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that Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of Beijing Tiantan Biological Products Co., Ltd., has withdrawn its drug registration application for "Recombinant Human Coagulation Factor VIIa for Injection" due to the need for additional clinical trial data for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]

（文章来源：证券日报） 证券日报网讯 11月19日晚间，天坛生物发布公告称，公司下属成都蓉生药业有限责任公司（简称"成都 蓉生"）研发的"注射用重组人凝血因子VIIa"于2025年1月向国家药品监督管理局药品审评中心（CDE） 递交上市许可申请，并获得《受理通知书》（受理号：CXSS2500005）。自获得该产品上市许可申请受 理以来，成都蓉生持续开展配合审评相关工作。近日，根据CDE审评意见，该产品需补充儿童（<12 岁）患者群体的临床试验相关数据。据此，成都蓉生向CDE提出了药品注册撤回申请，将在补充完善相 关临床数据工作后，重新提交药品上市许可注册申请。 ...

Core Viewpoint - TianTan Biological announced the withdrawal of the drug registration application for "Recombinant Human Coagulation Factor VIIa Injection" due to the need for additional clinical trial data for pediatric patients under 12 years old [1][3]. Group 1 - TianTan Biological's subsidiary, Chengdu Rongsheng Pharmaceutical Co., Ltd., submitted the drug registration application to the National Medical Products Administration (NMPA) in January and received an acceptance notice [3]. - Since receiving the acceptance notice, Chengdu Rongsheng has been actively cooperating with the review process [3]. - The company plans to resubmit the drug registration application after completing the necessary clinical data for the pediatric population [1].

北京天坛生物制品股份有限公司下属成都蓉生药业有限责任公司（以下简称 "成都蓉生"）研发的"注射用重组人凝血因子Ⅶa"于 2025 年 1 月向国家药品 监督管理局药品审评中心（CDE）递交上市许可申请，并获得《受理通知书》（受 理号：CXSS2500005）。自获得该产品上市许可申请受理以来，成都蓉生持续开展 配合审评相关工作。 证券代码：600161 证券简称：天坛生物 公告编号：2025-053 近日，根据 CDE 审评意见，该产品需补充儿童（＜12 岁）患者群体的临床 试验相关数据。据此，成都蓉生向 CDE 提出了药品注册撤回申请，将在补充完善 相关临床数据工作后，重新提交药品上市许可注册申请。现将有关信息披露如下： 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 *注：以上资料来自国家药品监督管理局网站（https://www.nmpa.gov.cn/）。 国际市场情况： | 企业名称 | 国家 | 规格 | 剂型 | | --- | --- | --- ...

Core 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]

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]

Core Viewpoint - TianTan Bio (600161.SH) announced that its subsidiary Chengdu Rongsheng Pharmaceutical has submitted a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, receiving an 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] - Recent feedback from the NMPA indicates that additional clinical trial data for pediatric patients (under 12 years old) is required [1] Group 2 - In response to the NMPA's request, Chengdu Rongsheng has submitted a withdrawal application for the drug registration [1] - The company plans to supplement and improve the relevant clinical data before resubmitting the marketing authorization application [1]

证券日报网讯天坛生物11月18日在互动平台回答投资者提问时表示，血液制品产品从血浆采集到实现销 售收入需要经过检疫、生产、检验、批签发等相关工作，需要一定的时间周期，2024年，公司全年实现 采集血浆约2781吨，同比增长15.15%。公司持续深化生产精细化管理，严格执行生产计划，确保血浆 应投尽投，产品应交尽交，保障产品市场供应；同时，通过加强市场拓展，提高产品终端覆盖率、提高 产品销量。 （文章来源：证券日报） ...

证券日报网讯天坛生物11月18日在互动平台回答投资者提问时表示，公司密切关注市场动态，及时分析 研判，适时调整销售策略。 （文章来源：证券日报） ...

Group 1 - The core transaction on November 17 involved a block trade of 1.5 million shares of Tiantan Biological, with a transaction value of 27.51 million yuan and a price of 18.34 yuan per share [2][3] - The buyer was Guotai Junan Securities Co., Ltd. headquarters, while the seller was China International Capital Corporation Shanghai branch [2] - Over the past three months, there have been two block trades for this stock, totaling 49.61 million yuan [3] Group 2 - The closing price of Tiantan Biological on the day of the transaction was 18.34 yuan, reflecting a decrease of 1.34% [3] - The stock had a turnover rate of 0.54% for the day, with a total trading volume of 198 million yuan and a net outflow of 63.53 million yuan in main funds [3] - The latest margin financing balance for the stock is 1.463 billion yuan, with a decrease of 13.56 million yuan over the past five days, representing a decline of 0.92% [4]