BTBP(SH:600161) Ge Long Hui A P P·2025-11-19 09:23Core Viewpoint - TianTan Bio (600161.SH) has submitted a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, but has since withdrawn the application to supplement clinical trial data for pediatric patients under 12 years old [1] Group 1 - TianTan Bio's subsidiary, Chengdu Rongsheng Pharmaceutical Co., Ltd., is responsible for the development of the product [1] - The application received an acceptance notice from the Center for Drug Evaluation (CDE) with acceptance number CXSS2500005 [1] - The CDE has requested additional clinical trial data specifically for the pediatric patient group, leading to the withdrawal of the marketing authorization application [1]