证券代码：600161 证券简称：天坛生物 公告编号：2025-048 北京天坛生物制品股份有限公司关于下属企业获得药物临床试验批准通知书的公告 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。 近日，北京天坛生物制品股份有限公司下属国药集团昆明血液制品有限公司（以下简称"天坛昆明"）获 得国家药品监督管理局签发的《药物临床试验批准通知书》，同意天坛昆明开展"人纤维蛋白原"临床试 验。现将有关信息披露如下： 一、概况 （一）产品信息 ■ （二）产品主要市场情况 国内市场： 登录新浪财经APP 搜索【信披】查看更多考评等级 ■ *注：上述国内市场主要情况来自国家药品监督管理局官方网站（http://www.nmpa.gov.cn）。 国际市场： ■ 二、风险提示 天坛昆明"人纤维蛋白原"产品后续尚需完成开展临床试验、提交药品上市许可申请、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、获得药品注册证书等审批程序，方可实现生产及 上市销售。药品的研发是一项长期工作，存在诸多内外部不确定因素，敬请广大投资者注意投资风 ...

（编辑 楚丽君） 证券日报网讯 9月30日晚间，天坛生物发布公告称，近日，公司下属国药集团昆明血液制品有限公司获 得国家药品监督管理局签发的《药物临床试验批准通知书》，同意天坛昆明开展"人纤维蛋白原"临床试 验。 ...

格隆汇9月30日丨天坛生物(600161.SH)公布，近日，北京天坛生物制品股份有限公司下属国药集团昆明 血液制品有限公司(简称"天坛昆明")获得国家药品监督管理局签发的《药物临床试验批准通知书》，同 意天坛昆明开展"人纤维蛋白原"临床试验。 ...

天坛昆明"人纤维蛋白原"产品后续尚需完成开展临床试验、提交药品上市许可申请、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、获得药品注册证书等审批程序，方可实现生产及 上市销售。 天坛生物（600161）(600161.SH)发布公告，近日，公司下属国药集团昆明血液制品有限公司(简称"天坛 昆明")获得国家药品监督管理局签发的《药物临床试验批准通知书》，同意天坛昆明开展"人纤维蛋白 原"临床试验。 ...

天坛昆明"人纤维蛋白原"产品后续尚需完成开展临床试验、提交药品上市许可申请、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、获得药品注册证书等审批程序，方可实现生产及 上市销售。 智通财经APP讯，天坛生物(600161.SH)发布公告，近日，公司下属国药集团昆明血液制品有限公司(简 称"天坛昆明")获得国家药品监督管理局签发的《药物临床试验批准通知书》，同意天坛昆明开展"人纤 维蛋白原"临床试验。 ...

格隆汇9月30日丨天坛生物(600161.SH)公布，近日，北京天坛生物制品股份有限公司下属国药集团昆明 血液制品有限公司(简称"天坛昆明")获得国家药品监督管理局签发的《药物临床试验批准通知书》，同 意天坛昆明开展"人纤维蛋白原"临床试验。 ...

人民财讯9月30日电，天坛生物（600161）9月30日公告，下属公司天坛昆明获得国家药品监督管理局签 发的《药物临床试验批准通知书》，同意天坛昆明开展"人纤维蛋白原"临床试验。该药品适应症为先天 性纤维蛋白原减少或缺乏症等。 ...

格隆汇9月30日｜近日，北京天坛生物制品股份有限公司下属国药集团昆明血液制品有限公司获国家药 监局《药物临床试验批准通知书》，同意开展"人纤维蛋白原"临床试验。该产品规格为0.5g(25m1)/瓶， 注册分类属治疗用生物制品，剂型为注射剂，研发投入599.25万元，适应症包括先天性及获得性纤维蛋 白原减少症。国内有多家企业生产同类产品，国际市场主要有CSLBehring、Octapharma等。不过，该产 品后续还需完成多道审批程序，药品研发存在不确定性，投资者需注意风险。 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1][6] Core Insights - The company has shown steady growth in plasma collection, with a total of 320.39 tons collected in the first half of 2025, representing a year-on-year increase of 7.2%, which is above the industry average [6][7] - The approval of high-concentration intravenous immunoglobulin (IVIG) in May 2025 positions the company as the third domestic entity to offer this product, enhancing its competitive edge [6][7] - Revenue for the first half of 2025 reached 1.008 billion yuan, a year-on-year increase of 12.51%, while net profit was 225 million yuan, reflecting a decline of 28.68% due to lower gross margins in blood products and amortization from the acquisition of Green Cross [6][7] Financial Performance Summary - Total revenue projections for 2025, 2026, and 2027 are 1.929 billion yuan, 2.248 billion yuan, and 2.601 billion yuan respectively, with corresponding net profits of 449 million yuan, 549 million yuan, and 665 million yuan [6][7] - Earnings per share (EPS) are forecasted to be 0.89 yuan, 1.09 yuan, and 1.32 yuan for 2025, 2026, and 2027 respectively, with price-to-earnings (P/E) ratios of 29.34, 24.01, and 19.82 [6][7] - The company’s gross margin for the first half of 2025 was 53.01%, down 14.02 percentage points year-on-year, while the net profit margin was 22.37%, down 12.88 percentage points year-on-year [6][7]

Core Viewpoint - The company, Weigao Biologics, reported stable financial performance in the first half of 2025 despite a decline in demand and prices in the blood products industry, achieving revenue of 518 million yuan and a net profit of 108 million yuan, maintaining profitability amidst industry challenges [1] Group 1: Financial Performance - In the first half of 2025, Weigao Biologics achieved operating revenue of 518 million yuan and a net profit attributable to shareholders of 108 million yuan, with a non-recurring net profit of 106 million yuan, showing stability compared to the same period last year [1] - The company has become one of the few publicly listed companies in the blood products sector to maintain steady profits amid declining industry demand and prices [1] Group 2: Industry Position and Expansion Plans - The blood products industry is undergoing significant consolidation, with state-owned enterprises projected to account for 36% of national production capacity and 39% of plasma collection by 2024 [1] - Weigao Biologics announced plans for a private placement to raise up to 1.5 billion yuan, with 1.2 billion yuan allocated to an intelligent industrial base project aimed at doubling its plasma processing capacity from 650 tons to 1200 tons annually [2] - The intelligent factory will produce various blood products, helping to alleviate supply-demand imbalances and enhance the company's market share and industry standing [2] Group 3: Research and Development - The company has increased its R&D investment by 14% year-on-year, reaching 23.83 million yuan, focusing on addressing low plasma utilization and limited product variety in the domestic market [4] - Weigao Biologics has successfully launched 11 products across 23 specifications, positioning itself among the top players in the national blood products industry [3] Group 4: Innovation and New Product Development - The company is advancing the industrialization of new products, including the fourth-generation intravenous immunoglobulin and human fibrinogen adhesive, with ongoing clinical trials and regulatory processes [4] - The company emphasizes innovation as a key driver for development, aiming to transition from scale expansion to quality and efficiency improvements in the blood products sector [4] Group 5: Real Estate and Ecosystem Development - Weigao Biologics' property rental income increased by 28% to 73.67 million yuan in the first half of 2025, with an occupancy rate of approximately 80% in its life sciences park [7] - The Weigao Life Science Park has attracted over 60 enterprises and has been recognized as an exemplary case in the biopharmaceutical industry, enhancing the company's ecosystem and regional economic development [7][8] - The company has established three specialized industrial funds to invest in high-quality projects in biomedicine and medical devices, fostering synergy with its core business [8]