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

Group 1 - The company’s subsidiary, China Resources Saike Pharmaceutical Co., Ltd., has received the Drug Registration Certificate for Bisoprolol Amlodipine Tablets from the National Medical Products Administration [1] - Bisoprolol Amlodipine Tablets are used as an alternative therapy for hypertension in patients whose blood pressure is well controlled with the same dosage of single drugs [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 expected in November 2025 [1][2] Group 2 - The global sales of Bisoprolol Amlodipine Tablets are projected to reach approximately $74.05 million in 2024, with the product "Concor AMLO?" accounting for about $44.29 million of that total [3] - In China, there are 14 approved manufacturers of Bisoprolol Amlodipine Tablets, with 13 having passed the consistency evaluation, including the company [3] - The total sales in the domestic medical and retail market for Bisoprolol Amlodipine Tablets are estimated to be around 4.29 million RMB, with Merck holding a market share of 99.90% [3]