Registration with the NMPA, China’s Regulatory Equivalent to the FDA, is a Prerequisite to Marketing and Distribution
BEIJING, July 10, 2023 (GLOBE NEWSWIRE) -- 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/.
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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