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华北制药股份有限公司关于下属公司获得《药品注册证书》的公告
Core Viewpoint - North China Pharmaceutical Co., Ltd. has announced that its wholly-owned subsidiary, Hebei Huamin Pharmaceutical Co., Ltd., has received the Drug Registration Certificate for Cefprozil Tablets (0.25g) from the National Medical Products Administration, which is expected to enhance the company's product portfolio and market competitiveness [1][6]. Group 1: Drug Registration Details - The Drug Registration Certificate for Cefprozil Tablets (0.25g) was approved by the National Medical Products Administration [1]. - Cefprozil is a second-generation cephalosporin antibiotic, initially developed by Bristol-Myers Squibb in 1991, and was the first oral cephalosporin approved by the FDA for treating pediatric otitis media and sinusitis [1][2]. Group 2: Indications and Market Situation - The approved indications for Cefprozil in China include treatment for upper respiratory infections, lower respiratory infections, and skin and soft tissue infections caused by sensitive bacteria [2]. - Currently, there are 10 companies, including Huamin, that hold the Drug Registration Certificate for Cefprozil Tablets (0.25g) in China. Sales figures for Cefprozil Tablets in sample hospitals from 2023 to the first three quarters of 2025 are reported as 141.7 million, 134.99 million, and 74.22 million yuan respectively [5]. Group 3: Research and Development Investment - The cumulative R&D investment for the drug has reached 14.6458 million yuan (unaudited) [3]. Group 4: Future Prospects - Following the receipt of the Drug Registration Certificate, the company can arrange for production and market the product [4].