国家药品监督管理局药品审评中心数据显示，2025年12月13日，Merck Healthcare Germany GmbH的富 马酸比索洛尔片申请已获受理，受理号为JYHZ2500291。 受理号JYHZ2500291药品名称富马酸比索洛尔片药品类型化药申请类型进口再注册注册分类企业名称 Merck Healthcare Germany GmbH;Merck Healthcare KGaA;Merck Serono Co. Ltd.;承办日期2025年12月13 日 来源：新浪财经-鹰眼工作室 声明：市场有风险，投资需谨慎。 本文为AI大模型基于第三方数据库自动发布，任何在本文出现的信 息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不构成 个人投资建议。受限于第三方数据库质量等问题，我们无法对数据的真实性及完整性进行分辨或核验， 因此本文内容可能出现不准确、不完整、误导性的内容或信息，具体以公司公告为准。如有疑问，请联 系biz@staff.sina.com.cn。 ...

Core Viewpoint - The announcement indicates that the company's wholly-owned subsidiary, Four Ring Pharmaceutical, has had several of its products included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025), which may influence future sales but will not significantly impact the company's current operating performance [1] Group 1: Product Inclusion - A total of 34 products from the company's subsidiaries, including Beijing Huasu, Shandong Huasu, and Duoduo Pharmaceutical, have been included in the 2025 drug catalog [1] - New products added to the catalog include Sulfate Fish Protein Injection and Compound Pancreatin Powder [1] - Products previously included in the 2024 catalog, such as Bisoprolol Fumarate Tablets and Benidipine Hydrochloride Tablets, will continue to be listed [1] Group 2: Product Changes - Beijing Huasu's "Compound Chlorphentermine Injection" has been removed from the 2025 catalog [1] - Duoduo Pharmaceutical's "Ambroxol Hydrochloride Injection" has been newly included in the catalog [1] Group 3: Market Impact - The future sales of the included products may be affected by changes in the market environment and other factors [1] - The company states that these changes will not have a major impact on its current operating performance [1]

Group 1 - Warner Pharmaceuticals received the drug registration certificate for polyethylene glycol sodium potassium powder, which is indicated for the treatment of chronic constipation and fecal impaction [1] - The approval of the drug registration certificate enriches the company's formulation product variety and positively impacts the optimization of the product structure [1] - Warner Pharmaceuticals reported a revenue of 714 million yuan for the first half of 2025, a year-on-year decrease of 3.37%, with a net profit attributable to shareholders of 71 million yuan, down 36.95% [1] Group 2 - Renfu Pharmaceutical announced that its subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., received the drug registration certificate for dapoxetine hydrochloride tablets, which are used to treat premature ejaculation [2] - The total sales of dapoxetine hydrochloride tablets in 2024 are estimated to be around 1.1 billion yuan, with major manufacturers including Shandong Huabo Kaisheng Biotechnology Co. and Sichuan Kelun Pharmaceutical Co. [2] - Anglikon received the drug registration certificate for azilsartan potassium tablets, which are indicated for the treatment of primary hypertension in adults [3] - Xinhua Pharmaceutical announced the approval of fumarate bisoprolol tablets, indicated for hypertension and chronic stable heart failure with reduced left ventricular function [3]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the marketing of Fumarate Bisoprolol Tablets, which are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Summary by Category Product Approval - The approval includes the issuance of a Drug Registration Certificate for Fumarate Bisoprolol Tablets [1] - The product is intended for use under medical supervision alongside ACE inhibitors, diuretics, and selectively used cardiac glycosides [1] Indications - Fumarate Bisoprolol Tablets are indicated for the treatment of: - Hypertension - Coronary heart disease (angina) - Chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Fumarate Bisoprolol Tablets, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The Fumarate Bisoprolol Tablets are indicated for the treatment of hypertension and coronary heart disease (angina) [1] - The product is also indicated for chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] - The use of this medication requires adherence to medical advice, including the use of ACE inhibitors, diuretics, and selectively using cardiac glycosides [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received the drug registration certificate for Fumarate Bisoprolol Tablets from the National Medical Products Administration, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The approval is for Fumarate Bisoprolol Tablets, which are indicated for hypertension and coronary heart disease (angina) [1] - The product is also indicated for chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Group 2: Treatment Guidelines - The use of Fumarate Bisoprolol Tablets should be accompanied by ACE inhibitors, diuretics, and selectively used cardiac glycosides as per medical advice [1]

Core Viewpoint - The announcement indicates that Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of Fumarate Bisoprolol tablets, which are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Group 1 - The approved drug, Fumarate Bisoprolol, targets specific cardiovascular conditions [1] - The estimated sales revenue for Fumarate Bisoprolol tablets in Chinese public medical institutions is approximately RMB 1.228 billion in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received the drug registration certificate for Fumarate Bisoprolol Tablets from the National Medical Products Administration, enhancing its cardiovascular product line and providing more options for clinical medication [1]. Group 1 - The company has been approved for the registration of Fumarate Bisoprolol Tablets [1]. - This approval enriches the company's cardiovascular product offerings [1]. - The new product provides additional choices for clinical medication [1].

Core 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]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration certificate of Fumaric Acid Bisoprolol Tablets, enhancing its cardiovascular product line and providing more options for clinical medication [1] Company Summary - The approval of Fumaric Acid Bisoprolol Tablets enriches the company's cardiovascular product offerings [1] - This development indicates the company's commitment to expanding its portfolio in the cardiovascular sector [1] Industry Summary - The approval reflects ongoing regulatory support for new pharmaceutical products in the cardiovascular market [1] - The introduction of new medications can lead to increased competition and innovation within the cardiovascular treatment landscape [1]