Zheng Quan Zhi Xing·2025-06-06 09:20Core 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].