Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the
Center for Drug Evaluation (CDE) of China’s National Medical
Products Administration (NMPA) has granted priority review to
repotrectinib for the treatment of adult patients with locally
advanced or metastatic ROS1-positive non-small-cell lung cancer
(NSCLC).
“The CDE’s decision to grant priority review to repotrectinib
underscores repotrectinib as a potential next-generation
best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve
and pretreated patients in China,” said Rafael G. Amado, M.D.,
President, Head of Global Oncology Research and Development at Zai
Lab. “We thank the agency for their commitment and continued
support to patients in need, and we look forward to our continued
partnership with regulatory authorities in China to bring this
important medicine to patients in need as soon as possible.”
Priority review was established in China to encourage innovative
drug development with significant clinical value and urgent
clinical need. It is implemented under the Drug Registration
Regulation (Bureau Order 27) and the Working Procedure for Priority
Review and Approval of Drug Marketing Authorization (Interim, NMPA
2020 No. 82) effective on July 1, 2020, and July 7, 2020,
respectively. According to the regulation and guidance, the
regulatory authority will prioritize the evaluation resources for
applications under priority review to expedite the review and
approval timelines.
About Repotrectinib
Repotrectinib is a next-generation tyrosine kinase inhibitor
targeting the ROS1 and NTRK oncogenic drivers of advanced solid
tumors, including NSCLC. Patients with tumor harboring ROS1 and
NTRK gene fusions treated with approved targeted therapies often
develop resistance mutations, limiting binding of these drugs to
their target, eventually leading to tumor progression.
Repotrectinib is the first next-generation TKI for ROS1-positive
metastatic NSCLC, uniquely designed to address key drivers of
disease progression. Zai Lab and Turning Point Therapeutics, Inc.
(Turning Point Therapeutics, acquired by Bristol Myers Squibb) are
studying repotrectinib in TRIDENT-1, a registrational Phase 1/2
study in adults, and CARE, a Phase 1/2 study in pediatric patients.
Repotrectinib has shown robust antitumor activity and durable
responses among TKI-naïve and pre-treated patients. Zai Lab is
enrolling patients in the registrational TRIDENT-1 study in Greater
China (Mainland China, Hong Kong, Taiwan, and Macau), while Turning
Point Therapeutics is enrolling patients in other regions of the
world.
Repotrectinib has been granted three Breakthrough Therapy
Designations from the U.S. Food and Drug Administration in:
ROS1-positive metastatic NSCLC patients who have not been treated
with a ROS1 TKI; ROS1-positive metastatic NSCLC patients who have
previously been treated with a ROS1 TKI and who have not received
prior platinum-based chemotherapy; and patients with advanced solid
tumors that have an NTRK gene fusion who have progressed following
treatment with one or two prior TRK TKIs, with or without prior
chemotherapy, and have not had satisfactory alternative treatments.
Additionally, repotrectinib was previously granted four Fast-Track
designations in ROS1-positive advanced NSCLC patients who are ROS1
TKI naïve; ROS1-positive advanced NSCLC patients who have been
previously treated with one prior line of platinum-based
chemotherapy and one prior ROS1 TKI; ROS1-positive advanced NSCLC
patients pretreated with one prior ROS1 TKI without prior
platinum-based chemotherapy; and NTRK-positive patients with
advanced solid tumors who have progressed following treatment with
at least one prior line of chemotherapy and one or two prior TRK
TKIs and have not had satisfactory alternative treatments.
Repotrectinib was also granted an Orphan Drug designation in
2017.
Repotrectinib has been granted three Breakthrough Therapy
Designations from the CDE of China’s NMPA in ROS1-positive
metastatic NSCLC patients who have not been treated with a ROS1
TKI; ROS1-positive metastatic NSCLC patients who have previously
been treated with a ROS1 TKI and who have not received prior
platinum-based chemotherapy; and ROS1-positive metastatic NSCLC
patients who have previously been treated with a ROS1 TKI and one
prior line of platinum-based chemotherapy.
Zai Lab has an exclusive license agreement with Turning Point
Therapeutics to develop and commercialize repotrectinib in Greater
China.
About Non-Small Cell Lung
Cancer in China
Lung cancer is both the most commonly diagnosed cancer type and
the leading cause of cancer death in China. The incidence of lung
cancer in China in 2020 was 815,563 cases, with 714,699 deaths.1
NSCLC accounts for approximately 85% of lung cancer, and about 70%
of NSCLC is locally advanced or metastatic at initial diagnosis. In
China, ROS1 rearrangements occur in 2-3% of patients with advanced
NSCLC.
1Globocan 2020.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative,
research-based, commercial-stage biopharmaceutical company based
in China and the United States. We
are focused on discovering, developing, and commercializing
innovative products that address medical conditions with
significant unmet needs in the areas of oncology, autoimmune
disorders, infectious diseases, and neuroscience. Our goal is to
leverage our competencies and resources to positively impact human
health in China and worldwide.
For additional information about Zai Lab, including our
products, business activities and partnerships, research, and other
events or developments, please visit www.zailaboratory.com or
follow us at www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains statements about future
expectations, plans and prospects for Zai Lab, including, without
limitation, statements regarding the prospects of and plans for
commercializing repotrectinib in the Greater China region, the
potential efficacy and safety of repotrectinib, and the regulatory
pathway afforded by the Priority Review. It should be noted that
Priority Review is not a guarantee of approval. These
forward-looking statements may contain words such as “aim,”
“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,”
“goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,”
“would” and other similar expressions. Such statements constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are not statements of historical fact, nor are they
guarantees or assurances of future performance. Forward-looking
statements are based on our expectations and assumptions as of the
date of this press release and are subject to inherent
uncertainties, risks, and changes in circumstances that may differ
materially from those contemplated by the forward-looking
statements. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including but not limited to (1) our ability to
successfully commercialize and generate revenue from our approved
products, (2) our ability to obtain funding for our operations and
business initiatives, (3) the results of our clinical and
pre-clinical development of our product candidates, (4) the content
and timing of decisions made by the relevant regulatory authorities
regarding regulatory approvals of our product candidates, (5) the
effects of the novel coronavirus (COVID-19) pandemic on our
business and results of operations, and (6) risks related to doing
business in China, and (7) other factors identified in our most
recent annual and quarterly reports and in other reports we have
filed with the U.S. Securities and Exchange Commission (SEC).
We anticipate that subsequent events and developments will
cause our expectations and assumptions to change, and we undertake
no obligation to update or revise any forward-looking statements,
whether as a result of new information, future events, or
otherwise, except as may be required by law. These forward-looking
statements should not be relied upon as representing our views as
of any date subsequent to the date of this press release.
Our SEC filings can be found on our website at
www.zailaboratory.com and on the SEC’s website at www.SEC.gov.
For more information, please contact:
Investor Relations: Christine Chiou / Lina
Zhang+1 (917) 886-6929 / +86 136 8257
6943christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media: Jennifer Chang / Xiaoyu Chen+1 917 446
3140 / +86 185 0015 5011jennifer.chang@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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