Core Viewpoint - The company has completed pre-NDA communication with the National Medical Products Administration of China regarding the new drug application for denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris, with plans to submit the application soon [1][2] Group 1: Drug Development Progress - Denifanstat (ASC40) has successfully completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for treating moderate to severe acne vulgaris [1] - In the Phase III study, denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints, showing significant improvement compared to placebo [2] - The drug demonstrated good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2), and no Grade 3 or 4 TEAEs reported [2] Group 2: Licensing and Presentation - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2] - The results of the Phase III study were presented orally at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris on September 17, 2025 [2]
歌礼制药-B(01672)与国家药监局完成地尼法司他(ASC40)的新药上市申请前沟通