Shineco, Inc. Subsidiary Receives Prior Approval Supplement from the NMPA Jiangsu Bureau for the Marketing Approval of “Cardiac 5-Minute Test”
19 Dezembro 2022 - 11:00AM
Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: SISI), a
producer and distributor of Chinese herbal medicines, organic
agricultural and other biotech products, announced that the
Company’s controlled affiliate Changzhou Biowin Pharmaceutical Co.,
Ltd. ("CBP") has received the Prior Approval Supplement from the
Jiangsu Medical Products Administration (“NMPA Jiangsu Bureau”) for
the marketing approval of “Cardiac 5-minute Test.” This product is
a combo test of three major cardiac markers and can detect cardiac
troponin I (“cTnI”), myoglobin and fatty acid binding protein
(“FABP”) for the clinical diagnosis of acute myocardial infarction
(“AMI”) in one test. We believe it is a breakthrough of the
clinical diagnosis of AMI and takes only 5 minutes to complete
detection.
Cardiovascular disease is the leading cause of
death in the world, especially for those over 50 years old. About
half of the deaths are associated with AMI related causes. The time
from onset to diagnosis of AMI is an important factor affecting
prognosis. If diagnosed and treated timely, the mortality rate can
be reduced to less than 2%, but if not, the mortality rate can
exceed 10%. Therefore, the US and International AMI guideline
requires clinicians to complete diagnosis within 10 minutes of
arrival. However, current lab tests cannot meet this demand and
need over 20 minutes upon arrival to obtain the test result. We
believe that if approved, this Cardiac 5-minute Test has the
potential to be one of the leading products in this field to meet
the demand of obtaining the test result in less than 10 minutes
upon arrival, provide an effective tool to improve the prognosis of
acute myocardial infarction, and become a leading rapid test
product for the diagnosis of acute myocardial infarction in the
global myocardial infarction rapid test market of over US$3.5
billion.
“We are very glad to receive the first review
report from the Chinese FDA Bureau for our application of the
marketing approval of the Cardiac 5-minute Test. This is a very
important milestone for our product to be on the market in China
soon, and we are expecting to receive the final marketing approval
in China within three months,” said Dr. Marvin Liu, CEO of CBP and
the inventor of this technology, “Our 5-minute test is not only
rapid, but also accurate, easy to use, and portable. In addition,
it can be used as a point-of-care testing (POCT) product as well.
The POCT market in China, Europe, the United States and other
countries has expanded rapidly and maintained a high growth rate in
recent years. This high clinical demand, combined with our
technological breakthrough for the rapid diagnosis of acute
myocardial infarction, will allow us to develop a strong
competitive advantage in target markets of China as well as other
countries in the world.”
About
Shineco,
Inc.Incorporated in Delaware in August 1997 and
headquartered in Beijing, China, Shineco is a holding company.
Utilizing modern engineering technologies and biotechnologies,
Shineco produces, among other products, Chinese herbal medicines,
organic agricultural produce, and specialized textiles. For more
information about Shineco, please visit www.biosisi.com.
Forward-Looking StatementsThis
news release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
These forward-looking statements can be identified by terminology
such as “may”, “will”, “should”, “could”, “intend”, “expect”,
“plan”, “budget”, “forecast”, “anticipate”, “believe”, “estimate”,
“predict”, “potential”, “continue”, “evaluating” or similar words.
Forward-looking statements should not be relied upon because they
are neither historical facts nor assurances of future performance.
Instead, they are based only on our current beliefs, expectations
and assumptions regarding the future of our business, future plans
and strategies, projections, anticipated events and trends, the
economy and other future conditions. Examples of forward-looking
statements include, among others, statements we make regarding the
innovativeness and market position of our products and services,
our competitive strengths, and our expectation that the Cardiac
5-minute Test will be one of the leading products in this field to
meet the demand of obtaining the test result shortly upon arrival.
You are cautioned not to rely on any forward-looking statements.
Actual results may differ materially from historical results or
those indicated by the forward-looking statements as a result of a
variety of factors including, but not limited to, risks and
uncertainties associated with the Company’s ability to raise
additional funding, its ability to maintain and grow its business,
variability of operating results, its ability to maintain and
enhance its brand, its development and introduction of new products
and services, the ability to obtain all necessary regulatory
approvals in the jurisdictions where it intends to market and sell
its products the successful integration of acquired companies,
technologies and assets into its portfolio of products and
services, marketing and other business development initiatives,
competition in the industry, general government regulations,
economic conditions, the impact of the COVID-19 pandemic,
dependence on key personnel, the ability to attract, hire and
retain personnel who possess the technical skills and experience
necessary to meet the requirements of its clients, and its ability
to protect its intellectual property. Shineco encourages you to
review other factors that may affect its future results in its
filings with the Securities and Exchange Commission. The
forward-looking statements in this press release are based only on
information currently available to us and speak only as of the date
of this press release, and Shineco assumes no obligation to update
any forward-looking statements except as required by the applicable
rules and regulations.
For more information,
please contact:
Tina XiaoAscent Investor Relations LLCPhone:
+1-917-609-0333Email: tina.xiao@ascent-ir.com
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