CHENGYIPHARMA: Ethyl Eicosapentaenoate Soft Capsules have obtained the drug registration certificate

Zhitong
2025.09.01 11:27
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CHENGYIPHARMA announced that its eicosapentaenoic acid ethyl ester soft capsules have obtained the drug registration certificate from the National Medical Products Administration. This drug is used to lower triglyceride levels in adult patients with severe hypertriglyceridemia based on dietary control and can be used in conjunction with statins to reduce the risk of cardiovascular events. The impact on the risk of pancreatitis in patients with severe hypertriglyceridemia has not yet been assessed

According to the Zhitong Finance APP, CHENGYIPHARMA (603811.SH) announced that it has recently received the "Drug Registration Certificate" (Certificate No.: 2025S02619, 2025S02620) approved and issued by the National Medical Products Administration (referred to as "NMPA") for ethyl eicosapentaenoate soft capsules.

Based on dietary control, this product is used to lower triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥500mg/dL). It is used in combination with statins for adult patients diagnosed with cardiovascular disease or diabetes with ≥2 other cardiovascular disease risk factors, combined with hypertriglyceridemia (≥150mg/dL), to reduce the risk of cardiovascular events (myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization). The effect of this product on the risk of pancreatitis in patients with severe hypertriglyceridemia has not been evaluated