitting such filings, or may otherwise be required in order for the Company to satisfy the regulatory requirements in respect of the CSRC Filing.

Article IV

MISCELLANEOUS

Section 4.1      Governing Law; Arbitration. This Agreement shall be governed and interpreted in accordance with the laws of the State of New York. Any dispute, controversy or claim arising out of or relating to this Agreement, or the interpretation, breach, termination or validity hereof, shall be submitted to arbitration upon the request of any party with notice to the other party. The arbitration shall be conducted in Hong Kong under the auspices of the Hong Kong International Arbitration Centre (“HKIAC”) in accordance with the HKIAC Administered Arbitration Rules then in effect, which rules are deemed to be incorporated by reference into this Section 4.1. There shall be three (3) arbitrators. The complainant and the respondent to such dispute shall each select one arbitrator within thirty (30) days after giving or receiving the demand for arbitration. The Chairman of the HKIAC shall select the third arbitrator. If either party to the arbitration does not appoint an arbitrator who has consented to participate within 30 days after selection of the first arbitrator, the relevant appointment shall be made by the Chairman of the HKIAC. The arbitration proceedings shall be conducted in English. Each party irrevocably waives, to the fullest extent it may effectively do so, any objection which it may now or hereafter have to the laying of venue of any such arbitration in Hong Kong and the HKIAC, and hereby submits to the exclusive jurisdiction of HKIAC in any such arbitration. The award of the arbitration tribunal shall be conclusive and binding upon the disputing parties, and any party to the dispute may apply to a court of competent jurisdiction for enforcement of such award. Any party to the dispute shall be entitled to seek preliminary injunctive relief, if possible, from any court of competent jurisdiction pending the constitution of the arbitral tribunal.

Section 4.2      Amendment. This Agreement shall not be amended, changed or modified, except by another agreement in writing executed by the Parties.

Section 4.3      Binding Effect. This Agreement shall inure to the benefit of, and be binding upon, each of the Parties and their respective heirs, successors and permitted assigns and legal representatives.

Section 4.4      Assignment. Neither this Agreement nor any of the rights, duties or obligations hereunder may be assigned by a Party without the express written consent of the other Parties, except that the Purchaser may assign all or any part of its rights and obligations hereunder to any Affiliate of the Purchaser without the consent of the Company; provided that no such assignment shall relieve the Purchaser of its obligations hereunder if such assignee does not perform such obligations. Any purported assignment in violation of the foregoing sentence shall be null and void. For purposes of this Agreement, “Affiliate” of a person means any other person that directly or indirectly Controls, is Controlled by or is under common Control with such person, where “Control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management of a person, whether through the ownership of voting securities, by contract, credit arrangement or proxy, as trustee, executor or agent or otherwise.

Section 4.5      Notices. All notices, requests, demands and other communications that are required or may be given pursuant to the terms of this Agreement shall be in writing, and delivery shall be deemed sufficient in all respects and to have been duly given as follows: (a) on the actual date of service if delivered personally, (b) at the time of receipt if given by electronic mail to the email addresses set forth in this Section 4.5, (c) on the third Business Day after mailing if mailed by first-class mail return receipt requested, postage prepaid and properly addressed as set forth in this Section 4.5, or (d) on the day after delivery to a nationally recognized overnight courier service during its business hours for overnight delivery against receipt, and properly addressed as set forth in this Section 4.5:

	If to the Purchaser, at:	***
		Attention: ***

		Email: ***

	If to the Company, at:	9620 Medical Center Drive, Suite 300 Rockville, MD 20850 Attn: Rui Zhang

Any Party may change its address for purposes of this Section 4.5 by giving the other Parties hereto written notice of the new address in the manner set forth above. For purposes of this Agreement, “Business Day” means any day other than Saturday, Sunday or another day on which commercial banks located in the Cayman Islands, New York City, mainland China or Hong Kong are authorized or required by law or executive order to be closed.

Section 4.6      Entire Agreement. This Agreement and the other Transaction Documents together constitute the entire understanding and agreement between the Parties with respect to the matters covered hereby, and all prior agreements and understandings, oral or in writing, if any, between the Parties with respect to the matters covered hereby are merged and superseded by this Agreement and the other Transaction Documents.

Section 4.7      Severability. If any provisions of this Agreement shall be adjudicated to be illegal, invalid or unenforceable in any action or proceeding whether in its entirety or in any portion, then such provision shall be deemed amended, if possible, or deleted, as the case may be, from the Agreement in order to render the remainder of the Agreement and any provision thereof both valid and enforceable, and all other provisions hereof shall be given effect separately therefrom and shall not be affected thereby.

Section 4.8      Fees and Expenses. Except as otherwise provided in this Agreement, each of the Parties will bear its own costs and expenses incurred in connection with the negotiation, preparation and execution of this Agreement and the transactions contemplated hereby, including fees and expenses of attorneys, accountants, consultants and financial advisors.

Section 4.10    Specific Performance. The Parties agree that irreparable damage would occur in the event any provision of this Agreement is not performed in accordance with the terms hereof and that the Parties shall be entitled to specific performance of the terms hereof, in addition to any other remedy at law or equity.

Section 4.11    Termination. This Agreement may be terminated and the transactions contemplated by this Agreement abandoned at any time prior to the Closing:

(a)

by mutual agreement of the Company and the Purchaser;

(b)

(c)

(d)

(e)

by the Company in the event that the Closing shall not have occurred by September 25, 2024,

in each case this Agreement shall forthwith become void and there shall be no liability or obligation on the part of the Parties, except that the provisions of Section 4 hereof shall remain in full force and effect; provided that nothing herein shall relieve any Party hereto from liability for any breach of this Agreement that occurred prior to such termination.

Section 4.12      Acknowledgements Regarding Placement Agent.

(a)

The Purchaser acknowledges that the Placement Agent is acting as a placement agent on a “best efforts” basis for the Ordinary Shares being offered hereby and will be compensated by the Company for acting in such capacity. The Purchaser represents that the Purchaser was contacted regarding the sale of the Ordinary Shares by the Placement Agent or the Company (or an authorized agent or representative thereof) with whom the Purchaser entered into a verbal or written confidentiality agreement.

(b)

Section 4.13      Exculpation of the Placement Agent. Each Party hereto agrees for the express benefit of the Placement Agent and its Affiliates and representatives that:

(a)

The Placement Agent and its Affiliates and representatives (i) have no duties or obligations other than those specifically set forth herein or in that certain Engagement Letter by and between the Company and the Placement Agent, dated June 26, 2024 (the “Engagement Letter”); (ii) shall not be liable for any improper payment made in accordance with the information provided by the Company; (iii) make no representation or warranty, and have no responsibilities as to the validity, accuracy, value or genuineness of any information, certificates or documentation delivered by or on behalf of the Company pursuant to this Agreement or in connection with any of the transactions contemplated hereby, including any offering or marketing materials; and (iv) shall not be liable (A) for any action taken, suffered or omitted by any of them in good faith and reasonably believed to be authorized or within the discretion or rights or powers conferred upon them by this Agreement or any Transaction Document, or (B) for anything which any of them may do or refrain from doing in connection with this Agreement or any Transaction Document, except in each case for such person’s own gross negligence, willful misconduct or bad faith.

