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恒瑞医药:降血脂产品二十碳五烯酸乙酯软胶囊获批上市
Core Viewpoint - Heng Rui Medicine has received approval for the launch of Eicosapentaenoic Acid Ethyl Ester soft capsules, aimed at reducing triglyceride levels in patients with severe hypertriglyceridemia and those with cardiovascular disease risk factors [1][2] Group 1: Product Approval and Mechanism - The Eicosapentaenoic Acid Ethyl Ester soft capsules are approved for use in adults with triglyceride levels ≥500 mg/dL and in combination with statins for patients with cardiovascular disease or diabetes with additional risk factors [1] - Eicosapentaenoic Acid (EPA) is known to lower the synthesis and/or secretion of very low-density lipoprotein triglycerides (VLDL-TG) and improve the clearance of triglycerides from VLDL particles, which is crucial as elevated triglyceride levels are an independent risk factor for ischemic cardiovascular events [1] - Current medications for lowering triglycerides include fibrates, niacin, and mixed omega-3 polyunsaturated fatty acids, but these have not shown clear benefits in reducing cardiovascular events, highlighting the need for effective alternatives [1] Group 2: Development and Financial Aspects - The Eicosapentaenoic Acid Ethyl Ester soft capsules were developed by Amarin Corporation and were first approved in the U.S. in July 2012, with domestic approval granted in June 2023 [2] - The total R&D investment for the Eicosapentaenoic Acid Ethyl Ester project has reached approximately 12.51 million yuan [2] - On September 5, Heng Rui Medicine announced an exclusive licensing agreement with Braveheart Bio for the Myosin small molecule inhibitor HRS-1893, which includes a total payment of up to $75 million and potential milestone payments of up to $1.013 billion related to clinical development and sales [2]
恒瑞医药再启NewCo模式,心肌病药10亿美元“借船”出海
Guan Cha Zhe Wang· 2025-09-09 11:40
【文/王力 编辑/周远方】 9月5日,恒瑞医药宣布与美国Braveheart Bio公司达成独家许可协议,将其自主研发的心肌肌球蛋白小分子抑制剂HRS-1893项目的海外权益授权给这家新成 立的公司。 根据协议,恒瑞医药将获得6500万美元首付款(含一半现金及一半股权)和1000万美元技术转移款,以及最高可达10.13亿美元的临床开发和销售里程碑付 款加销售提成。 这是恒瑞医药继2024年5月以60亿美元将其GLP-1类创新药组合授权给由贝恩资本等组建的新公司后,第二次采用NewCo模式实现创新药出海。 NewCo模式再试水,心肌病治疗市场添新药 恒瑞医药此次的合作方Braveheart Bio是一家2024年在美国特拉华州设立的公司,主要投资方包括欧洲知名生命科学风投Forbion资本和全球顶级医疗健康投 资机构OrbiMed等。 据悉,Spin off-NewCo(以下称"NewCo"/"NewCo")模式是指由资本方牵头成立新公司,药企将研发管线授权给该公司并获得相应股权和现金,双方通 过"药企出技术、资本方出资金"的方式共同承担风险、共享收益的创新药合作模式。 截图来自恒瑞医药公告 恒瑞医药执行副总裁 ...
