株洲千金药业股份有限公司关于子公司获得药品注册证书的公告

Core Viewpoint - The announcement highlights that Zhuzhou Qianjin Pharmaceutical Co., Ltd.'s subsidiary, Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd., has received drug registration certificates for Fumarate Bisoprolol Tablets (2.5mg, 5mg) from the National Medical Products Administration, indicating successful compliance with drug registration requirements [1][2]. Group 1: Drug Information - Drug Name: Fumarate Bisoprolol Tablets - Dosage Forms: Tablets - Specifications: 2.5mg, 5mg - Registration Classification: Class 4 Chemical Drug - Approval Numbers: National Drug Approval Code H20253939, H20253940 - License Holder: Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd. [1][2]. Group 2: Market Context - Fumarate Bisoprolol Tablets are selective β-receptor blockers used for treating hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular function (ejection fraction ≤ 35%). - The drug was first launched in Germany in 1986 and entered the Chinese market in 1998. Other manufacturers with registration include Merck Germany and Chengdu Yuandong Biological Pharmaceutical Co., Ltd. - The domestic market sales for Fumarate Bisoprolol Tablets in 2023 are approximately RMB 1.342 billion [2]. Group 3: Company Impact - The receipt of the drug registration certificate for Fumarate Bisoprolol Tablets signifies passing the consistency evaluation, enhancing the company's product pipeline and supporting sustainable development. - The company has invested a total of RMB 7.1965 million in the research and development of Fumarate Bisoprolol Tablets (2.5mg, 5mg) [2][3].