Recombinant Human Thymosin β4 Applies for New Drug Clinical Trials

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2013-12-17


Recently, our company’s independently developed recombinant human thymosin β4 has been formally submitted to the National Medical Products Administration for clinical trial approval and has received a notice of acceptance (Acceptance No.: CXSL1300108 Beijing). Its intended indication is acute myocardial infarction, and it is classified as a Class 1 novel therapeutic biological product.

Thymosin β4 is a small-molecule protein naturally present in the human body, possessing a variety of biological functions including cardioprotection and myocardial repair, promotion of angiogenesis, enhancement of cell migration, anti-apoptotic effects, and anti-inflammatory properties. Clinically, it holds promise for the treatment of diseases such as acute myocardial infarction, dry eye syndrome, and skin injuries.

After years of research, this project has now completed all preclinical studies of the system and has preliminarily demonstrated the efficacy and safety of this product in the treatment of acute myocardial infarction. It holds promise as a new therapeutic option for acute myocardial infarction. The 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 included in the national “11th Five-Year Plan” and “12th Five-Year Plan” special programs for “Major New Drug Development.” The company will actively advance clinical trials of this product for acute myocardial infarction while accelerating the R&D progress for indications such as dry eye syndrome and skin injuries.

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