Core Insights - The company has completed Pre-NDA communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne and plans to submit a New Drug Application soon [1][2] - Denifanstat (ASC40) has successfully met all primary, key secondary, and secondary efficacy endpoints in the Phase III study, showing significant improvement compared to placebo [2] - The safety profile of denifanstat (ASC40) is favorable, with all treatment-emergent adverse events being mild or moderate, and no severe adverse events reported [2] Company Developments - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) [1] - The results of the Phase III study were presented at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]
歌礼制药-B与国家药监局完成地尼法司他(ASC40)的新药上市申请前沟通