Zhejiang Hisoar Pharmaceutical's (002099.SZ) invested company's innovative drug recombinant batroxobin for injection has received approval for clinical trials.

Zhejiang Hisoar Pharmaceutical (002099.SZ) announced that the company recently received a "Notice Letter" issued by its industrial fund manager, Beijing Guoxin Zhongshu Investment Management Co., Ltd. The company learned that Guoxin Haixiang Equity Investment Partnership Enterprise (Limited Partnership) (hereinafter referred to as "Guoxin Haixiang"), an invested company of Beijing Greatson Biotechnology Co., Ltd. (hereinafter referred to as "Greatson"), received the "Drug Clinical Trial Approval Notice" officially issued by the National Medical Products Administration (NMPA) for the innovative biological drug recombinant batroxobin developed independently by Greatson for injection. This approval allows the product to conduct clinical trials. The injection recombinant batroxobin developed independently by Greatson uses the Pichia pastoris expression system for production, and the target protein is derived from the blood coagulation enzyme batroxobin from the Brazilian lancehead snake. Compared with traditional snake venom extraction products, recombinant batroxobin can ensure a continuous and abundant supply, reduce the risk of contamination from exogenous viruses, toxins, etc., and avoid the safety hazards of traditional processes. Greatson has conducted comprehensive non-clinical studies showing that the product has significant hemostatic efficacy in various animal models, is superior to the positive control drug in terms of efficacy, has good safety, and has a No Observed Adverse Effect Level (NOAEL) exceeding 50 times the effective dose.