(b)

The Placement Agent and its Affiliates and representatives shall be entitled to (1) rely on, and shall be protected in acting upon, any certificate, instrument, notice, letter or any other document or security delivered to any of them by or on behalf of the Company, and (2) be indemnified by the Company for acting as a Placement Agent hereunder pursuant to the indemnification provisions set forth in the Engagement Letter.

Section 4.14    Headings. The headings of the various articles and sections of this Agreement are inserted merely for the purpose of convenience and do not expressly or by implication limit, define or extend the specific terms of the section so designated.

Section 4.15    Third-Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto, their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other person, except as set forth in Sections 3.6(d), 3.6(e), 4.12, 4.13 and 4.15 of this Agreement. The Placement Agent shall be the third-party beneficiary of the representations and warranties of the Company and the Purchaser in Article II.

Section 4.16    Execution in Counterparts. For the convenience of the Parties and to facilitate execution, this Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, but all of which together shall constitute but one and the same instrument.

Section 4.17    Remedies and Waivers  No delay or omission by any Party in exercising any right, power or remedy provided by law or under this Agreement or any other documents referred to in it shall: (i) affect that right, power or remedy; or (ii) operate as a waiver thereof. The single or partial exercise of any right, power or remedy provided by law or under this Agreement shall not preclude any other or further exercise or any other right, power or remedy. Except as otherwise expressly provided in this Agreement, the rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by law.

[signature pages follow]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

	CASI Pharmaceuticals, Inc.

	By:	/s/ Wei-Wu He
	Name:	Wei-Wu He
	Title:	Chairman and Chief Executive Officer

[Signature Page to Subscription Agreement]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

	PANACEA VENTURE HEALTHCARE FUND II, L.P.

	By: Panacea Venture Healthcare Fund II GP Company, Ltd., its general partner

	By: Panacea Innovation Limited, its sole owner

	By:	/s/ Andrew Aherrera
	Name:	Andrew Aherrera
	Title:	Authorized Signatory

[Signature Page to Subscription Agreement]

Schedule I

Purchaser		Purchase Price for Ordinary Shares				Purchased Ordinary Shares
PANACEA VENTURE HEALTHCARE FUND II, L.P.		US$	1,000,000				200,000

Exhibit 4.5

Execution Version

SUBSCRIPTION AGREEMENT

This Subscription Agreement (this “Agreement”) is made as of June 26, 2024 by and between:

(1)

(2)

Dr. Wei-Wu He, a citizen of United States with address of principal business office at 1701-1702, China Central Office Tower 1, No. 81 Jianguo Road Chaoyang District, Beijing, 100025, People’s Republic of China; and

(3)

HE Family GRAT, a grantor retained annuity trust organized under the law of Nevada, with address of principal business office at 100 W. Liberty St. STE. 100, Reno, NV, 89501-1927 (each person under (2) and (3), a “Purchaser”).

The Company, on the one hand, and each Purchaser, on the other hand, are hereinafter each referred to as a “Party” and collectively as the “Parties”.

W I T N E S S E T H:

WHEREAS, upon the terms and subject to the conditions of this Agreement, the Company desires to issue and sell to each Purchaser, and each Purchaser wishes to purchase from the Company, ordinary shares of the Company, par value US$0.0001 per share (“Ordinary Shares”) in a private placement exempt from securities registration afforded by Section 4(a)(2) under the U.S. Securities Act of 1933, as amended (the “Securities Act”);

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises hereinafter set forth, the Parties hereto agree as follows:

Article I

PURCHASE AND SALE

Section 1.1     Issuance, Sale and Purchase of Ordinary Shares. Upon the terms and subject to the conditions of this Agreement, each Purchaser hereby agrees to purchase from the Company, and the Company hereby agrees to issue, sell and deliver to each Purchaser, at the Closing (as defined below), that number of Ordinary Shares for the amount of consideration set forth opposite such Purchaser’s name on Schedule I hereto (the “Purchase Price”), free and clear of all liens or encumbrances (except for restrictions arising under the Securities Act or created by virtue of this Agreement). The Ordinary Shares issued to the Purchasers pursuant to this Agreement at the Closing pursuant to Schedule I shall be referred to herein as the “Purchased Shares”.

Section 1.2     Closing.

(a)            Closing. The closing (the “Closing”) of the sale and purchase of the Purchased Shares pursuant to Section 1.1 shall take place remotely via the electronic exchange of the closing documents and signatures on the third Business Day following the satisfaction or, to the extent permitted by applicable Law, waiver of the conditions precedent specified in Section 1.3 or such other time as the Parties may mutually agree upon. The date and time of the Closing are referred to herein as the “Closing Date”.

(b)            Payment and Delivery. At the Closing, each Purchaser shall pay and deliver the Purchase Price to the Company in U.S. dollars by wire transfer, or by such other method mutually agreeable to the Parties, of immediately available funds to such bank account(s) designated in writing by the Company, and the Company shall have the Purchased Shares issued and registered in the name of such Purchaser or in such nominee name as it may designate and shall deliver to such Purchaser a copy of duly executed share certificate(s) registered in the name of such Purchaser (the original copies of which shall be delivered to such Purchaser as soon as commercially practicable following the Closing), together with a certified true copy of the relevant extract of the register of members of the Company, evidencing the Purchased Shares being issued and sold to such Purchaser.

(c)            Restrictive Legend and Transfer Restrictions. Each certificate representing the Purchased Shares shall be endorsed with the following legend:

Section 1.3     Closing Conditions.

(a)            Conditions to the Purchaser’s Obligations to Effect the Closing. The obligation of each Purchaser to purchase and pay for the Purchased Shares as contemplated by this Agreement is subject to the satisfaction, on or before the Closing Date of the following conditions, any of which may only be waived in writing by such Purchaser in its sole discretion:

(i)            All corporate and other actions required to be taken by the Company in connection with the issuance and sale of the Purchased Shares hereunder and any other transactions contemplated under this Agreement and all the agreements and other documents required in connection with implementing the transactions contemplated hereby (together, the “Transaction Documents”) shall have been completed.

(ii)            The representations and warranties of the Company contained in Section 2.1 of this Agreement shall have been true and correct in all material respects (or if qualified by materiality or a Material Adverse Effect, true and correct in all respects) on the date of this Agreement and on and as of the Closing Date; and the Company shall have performed and complied in all material respects with all, and not be in breach or default in any material respects under any, agreements, covenants, conditions and obligations contained in this Agreement or any other Transaction Document that are required to be performed or complied with on or before the Closing Date.

(iv)          Since the date hereof, no event or series of events shall have occurred that has had or would reasonably be expected to have a Material Adverse Effect.

(vii)          An authorized officer of the Company shall have delivered to the Purchaser at the Closing Date a certificate certifying that the conditions specified in Sections 1.3(a)(i), (ii), (iii), (iv) and (v) of this Agreement have been fulfilled.

