Core Insights - The company, Gilead Sciences-B (01672.HK), has recently completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris [1][2] - Gilead plans to submit the New Drug Application shortly, following the completion of Phase II (NCT05104125) and Phase III studies (NCT06192264) for denifanstat [1] Group 1 - In the Phase III study, denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints, significantly improving moderate to severe acne vulgaris compared to placebo [2] - Denifanstat (ASC40) demonstrated good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2) [2] - There were no Grade 3 or 4 TEAEs related to denifanstat (ASC40), nor any serious adverse events (SAEs) associated with the treatment [2] Group 2 - Gilead reported the results of the Phase III study at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2]
歌礼制药-B(01672.HK)与药监局完成地尼法司他(ASC40)的新药上市申请前沟通 将于近日提交新药上市申请