Tiantan Biological subsidiary concludes phase III trial for prothrombin complex

Beijing Tiantan Biological Products Co., Ltd. announced that its subsidiary, Sinopharm Group Guizhou Biological Pharmaceutical Co., Ltd. (Tiantan Guizhou), has completed Phase III clinical trials for its "Human Prothrombin Complex" and obtained the summary report. This product treats deficiencies in coagulation factors II, VII, IX, and X, including hemophilia B, and other coagulation disorders. The total research and development investment for this product was yuan 4239.63.

The clinical trial results indicate that the Human Prothrombin Complex significantly increased coagulation factor II/VII/IX/X levels, improved coagulation function, and ameliorated bleeding symptoms and signs in hemophilia B patients, demonstrating good efficacy and a favorable safety profile. The product is administered as an injection, with each bottle containing 300 IU (15ml).

Tiantan Guizhou will now proceed with submitting a registration application to the National Medical Products Administration. The company notes that the timeline for regulatory review and obtaining a drug registration certificate is uncertain. Following approval and GMP compliance, the product can be manufactured and released for market.