(b)            Conditions to the Company’s Obligations to Effect the Closing. The obligation of the Company to issue, sell and deliver the Purchased Shares to each Purchaser as contemplated by this Agreement is subject to the satisfaction, on or before the Closing Date of each of the following conditions, any of which may only be waived in writing by the Company in its sole discretion:

(i)            All corporate and other actions, as applicable, required to be taken by such Purchaser in connection with the purchase of the Purchased Shares hereunder and any other transactions contemplated under the Transaction Documents shall have been completed.

(ii)            The representations and warranties of such Purchaser contained in Section 2.2 of this Agreement shall have been true and correct in all material respects (or if qualified by materiality or a Material Adverse Effect, true and correct in all respects) on the date of this Agreement and on and as of the Closing Date; and such Purchaser shall have performed and complied in all material respects with all, and not be in breach or default in any material respect under any, agreements, covenants, conditions and obligations contained in this Agreement or any other Transaction Document that are required to be performed or complied with on or before the Closing Date.

(iii)           No governmental authority of competent jurisdiction shall have enacted, issued, promulgated, enforced or entered any law (whether temporary, preliminary or permanent) that is in effect and restrains, enjoins, prevents, prohibits or otherwise makes illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company; and no action, suit, proceeding or investigation shall have been instituted by a governmental authority of competent jurisdiction or threatened that seeks to restrain, enjoin, prevent, prohibit or otherwise make illegal the consummation of the transactions contemplated by this Agreement or any other Transaction Document, or imposes any damages or penalties in connection with the transactions contemplated by this Agreement or any other Transaction Document that are substantial in relation to the Company.

Article II

REPRESENTATIONS AND WARRANTIES

Section 2.1     Representations and Warranties of the Company. The Company hereby represents and warrants to each Purchaser and Jefferies LLC (the “Placement Agent”), whom the Company has engaged as its exclusive placement agent in connection with the private placement of the Ordinary Shares, as of the date hereof and as of the Closing Date as follows:

(b)            Authority. The Company has full power and authority to enter into, execute and deliver this Agreement and other Transaction Documents and each agreement, certificate, document and instrument to be executed and delivered by the Company pursuant to this Agreement and other Transaction Documents and to perform its obligations hereunder and thereunder. The execution and delivery by the Company of this Agreement and other Transaction Documents and the performance by the Company of its obligations hereunder and thereunder have been duly authorized by all requisite actions on its part.

(d)            Capitalization.

(ii)            The rights of the Ordinary Shares to be issued to each Purchaser as Purchased Shares shall be as stated in the Amended and Restated Memorandum and Articles of Association of the Company.

(h)            SEC Documents. Since January 1, 2023, the Company has timely filed or furnished (including following any extensions of time for filing provided by Rule 12b-25 promulgated under the Exchange Act), as applicable, all reports, schedules, forms, statements and other documents required to be filed or furnished by it with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the Securities Act or the Exchange Act and the rules and regulations promulgated thereunder (all of the foregoing documents filed with or furnished to the SEC and all exhibits included therein and financial statements, notes and schedules thereto and documents incorporated by reference therein being hereinafter referred to as the “SEC Documents”). Each of SEC Documents complied in all material respects with the requirements of the Securities Laws and the rules and regulations of the SEC promulgated thereunder. Since January 1, 2023, none of the SEC Documents, at the time they were filed or furnished, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. As of the date of this Agreement, the Company’s Ordinary Shares are listed on Nasdaq, and the Company has not received any notification that the Commission or Nasdaq is contemplating suspending or terminating such listings (or the applicable registration under the Exchange Act related thereto).

(l)            Intellectual Property. In each case except as otherwise disclosed in the SEC Documents, (1) the Company and each of its Subsidiaries owns or has obtained valid and enforceable licenses for the inventions, patents, patent applications, trademarks, trade names, service names, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information) and other intellectual property described in the SEC Documents as being owned or licensed by it or which are necessary for the conduct of its business as currently conducted or as currently proposed to be conducted (with respect to the development and commercialization of the product candidates described in the SEC Documents, except where the failure to own or license such rights would not, individually or in the aggregate, have a Material Adverse Effect) (collectively, “Intellectual Property”), and to the Company’s knowledge the conduct of its business does not infringe, misappropriate, or otherwise conflict in any material respect with any such rights of others; (2) the Intellectual Property of the Company is subsisting, free and clear of all material liens, and has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part and the Company has no knowledge of any facts which would form a reasonable basis for any such adjudication except where such adjudication or material liens would not, individually or in the aggregate, have a Material Adverse Effect; (3) to the Company’s knowledge, there are no third parties who have rights to any Intellectual Property, except for any customary reversionary rights of third-party licensors with respect to Intellectual Property that is disclosed in the SEC Documents as licensed to the Company or a Subsidiary; and, to the Company’s knowledge, there is no infringement by third parties of any Intellectual Property; and (4) the Company and each Subsidiary has complied in all material respects with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or a Subsidiary, and all such agreements are in full force and effect except as would not have a Material Adverse Effect. The Company and each Subsidiary has taken commercially reasonable steps to protect, maintain, and safeguard its Intellectual Property, including the execution of appropriate nondisclosure, confidentiality agreements, and invention assignment agreements and invention assignments with its employees or consultants, and, to the Company’s knowledge, no employee of the Company or consultant is in or has been in violation of any material term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement, or any restrictive covenant to or with a former employer where the basis of such violation relates to Intellectual Property except as would not have a Material Adverse Effect.

(m)            Regulatory Matters. Except as disclosed in the SEC Documents: (1) All material franchises, permits, licenses, consents and other permissions, authorizations, orders, filings, registrations, notifications, certificates, clearances, qualifications and approvals (“Permits”), for carrying on the business of the Company described in the SEC Documents, including all Permits required therefor by any applicable Regulatory Agency, have been obtained and are in full force and effect, except as would not have a Material Adverse Effect. The Company has not been notified in writing that any such Permits will be revoked or is incapable of renewal, except for any approvals required from the applicable Regulatory Agencies for the clinical development or marketing of any of the Company’s product candidates that has not yet been initiated or where the failure to obtain any such Permit would not have a Material Adverse Effect. (2) As to each drug product candidate subject to the jurisdiction of any U.S. federal, state, local or foreign regulatory body that regulates the types of matters subject to the jurisdiction of the FDA (each, a “Health Authority”) that is manufactured, packaged, labeled, tested by the Company (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested by or on behalf of the Company in compliance in all material respects with all applicable requirements under any applicable laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company, and the Company has not received any written notice, warning letter or other communication from any Health Authority, which (A) imposes a hold on or requires or threatens the termination, suspension or modification of any pre-clinical or clinical investigation or study being conducted on any Pharmaceutical Product by or on behalf of the Company or in which the Company has participated, (B) enjoins production at any facility of or utilized by the Company, (C) enters or proposes to enter into a consent decree of permanent injunction with the Company, or (D) otherwise alleges any material violation of any laws, rules or regulations by the Company. The currently pending clinical trials, studies and other preclinical tests of the Pharmaceutical Products conducted by or on behalf of the Company are being conducted in all material respects in compliance with all applicable requirements of Health Authorities, including, but not limited to, the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder, and in accordance with experimental protocols, procedures and with controls generally used by qualified experts in the preclinical or clinical study of new drugs. The Company has not been informed in writing by any Health Authority that such Health Authority will prohibit the marketing, sale, license or use in any jurisdiction in which the Company operates of any Pharmaceutical Product proposed to such Health Authority to be developed, produced or marketed by the Company nor, to the Company’s knowledge, has any Health Authority expressed in any meeting with the Company or written communication to the Company any concern as to approving or clearing for marketing any Pharmaceutical Product being developed or proposed to be developed by the Company. To the Company’s knowledge, there are no serious adverse events that have resulted from any of such studies, tests or trials that were not disclosed as required to any Health Authority. (3) The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the SEC Documents were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and to the Company’s knowledge no other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the SEC Documents; the Company and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any other Regulatory Agency; neither the Company nor any of its Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials or preclinical tests that are described or referred to in the SEC Documents; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies. As used herein, “Regulatory Agency” means all applicable statutes, rules, regulations and policies of applicable regulatory authorities, including but are not limited to the United States Food and Drug Administration (“FDA”) and the National Medial Product Administration of the People’s Republic of China, in each case that is responsible for registrations necessary for, or otherwise governs, the manufacture, handling, use, storage, import, transport, distribution or sale of any pharmaceutical product.

