Rosuvastatin Ezetimibe Tablets (I) Receive Registration Approval

2026-10-20 来源: drugdu 41

Shanghai Securities News (China Securities Network) - Peking University MedicineOn the evening of October 19th, the company announced that it had recently received a Drug Registration Certificate issued by the National Medical Products Administration. Its application for "Rosuvastatin Ezetimibe Tablets (I)" has been reviewed and found to meet the relevant requirements for drug registration, and has been approved for registration. It is understood that the drug is classified as a Class 4 chemical drug, and each tablet contains 10mg of rosuvastatin calcium (calculated as C22H28FN3O6S) and 10mg of ezetimibe.
Data shows that rosuvastatin-ezetimibe tablets (I) are a compound preparation composed of rosuvastatin (an HMG-CoA reductase inhibitor) and ezetimibe (a cholesterol absorption inhibitor). Their mechanisms of action are complementary; by inhibiting cholesterol absorption and synthesis, they lower plasma levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), while increasing high-density lipoprotein cholesterol (HDL-C) levels. It is mainly used for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH).
Peking University Medicine stated that obtaining the aforementioned drug registration approvals further enriches the company's existing product portfolio, enhances its competitiveness in the chronic disease product market, and will have a positive impact on the company's future performance.

Source: https://finance.eastmoney.com/a/202610193900214984.html

责编: editor
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