Core Viewpoint - TianTan Bio (600161.SH) announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. has submitted a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, and has received the acceptance notice [1] Group 1 - The product's marketing authorization application has been accepted by the NMPA, with acceptance number CXSS2500005 [1] - Chengdu Rongsheng is actively conducting work to support the review process since the acceptance of the application [1] - The NMPA has requested additional clinical trial data for the pediatric population (under 12 years old), leading Chengdu Rongsheng to withdraw the drug registration application [1] Group 2 - Chengdu Rongsheng plans to supplement and improve the relevant clinical data before resubmitting the marketing authorization application [1]
天坛生物:撤回注射用重组人凝血因子Ⅶa药品注册申请