Regulatory Approval for Icosapent Ethyl Soft Capsules Achieved with Kangchuanji's Support
2025-06-09
According to the drug approval information released by NMPA, our partner has obtained the "Drug Registration Certificate" from the National Medical Products Administration for its Icosapent Ethyl Soft Capsules (0.5 g and 1.0 g), granting marketing authorization. Kangchuanji provided R&D support for this product.
Icosapent Ethyl Soft Capsules are a highly purified omega-3 fatty acid ethyl ester. They effectively inhibit cholesterol synthesis in the liver, reduce blood cholesterol and triglyceride levels, and thereby lower blood lipids. Numerous clinical studies have shown significant lipid-controlling effects. When used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL), a daily dose of 4 g for 12 weeks can lower triglyceride levels by approximately 16–26%.
Moreover, this drug has demonstrated outstanding benefits in cardiovascular disease prevention. The landmark REDUCE-IT study, published in The New England Journal of Medicine, showed that in high-risk patients with hypertriglyceridemia who were already on statin therapy, the addition of icosapent ethyl reduced the relative risk of major adverse cardiovascular events by 25%.
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