证券代码：600332 证券简称：白云山 公告编号：2025－048 广州白云山医药集团股份有限公司 关于分公司收到药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，广州白云山医药集团股份有限公司（以下简称"本公司"）分公司广州白云山医药集团股份有限公 司白云山制药总厂（以下简称"白云山制药总厂"）收到国家药品监督管理局核准签发关于他达拉非片 （2.5mg、5mg）的《药品注册证书》。现将相关情况公告如下： 一、药品的基本情况 药品通用名称：他达拉非片 主要成份：他达拉非 剂型：片剂 上市许可持有人：（1）名称：广州白云山医药集团股份有限公司白云山制药总厂；（2）地址：广州市 白云区同和街云祥路88号 生产企业：（1）名称：广州白云山医药集团股份有限公司白云山制药总厂；（2）地址：广州市白云区 同和街云祥路88号 受理号：CYHS2400338、CYHS2400337 药品批准文号：国药准字H20254302、国药准字H20254301 药品批准文号有效期：至2030年05月26日 审批结论：根据《中华 ...

Core Viewpoint - The company has received the drug registration certificate for Tadalafil tablets (2.5mg, 5mg), enhancing its product offerings in the male medication market and improving its competitive position in this sector [1][2]. Drug Information - The drug's generic name is Tadalafil, with active ingredients being Tadalafil in tablet form, available in specifications of 2.5mg and 5mg [1]. - The registration classification is categorized as a Class 4 chemical drug, with certificate numbers 2025S01530 and 2025S01529 [1]. - The drug is approved for use in treating erectile dysfunction (ED) and was originally developed by Eli Lilly, receiving approvals in the EU and the US in 2002 and 2003, respectively, and in China in 2004 [1]. Market Context - The registration application for Tadalafil tablets was accepted on January 24, 2024, and the approval is valid until May 26, 2030 [1]. - Major competitors in the domestic market include Guangdong Dongyangguang Pharmaceutical Co., Ltd., Jiangsu Tianshili Diyi Pharmaceutical Co., Ltd., and Lefusi Health Industry Co., Ltd., with sales figures of RMB 185.73 million, RMB 1.294 billion, and RMB 1.61182 billion, respectively [1]. - The company has invested approximately RMB 2.5401 million and RMB 4.2976 million in the R&D of Tadalafil tablets (2.5mg and 5mg) [1]. Impact on the Company - The acquisition of the drug registration certificate will diversify the product range of the company's male medication offerings, thereby enhancing its competitiveness in the male medication market [2]. - The company plans to commence production in accordance with regulatory requirements and market demand [2].