证券代码：600161 证券简称：天坛生物 公告编号：2025-029 北京天坛生物制品股份有限公司 | 产品 | 新增适应症 | 获得临床试验批准 | 规格 | 注册 | 剂型 | 研发 | | --- | --- | --- | --- | --- | --- | --- | | 名称 | | 通知书时间和编号 | | 分类 | | 投入 | | 静注人免 疫球蛋白 | 慢性炎性脱髓鞘性多 发性神经根神经病 | 2024 年 09 月 11 日 2024LP02047 | 5g/瓶 （10%， | 治 疗 用 生 物 制 | 注射剂 | 1852.08 万元 | | （pH4） | | | 50ml） | 品 | | | 上述产品获批新增适应症还需履行的主要程序包括：完成Ⅲ期临床试验，提 交新增适应症许可申请、通过国家药品监督管理局药品审评中心审评及国家药品 监督管理局审批后，获批新增适应症。 （二） 同类产品市场情况 本次新增适应症为国内首个静注人免疫球蛋白产品获准开展慢性炎性脱髓 鞘性多发性神经根神经病适应症的临床研究。 | 企业名称 CSL Behring | 国家 美国 | 规格 5g/瓶、10g ...

Core Insights - Human fibrinogen is recognized globally for its clinical application value in regulating coagulation function, with increasing demand driven by aging populations and rising living standards [1][13] - The market size for human fibrinogen in China is projected to grow from 1.529 billion yuan in 2021 to 2.15 billion yuan in 2024, reflecting a compound annual growth rate (CAGR) of 12.0% [1][13] - The production process of human fibrinogen is expected to improve with technological advancements, leading to enhanced product quality and continuous market growth [1][13] Industry Overview - Fibrinogen is a key substrate in the coagulation and hemostasis process, essential for maintaining normal coagulation and promoting platelet aggregation [3] - Human fibrinogen is derived from healthy human plasma, processed to remove viruses, and is used as an effective replacement therapy for fibrinogen deficiency [3] - The normal concentration of fibrinogen in the human body is maintained at 2-4 g/L, and it is crucial for correcting hypofibrinogenemia and improving coagulation disorders [3] Market Dynamics - The number of blood collection stations and plasmapheresis stations in China is increasing, with 3 new stations approved and 17 new operational stations in 2024, leading to a steady rise in plasma collection [8] - The total plasma collection volume in 2024 is expected to reach 13,400 tons, a year-on-year increase of 10.94%, with major companies like Tian Tan Biological, Taibang Biological, and Shanghai Raist accounting for approximately 80% of the domestic plasma collection [8] - The growth in the number of medical institutions, driven by an aging population and increased health awareness, is expected to boost the demand for human fibrinogen [11] Competitive Landscape - The human fibrinogen industry is attracting significant attention from capital markets, with increasing competition as more companies enter the field [17] - Key players in the industry include Huaren Boya Biological Pharmaceutical Group, Shanghai Raist Blood Products, and Beijing Tiantan Biological Products, among others [17][18] Future Trends - Continuous government policy support is expected to benefit the human fibrinogen market, with initiatives aimed at improving the quality and safety of blood products [22] - Companies are focusing on optimizing production processes and enhancing plasma utilization rates, which will drive overall industry progress [23] - The expansion of medical insurance coverage and rising consumer spending on healthcare are anticipated to gradually increase the market demand for human fibrinogen [24]

证券代码：600161 证券简称：天坛生物 公告编号：2025-028 北京天坛生物制品股份有限公司 关于下属企业获得药品补充申请批准通知书的公告 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。 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"）于近日收到国家药品监督管理局签发的《药品补充申请批准通知书》， 成都蓉生研制的 2.5g/瓶（10%，25ml）规格的"静注人免疫球蛋白（pH4）"符合 药品注册的相关要求。具体情况如下： 一、概况 （一）产品信息 | 申报生 | 注 | 产获得 | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 产品 | 册 | 剂 | 研发 | 适应症 | 文件名称 | 受理的 | 规格 | 名称 | 分 | 型 | 投入 | | | | 时间及 | 类 | 受理号 | | | | | | | | ...

