On November 23, 2020, the Phase IIa clinical trial for the indication of ischemia-reperfusion injury (MIRI) caused by acute myocardial infarction, using the company’s independently developed “Recombinant Human Thymosin β4 for Injection,” successfully completed enrollment of its first patient at Beijing Chaoyang Hospital, affiliated with Capital Medical University. This clinical trial is led by Fuwai Hospital of the Chinese Academy of Medical Sciences and is being conducted across five participating research centers. All centers were fully activated by the end of October and have now officially entered the screening and enrollment phase. The trial is expected to complete full enrollment by the end of July next year.

　　Thymosin β4 is a small-molecule protein naturally present in the human body. It exhibits a variety of biological functions, including cardioprotection and myocardial repair, inflammation regulation, angiogenesis promotion, and enhanced cell migration. Additionally, it holds potential for developing therapeutic agents targeting a range of conditions such as dry eye syndrome, skin injuries, and corneal damage.

　　“Recombinant Human Thymosin β4 for Injection” is an innovative drug developed by our company. We have now systematically completed all preclinical studies, and the results of Phase I clinical trials indicate that this product exhibits good safety profile in the treatment of MIRI. Currently, there are no effective drugs available worldwide for either the prevention or treatment of MIRI. If this drug is successfully developed, it will provide a new therapeutic approach for MIRI, playing a crucial role in preserving cardiac function and improving patients’ quality of life.

　　This project possesses independent intellectual property rights and has been granted invention patents in China, the United States, Europe, Japan, and South Korea. It has also been successively included in the national special programs for “Major New Drug Development” during the 11th, 12th, and 13th Five-Year Plans, and has received the “China Patent Excellence Award.”

　　Our company will effectively mobilize all relevant resources and, in compliance with GCP and regulatory requirements, ensure the smooth management of the Phase IIa clinical trial for this project. We will conduct the clinical study scientifically, rigorously, and in accordance with established protocols, and complete it on schedule.