(n)            No Registration. Assuming the accuracy of each Purchaser’s representations and warranties set forth in Section 2.2 of this Agreement, no registration under the Securities Act is required for the offer and sale by the Company of the Purchased Shares to such Purchaser as contemplated hereby nor under the Transaction Documents.

(o)            Offering.

(i)            Neither the Company nor anyone acting on its behalf has offered the Purchased Shares or any similar securities for sale to, or solicited any offer to buy any of the same from, or otherwise approached or negotiated in respect thereof with, any person other than the Purchasers and such other purchasers pursuant to certain subscription agreements and subscription and purchaser agreements entered into on the date hereof (collectively, the “PIPE Purchasers”), each of which has been offered the Purchased Shares at a private sale for investment. “Institutional Accredited Investor” means an institutional accredited investor as defined in Rule 501(a)(1), (2), (3) or (7) under the Securities Act.

(ii)           None of the Company nor any of its affiliates has offered the Purchased Shares or any similar securities during the six months prior to the date hereof to anyone other than the PIPE Purchasers. The Company has no intention to offer the Purchased Shares or any similar security during the six months from the date hereof.

(iii)            Neither the Company nor any person acting on its behalf has offered or sold the Purchased Shares by any form of general solicitation or general advertising, including, but not limited to, the following: (1) any advertisement, article, notice or other communication published in any newspaper, magazine, or similar media or broadcast over television or radio; (2) any website posting or widely distributed email; or (3) any seminar or meeting whose attendees have been invited by any general solicitation or general advertising.

(iv)            Other than the Placement Agent, the Company has not dealt with any broker, finder, commission agent, placement agent or arranger in connection with the sale of the Purchased Shares and the transactions contemplated by this Agreement, and the Company is not under any obligation to pay any broker’s fee or commission in connection with such transactions other than to the Placement Agent. Neither the Company nor any of its affiliates nor any other person acting on its behalf (other than its officers acting in such capacity) has solicited offers for, or offered or sold, the Purchased Shares other than through the Placement Agent.

(v)            The Company shall exercise reasonable care to assure that the Purchasers and any subsequent transferees are not underwriters within the meaning of the Securities Act.

(p)            No Additional Representations. The Company makes no representations or warranties as to any matter whatsoever except as expressly set forth in the Transaction Documents or in any certificate delivered by the Company to each Purchaser and the Placement Agent in accordance with the terms thereof.

Section 2.2     Representations and Warranties of the Purchasers. Each Purchaser hereby, severally but not jointly, represents and warrants to the Company and the Placement Agent as of the date hereof and as of the Closing Date as follows:

(b)            Authority. The Purchaser has full power and authority to enter into, execute and deliver the Transaction Documents and each agreement, certificate, document and instrument to be executed and delivered by it pursuant to the Transaction Documents and to perform its obligations hereunder and thereunder. The execution and delivery by the Purchaser of the Transaction Documents and the performance by it of its obligations hereunder and thereunder have been duly authorized by all requisite actions on its part.

(d)            Noncontravention. Neither the execution and the delivery of this Agreement, nor the consummation of the transactions contemplated hereby, will (i) where applicable, violate any provision of the organizational documents of the Purchaser or violate any constitution, statute, regulation, rule, injunction, judgment, order, decree, ruling, charge, or other restriction of any government, governmental entity or court to which the Purchaser is subject, or (ii) conflict with, result in a breach of, constitute a default under, result in the acceleration of or creation of an encumbrance under, or create in any party the right to accelerate, terminate, modify, or cancel, any agreement, contract, lease, license, instrument, or other arrangement to which the Purchaser is a party or by which the Purchaser is bound or to which any of the Purchaser’s assets are subject. There is no action, suit or proceeding, pending or, threatened against the Purchaser that questions the validity of this Agreement or other Transaction Documents or the right of the Purchaser to enter into this Agreement or other Transaction Documents or to consummate the transactions contemplated hereby and thereby.

(f)            Status and Investment Intent

(i)            Experience. The Purchaser is a sophisticated investor with knowledge and experience in financial and business matters such that the Purchaser is capable of evaluating the merits and risks of the investment in the Purchased Shares. The Purchaser is able to bear the economic risks of an investment in the Purchased Shares.

(ii)            Purchase Entirely for Own Account. The Purchaser is acquiring the Purchased Shares for its own account for investment purposes only and not with the view to, or with any intention of, resale, distribution or other disposition thereof. The Purchaser does not have any direct or indirect arrangement, or understanding with any other person to distribute, or regarding the distribution of the Purchased Shares in violation of the Securities Act or any other applicable state securities law. The Purchaser is not a broker-dealer registered with the SEC under the Exchange Act or an entity engaged in a business that would require it to be so registered as a broker-dealer.

(iii)            Restricted Securities. The Purchaser acknowledges that the Purchased Shares are “restricted securities” that have not been registered under the Securities Act or any applicable state securities law, and the Purchased Shares will bear a restrictive legend substantially in the form set forth in Section 1.2(c). The Purchaser further acknowledges that, absent an effective registration under the Securities Act, the Purchased Shares may only be offered, sold or otherwise transferred (A) to the Company, (B) outside the United States in accordance with Rule 904 of Regulation S under the Securities Act, or (C) pursuant to an exemption from registration under the Securities Act, including the exemption provided by Rule 144 of the Securities Act. Assuming the validity of the representations of the Company, the Purchaser further acknowledges that the Company is not required to register the Purchased Shares and the Warrant. The Purchaser represents and warrants that such Purchaser will not sell, transfer or otherwise dispose of the Purchased Shares or the Warrant or any interest therein except in a registered transaction or in a transaction exempt from or not subject to the registration requirements of the Securities Act.

