Core Viewpoint - Heng Rui Medicine (01276.HK) announced the approval of its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. for the launch of Eicosapentaenoic Acid Ethyl Ester Soft Capsules by the National Medical Products Administration [1] Group 1: Product Approval - The product is indicated for lowering triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) on a controlled diet [1] - It is also used in combination with statins for adult patients diagnosed with cardiovascular diseases or diabetes with ≥2 other cardiovascular disease risk factors, who have hypertriglyceridemia (≥150 mg/dL), to reduce the risk of cardiovascular events [1]

Core Viewpoint - The approval of Eicosapentaenoic Acid Ethyl Ester Soft Capsules by Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Heng Rui Medicine, marks a significant advancement in the company's product offerings and aligns with the growing demand for effective cardiovascular treatments [1] Company Summary - Heng Rui Medicine's subsidiary received notification from the National Medical Products Administration for the market approval of Eicosapentaenoic Acid Ethyl Ester Soft Capsules [1] - The product was developed by Amarin Corporation and was first approved in the United States in July 2012, with domestic approval granted in June 2023 [1] - The soft capsules offer multiple benefits compared to traditional lipid-lowering drugs, including lowering triglycerides (TG), anti-inflammatory effects, antioxidant properties, anti-thrombotic effects, and the ability to reverse plaques, effectively reducing the incidence of ischemic cardiovascular events [1] - The total research and development investment for the Eicosapentaenoic Acid Ethyl Ester Soft Capsules project has reached approximately 12.51 million yuan [1] Industry Summary - The approval of this product is indicative of the increasing focus on innovative therapies in the cardiovascular sector, highlighting the potential for growth in this market [1] - The product's unique mechanisms of action may position it favorably against traditional therapies, suggesting a shift in treatment paradigms for cardiovascular diseases [1]

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：600276 证券简称：恒瑞医药 公告编号：临 2025-142 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司成都盛迪医 药有限公司收到国家药品监督管理局（以下简称"国家药监局"）的通知，批准 公司二十碳五烯酸乙酯软胶囊上市。现将相关情况公告如下： 一、药品的基本情况 药品名称：二十碳五烯酸乙酯软胶囊 剂型：胶囊剂 规格：0.5g、1.0g 二十碳五烯酸乙酯软胶囊由 Amarin 公司开发，最早于 2012 年 7 月在美国获 批上市，并于 2023 年 6 月在国内获批。与传统降脂药相比，其具备降 TG、抗炎、 抗氧化、抗栓、逆转斑块等多重获益机制，可有效降低缺血性心血管事件的发生 率。公司本次获批视同通过仿制药质量和疗效一致性评价。截至目前，二十碳五 烯酸乙酯软胶囊项目累计研发投入约 1,251 万元。 三、风险提示 受理号：CYHS2301896、CYHS2301897 处方药/非处方药：处方药 批 ...

Investment Rating - The report assigns a "Buy" rating for the company, indicating an expected stock price increase of over 20% relative to the benchmark index within the next six months [9][15]. Core Insights - The company reported a revenue of 15.76 billion yuan in the first half of 2025, representing a year-on-year growth of 15.9%, with a net profit of 4.45 billion yuan, up 29.7% [4]. - The revenue from innovative drugs reached 7.57 billion yuan in the first half of 2025, with an estimated growth rate of approximately 23% year-on-year [5][6]. - The company has received approvals for six Class 1 innovative drugs and has multiple drugs in various clinical trial phases, indicating a robust pipeline for future growth [7]. Financial Performance - The company’s projected revenues for 2025, 2026, and 2027 are 34.44 billion yuan, 39.05 billion yuan, and 43.88 billion yuan, respectively, with year-on-year growth rates of 23.1%, 13.4%, and 12.4% [8][11]. - The net profit attributable to the parent company is expected to be 9.18 billion yuan, 10.72 billion yuan, and 11.79 billion yuan for the years 2025, 2026, and 2027, reflecting growth rates of 44.9%, 16.8%, and 10.0% [8][11]. Business Development - The company has established a clear plan for future innovative drug production, including a share repurchase plan of 1 to 2 billion yuan aimed at employee stock ownership [7]. - Licensing income has become a significant component of the company's revenue, with 1.99 billion yuan generated from licensing agreements in the first half of 2025 [5][6].

