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]

Core Insights - Ascletis Pharma Inc. announced that denifanstat (ASC40), a first-in-class oral fatty acid synthase (FASN) inhibitor, successfully met all primary and secondary endpoints in a Phase III clinical trial for moderate to severe acne vulgaris [1][6][10] Clinical Trial Overview - The Phase III trial was a randomized, double-blind, placebo-controlled study conducted in China with 480 patients, comparing 50 mg denifanstat to a placebo over 12 weeks [2] - Baseline characteristics were well balanced between the treatment and placebo groups, with total lesion counts of 102.2 for denifanstat and 102.1 for placebo [11] Efficacy Results - Primary endpoints showed a treatment success rate of 33.2% for denifanstat versus 14.6% for placebo (p<0.0001) [3] - Denifanstat achieved a 57.4% reduction in total lesion count compared to 35.4% for placebo (p<0.0001) and a 63.5% reduction in inflammatory lesions compared to 43.2% for placebo (p<0.0001) [3] - Key secondary endpoint results included a 51.9% reduction in non-inflammatory lesions for denifanstat versus 28.9% for placebo (p<0.0001) [3] Safety Profile - Denifanstat demonstrated a favorable safety and tolerability profile, with treatment-emergent adverse events (TEAEs) comparable to placebo [4] - No TEAEs related to denifanstat exceeded 10%, and all reported adverse events were mild or moderate [4] Mechanism of Action - Denifanstat works by directly inhibiting facial sebum production and inflammation, addressing the underlying causes of acne [5] - This mechanism differentiates denifanstat from other acne treatments that do not target the root cause of the condition [5] Comparative Efficacy - In non-head-to-head comparisons, denifanstat was found to be 98% and 178% more effective than sarecycline and doxycycline, respectively, in terms of placebo-adjusted treatment success [7][8] - Denifanstat was also 60% more effective than clascoterone cream regarding treatment success [7][8] Market Potential - Denifanstat is positioned as a first-in-class oral acne therapeutic with exceptional efficacy and a favorable safety profile, potentially improving patient compliance compared to topical treatments [9] - The company plans to submit denifanstat for approval to the China National Medical Products Administration (NMPA) [6]