(iv)            Information. The Purchaser has carefully reviewed all documents relating to the transactions contemplated by this Agreement and has been provided with all other materials that it considers relevant to the transactions contemplated by this Agreement, has had a full opportunity to ask questions of and receive answers from the Company or any person acting on behalf of the Company concerning the terms and conditions of transactions contemplated by this Agreement. The Purchaser was given the opportunity to ask questions and receive answers concerning the terms and conditions of the offering and to obtain any additional information which the Company possesses or can acquire without unreasonable effort or expense. In making its decision to invest in the Company, the Purchaser is not relying upon, and has not relied upon, any statement, representation or warranty made by any person, except for the statements, representations and warranties contained in this Agreement. The Purchaser is relying solely on its own counsel and other advisors as to the financial, tax, legal and related matters concerning an investment in Purchased Shares. The Purchaser understands that the Placement Agent has acted solely as the agent of the Company in this private placement of the Purchased Shares and the Purchaser has not relied on the business or legal advice of the Placement Agent or any of its agents, representatives, counsel or Affiliates in making its investment decision hereunder, and confirms that none of such persons has made any representations or warranties to the Purchaser in connection with the transactions contemplated by this Agreement. Neither the Placement Agent nor any of its agents, representatives, counsel or Affiliates has any responsibility with respect to the completeness or accuracy or any information or materials furnished to the Purchaser in connection with the transactions contemplated by this Agreement. The purchase of Purchased Shares by the Purchaser has not been solicited by or through anyone other than the Issuer or the Placement Agent.

(v)            Status. The Purchaser is either (x) a non-U.S. person located outside of the United States, as such terms are defined in Rule 902 of Regulation S under the Securities Act or (y) an “accredited investor”, as that term is defined in Rule 501 of Regulation D under the Securities Act or a “qualified institutional buyer” as defined in Rule 144A promulgated under the Securities Act acting for its own account (and not for the account of others). The Purchaser has not been subject to any “directed selling efforts” within the meaning of Rule 903 of Regulation S under the Securities Act in connection with its execution of this Agreement.

(vi)            FINRA. The Purchaser does not, directly or indirectly, own more than five per cent of the outstanding common stock (or other voting securities) of any member of the Financial Industry Regulatory Authority, Inc. (“FINRA”) or a holding company for a FINRA member, and is not otherwise a “restricted person” for the purposes of FINRA Rule 5130.

(i)             No Additional Representations. The Purchaser makes no representations or warranties as to any matter whatsoever except as expressly set forth in the Transaction Documents or in any certificate delivered by the Purchaser to the Company in accordance with the terms thereof.

Article III

Post-Closing COVENANTS

Section 3.1     Further Assurances. Each of the Purchasers and the Company shall use all reasonable efforts to fulfill or obtain the fulfillment of the conditions precedent to the consummation of the transactions contemplated by this Agreement on a timely basis, including the execution and delivery of any documents, certificates, instruments or other papers that are reasonably required for the consummation of such transactions, and will cooperate and consult with the other and use reasonable efforts to prepare and file all necessary documentation, to effect all necessary applications, notices, petitions, filings and other documents, and to obtain all necessary permits, consents, orders, approvals and authorizations of, or any exemption by, all governmental entities, necessary or advisable to consummate the transactions contemplated by this Agreement.

Section 3.2     Listing. The Company shall use commercially reasonable efforts to maintain the listing and trading of its Ordinary Shares on the Nasdaq Capital Market and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the rules and regulations of NASDAQ.

Section 3.3     Disclosure. The Company shall, not later than 6:00 p.m., New York City time, on the trading day immediately after the date of this Agreement, disseminate a public announcement disclosing the execution of this Agreement and the material terms of the Transaction Documents pursuant to the applicable rules and regulations (the “Public Announcement”). After each of the furnishing of the Public Announcement and the Closing, the Company shall have publicly disclosed all material, nonpublic information delivered to the Purchaser (or the Purchaser’s representatives or agents) by the Company, or any of its officers, directors, employees, agents or representatives (if any) in connection with the transactions contemplated by the Transaction Documents. The Company shall provide the Purchaser a reasonable opportunity to comment on a draft of the Public Announcement prior to its dissemination and shall give reasonable consideration to all such comments. The Purchaser covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed by the Company as described in this Section 3.3, the Purchaser shall maintain the confidentiality of all disclosures made to it in connection with the transactions contemplated by the Transaction Documents (including the existence and terms of the transactions contemplated thereby), except that the Purchaser may disclose the terms of such transactions to its financial, accounting, legal and other advisors (provided that the Purchaser directs such persons to maintain the confidentiality of such information).

Section 3.4     Reservation. As of the date hereof, the Company has available and, as long as the Purchased Warrant remains outstanding, the Company shall authorize, reserve and keep available at all times, free of preemptive and other similar rights of shareholders, the requisite aggregate number of authorized but unissued Ordinary Shares to enable the Company to timely effect the exercise of the Purchased Warrant, assuming the Purchased Warrant is exercisable in full and without regard to any limitations on the exercise of the Purchased Warrant set forth therein.

Section 3.5     [Reserved]

Section 3.6     Registration of Purchased Shares.

(a)            The Company shall prepare and file with the SEC a registration statement on appropriate form pursuant to the Securities Act (the “Registration Statement”) with respect to all Purchased Shares owned by the Purchasers as promptly as reasonably practicable and in any event no later than sixty (60) days after the Closing to cover the sale of such Purchased Shares pursuant to such Registration Statement, and shall use its best efforts to cause such Registration Statement to be declared effective by the SEC as soon as practicable.

(b)            All fees and expenses incurred in connection with the preparation and filing of the Registration Statement (excluding any underwriting discounts and selling commissions, stock transfer taxes and fees and all legal fees and expenses of legal counsel for the Purchasers) shall be borne by the Company.

(d)            Each Purchaser shall indemnify and hold harmless the Company, its officers, directors, agents, partners, members, managers, stockholders, advisors, Affiliates and employees of each of them, to the fullest extent permitted by applicable law, from and against all losses or reasonable and documented expenses, as incurred, arising out of or are based solely upon any actual or alleged untrue statement of a material fact contained in the Registration Statement, any Prospectus, or any form of prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any actual or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, or any form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading (i) to the extent that such untrue statements or omissions are based solely upon information regarding such Purchaser furnished in writing to the Company by such Purchaser expressly for use therein, (ii) to the extent that such information relates to such Purchaser or such Purchaser’s proposed method of distribution of Purchased Shares and was supplied by such Purchaser expressly for use in the Registration Statement, such Prospectus or such form of Prospectus or in any amendment or supplement thereto, or (iii) in the case of an occurrence of an event of (x) the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement covering any or all of the Purchased Shares or the initiation of any proceedings for that purpose; or (y) the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Purchased Shares for sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose, to the extent related to the use by such Purchaser of an outdated or defective Prospectus after the Company has notified such Purchaser in writing that the Prospectus is outdated or defective and prior to the receipt by such Purchaser of an advice in writing by the Company that the use of the applicable Prospectus (as it may have been supplemented or amended) may be resumed. In no event shall the liability of such Purchaser under this Agreement be greater in amount than the dollar amount of the net proceeds received by such Purchaser upon the sale of the Purchased Shares giving rise to such indemnification obligation. For the purpose of this Section 3.6(d), Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Purchased Shares covered by a Registration Statement, and all other amendments and supplements to the Prospectus, including post effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.

