Core Insights - The biopharmaceutical sector is one of the fastest-growing areas in the pharmaceutical industry, driven by an aging population and increased public health awareness [1][5] - China's biopharmaceutical market is projected to grow from CNY 312 billion in 2019 to CNY 587.1 billion in 2024, and is expected to reach CNY 675.2 billion by 2025, with a potential to hit CNY 1.149 trillion in the next five years [1][5][6] - Innovation remains the core driver of growth in the biopharmaceutical industry, which is capital-intensive and requires significant R&D investment [1][6] Industry Definition and Classification - Biopharmaceuticals are medical products manufactured using biological methods, aimed at replicating the activity of natural substances [2][4] - They can be categorized into vaccines, blood products, biopharmaceutical drugs, diagnostic reagents, and others, with further subdivisions based on source or mechanism of action [2] Current Industry Status - The global biopharmaceutical market is expected to grow from USD 286.4 billion in 2019 to USD 461.6 billion in 2024, with the original biopharmaceutical market projected to increase from USD 268.9 billion to USD 427.9 billion in the same period [5] - China plays a significant role in the global biopharmaceutical market, with rapid growth driven by favorable policies, increased R&D investment, and advancements in biotechnology [5][6] Industry Development Environment - Policies - The Chinese government has implemented various laws and policies to encourage biopharmaceutical R&D, including the Drug Registration Management Measures and regulations for clinical research and application of biomedical technologies [7] Competitive Landscape - The biopharmaceutical sector is recognized as a "new frontier" in the pharmaceutical industry, with major global players actively entering the market [9] - Key companies in China's biopharmaceutical industry include WuXi AppTec, Hengrui Medicine, ZhiFei Biological, BeiGene, and others, with a competitive landscape characterized by differentiated strategies [9] Future Development Trends - Market demand for biopharmaceuticals is expected to continue growing, supported by policy backing, technological advancements, and increased health awareness [10] - Domestic companies are transitioning from biosimilars to First-in-Class drugs, with examples like Hengrui Medicine's ADC drug showing superior efficacy [10][11] - Personalized medicine based on genetic testing is anticipated to become a trend, with increasing international recognition of Chinese innovative drugs [11]

证券代码：600161 证券简称：天坛生物 公告编号：2025-055 北京天坛生物制品股份有限公司 第九届董事会第二十七次会议决议公告 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。 北京天坛生物制品股份有限公司（以下简称"公司"）第九届董事会第二十七次会议于2025年11月21日发 出会议通知，于2025年11月28日以通讯表决方式召开。会议应参加表决董事九人，实际参加表决董事九 人。会议符合《公司法》及《公司章程》的有关规定，会议审议通过以下议案： 一、审议通过《关于天坛瑞德增资当阳瑞德单采血浆站有限公司的议案》 本议案已经董事会战略与投资委员会事前认可。 三、审议通过《关于挂牌转让上海上生生物制品经营有限公司100%股权项目审批的议案》 本议案已经董事会战略与投资委员会事前认可。 同意公司下属国药集团上海血液制品有限公司将所持有的上海上生生物制品经营有限公司100%股权以 不低于1,550.00万元的价格，在国务院国有资产监督管理委员会指定的产权交易机构公开挂牌转让。 表决结果：9票同意，0票反对，0票弃权。 四、审议 ...

每经头条（nbdtoutiao）——已有75人遇难，1名死者为消防员，还有10名消防员受伤！记者现场直击香 港大埔火灾：燃烧的宏福苑，五级大火的五个谜团 （记者 曾健辉） 截至发稿，天坛生物市值为342亿元。 每经AI快讯，天坛生物（SH 600161，收盘价：17.29元）11月28日晚间发布公告称，公司第九届第二十 七次董事会会议于2025年11月28日以通讯表决方式召开。会议审议了《关于修订 <全面风险管理办法> 的议案》等文件。 2025年1至6月份，天坛生物的营业收入构成为：生物制品行业占比99.68%，其他业务占比0.32%。 ...

证券代码：600161 证券简称：天坛生物 公告编号：2025-055 北京天坛生物制品股份有限公司 第九届董事会第二十七次会议决议公告 三、审议通过《关于挂牌转让上海上生生物制品经营有限公司 100%股权项目审 批的议案》 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。 北京天坛生物制品股份有限公司（以下简称"公司"）第九届董事会第二十七次 会议于 2025 年 11 月 21 日发出会议通知，于 2025 年 11 月 28 日以通讯表决方式召开。 会议应参加表决董事九人，实际参加表决董事九人。会议符合《公司法》及《公司章 程》的有关规定，会议审议通过以下议案： 一、审议通过《关于天坛瑞德增资当阳瑞德单采血浆站有限公司的议案》 本议案已经董事会战略与投资委员会事前认可。 同意公司下属武汉中原瑞德生物制品有限责任公司（以下简称"天坛瑞德"）全 额出资 1,000 万元增加当阳瑞德单采血浆站有限公司（以下简称"当阳浆站"）注册 资本，增资完成后，当阳浆站注册资本由 1,000 万元增加至 2,000 万元，天坛瑞德持 有 10 ...

获受理10个多月后，天坛生物（SH600161，股价17.61元，市值348.22亿元）旗下一款投入2.66亿元研 发的血友病药物，撤回了上市申请。 11月19日晚间，这家国内头部血液制品公司发布公告，称下属企业成都蓉生药业有限责任公司（以下简 称成都蓉生）撤回了"注射用重组人凝血因子Ⅶa"的药品注册申请，原因是根据CDE（国家药品监督管 理局药品审评中心）的审评意见，需要补充儿童（＜12岁）患者群体的临床试验相关数据。 《每日经济新闻》记者注意到，目前国内共有2款同类药物获批，分别来自丹麦药企诺和诺德和国内药 企正大天晴药业集团南京顺欣制药有限公司（以下简称正大天晴），后者的药物于今年7月获批，适用 于符合条件的成人及青少年（12岁以上）先天性血友病患者的出血治疗。 那么，问题来了：同类国产药物的获批适应证不包含12岁以下患者，成都蓉生为何需要补充儿童数据？ 被外资企业占有九成以上份额的罕见病儿童药物市场，正在发生哪些变化？ 唯一国产药物7月获批 要了解注射用重组人凝血因子Ⅶa这款药物，首先要了解血友病。 在相关资料中，正大天晴表示该药物实现了本土化生产，打破了进口依赖，解决了进口rFⅦa供应短缺 的现状。 ...

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]