Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration

Core Insights - Ascletis Pharma Inc. has successfully completed the Phase III clinical trial for denifanstat (ASC40), demonstrating significant efficacy in treating moderate-to-severe acne vulgaris compared to placebo [1][4] - The company plans to submit a New Drug Application (NDA) to the China National Medical Products Administration (NMPA) following a pre-NDA consultation [2][3] Group 1: Clinical Trial Results - Denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints in the Phase III trial, showing significant improvement in acne vulgaris [1][4] - The safety profile of denifanstat (ASC40) was favorable, with all treatment-emergent adverse events being mild or moderate, and no serious adverse events reported [4] Group 2: Regulatory and Development Plans - Ascletis has completed the pre-NDA consultation with NMPA, which began in June 2025 and concluded in October 2025, and plans to submit the NDA soon [2][3] - The results of the Phase III study were presented at the European Academy of Dermatology and Venereology Congress in September 2025 [5] Group 3: Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing therapeutics for metabolic diseases, utilizing advanced drug discovery technologies [6] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [6]