Ge Long Hui·2025-10-13 08:49Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Fumaric Acid Bisoprolol Tablets, indicating a significant advancement in its product portfolio and potential market impact [1] Group 1: Product Approval and Registration - The company has been granted a drug registration certificate for Fumaric Acid Bisoprolol Tablets, confirming compliance with the relevant drug registration requirements [1] - The registration process included submission of application materials to the Center for Drug Evaluation (CDE) in February 2024, with approval granted in October 2025 [1] Group 2: Indications and Usage - Fumaric Acid Bisoprolol Tablets are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] - The use of this medication should be accompanied by ACE inhibitors, diuretics, and selectively used cardiac glycosides as per medical advice [1] Group 3: Market Potential - The drug is classified as a Category A product in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024 edition) [1] - Estimated sales for Fumaric Acid Bisoprolol Tablets in Chinese public medical institutions are projected to be approximately RMB 1.228 billion in 2024 [1]