Tiantan biological subsidiary advances hemophilia drug to phase III trials

Chengdu Rongsheng Pharmaceuticals, a subsidiary of Beijing Tiantan Biological Products Corp., has officially commenced Phase III clinical trials for its "Recombinant Human Coagulation Factor VII-Fc Fusion Protein for Injection." The drug received its clinical trial approval on December 19, 2023. It is intended for the control and prevention of bleeding in hemophilia A patients, as well as for surgical bleeding prevention in these patients. The product is not indicated for von Willebrand disease.

The drug will be available in 250IU/vial and 1000IU/vial specifications. To date, the company has invested 9868.32万元 in the research and development of this drug. Currently, there are no domestic or international products of this specific type available on the market from Chengdu Rongsheng. However, other companies like Sanofi offer similar treatments in various dosages.

The successful completion of Phase III trials, subsequent approval by the National Medical Products Administration, and obtaining the drug registration certificate are still required before the product can be manufactured and sold. Investors are cautioned to be aware of the inherent uncertainties and risks associated with long-term pharmaceutical research and development.