Section 3.7     CSRC Filing.

(a)            The Company undertakes to file or cause to be filed with the China Securities Regulatory Commission (the “CSRC”) the requisite information and documents within three (3) Business Days or other timeframe prescribed by the CSRC following the Closing in accordance with the Trial Administrative Measures of Overseas Securities Offering and Listing by Domestic Companies (境内企业境外发行证券和上市管理试行办法) and supporting guidelines issued by the CSRC on February 17, 2023, as amended, supplemented or otherwise modified from time to time (the “CSRC Filing”).

Article IV

MISCELLANEOUS

Section 4.1     Governing Law; Arbitration. This Agreement shall be governed and interpreted in accordance with the laws of the State of New York. Any dispute, controversy or claim arising out of or relating to this Agreement, or the interpretation, breach, termination or validity hereof, shall be submitted to arbitration upon the request of any party with notice to the other party. The arbitration shall be conducted in Hong Kong under the auspices of the Hong Kong International Arbitration Centre (“HKIAC”) in accordance with the HKIAC Administered Arbitration Rules then in effect, which rules are deemed to be incorporated by reference into this Section 4.1. There shall be three (3) arbitrators. The complainant and the respondent to such dispute shall each select one arbitrator within thirty (30) days after giving or receiving the demand for arbitration. The Chairman of the HKIAC shall select the third arbitrator. If either party to the arbitration does not appoint an arbitrator who has consented to participate within 30 days after selection of the first arbitrator, the relevant appointment shall be made by the Chairman of the HKIAC. The arbitration proceedings shall be conducted in English. Each party irrevocably waives, to the fullest extent it may effectively do so, any objection which it may now or hereafter have to the laying of venue of any such arbitration in Hong Kong and the HKIAC, and hereby submits to the exclusive jurisdiction of HKIAC in any such arbitration. The award of the arbitration tribunal shall be conclusive and binding upon the disputing parties, and any party to the dispute may apply to a court of competent jurisdiction for enforcement of such award. Any party to the dispute shall be entitled to seek preliminary injunctive relief, if possible, from any court of competent jurisdiction pending the constitution of the arbitral tribunal.

Section 4.2     Amendment. This Agreement shall not be amended, changed or modified, except by another agreement in writing executed by the Parties.

Section 4.3     Binding Effect. This Agreement shall inure to the benefit of, and be binding upon, each of the Parties and their respective heirs, successors and permitted assigns and legal representatives.

Section 4.4     Assignment. Neither this Agreement nor any of the rights, duties or obligations hereunder may be assigned by a Party without the express written consent of the other Parties, except that each Purchaser may assign all or any part of its rights and obligations hereunder to any Affiliate of such Purchaser without the consent of the Company; provided that no such assignment shall relieve such Purchaser of its obligations hereunder if such assignee does not perform such obligations. Any purported assignment in violation of the foregoing sentence shall be null and void. For purposes of this Agreement, “Affiliate” of a person means any other person that directly or indirectly Controls, is Controlled by or is under common Control with such person, where “Control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management of a person, whether through the ownership of voting securities, by contract, credit arrangement or proxy, as trustee, executor or agent or otherwise.

Section 4.5     Notices. All notices, requests, demands and other communications that are required or may be given pursuant to the terms of this Agreement shall be in writing, and delivery shall be deemed sufficient in all respects and to have been duly given as follows: (a) on the actual date of service if delivered personally, (b) at the time of receipt if given by electronic mail to the email addresses set forth in this Section 4.5, (c) on the third Business Day after mailing if mailed by first-class mail return receipt requested, postage prepaid and properly addressed as set forth in this Section 4.5, or (d) on the day after delivery to a nationally recognized overnight courier service during its business hours for overnight delivery against receipt, and properly addressed as set forth in this Section 4.5:

If to the Purchasers, at:

He Family GRAT

100 W. Liberty St. STE. 100, Reno, NV, 89501-1927

Attn: Wei-Wu He

If to the Company, at:

9620 Medical Center Drive, Suite 300

Rockville, MD 20850

Attn: Rui Zhang

Section 4.6     Entire Agreement. This Agreement and the other Transaction Documents together constitute the entire understanding and agreement between the Parties with respect to the matters covered hereby, and all prior agreements and understandings, oral or in writing, if any, between the Parties with respect to the matters covered hereby are merged and superseded by this Agreement and the other Transaction Documents.

Section 4.7     Severability. If any provisions of this Agreement shall be adjudicated to be illegal, invalid or unenforceable in any action or proceeding whether in its entirety or in any portion, then such provision shall be deemed amended, if possible, or deleted, as the case may be, from the Agreement in order to render the remainder of the Agreement and any provision thereof both valid and enforceable, and all other provisions hereof shall be given effect separately therefrom and shall not be affected thereby.

Section 4.8     Fees and Expenses. Except as otherwise provided in this Agreement, each of the Parties will bear its own costs and expenses incurred in connection with the negotiation, preparation and execution of this Agreement and the transactions contemplated hereby, including fees and expenses of attorneys, accountants, consultants and financial advisors.

Section 4.9     Announcement. Without limiting any other provision of this Agreement, the Company and Purchasers, to the extent permitted by applicable law, will consult with each other before issuance of, and provide each other the opportunity to review, comment upon and concur with, and use all reasonable efforts to agree on, any press release or public statement with respect to the Transaction Documents and the transactions contemplated hereby and thereby, and will not (to the extent practicable) issue any such press release or make any such public statement prior to such consultation and agreement, except as may be required by law, rules, regulations or any listing agreement with or requirement of NASDAQ or any other applicable securities exchange, provided that the disclosing Party shall, to the extent permitted by applicable law, rules, regulations or any listing agreement with or requirement of NASDAQ or any other applicable securities exchange and if reasonably practicable, inform the other Parties about the disclosure to be made pursuant to such requirements prior to the disclosure.

Section 4.11    Termination. This Agreement may be terminated and the transactions contemplated by this Agreement abandoned at any time prior to the Closing:

(a)

by mutual agreement of the Company and the Purchasers;

(b)

(c)

(d)

(e)

by the Company in the event that the Closing shall not have occurred by September 25, 2024,

Section 4.12     Acknowledgements Regarding Placement Agent.

(a)

Each Purchaser acknowledges that the Placement Agent is acting as a placement agent on a “best efforts” basis for the Ordinary Shares being offered hereby and will be compensated by the Company for acting in such capacity. Each Purchaser represents that such Purchaser was contacted regarding the sale of the Ordinary Shares by the Placement Agent or the Company (or an authorized agent or representative thereof) with whom such Purchaser entered into a verbal or written confidentiality agreement.

