Core Viewpoint - Shanghai Laishi (002252) has confirmed that several of its products have been included in the 2024 National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List [2] Group 1: Product Inclusion in Medical Insurance - The following products from Shanghai Laishi and its subsidiaries are included in the medical insurance directory: human albumin, intravenous human immunoglobulin (PH4), human fibrinogen, prothrombin complex, coagulation factor VIII, human immunoglobulin, tetanus human immunoglobulin, and rabies human immunoglobulin [2]

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 ...

Core Viewpoint - TianTan Biological announced the approval of a clinical trial for "human fibrinogen" by the National Medical Products Administration [1] Group 1 - TianTan Biological's subsidiary, Kunming Blood Products Co., Ltd., received the clinical trial approval notice [1] - The approval allows the company to conduct clinical trials for "human fibrinogen" [1]

Core Viewpoint - Tian Tan Biological Products Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of "human fibrinogen" [1] Group 1 - Tian Tan Kunming, a subsidiary of Tian Tan Biological, is authorized to conduct clinical trials for "human fibrinogen" [1]

Core Viewpoint - Tian Tan Biological (600161.SH) has received approval from the National Medical Products Administration for clinical trials of its "human fibrinogen" product, marking a significant step towards potential market entry [1] Group 1 - Tian Tan Biological's subsidiary, China National Pharmaceutical Group Kunming Blood Products Co., Ltd. (referred to as "Tian Tan Kunming"), has been granted the Clinical Trial Approval Notice for "human fibrinogen" [1] - The product will need to complete clinical trials, submit a drug marketing authorization application, pass the review by the National Medical Products Administration's Drug Evaluation Center, and obtain a drug registration certificate before it can be produced and sold [1]

Core Viewpoint - Tian Tan Biological (600161.SH) has received approval from the National Medical Products Administration for clinical trials of its "human fibrinogen" product, marking a significant step towards potential market entry [1] Group 1: Company Developments - Tian Tan's subsidiary, Kunming Blood Products Co., Ltd., has been granted the Clinical Trial Approval Notice for "human fibrinogen" [1] - The company must complete several steps, including conducting clinical trials, submitting a drug marketing application, and obtaining necessary approvals before production and sales can commence [1] Group 2: Regulatory Environment - The approval from the National Medical Products Administration is a crucial regulatory milestone for the company [1] - The process includes clinical trials, review by the drug evaluation center, and final approval from the National Medical Products Administration [1]

Core Viewpoint - Tian Tan Biological Products Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for "human fibrinogen" [1] Company Summary - Tian Tan Kunming, a subsidiary of Tian Tan Biological Products, is the entity that obtained the clinical trial approval [1]

Core Viewpoint - TianTan Biological (600161) has received approval from the National Medical Products Administration for clinical trials of "human fibrinogen" to treat congenital fibrinogen deficiency or lack [1] Company Summary - TianTan Kunming, a subsidiary of TianTan Biological, has been granted a Clinical Trial Approval Notice for the drug "human fibrinogen" [1] - The drug is indicated for conditions such as congenital fibrinogen deficiency or lack [1]

Core Viewpoint - Beijing Tiantan Biological Products Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for "human fibrinogen" [1] Company Summary - The product is classified as a therapeutic biological product with a specification of 0.5g (25ml) per bottle and is in injectable form [1] - The research and development investment for this product amounts to 5.9925 million yuan [1] - Indications for the product include congenital and acquired fibrinogen deficiency [1] Industry Summary - Several domestic companies produce similar products, while the international market includes competitors such as CSL Behring and Octapharma [1] - The product must complete multiple approval processes before it can be marketed, indicating uncertainty in drug development [1]

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]