Core Viewpoint - Tian Tan Biological has withdrawn its application for a hemophilia drug after 10 months of acceptance, citing the need for additional clinical trial data for children under 12 years old as per the CDE's review [1][4]. Group 1: Company Developments - Tian Tan Biological's drug, "Recombinant Human Coagulation Factor VIIa," had an investment of 266 million yuan in R&D and was expected to treat bleeding in patients aged 12 and older [1][3]. - The company’s product was designed to be similar to the imported drug Novoseven, which has been in the market for over 20 years without any domestic alternatives until recently [2][3]. - The recent announcement did not specify age groups for the drug's indications, aligning it closely with the imported product [4]. Group 2: Market Context - The hemophilia drug market is predominantly controlled by foreign companies, with over 90% market share, highlighting the challenges faced by domestic firms [7]. - The approval of the first domestic recombinant factor VIIa by Zhengda Tianqing in July 2023 marked a significant milestone, although its indications are limited compared to Novoseven [2][6]. - The domestic market for rare disease drugs is evolving, with 21 rare disease drugs approved in the first half of 2025, indicating a shift towards addressing previously unmet needs [7][8]. Group 3: Regulatory and Industry Trends - Regulatory bodies are increasingly focused on ensuring that new drugs address comprehensive patient needs, particularly for children, as seen in the requirement for additional pediatric data for Tian Tan's drug [6]. - The Chinese government has initiated programs to support the development of pediatric drugs and streamline approval processes, which may enhance the availability of treatments for rare diseases [7]. - The competitive landscape is changing, with domestic companies pushing for market share, leading to price reductions in existing treatments, thereby improving accessibility for patients [8].

Core Viewpoint - Tian Tan Bio announced that its controlling shareholder, China National Biological Group Corporation, will transfer 18,802,366 shares (0.95% of total shares) to itself without compensation, resulting in China National holding 46.59% of the total shares post-transfer [1] Summary by Sections - **Share Transfer Details** - The transfer involves 18,802,366 shares from Beijing Biological Products Research Institute to China National [1] - After the transfer, China National will directly hold 921,302,854 shares, representing 46.59% of the total share capital [1] - **Ownership Structure Post-Transfer** - Beijing Biological Products Research Institute will no longer hold any shares in the company [1] - China National and its concerted parties will collectively hold 991,120,289 shares, maintaining a total ownership of 50.12% [1]

Core Viewpoint - The announcement details a non-compensatory transfer of shares from a subsidiary of the controlling shareholder to the parent company, which will not change the control structure of the company [2][3]. Group 1: Share Transfer Details - Beijing Tian Tan Biological Products Co., Ltd. (the "Company") announces that its controlling shareholder, China National Pharmaceutical Group Co., Ltd. ("China Bio"), will transfer 18,802,366 shares (0.95% of total shares) from its wholly-owned subsidiary, Beijing Biological Products Research Institute Co., Ltd. ("Beijing Institute"), to China Bio without compensation [2][4]. - After the transfer, China Bio will directly hold 921,302,854 shares, representing 46.59% of the total share capital, while Beijing Institute will no longer hold any shares [2][4]. - The total shares held by China Bio and its concerted parties will remain unchanged at 991,120,289 shares, accounting for 50.12% of the total share capital [2]. Group 2: Control and Regulatory Implications - This equity change will not result in a change of the controlling shareholder or the actual controller of the Company [3][5]. - The transfer does not trigger a mandatory tender offer and does not require the disclosure of an equity change report, acquisition report, or tender offer report [5]. - Subsequent to the transfer, the Company will need to complete share transfer registration and will fulfill its information disclosure obligations based on the progress of the matter [5].

证券代码：600161 证券简称：天坛生物 公告编号：2025-054 北京天坛生物制品股份有限公司 关于控股股东权益变动的提示性公告 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。 重要内容提示： 北京天坛生物制品股份有限公司（以下简称"公司"）控股股东中国生物技 术股份有限公司（以下简称"中国生物"）全资子公司北京生物制品研究所有限责 任公司（以下简称"北京所"）拟将持有的公司 18,802,366 股股份（占公司股份 总数的 0.95%）无偿划转至中国生物。上述无偿划转事项完成后，中国生物将直接 持有公司 921,302,854 股股份，占公司总股本的 46.59%，北京所不再持有公司股 份；中国生物及其一致行动人合计持有公司 991,120,289 股股份，占公司总股本的 50.12%，保持不变。 本次股东权益变动系因无偿划转所致，不涉及要约收购。 本次权益变动不会导致公司控股股东及实际控制人发生变化。 一、本次权益变动基本情况 近日，公司收到控股股东中国生物通知，中国生物全资子公司北京所拟将持有 的公司 18,802 ...

Core Viewpoint - Tian Tan Bio's application for a hemophilia drug was withdrawn after 10 months of acceptance due to the need for additional clinical trial data for children under 12 years old, highlighting regulatory scrutiny in the rare disease market [2][11]. Company Summary - Tian Tan Bio's subsidiary Chengdu Rongsheng Pharmaceutical withdrew the registration application for "Recombinant Human Coagulation Factor VIIa Injection," which had a research investment of 266 million yuan [2][5]. - The drug's indication was aligned with that of imported products, focusing on adult and adolescent patients, but lacked data for younger patients, which is now a regulatory requirement [4][11]. - The company had previously completed a Phase III clinical trial, but the latest announcement did not specify age groups for the patient population [4][5]. Industry Summary - The hemophilia drug market in China is dominated by foreign companies, with over 90% market share, and there is a growing demand for domestic alternatives [12][13]. - The recent approval of a similar drug by Zhengda Tianqing, which does not cover children under 12, indicates a gap in the market that domestic companies are trying to fill [8][11]. - Regulatory bodies are pushing for comprehensive data that includes pediatric populations, reflecting a shift towards more inclusive treatment options for rare diseases [11][12]. - The domestic pharmaceutical industry is accelerating its efforts in rare disease drug development, with 21 rare disease drugs approved in the first half of 2025, indicating a positive trend towards addressing unmet medical needs [12][13].

Core Viewpoint - Tian Tan Biological announced the withdrawal of the drug registration application for "Recombinant Human Coagulation Factor VIIa" by its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. due to the need for additional clinical trial data for pediatric patients under 12 years old [1] Group 1: Company Actions - The product's market authorization application was submitted to the National Medical Products Administration (NMPA) on January 2025 and received an acceptance notice [1] - Following the NMPA's review comments, Chengdu Rongsheng decided to withdraw the drug registration application to supplement the required clinical data [1] - The company plans to resubmit the drug registration application after completing the necessary clinical trials [1] Group 2: Impact on Business - The announcement states that the withdrawal of the drug registration application will not have a significant impact on the company's operating performance [1] - The company must complete the clinical trial data and pass the review and approval processes to achieve production and market sales [1] Group 3: Industry Considerations - The announcement highlights the long-term and uncertain nature of drug development, indicating potential risks for investors [1]

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]

Core Viewpoint - TianTan Biological announced that its subsidiary Chengdu Rongsheng Pharmaceutical will submit a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, following the receipt of the acceptance notice [2] Group 1 - The product's marketing authorization application has been accepted by the NMPA, with acceptance number CXSS2500005 [2] - Chengdu Rongsheng is actively working on the review process and has been requested to provide additional clinical trial data for pediatric patients under 12 years old [2] - As a result of the need for additional data, Chengdu Rongsheng has submitted a request to withdraw the drug registration application and plans to resubmit it after completing the necessary clinical data [2]

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 | | --- | --- | --- ...