(b)

Section 4.13     Exculpation of the Placement Agent. Each Party hereto agrees for the express benefit of the Placement Agent and its Affiliates and representatives that:

(a)

(b)

Section 4.14     Headings. The headings of the various articles and sections of this Agreement are inserted merely for the purpose of convenience and do not expressly or by implication limit, define or extend the specific terms of the section so designated.

Section 4.15     Third-Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto, their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other person, except as set forth in Sections 3.6(d),3.6(e), 4.12, 4.13 and 4.15 of this Agreement. The Placement Agent shall be the third-party beneficiary of the representations and warranties of the Company and the Purchasers in Article II.

Section 4.16     Execution in Counterparts. For the convenience of the Parties and to facilitate execution, this Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, but all of which together shall constitute but one and the same instrument.

Section 4.17     Remedies and Waivers. No delay or omission by any Party in exercising any right, power or remedy provided by law or under this Agreement or any other documents referred to in it shall: (i) affect that right, power or remedy; or (ii) operate as a waiver thereof. The single or partial exercise of any right, power or remedy provided by law or under this Agreement shall not preclude any other or further exercise or any other right, power or remedy. Except as otherwise expressly provided in this Agreement, the rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by law.

[signature pages follow]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

CASI Pharmaceuticals, Inc.

	By:	/s/ Wei-Wu He
	Name:	Wei-Wu He
	Title:	Chairman and Chief Executive Officer

[Signature Page to Subscription Agreement]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

Wei-Wu He

	/s/ Wei-Wu He
	Name:	Wei-Wu He

[Signature Page to Subscription Agreement]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

He Family GRAT

	By:	/s/ Wei-Wu He
	Name:	Wei-Wu He

[Signature Page to Subscription Agreement]

Schedule I

Purchasers	Total Purchase Price		Purchased Shares
Dr. Wei-Wu He	US$	1,000,000		200,000
HE Family GRAT	US$	500,000		100,000

Exhibit 5.1

Our ref JLH/815438-000001/29955087v3

CASI Pharmaceuticals, Inc.

1701-1702, China Central Office Tower 1

No. 81 Jianguo Road Chaoyang District

Beijing, 100025

People’s Republic of China

16 August 2024

Dear Sirs

CASI Pharmaceuticals, Inc.

We have acted as Cayman Islands legal advisers to CASI Pharmaceuticals, Inc. (the "Company") in connection with the Company’s registration statement on Form F-3, including all amendments or supplements thereto (the "Registration Statement"), filed with the Securities and Exchange Commission under the U.S. Securities Act of 1933, as amended to date relating to the resale by certain selling shareholders named in the Registration Statement (the “Selling Shareholders”) of up to an aggregate of 3,000,000 shares of par value US$0.0001 each (the "Shares"), comprising (i) 1,020,000 Shares which have been issued to the Selling Shareholders pursuant to the Purchase Agreements (as defined below) (the "Purchased Shares") and (ii) 1,980,000 Shares issuable to the Selling Shareholders under the Warrants (as defined below) (the "Warrant Shares").

We are furnishing this opinion as Exhibits 5.1 and 23.2 to the Registration Statement.

Documents Reviewed

For the purposes of this opinion, we have reviewed only originals, copies or final drafts of the following documents:

1.1

The Certificate of Incorporation dated 10 January 2023 and the Certificate of Incorporation on Change of Name dated 21 March 2023.

1.2

The Amended and Restated Memorandum and Articles of Association of the Company as adopted by a special resolution of the Company dated 20 March 2023 and effective on 21 March 2023 (the "Memorandum and Articles").

1.3

The written resolutions of the board of directors of the Company dated 26 June 2024 (the "Board Resolutions").

1.4

A certificate from a director of the Company, a copy of which is attached hereto (the "Director's Certificate").

1.5

A certificate of good standing dated 2 May 2024, issued by the Registrar of Companies in the Cayman Islands (the "Certificate of Good Standing").

1.6

The Registration Statement.

1.7

The register of members of the Company as provided by the Company on 8 August 2024.

1.8

A subscription agreement dated 26 June 2024 entered into between the Company and PANACEA VENTURE HEALTHCARE FUND II, L.P.

1.9

A subscription agreement dated 26 June 2024 entered into between the Company, Dr. Wei-Wu He and HE Family GRAT.

1.10

A subscription and purchase agreement dated 26 June 2024 entered into between the Company, Venrock Healthcare Capital Partners EG, L.P., Venrock Healthcare Capital Partners III, L.P. and VHCP Co-Investment Holdings III, LLC.

1.11

A subscription and purchase agreement dated 26 June 2024 entered into between the Company and Foresite Capital Fund VI LP.

1.12

A warrant issued to Venrock Healthcare Capital Partners EG, L.P. by the Company dated 15 July 2024.

1.13

A warrant issued to Venrock Healthcare Capital Partners III, L.P. by the Company dated 15 July 2024.

1.14

A warrant issued to VHCP Co-Investment Holdings III, LLC by the Company dated 15 July 2024.

1.15

A warrant issued to Foresite Capital Fund VI LP by the Company dated 15 July 2024.

Documents 1.8 to 1.15 are collectively referred to as the "PIPE Transaction Documents". Documents 1.8 to 1.11 are collectively referred to as the "Purchase Agreements". Documents 1.12 to 1.15 are collectively referred to as the “Warrants”.

Assumptions

The following opinions are given only as to, and based on, circumstances and matters of fact existing and known to us on the date of this opinion letter. These opinions only relate to the laws of the Cayman Islands which are in force on the date of this opinion letter. In giving these opinions we have relied (without further verification) upon the completeness and accuracy, as of the date of this opinion letter, of the Director's Certificate, the Register of Members, and the Certificate of Good Standing. We have also relied upon the following assumptions, which we have not independently verified:

2.1

Copies of documents, conformed copies or drafts of documents provided to us are true and complete copies of, or in the final forms of, the originals.

2.2

All signatures, initials and seals are genuine.

2.3

There is nothing contained in the minute book or corporate records of the Company (which, other than the records set out in paragraph 1 of this opinion letter, we have not inspected) which would or might affect the opinions set out below.

2.4

There is nothing under any law (other than the law of the Cayman Islands), which would or might affect the opinions set out below.

2.5

The Company have received money or money's worth in consideration for the issue of the Purchased Shares pursuant to the Purchase Agreements and the Company will receive money or money's worth in consideration for the issue of the Warrant Shares pursuant to the Warrants. None of the Shares will be issued for less than their par value.

2.6

The Company will have sufficient authorised but unissued shares in its authorised share capital to effect the issue of the Warrant Shares at the time of issuance.

2.7

No invitation has been or will be made by or on behalf of the Company to the public in the Cayman Islands to subscribe for any of the Shares.

Opinion

Based upon the foregoing and subject to the qualifications set out below and having regard to such legal considerations as we deem relevant, we are of the opinion that:

3.1

The Company has been duly incorporated as an exempted company with limited liability and is validly existing and in good standing with the Registrar of Companies under the laws of the Cayman Islands.

3.2

The authorised share capital of the Company is US$50,000 divided into 500,000,000 shares of a par value of US$0.0001 each.

