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]

Core Insights - Ascletis Pharma Inc. is focused on developing innovative treatments for metabolic diseases, with a significant breakthrough in selecting ASC37 for clinical development targeting obesity treatment [1][4] Development and Technology - ASC37 utilizes Ascletis' proprietary Peptide Oral Transport ENhancement Technology (POTENT), achieving an average absolute oral bioavailability of 4.2%, which is significantly higher than competitors like semaglutide, tirzepatide, and retatrutide by 9-, 30-, and 60-fold respectively [3][5] - The drug's exposure level is approximately 57 times that of retatrutide, with a half-life of about 56 hours, indicating potential for less frequent dosing, a feature preferred by patients [3][5] Regulatory and Strategic Plans - Ascletis plans to submit an Investigational New Drug Application (IND) to the U.S. FDA for ASC37 in the second quarter of 2026, demonstrating the company's commitment to addressing unmet needs in obesity treatment [4][5] - The company will host a conference call in Mandarin on December 1, 2025, to discuss ASC37's development and strategic direction in the obesity treatment landscape [4]