Tiantan Biological subsidiary wins clinical trial approval for fibrinogen product

Beijing Tiantan Biological Products Co., Ltd. announced its subsidiary, Sinopharm Group Kunming Blood Products Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for its "human fibrinogen" product. The notice was issued on September 28, 2025. The product is indicated for congenital and acquired fibrinogen deficiency.

The clinical trials will assess 0.5g (25ml)/bottle formulations, classified as therapeutic biologics. The estimated research and development investment for this product is CNY 599.25 million.

The company cautioned investors that the "human fibrinogen" product still requires further clinical trials, submission of marketing applications, and approval from the National Medical Products Administration to achieve production and market sales. Drug development is a lengthy process with various internal and external uncertainties.