北京天坛生物制品股份有限公司关于下属企业撤回药品注册申请的公告

Group 1 - The announcement details that Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of Beijing Tiantan Biological Products Co., Ltd., has withdrawn its drug registration application for "Recombinant Human Coagulation Factor VIIa for Injection" due to the need for additional clinical trial data for pediatric patients under 12 years old [1][2] - The product's registration application was initially submitted to the National Medical Products Administration (NMPA) on January 2025 and received an acceptance notice [1] - The company plans to supplement the required clinical data and will resubmit the drug registration application after completing this work [1][2] Group 2 - The withdrawal of the drug registration application is not expected to have a significant impact on the company's operating performance [2] - The drug development process is described as a long-term endeavor that involves various internal and external uncertainties [2]