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
Shang Hai Zheng Quan Bao·2025-06-06 19:55

Group 1 - The company has received the drug registration certificate for Tadalafil tablets (2.5mg, 5mg) from the National Medical Products Administration [1][2] - Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor primarily used for treating erectile dysfunction (ED) [2] - The original manufacturer of Tadalafil is Eli Lilly, which received approvals in the EU and the US in November 2002 and November 2003, respectively, and in China in December 2004 [2] Group 2 - The company submitted the drug registration application for Tadalafil on January 2, 2024, and received acceptance on January 24, 2024 [2] - In 2024, the sales figures for Tadalafil tablets in Chinese public hospitals, urban pharmacies, and online pharmacies were approximately RMB 185.73 million, RMB 1.294 billion, and RMB 1.61182 billion, respectively [2] - The company has invested approximately RMB 2.54 million and RMB 4.30 million in the R&D of 2.5mg and 5mg Tadalafil tablets, respectively [3] Group 3 - The approval of Tadalafil tablets enhances the company's product offerings in the male medication sector, potentially increasing its market competitiveness [3] - The company plans to commence production in accordance with relevant requirements and market demand [3]