3.3

The issue and allotment of the Shares to be offered and sold by the Selling Shareholders have been duly authorised. The Purchased Shares have been legally issued and allotted, and are fully paid and non-assessable, and the Warrant Shares, when allotted, issued and paid for pursuant to and in accordance with the terms of the Warrants, will be legally issued and allotted, and will be fully paid and non-assessable. As a matter of Cayman Islands law, a share is only issued when it has been entered in the register of members (shareholders).

Qualifications

The opinions expressed above are subject to the following qualifications:

4.1

To maintain the Company in good standing with the Registrar of Companies under the laws of the Cayman Islands, annual filing fees must be paid and returns made to the Registrar of Companies within the time frame prescribed by law.

4.2

In this opinion the phrase "non-assessable" means, with respect to shares in the Company, that a shareholder shall not, solely by virtue of its status as a shareholder and in absence of a contractual arrangement, or an obligation pursuant to the memorandum and articles of association, to the contrary, be liable for additional assessments or calls on the shares by the Company or its creditors (except in exceptional circumstances, such as involving fraud, the establishment of an agency relationship or an illegal or improper purpose or other circumstances in which a court may be prepared to pierce or lift the corporate veil).

4.3

The obligations of the Company may be subject to restrictions pursuant to:

(a)

United Nations and United Kingdom sanctions extended to the Cayman Islands by Orders in Council; and

(b)

sanctions imposed by Cayman Islands authorities under Cayman Islands legislation.

4.4

We express no opinion as to the meaning, validity or effect of any references to foreign (i.e. non-Cayman Islands) statutes, rules, regulations, codes, judicial authority or any other promulgations and any references to them in the PIPE Transaction Documents.

Except as specifically stated herein, we make no comment with respect to any representations and warranties which may be made by or with respect to the Company in any of the documents or instruments cited in this opinion or otherwise with respect to the commercial terms of the transactions, which are the subject of this opinion.

We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and to the reference to our name under the headings "Enforceability of Civil Liabilities" and "Legal Matters" and elsewhere in the Registration Statement. In giving such consent, we do not thereby admit that we come within the category of persons whose consent is required under Section 7 of the U.S. Securities Act of 1933, as amended, or the Rules and Regulations of the Commission thereunder.

Yours faithfully

Maples and Calder (Hong Kong) LLP

/s/ Maples and Calder (Hong Kong) LLP

Director's Certificate

August 12, 2024

To:	Maples and Calder (Hong Kong) LLP
	26th Floor, Central Plaza
	18 Harbour Road
	Wanchai, Hong Kong

Dear Sirs

CASI Pharmaceuticals, Inc. (the "Company")

I, the undersigned, being a director of the Company, am aware that you are being asked to provide a legal opinion (the "Opinion") in relation to certain aspects of Cayman Islands law. Capitalised terms used in this certificate have the meaning given to them in the Opinion. I hereby certify that:

The Memorandum and Articles remain in full force and effect and are unamended.

The Board Resolutions were duly passed in the manner prescribed in the Memorandum and Articles (including, without limitation, with respect to the disclosure of interests (if any) by directors of the Company) and have not been amended, varied or revoked in any respect.

The authorised share capital of the Company is US$50,000 divided into 500,000,000 shares of a par value of US$0.0001 each.

The shareholders of the Company have not restricted or limited the powers of the directors of the Company in any way and there is no contractual or other prohibition (other than as arising under Cayman Islands law) binding on the Company prohibiting it from issuing and allotting the Shares or otherwise performing its obligations under the PIPE Transaction Documents.

The directors of the Company at the date of the Board Resolutions and as at the date of this certificate were and are as follows:

Zhenbo Su

Thomas Folinsbee

Wei-Wu He

Y. Alexander Wu

Xuebo Zeng

Each director of the Company considers the transactions contemplated by the Registration Statement and the PIPE Transaction Documents to be of commercial benefit to the Company and has acted bona fide in the best interests of the Company, and for a proper purpose of the Company in relation to the transactions which are the subject of the Opinion.

The Company is not subject to the requirements of Part XVIIA of the Companies Act (As Revised).

To the best of my knowledge and belief, having made due inquiry, the Company is not the subject of legal, arbitral, administrative or other proceedings in any jurisdiction, except for the arbitration proceeding initiated with the Hong Kong International Arbitration Centre and the related PRC court enforcement proceedings in connection with the dispute between the Company and Juventas Cell Therapy Ltd. (the "Arbitration Proceeding"), and neither the directors nor shareholders of the Company have taken any steps to have the Company struck off or placed in liquidation. Further, no steps have been taken to wind up the Company or to appoint restructuring officers or interim restructuring officers, and no receiver has been appointed in relation to any of the Company's property or assets. The Arbitration Proceeding will not result in the Company being unable to perform its obligations under the PIPE Transaction Documents or to register the transfer of the Shares being offered and sold by the Selling Shareholders as contemplated by the Registration Statement.

The Company is not a central bank, monetary authority or other sovereign entity of any state and is not a subsidiary, direct or indirect, of any sovereign entity or state.

I confirm that you may continue to rely on this Certificate as being true and correct on the day that you issue the Opinion unless I shall have previously notified you personally to the contrary.

[signature page follows]

Signature:	/s/ Wei-Wu He
Name: Wei-Wu He
Title: Director

Exhibit 23.1

Consent of Independent Registered Public Accounting Firm

We consent to the use of our report dated March 28, 2024, with respect to the consolidated financial statements of CASI Pharmaceuticals, Inc., incorporated herein by reference and to the reference to our firm under the heading “Experts” in the prospectus.

/s/ KPMG Huazhen LLP

Beijing, China

August 16, 2024

Exhibit 107

Calculation of Filing Fee Table

Form F-3

(Form Type)

CASI Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

Table 1: Newly Registered Securities

Security
Type

Security
Class
Title

Fee
Calculation or
Carry Forward
Rule

Amount
Registered⁽¹⁾

Proposed
Maximum
Offering
Price Per
Unit⁽³⁾

Maximum
Aggregate
Offering
Price

Fee Rate

Amount of
Registration
Fee

Fees to Be Paid

Equity

Ordinary Shares, par value
$0.0001 per share⁽²⁾

Rule 457(c)

3,000,000

       6.435

19,305,000

0.00014760

2,849.42

Total Offering Amounts

3,000,000

19,305,000

2,849.42

(1)	In accordance with Rule 416(a), the registrant is also registering hereunder an indeterminate number of shares that may be issued and resold resulting from share splits, share dividends or similar transactions.

(2)	As described in greater detail in the prospectus contained in this registration statement, the ordinary shares to be offered for resale by selling shareholders include an aggregate of 1,020,000 ordinary shares issued to the selling shareholders and 1,980,000 ordinary shares issuable upon exercise of certain pre-funded warrants issued to certain selling shareholders in connection with a private placement transaction entered into on June 26, 2024.

(3)	Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(c) under the Securities Act of 1933, based upon the average of the high and low prices of the registrant’s ordinary shares on the Nasdaq Capital Market on August 15, 2024.

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