Tiantan Biological's prothrombin complex drug enters phase III trial

Beijing Tiantan Biological Products Corporation (Tiantan Biological) announced that its subsidiary, Sinopharm Wuhan Biological Products Co., Ltd., has officially commenced Phase III clinical trials for its "human prothrombin complex." The drug is designed to treat various congenital and acquired deficiencies of coagulation factors II, VII, IX, and X, including hemophilia B and conditions related to anticoagulant overdose or liver disease.

The human prothrombin complex received its clinical trial approval on April 2, 2024. The total research and development investment for this drug stands at RMB 3786.86万元. The drug is classified as a therapeutic biological product and will be administered as an injection.

Tiantan Biological highlights that the drug's development is a long-term endeavor. Further steps include completing Phase III trials, submitting marketing authorization applications, and obtaining regulatory approvals and drug registration certificates. The company advises investors to be aware of the inherent uncertainties in drug development.