Recombinant human thymosin β4 has received clinical trial approval.

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2015-12-24


Recently, recombinant human thymosin β4, independently developed by Beijing Northland Biotechnology Co., Ltd., has received the Phase I/II clinical trial approval from the National Medical Products Administration. The approved indication for this trial is the treatment of acute myocardial infarction. This project is classified as a Class 1 new biological product for therapeutic use and is being reviewed under the framework of a major special program.

Thymosin β4 is a small-molecule protein naturally present in the human body, possessing multiple biological functions such as cardioprotection and repair, angiogenesis promotion, cell migration enhancement, anti-apoptosis, and anti-inflammation. It can be used to develop drugs for indications including skin injuries, corneal injuries, dry eye syndrome, and myocardial infarction. After years of research, NORTHLAND has systematically completed all preclinical studies, preliminarily demonstrating the efficacy and safety of this product in the treatment of acute myocardial infarction, and it holds promise as a new drug for the treatment of acute myocardial infarction.

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 “11th Five-Year Plan” and “12th Five-Year Plan” special programs for “Major New Drug Development.” In August 2015, NORTHLAND successfully transferred the indications for dry eye syndrome and hair growth of this product to Huons Corporation of South Korea, thereby expanding the scope of the project’s applications. Meanwhile, the project was awarded the “China Patent Excellence Award” by the National Intellectual Property Administration in 2015.

The company will scientifically design the clinical trial protocol for this product and rigorously advance the clinical study on acute myocardial infarction in strict accordance with GCP requirements. At the same time, we will accelerate the R&D progress for treating conditions such as dry eye syndrome and skin injuries.

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