证券代码：600161 证券简称：天坛生物 公告编号：2025-056 北京天坛生物制品股份有限公司 关于下属企业获得临床试验总结报告的公告 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。 1、国内市场情况： | 企业名称 上海莱士血液制品股份有限公司 | 规格 200IU/瓶、300IU/瓶 | 剂型 | | --- | --- | --- | | 华兰生物工程股份有限公司 | 100IU/瓶、200IU/瓶、300IU/瓶、400IU/瓶、1000IU/瓶 | | | 诺一生物医药股份有限公司 | 200IU/瓶、300IU/瓶、400IU/瓶 | | | 贵州泰邦生物制品有限公司 | 300IU/瓶 | | | 山东泰邦生物制品有限公司 | 300IU/瓶 | | | 南岳生物制药有限公司 | 200IU/瓶、300IU/瓶 | | | 山西康宝生物制品股份有限公司 | 300IU/瓶 | | | 博晖生物制药（河北）有限公司 | 300IU/瓶 | | | 广东卫伦生物制药有限公司 | 300IU/瓶 | 注射剂 | ...

Core Viewpoint - Tiantan Biological (600161.SH) announced that its subsidiary, Guizhou Biological Pharmaceutical Co., Ltd., has completed Phase III clinical trials for "Prothrombin Complex Concentrate" and received the clinical trial summary report [1] Group 1: Clinical Trial Results - The clinical trial results indicate that the Prothrombin Complex Concentrate significantly enhances coagulation factor levels II/VII/IX/X in patients with Hemophilia B [1] - The treatment improves coagulation function and alleviates bleeding symptoms and signs in patients with Hemophilia B, demonstrating good efficacy [1] - Safety analysis results show that the drug has a favorable safety profile during clinical application for patients with Hemophilia B [1]

Core Viewpoint - TianTan Biological (600161.SH) announced that its subsidiary, Guizhou Biological Pharmaceutical Co., Ltd., has completed Phase III clinical trials for "Prothrombin Complex Concentrate" and received the clinical trial summary report [1] Group 1: Clinical Trial Results - The clinical trial results indicate that the Prothrombin Complex Concentrate significantly enhances coagulation factor levels II/VII/IX/X in patients with Hemophilia B [1] - The treatment improves coagulation function and alleviates bleeding symptoms and signs in patients with Hemophilia B, demonstrating good efficacy [1] Group 2: Safety Analysis - Safety analysis results show that the drug has a good safety profile during clinical application for patients with Hemophilia B [1]

Core Viewpoint - Tiantan Biological announced that its subsidiary Tiantan Guizhou has completed Phase III clinical trials for "Prothrombin Complex Concentrate," which is primarily used to treat congenital and acquired coagulation factor deficiencies, including Hemophilia B [1] Group 1 - The clinical trial results indicate that the drug significantly improves coagulation factor levels in patients with Hemophilia B and alleviates bleeding symptoms, demonstrating good efficacy and safety [1] - The research and development investment for this product amounted to 42.3963 million yuan [1] - Tiantan Guizhou plans to submit a registration application to the National Medical Products Administration, although the review timeline and the issuance of the drug registration certificate remain uncertain [1] Group 2 - Once approved, the product will be eligible for production and market sales [1]

Core Viewpoint - Tian Tan Biological Products Co., Ltd. has announced the successful completion of Phase III clinical trials for its "Prothrombin Complex Concentrate," indicating a significant advancement in treatment options for patients with various coagulation factor deficiencies [1] Group 1: Product Information - The product, Prothrombin Complex Concentrate, is primarily indicated for the treatment of congenital and acquired deficiencies of coagulation factors II, VII, IX, and X [1] - Specific indications include treatment for conditions such as Hemophilia B, anticoagulant overdose, vitamin K deficiency, liver disease-related coagulopathy, and surgical patients with prolonged prothrombin time [1] Group 2: Clinical Trial Results - Clinical trial results demonstrate that the infusion of the Prothrombin Complex Concentrate significantly increases the levels of coagulation factors II, VII, IX, and X in patients with Hemophilia B, thereby improving their coagulation function and alleviating bleeding symptoms [1] - Safety analysis indicates that the drug has a good safety profile during clinical application for patients with Hemophilia B [1]

Core Viewpoint - TianTan Biological (600161) announced the completion of Phase III clinical trials for its "Prothrombin Complex Concentrate," demonstrating significant efficacy and safety for patients with Hemophilia B [1] Group 1: Clinical Trial Results - The clinical trial results indicate that the infusion significantly increases coagulation factor levels II/VII/IX/X in patients with Hemophilia B [1] - The treatment improves coagulation function and alleviates bleeding symptoms and signs in Hemophilia B patients [1] Group 2: Safety Analysis - Safety analysis results show that the drug has good safety profiles during clinical application for Hemophilia B patients [1]

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 ...

Company Overview - TianTan Biological (SH 600161) announced on November 28 that its 27th meeting of the 9th Board of Directors was held via telecommunication to review the proposal for amending the "Comprehensive Risk Management Measures" [1] - As of the report date, TianTan Biological has a market capitalization of 34.2 billion yuan [1] Industry Insights - For the first half of 2025, the revenue composition of TianTan Biological indicates that the biopharmaceutical sector accounts for 99.68% of its total revenue, while other businesses contribute 0.32% [1]

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 ...