Tiantan Biological unit withdraws drug application for coagulation factor

Chengdu Rongsheng, a subsidiary of Beijing Tiantan Biological Products, has withdrawn its application for marketing approval for "Recombinant Human Coagulation Factor VIIa for Injection." The application was withdrawn following CDE feedback requiring additional clinical trial data for pediatric patients under 12 years old. The company plans to resubmit the application after completing the necessary supplementary clinical data.

The drug, indicated for treating bleeding in patients with hemophilia and other coagulation disorders, incurred an R&D investment of CNY 26,640.6. The withdrawal is not expected to significantly impact the company's operating performance. The development of pharmaceutical products is a long-term process with inherent uncertainties, and investors are advised to exercise caution.