天坛生物:完成Ⅲ期临床试验总结报告

Core Viewpoint - Tiantan Biological announced that its subsidiary Tiantan Guizhou has completed Phase III clinical trials for "Prothrombin Complex Concentrate," which is primarily used to treat congenital and acquired coagulation factor deficiencies, including Hemophilia B [1] Group 1 - The clinical trial results indicate that the drug significantly improves coagulation factor levels in patients with Hemophilia B and alleviates bleeding symptoms, demonstrating good efficacy and safety [1] - The research and development investment for this product amounted to 42.3963 million yuan [1] - Tiantan Guizhou plans to submit a registration application to the National Medical Products Administration, although the review timeline and the issuance of the drug registration certificate remain uncertain [1] Group 2 - Once approved, the product will be eligible for production and market sales [1]