福元医药：依折麦布阿托伐他汀钙片（Ⅰ）获药品注册证书

Core Viewpoint - The company has received approval from the National Medical Products Administration for the production of Ezetimibe and Atorvastatin Calcium Tablets (I), marking a significant milestone for its product portfolio in the cholesterol management market [1] Company Summary - The approved drug, Ezetimibe and Atorvastatin Calcium Tablets (I), was developed by Organon and was first approved by the FDA in May 2013 [1] - The drug is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) [1] - The company received the acceptance notice for the application on January 8, 2025, and has recently obtained the drug registration certificate from the National Medical Products Administration [1] - The issuance of the drug registration certificate is considered equivalent to passing the consistency evaluation according to national policy regulations [1] Industry Summary - The approval of Ezetimibe and Atorvastatin Calcium Tablets (I) in China is part of a broader trend in the pharmaceutical industry focusing on cholesterol-lowering medications [1] - The market for cholesterol management drugs is expected to grow, driven by increasing awareness of cardiovascular diseases and the need for effective treatment options [1]