Beijing Tiantan Biological Products Corporation (600161.SH): Withdrawal of the registration application for injectable recombinant human coagulation factor VIIa drug.

Beijing Tiantan Biological Products Corporation (600161.SH) has announced that its subsidiary, Chengdu Rongsheng Pharmaceutical Co., Ltd. (hereinafter referred to as Chengdu Rongsheng), has submitted an application for the market approval of "Recombinant Human Coagulation Factor VIIa for Injection" to the Center for Drug Evaluation (CDE) of the National Medical Products Administration in January 2025, and has obtained the "Acceptance Notification" (Acceptance Number: CXSS2500005). Since the acceptance of the market approval application for this product, Chengdu Rongsheng has been carrying out related evaluation work continuously. Recently, based on the evaluation feedback from CDE, it is required to supplement clinical trial data for the pediatric population (<12 years old). Therefore, Chengdu Rongsheng has submitted a request for withdrawal of the drug registration to CDE, and will resubmit the application for drug market approval registration after completing the necessary clinical data.