Core Insights - Sagimet Biosciences Inc. has granted an exclusive license for denifanstat to Ascletis Pharma Inc. for the treatment of moderate to severe acne in China, following the acceptance of its New Drug Application (NDA) by China's National Medical Products Administration (NMPA) [1][2] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor, which has shown positive results in clinical trials for both acne and metabolic dysfunction associated steatohepatitis (MASH) [2][3] Company Overview - Sagimet Biosciences is focused on developing novel FASN inhibitors aimed at addressing dysfunctional metabolic and fibrotic pathways, particularly those linked to the overproduction of palmitate [3] - The company has successfully completed Phase 2b clinical trials for denifanstat in MASH and has partnered with Ascletis for its Phase 3 clinical trials in moderate-to-severe acne, where denifanstat met all primary and secondary endpoints [3] Clinical Development - Denifanstat has been well tolerated in clinical trials, with Ascletis' Phase 3 trial demonstrating success in treating moderate to severe acne vulgaris [2] - Sagimet is also testing a combination of denifanstat and resmetirom in a Phase 1 PK clinical trial, targeting cirrhotic patients with F4-stage MASH, and is developing a second oral FASN inhibitor, TVB-3567, which is currently in Phase 1 trials [3]