Group 1 - Company Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Heng Rui Medicine (600276.SH), has received approval from the National Medical Products Administration for the market launch of Eicosapentaenoic Acid Ethyl Ester Soft Capsules [1] - Eicosapentaenoic acid (EPA) is a stable ethyl ester of omega-3 fatty acid, which has been shown to reduce the synthesis and/or secretion of very low-density lipoprotein triglycerides (VLDL-TG) in the liver and improve the clearance rate of triglycerides (TG) in circulating VLDL particles [1] - Elevated TG levels are an independent risk factor for increased ischemic cardiovascular events, highlighting the clinical need for a drug that can safely and effectively lower TG levels and the incidence of ischemic cardiovascular events, particularly in combination with statins and with a low incidence of adverse reactions [1] Group 2 - Current medications for lowering TG include fibrates, niacin, and mixed omega-3 polyunsaturated fatty acids, but studies indicate that these drugs do not provide clear benefits in reducing cardiovascular events [1]

Core Viewpoint - Heng Rui Medicine (600276) announced the approval of its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. for the market launch of Eicosapentaenoic Acid Ethyl Ester Soft Capsules by the National Medical Products Administration [1] Group 1 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio [1] - Eicosapentaenoic Acid Ethyl Ester is known for its health benefits, which may attract consumer interest and drive sales [1] - The launch could strengthen the company's position in the pharmaceutical market, particularly in the area of dietary supplements [1]

批准的适应症：在控制饮食的基础上，本品用于降低重度高甘油三酯血症(≥500mg/dL)成年患者的甘油 三酯(TG)水平。与他汀类药物联合使用，用于确诊心血管疾病或糖尿病伴≥2种其他心血管疾病危险因 素，合并高甘油三酯血症(≥150mg/dL)的成年患者，以降低心血管事件风险。 智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司子公司成都盛迪医药有限公司收到国家 药品监督管理局(简称"国家药监局")的通知，批准公司二十碳五烯酸乙酯软胶囊上市。 ...

恒瑞医药签署HRS-1893项目授权许可协议，总金额最高有望超10亿美元。近日，江苏恒瑞医药股份有 限公司与美国BraveheartBio,Inc.达成协议，将具有自主知识产权的1类创新药HRS-1893项目有偿许可给 BraveheartBio。根据公司公告，BraveheartBio将向恒瑞支付6500万美元首付款（含3250万美元现金和等 值3250万美元的BraveheartBio公司股权）和完成技术转移后的1000万美元近期里程碑款，总计7500万美 元。恒瑞有资格获得与临床开发和销售相关的里程碑付款，最高可达10.13亿美元。根据HRS-1893在除 中国大陆、香港特别行政区、澳门特别行政区及台湾地区以外的全球范围的销售情况，BraveheartBio将 向恒瑞支付相应的销售提成。根据恒瑞医药，HRS-1893是一种Myosin选择性抑制剂，可通过抑制心肌 肌球蛋白三磷酸腺苷（ATP）酶活性，从而抑制心肌过度收缩，减少左心室肥厚并改善舒张期松弛。该 药物目前正处于III期临床开发阶段，用于治疗梗阻性肥厚型心肌病（oHCM）。肥厚型心肌病 （HCM）是一种以左心室肥厚为突出特征的原发性心肌病，是最常 ...

