提升核心竞争力，血制品龙头加速发展 天坛生物(600161) 天坛生物跟踪报告 | [姓名table_Authors] | 电话 | 邮箱 | 证书编号 | | --- | --- | --- | --- | | 彭娉(分析师) | 021-23185619 | pengping@gtht.com | S0880525040080 | | 郑琴(分析师) | 021-23219808 | zhengqin@gtht.com | S0880525040108 | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | | [Table_Invest] 评级： | 增持 | | --- | --- | | [Table_Target] 目标价格(元): | 25.82 | [当前价格 Table_CurPrice] (元)： 19.82 [Table_Market] 交易数据 | 52 周内股价区间(元) | 18.98-25.86 | | --- | --- | | 总市值(百万元) | 39,192 | | 总股本/流通A股(百万股) ...

一、 概况 | （一） | 产品信息 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 产品 | | 获得临床试验批准 | | | | 注册 | | 研发 | | | 新增适应症 | | | 规格 | | 剂型 | | | | 名称 | | 通知书时间和编号 | | | | 分类 | | 投入 | | 静注人免 | | | | 5g/瓶 | | 治疗用 | 1852.08 | | | | 慢性炎性 脱髓鞘性多 | 2024 年 09 月 | | 11 日 | | | | | | 疫球蛋白 | | | | （10%， | | 生物制 | 注射剂 | | | | 发性神经根神经病 | | 2024LP02047 | | | | 万元 | | | （pH4） | | | | 50ml） | 品 | | | | 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 关于下属企业药品临床试验进展的公告 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 ...

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 | | | | | | | | ...

天坛生物（600161）公告，公司下属成都蓉生药业有限责任公司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。该产品适应症包括治疗原发性免疫球蛋白G缺乏症、继发性免疫球蛋白G缺陷 病以及自身免疫性疾病等。产品在生产、上市销售前还需履行的主要审批程序包括通过GMP符合性检 查并获得四川省药品监督管理局签发的《药品GMP符合性检查告知书》。国内市场尚无2.5g/瓶(10%， 25ml)规格的"静注人免疫球蛋白(pH4)"产品上市。 ...

行 华福证券 医药生物 2025 年 07 月 06 日 业 研 究 医药生物 皮丙：血制品下一个大品种，天坛生物独家报产 投资要点： 行 业 定 期 报 行情回顾：本周（2025 年 6 月 30 日- 2025 年 7 月 4 日）中信医药指数 上涨 3.6%，跑赢沪深 300 指数 2.0pct，在中信一级行业分类中排名第 4 位； 2025年初至今中信医药生物板块指数上涨10.8%，跑赢沪深300指数9.6pct， 在中信行业分类中排名第 6 位。本周涨幅前五的个股为：塞力医疗 （+51.55%）、广生堂（+48.64%）、神州细胞（+45.01%）、热景生物（44.30%）、 上海谊众（+32.20%）。 告 周专题：皮丙：血制品行业下一个大品种。皮丙全称为皮下注射人免 疫球蛋白（SCIG），跟静丙的主要成分相同，但给药方式不同。相比静丙， 皮丙具有耐受性好、不良反应发生率低、经济成本低、患者满意度较高、 可维持稳定的生理水平的血清 IgG 浓度、可自我给药、易于患者自我管理 等优点。2024 年皮丙全球市场规模约为 49 亿美元，达静丙市场规模的 1/2。 目前国内并无上市的皮丙产品，天坛生物已经 ...

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].