Approval Provides Strong Support for the Product’s Marketing in China
BEIJING, April 04, 2023 (GLOBE NEWSWIRE) -- 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.
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.
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David J. Rudnick