Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for Ezetimibe and Atorvastatin Calcium Tablets (I), which will enhance the company's product line and market competitiveness [1][5]. Drug Registration Certificate Details - The drug registration certificate (Certificate No. 2025S03344) was issued by the National Medical Products Administration (NMPA) for Ezetimibe and Atorvastatin Calcium Tablets (I), which contains 10mg of Ezetimibe and 10mg of Atorvastatin Calcium per tablet [1][2]. - The drug is indicated for hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) and was first approved by the FDA in May 2013 [1][2]. R&D Investment - The total R&D investment for this drug has reached RMB 5.0458 million (unaudited) as of the date of the announcement [3]. Market Status of Similar Drugs - According to data from Minai Network, the sales revenue of Ezetimibe and Atorvastatin Calcium Tablets in China for the first half of 2025 was approximately RMB 8.64 million, with sales from urban public hospitals and county-level public hospitals accounting for RMB 6.74 million [4]. - Sales from urban community centers and township health clinics were RMB 1.77 million, while urban pharmacies and online pharmacies contributed RMB 0.13 million [4].

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]