华润双鹤药业股份有限公司关于全资子公司华润赛科药业有限责任公司比索洛尔氨氯地平片获得药品注册证书的公告

Core Viewpoint - The announcement highlights that China Resources Double Crane Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, China Resources Saike Pharmaceutical Co., Ltd., has received a drug registration certificate for Bisoprolol Amlodipine Tablets, which is a significant development for the company's product line and market competitiveness [1][4]. Group 1: Drug Registration and Development - The drug registration certificate for Bisoprolol Amlodipine Tablets was issued by the National Medical Products Administration (NMPA) [1]. - The research and development of this drug began in November 2022, with the application for market approval submitted in June 2024 and the approval granted in November 2025 [1][2]. Group 2: Market Situation - Bisoprolol Amlodipine Tablets, developed by Merck Kft, were approved for sale in the EU in November 2017 and in China in May 2021 [3]. - The global sales of Bisoprolol Amlodipine Tablets are projected to reach approximately $74.05 million in 2024, with Merck's product "Concor AMLO?" accounting for about $44.29 million of that total [3]. - In the Chinese market, the total sales of Bisoprolol Amlodipine Tablets are estimated to be around 4.29 million RMB in 2024, with Merck holding a dominant market share of 99.90% [3]. Group 3: Impact on the Company - The approval of the drug registration certificate is expected to enhance the company's product line and market competitiveness, while also providing valuable experience for future product development [4].