Shineco, Inc. announced 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. Following its approval by the NMPA, the Cardiac 5-MinuteTest 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.