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]