Shineco Subsidiary’s ‘Cardiac 5-Minute Test’ Passes Quality Inspection by China Regulator NMPA
04 Abril 2023 - 10:00AM
Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: SISI), a
producer and distributor of Chinese herbal medicines, organic
agricultural products and other biotech products, announced today
that its Cardiac 5-Minute Test, developed by its 51%-owned
subsidiary Changzhou Biowin Pharmaceutical Co., Ltd. (“Biowin”),
passed quality inspection by the Anhui Bureau of the National
Medical Products Administration (“NMPA"), China’s regulatory body
that supervises the safety and registration of drugs, medical
devices and cosmetics.
This milestone is vital for the Company since it
provides strong support for the product's marketing in China which
is expected to occur in the near future. The NMPA’s quality
inspection process for the 5-Minute Cardiac Test involved a
thorough evaluation of the test's performance including its
sensitivity to detect the limit of detection for early-stage
myocardial infarction, specificity as to its reaction to cardiac
markers only (and not to non-cardiac proteins), and an evaluation
of the test’s accuracy, precision and stability. The most crucial
aspect of the NMPA’s quality inspection was for the testing time of
the Cardiac 5-Minute Test: it took 5 minutes or less to reach
stable detection compared to over 15 minutes for other cardiac
marker tests that are currently on the market. The NMPA’s
requirements are essential for ensuring the accuracy and
reliability of the test results for medical practitioners which is
crucial for the diagnosis and management of myocardial
infarction.
Dr. Marvin Liu, CEO of Biowin, commented, “We
are pleased to announce that the Cardiac 5-Minute Test has
successfully passed quality inspection by China’s NMPA, which is
similar to the FDA in the US. This is a significant milestone and
reinforces our commitment to producing high-quality and reliable
cardiac tests. For patients with a myocardial infarction (AMI),
blood flow to the heart is blocked and the heart muscle can be
damaged. The longer the heart is deprived of blood flow, the more
severe the damage can be. The US and international AMI guidelines
require completion of a diagnosis within 10 minutes of the
patient's arrival at a clinician.”
“However, the current lab tests for AMI take
more than 20 minutes for it to provide results. Therefore, the
successful quality inspection of our Cardiac 5-Minute Test by the
NMPA is very important since the timely administration of
appropriate treatments following a diagnosis can improve the
patient's chances of survival and reduce the risk of long-term
complications,” Dr. Liu concluded.
Ms. Jennifer Zhan, CEO of Shineco, commented,
“We are pleased that Biowin’s robust diagnostic R&D pipeline
has generated positive results in a short period of time and are
enthused to see this breakthrough in the Point-of-Care Testing
industry. We believe that Biowin’s products that are designed for
the use of clinical diagnosis and the rapid screening of the most
common diseases have huge market potential worldwide. Our plan is
to seek appropriate regulatory approvals to market the Cardiac
5-Minute Test to take advantage of the estimated $3.5 billion
global market for myocardial infarction rapid testing. The
integration of Biowin in our upgraded value chain is consistent
with our goal to maximize shareholder returns.”
About
Shineco, Inc.
Shineco, Inc. (“Shineco” or the “Company)
utilizes modern engineering technologies and biotechnology systems
to develop and produce Chinese herbal medicines, organic
agricultural produce, and specialized textiles, among other
products. The Company also plans to develop innovative drugs and
medical devices as well as diagnostic devices and a treatment
platform for cancer patients. Shineco was incorporated in Delaware
in August 1997 and is headquartered in Beijing, China. For more
information about Shineco, please visit www.biosisi.com.
Forward-Looking Statements
This 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:
Precept Investor Relations LLCDavid J.
Rudnickdavid.rudnick@preceptir.comMobile: +1-646-694-8538
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