北京福元医药股份有限公司 关于氨氯地平贝那普利胶囊获得药品注册证书的公告

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for Amlodipine Benazepril Capsules, which will enhance the company's product line and market competitiveness [1][4]. Drug Registration Certificate Details - The drug is approved for production by the National Medical Products Administration, with the registration certificate number 2025S02582 [1]. - Amlodipine Benazepril Capsules are indicated for patients whose blood pressure is not adequately controlled by either Amlodipine or Benazepril alone, or for those requiring a switch from separate Amlodipine and Benazepril tablets [1]. R&D Investment - The company has invested a total of RMB 8.1616 million (approximately 1.1 million USD) in the research and development of this drug [2]. Market Situation of Similar Drugs - According to data from Minai Network, the sales revenue of Amlodipine Benazepril oral formulations in China is approximately RMB 1.12 billion (about 160 million USD) for 2024 [3]. - The sales distribution includes RMB 727 million (about 102 million USD) from urban public hospitals and county-level public hospitals, RMB 167 million (about 24 million USD) from urban community centers and township health clinics, and RMB 226 million (about 32 million USD) from urban pharmacies and online pharmacies [3]. Impact on the Company - The approval of the drug will enrich the company's product line and enhance its market competitiveness [4].