Core Viewpoint - TianTan Biological (600161) has received approval from the National Medical Products Administration for its 2.5g/bottle (10%, 25ml) "Intravenous Human Immunoglobulin (pH4)", marking a significant step in expanding its product offerings in the immunoglobulin market [1] Group 1: Product Approval - Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of TianTan Biological, has obtained the "Drug Supplement Application Approval Notice" for its new product [1] - The product is indicated for the treatment of primary immunoglobulin G deficiency, secondary immunoglobulin G deficiency diseases, and autoimmune diseases [1] - There are currently no other products with the same 2.5g/bottle (10%, 25ml) specification available in the domestic market [1] Group 2: Regulatory Compliance - The product must still undergo a GMP compliance inspection and obtain the "Drug GMP Compliance Inspection Notification" from the Sichuan Provincial Drug Administration before it can be produced and marketed [1]

Investment Rating - The industry rating is "Outperform the Market" [7] Core Viewpoints - The report highlights the potential of subcutaneous immunoglobulin (SCIG) as the next major product in the blood products sector, with Tian Tan Biologics positioned to be the first domestic manufacturer to market this product [3][4][15] - The global market size for SCIG is projected to reach approximately $4.9 billion in 2024, which is about half the size of the intravenous immunoglobulin (IVIG) market [3][19][26] - The report emphasizes the advantages of SCIG over IVIG, including better tolerability, lower incidence of adverse reactions, lower economic costs, higher patient satisfaction, and ease of self-administration [3][19][21] Summary by Sections Market Review - The CITIC Pharmaceutical Index increased by 3.6% during the week of June 30 to July 4, 2025, outperforming the CSI 300 Index by 2.0 percentage points [3][36] - Year-to-date, the CITIC Pharmaceutical Index has risen by 10.8%, surpassing the CSI 300 Index by 9.6 percentage points [3][36] - Notable stock performances included Seer Medical (+51.55%), Guangsheng Tang (+48.64%), and Shenzhou Cell (+45.01%) [3][51] Focus on SCIG - SCIG is recognized as the third-largest segment in the global blood products market, with a projected size of $4.9 billion, representing 15.5% of the market [26][29] - The report forecasts a compound annual growth rate (CAGR) of 7.2% for the immunoglobulin market (IVIG + SCIG) from 2025 to 2034, with SCIG expected to be the fastest-growing segment [26][29] - Tian Tan Biologics is expected to gain a significant competitive advantage as it is on track to be the first company to launch SCIG in China, with its application for production submitted and under review [3][34] Investment Recommendations - The report suggests focusing on innovative drugs as a primary investment theme, with a recommendation to consider leading companies and those with potential catalysts in their development pipelines [4][5] - The recommended investment portfolio includes companies such as Kangfang Biologics, Xinda Biologics, and Tian Tan Biologics [4][5][12]

Core Points - The company held its 22nd meeting of the 9th Board of Directors on June 30, 2025, via electronic communication, with all nine directors participating in the vote [1][2] - The board approved the revised "External Donation Management Measures" [1] - The company’s subsidiary, Lanzhou Biological Products Co., Ltd., will donate 800,000 yuan to the Gansu Provincial Health Development Foundation [3][4] - The company’s subsidiary, Nanjing Rouxin Plasma Collection Co., Ltd., will donate 30,000 yuan to the Nanjing Red Cross Society [5][6] - The announcement was made on June 30, 2025 [8]

北京天坛生物制品股份有限公司 第九届董事会第二十二次会议决议公告 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。 证券代码：600161 证券简称：天坛生物 公告编号：2025-027 一、审议通过《关于修订<对外捐赠管理办法>的议案》 同意修订后的《北京天坛生物制品股份有限公司对外捐赠管理办法》。 表决结果：9 票同意，0 票反对，0 票弃权。 同意公司下属南部县蓉生单采血浆有限公司向南部县红十字会捐赠 3 万元。 表决结果：9 票同意，0 票反对，0 票弃权。 特此公告。 北京天坛生物制品股份有限公司(以下简称"公司")第九届董事会第二十二 次会议于 2025 年 6 月 25 日以电子方式发出会议通知，于 2025 年 6 月 30 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： 二、审议通过《关于兰州血制向甘肃省卫生健康发展基金会实施捐赠的议 案》 同意公司下属国药集团兰州生物制药有限公司向甘肃省卫生健康发展基金 会捐赠 80 ...