Investment Rating - The report indicates a positive outlook for the pharmaceutical and biotechnology sector, with a weekly increase of 1.4%, outperforming the Wind All A index (-1.37%) and the CSI 300 index (-0.81%) [3][8]. Core Insights - The report highlights the acceleration of business development (BD) in small nucleic acid drugs, with significant deals announced by Arrowhead Pharmaceuticals and Novartis, indicating a strong interest in this area from multinational corporations [3][12]. - The report emphasizes the importance of the World Conference on Lung Cancer (WCLC) held from September 6-9, where several key research advancements in lung cancer were presented, suggesting potential investment opportunities in innovative drug companies participating in the conference [3][11]. - The report notes the strong performance of specific stocks within the sector, such as Haichen Pharmaceutical (28.7%), Changchun High-tech (24.2%), and Baihua Pharmaceutical (21.3%), while also identifying underperformers like Shuyou Shen (24%) and Guangsheng Tang (15.8%) [3][11]. Market Weekly Review - The pharmaceutical and biotechnology sector saw a weekly increase of 1.4%, with the best-performing sub-sectors being other biological products (4.86%), chemical products (4.52%), and medical research outsourcing (3.78%) [3][8]. - Conversely, sectors such as hospitals (-2.31%), vaccines (-2.08%), and medical devices (-1.97%) experienced declines [3][8]. - Notable individual stock performances included significant gains for Haichen Pharmaceutical, Changchun High-tech, and Baihua Pharmaceutical, while Shuyou Shen and Guangsheng Tang faced substantial losses [3][11]. Industry News and Key Company Announcements - Arrowhead Pharmaceuticals announced a global licensing and collaboration agreement with Novartis for a siRNA therapy targeting Parkinson's disease, with an upfront payment of $200 million and potential milestone payments totaling up to $2 billion [3][15]. - A strategic collaboration was established between Novartis and Wobang Pharmaceuticals for cardiovascular products, with an upfront payment of $160 million and potential total milestone payments of $5.2 billion [3][13]. - The report also mentions various clinical trial advancements and approvals for several companies, including the approval of new indications for existing drugs and the initiation of new clinical trials [3][16].

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology sector [5]. Core Viewpoints - The establishment of a "national team" in the biopharmaceutical sector is expected to lead to a revaluation of state-owned pharmaceutical enterprises, driven by policy support and innovation [2][22]. - The report highlights three main lines for the revaluation of state-owned pharmaceutical companies: valuation repair, integration benefits, and innovation premium [28]. Summary by Sections Market Review - Last week, the A-share pharmaceutical and biotechnology sector rose by 1.40%, outperforming the CSI 300 index by 2.21 percentage points [1][16]. - The Hong Kong Hang Seng Medical Health Index increased by 6.99%, surpassing the Hang Seng State-Owned Enterprises Index by 5.76 percentage points [1][16]. Company Updates - Recent clinical application approvals include DB-1418 from Ying'en Biotech and IBI3033 from Innovent Biologics [31]. - Notable companies in the sector include 恒瑞医药 (Hengrui Medicine), 鱼跃医疗 (Yuyue Medical), 迈瑞医疗 (Mindray Medical), and 联影医疗 (United Imaging Healthcare), all of which are recommended for investment [4][28]. Research and Development Progress - Several companies are advancing in clinical trials, including 恒瑞医药's HRS-9531, which is currently in Phase II [34]. - The report tracks the progress of various drug applications and clinical trials, indicating a robust pipeline in the sector [31][34]. Policy and Strategic Developments - The report discusses the strategic shift of state-owned enterprises from being industry stabilizers to innovation leaders, particularly in the context of accelerated drug approvals and healthcare payment reforms [2][22]. - The "target-guided innovation" development paradigm is emphasized, aiming for a deep integration of research and industrial capabilities [23]. Financial Performance and Projections - The report provides earnings forecasts and valuation tables for key companies, indicating potential growth and investment opportunities [4][28]. - The current price-to-earnings ratio for China National Pharmaceutical Group is noted at 7.8 times, suggesting room for valuation improvement as innovation business contributions increase [28].