9月9日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-09 10:10
Group 1 - Matrix Co., Ltd. announced that its wholly-owned subsidiary, Anke Technology, introduced a strategic investor, Shenzhen Jifu New Industry Venture Capital Fund, which invested 5 million yuan for a 10% stake [1] - Heng Rui Medicine received approval from the National Medical Products Administration for its Eicosapentaenoic Acid Ethyl Ester Soft Capsule, aimed at reducing triglyceride levels in patients with severe hypertriglyceridemia [1] - Mo Gao Co., Ltd. announced the resignation of its Vice President Jin Baoshan due to job transfer [1] Group 2 - Yao Wang Technology decided to terminate two fundraising projects and will permanently supplement the remaining funds into working capital [2] - Minhe Livestock reported sales of 25.53 million chicklings in August, generating revenue of 86.41 million yuan, with year-on-year growth of 27.60% [2] - Sichuan Jinding announced the resignation of its Director and General Manager Xiong Jifeng due to personal reasons [3] Group 3 - Taiji Group received approval for clinical trials of its Semaglutide Injection, aimed at blood sugar control in type 2 diabetes patients [5] - Jieput announced plans to increase capital in its affiliate, Suidong Intelligent Technology, with an investment of 5 million yuan for a 5% stake [7] - GeLing Deep Vision's controlling shareholders committed not to reduce their shareholdings for six months starting from September 17, 2025 [8] Group 4 - Huafeng Superfiber reported the resignation of its Vice President Liu Cong due to personal reasons [9] - Xiaoming Co., Ltd. reported sales revenue of 79.90 million yuan from chicken products in August, with year-on-year growth of 11.73% [11] - Lion Head Co., Ltd. announced that its application for issuing shares and cash to acquire assets has been accepted by the Shanghai Stock Exchange [12] Group 5 - Jinlong Automobile reported a bus sales volume of 4,074 units in August, a year-on-year increase of 23.6% [43] - Metro Design signed a contract for the Ho Chi Minh City urban rail transit project in Vietnam, with a total amount of 1.754 trillion VND [45] - North New Road and Bridge announced winning a mining construction project worth 504 million yuan [28]
恒瑞医药二十碳五烯酸乙酯软胶囊获药品注册批准
Bei Jing Shang Bao· 2025-09-09 09:48
Group 1 - The core point of the article is that Chengdu Shengdi Pharmaceutical Co., a subsidiary of Heng Rui Medicine, has received approval from the National Medical Products Administration for the launch of Eicosapentaenoic Acid Ethyl Ester Soft Capsules [1] - The approved indication is for the treatment of severe hypertriglyceridemia (≥500 mg/dL) in adult patients, in conjunction with dietary control, to lower triglyceride (TG) levels [1] - The product can also be used in combination with statins for adult patients diagnosed with cardiovascular diseases or diabetes with two or more other cardiovascular disease risk factors, to reduce the risk of cardiovascular events in cases of hypertriglyceridemia (≥150 mg/dL) [1]
恒瑞医药(01276.HK):二十碳五烯酸乙酯软胶囊获批上市
Ge Long Hui· 2025-09-09 09:36
格隆汇9月9日丨恒瑞医药(01276.HK)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 督管理局的通知,批准公司二十碳五烯酸乙酯软胶囊上市。 根据披露,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。 ...
恒瑞医药(01276):二十碳五烯酸乙酯软胶囊获批上市
智通财经网· 2025-09-09 09:31
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。 智通财经APP讯,恒瑞医药(01276)公布,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 理局的通知,批准公司二十碳五烯酸乙酯软胶囊上市。 ...
恒瑞医药(01276) - 海外监管公告 - 关於获得药品注册批准的公告
2025-09-09 09:26
江蘇恒瑞醫藥股份有限公司 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. (於中華人民共和國註冊成立的股份有限公司) (股份代號:1276) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年9月9日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 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 ...
恒瑞医药(600276) - 恒瑞医药关于获得药品注册批准的公告
2025-09-09 09:15
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 ...
恒瑞医药(600276):对外许可常态化,员工持股计划明确创新药产出规划
China Post Securities· 2025-09-09 09:12
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].
恒瑞医药(600276.SH):二十碳五烯酸乙酯软胶囊获得药品注册批准
Ge Long Hui A P P· 2025-09-09 09:11
格隆汇9月9日丨恒瑞医药(600276.SH)公布,子公司成都盛迪医药有限公司收到国家药品监督管理局的 通知,批准公司二十碳五烯酸乙酯软胶囊上市。二十碳五烯酸乙酯是ω-3脂肪酸二十碳五烯酸(EPA) 的稳定乙酯。研究表明,EPA可降低肝脏极低密度脂蛋白甘油三酯(VLDL-TG)的合成和/或分泌,并 提高循环VLDL颗粒中TG的清除率。而TG水平升高是增加缺血性心血管事件风险的独立危险因素。目 前降低TG的药物有贝特类、烟酸类和混合ω-3多不饱和脂肪酸。研究表明,上述药物无明确心血管事件 获益。因此,临床上亟需一种与他汀类药物合用、不良反应发生率低、可安全有效降低TG以及缺血性 心血管事件发生率的药物。 ...