Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: SISI), a
producer of technologically advanced healthcare products and
services, announced today that on June 21, 2023, Changzhou Biowin
Pharmaceutical Co., Ltd., a majority-owned subsidiary of the
Company ("Biowin"), received marketing and distribution approval
for its Cardiac 5-Minute Test from the Jiangsu Bureau of the
National Medical Products Administration (“NMPA"), which is China’s
regulatory equivalent of the U.S. Food and Drug Administration
(FDA). The effective date for the diagnostic medical product’s
registration with the NMPA is June 21, 2023, and it shall remain
valid for five years through June 20, 2028.
The Cardiac 5-Minute Test is a combination test
of three major cardiac markers and can detect cardiac troponin I,
myoglobin, and heart fatty acid binding protein for the clinical
diagnosis of acute myocardial infarction (“AMI”) in one test. The
approval by the NMPA provides strong support for Biowin’s business
development efforts which encompasses additional medical products
in the Point-of-Care Testing industry.
"We are very glad to have received marketing
approval for our Cardiac 5-Minute Test from the NMPA. This is a
significant milestone for our business, and we believe that the
diagnostic test will achieve high acceptance in the Chinese
market," said Dr. Marvin Liu, CEO of Biowin. “As the inventor of
the technology for the Cardiac 5-Minute Test, we are pleased that
its fast detection marks a significant technical breakthrough that
sets our diagnostic medical product apart from other products on
the market. It provides a new and highly valuable approach to
conducting cardiac marker tests within 5 minutes, which we believe
will save lives in China and throughout the world.”
“Based on the new approach of the Cardiac
5-Minute Test, we have designed a marketing plan that includes
having medical professionals take a leading role in promoting the
adoption of this new diagnostic medical product. We have begun to
establish a consultation program to secure professional validation
from clinical experts in cardiology, which in turn will help with
the promotion of this potentially life-saving test. We believe that
the regulatory approval of our Cardiac 5-Minute Test will
ultimately lead to substantial profitability for the Company,”
concluded Dr. Liu, CEO of Biowin.
Following its approval by the NMPA, the Cardiac
5-Minute Test has become the first and only product on the market
in China to complete the detection process for cardiac markers
within 5 minutes. The time from onset to diagnosis of acute
myocardial infarction (AMI) is an important factor affecting the
prognosis of cardiac patients. Electrocardiograms (ECGs) and
cardiac marker tests are the two major diagnostic methods for AMI.
The US, European, and Chinese AMI guidelines require clinicians to
establish the diagnosis by ECG within 10 minutes of the patient’s
arrival. However, approximately 40-50% of patients with AMI show
non-specific ECG results. This means that ECGs cannot cover the
diagnosis of all patients with AMI, and timely cardiac marker tests
are essential for establishing an AMI diagnosis. However, the time
required for blood sample collection and testing of current cardiac
marker test products exceeds 10 minutes and cannot meet the
clinical demand for a 10-minute diagnosis.
The Cardiac 5-Minute Test completes the
detection of AMI within 5 minutes, allowing additional time for
sample collection while still maintaining the total diagnostic time
within 10 minutes. This test not only meets the detection
requirements for AMI within 10 minutes but also provides effective
tools for managing AMI that improve the prognosis for cardiac
patients. We believe that the Cardiac 5-Minute Test will have a
wide range of point-of-service administration including hospitals,
emergency rooms, cardiology departments, and doctor’s offices. In
addition, the diagnostic medical product does not require cold
chain transportation since it can be stored at room
temperature.
About
Shineco, Inc.
Shineco Inc. (“Shineco” or the “Company”) aims
to ‘care for a healthy life and improve the quality of life’, by
providing safe, efficient and high-quality health products and
services to society. Shineco, operating through variable interest
entities and subsidiaries, has researched and developed 33 vitro
diagnostic reagents and related medical devices to date, and the
Company also produces and sells healthy and nutritious foods. 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:
Shineco,Inc.secretary@shineco.techMobile:
+86-010-68130220
Precept Investor Relations LLCDavid J.
Rudnickdavid.rudnick@preceptir.comMobile: +1-646-694-8538
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