Core Viewpoint - The Chinese blood products industry is undergoing significant consolidation, with major players engaging in aggressive mergers and acquisitions to capture plasma resources, leading to the emergence of potential super giants in the sector [1][5]. Industry Landscape - The blood products industry in China is characterized by a "four-way" competitive landscape, dominated by four major groups: China National Pharmaceutical Group (Sinopharm), Haier Group, China Resources, and Hualan Biological Engineering [2][4]. - The industry has transitioned into a stock competition era since 2001, with new entrants needing to acquire existing licensed companies due to a moratorium on new licenses [2][3]. Mergers and Acquisitions - Significant acquisitions include China Resources' acquisition of Boya Biological for 4.8 billion yuan, Haier's 12.5 billion yuan acquisition of Shanghai Laishi, and Sinopharm's 4.5 billion yuan acquisition of Pilin Biological [1][2]. - The consolidation trend has led to a sharp increase in market concentration, with the top five companies' market share rising from under 50% in 2019 to over 70% by 2024 [4]. Plasma Collection and Utilization - Sinopharm's network includes 154 plasma collection stations, accounting for nearly 40% of the national total, with a collection volume of over 4,000 tons by mid-2025 [3]. - The cost structure of blood products heavily relies on raw plasma, which constitutes over 60% of total costs, making scale efficiency crucial for profitability [5][6]. Market Demand and Supply Gap - The domestic blood products market surpassed 60 billion yuan in 2023, with a demand gap of 4,000 tons, highlighting the need for leading companies to enhance their supply capabilities through technological upgrades [5][6]. - China's per capita consumption of blood products is significantly lower than that of developed countries, indicating a structural supply-demand imbalance [7][8]. Technological Advancements - Companies are shifting from a resource-driven model to a dual strategy of resource acquisition and research and development to overcome technological barriers and meet high-value product demands [9][10]. - Sinopharm and Hualan Biological are focusing on developing high-purity albumin and advanced coagulation factors, with significant investments in R&D to support these initiatives [10][11]. Future Outlook - The ongoing consolidation and technological advancements suggest that the Chinese blood products industry is on the verge of producing a super giant capable of competing globally [5][11]. - The combination of policy support, resource acquisition, and technological innovation is expected to drive the industry towards a more competitive and innovative future [10][11].

证券代码：600161 证券简称：天坛生物 编号：2025-026 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。 近日，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"）收到四川省药品监督管理局颁发的《药品 GMP 符合性检查 告知书》。现就相关情况公告如下： 一、 药品 GMP 符合性检查告知书相关信息 编号：川许 2025116 被检查单位名称：成都蓉生药业有限责任公司 北京天坛生物制品股份有限公司 关于下属企业获得《药品GMP符合性检查告知书》的公告 检查地址：四川省成都市双流区菁园路 280 号 检查范围及相关车间、生产线：血液制品（皮下注射人免疫球蛋白），血液 制品生产车间，破袋融浆区、分离一区、分离二区、层析区、分装二区、分装一 区、包装区及辅助区域 检查时间：2025 年 4 月 7 日-2025 年 4 月 11 日 结论：符合《药品生产质量管理规范（2010 年修订）》及相关附录规定 发证机关：四川省药品监督管理局 二、 GMP 检查涉及的生产车间情况 车间名称：血液制品生产 ...

Group 1 - The core point of the article is that TianTan Biological (600161.SH) announced that its subsidiary Chengdu Rongsheng received a GMP compliance inspection notice from the Sichuan Provincial Drug Administration [1] - The inspection covered the production workshop and related areas for blood products (subcutaneous human immunoglobulin) [1] - Chengdu Rongsheng's blood product production workshop meets national GMP requirements and can commence production after obtaining the relevant registration certificate and production license [1] Group 2 - The product has completed Phase III clinical trials and a marketing authorization application has been submitted [1] - Future production may be influenced by various factors, indicating uncertainty [1]