Hengrui subsidiary secures approval for key cardiovascular drug

Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for its Icosapent Ethyl Softgel Capsules. The drug, classified as a Category 4 chemical medicine, will be available in 0.5g and 1.0g specifications. This approval allows the drug to be marketed for reducing high triglyceride levels in adult patients, particularly those with severe hypertriglyceridemia, and for mitigating cardiovascular event risk in patients with established cardiovascular disease or diabetes and high triglycerides when used in conjunction with statins.

Icosapent Ethyl Softgel Capsules are an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The drug's mechanism of action includes reducing the synthesis and/or secretion of very-low-density lipoprotein triglycerides (VLDL-TG) and enhancing the clearance of TG from circulating VLDL particles. Unlike older triglyceride-lowering medications like fibrates and niacin, this drug has demonstrated a clear benefit in reducing cardiovascular events.

The product's approval is considered equivalent to passing the quality and efficacy consistency evaluation for generic drugs. Jiangsu Hengrui Medicine has invested approximately CNY 12.51m in the development of this project. The company highlighted its commitment to quality and safety in drug development, manufacturing, and sales, while also cautioning investors about potential risks in production and marketing.