Core Insights - Ascletis Pharma Inc. has received acceptance for its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class oral fatty acid synthase inhibitor aimed at treating moderate-to-severe acne vulgaris, by the China National Medical Products Administration (NMPA) [2][3] - The Phase III clinical trial results demonstrated that denifanstat (ASC40) met all primary and secondary efficacy endpoints, showing significant improvement in acne vulgaris compared to placebo, with a favorable safety profile [4][5] Group 1 - The acceptance of the NDA is a significant milestone for Ascletis in its efforts to commercialize denifanstat (ASC40) [3] - Denifanstat (ASC40) has completed both Phase II and Phase III studies for the treatment of moderate-to-severe acne vulgaris [3][5] - The Phase III study results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025, indicating the company's active engagement in scientific discourse [5] Group 2 - The Phase III study reported that all treatment-emergent adverse events (TEAEs) related to denifanstat (ASC40) were mild or moderate, with no severe adverse events observed [4] - Ascletis has licensed denifanstat (ASC40) from Sagimet Biosciences Inc. for exclusive rights in Greater China, highlighting strategic partnerships in drug development [5] - Ascletis Pharma Inc. is focused on developing and commercializing innovative therapeutics for metabolic diseases, utilizing advanced technologies in drug discovery [6]