Business
Sagimet’s License Partner Ascletis Announced Acceptance of New Drug Application for Denifanstat for the Treatment of Moderate to Severe Acne by China’s National Medical Products Administration
SAN MATEO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that Ascletis Pharma Inc. issued a December 10 statement that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne. Sagimet has granted an exclusive lic
About this update from Sagimet Biosciences Inc. - Series A
[{"type":"image","alt":"Sagimet Biosciences Inc.","displaySize":"","headline":null,"caption":"Sagimet Biosciences Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":110,"url":"https://media.zenfs.com/en/globenewswire.com/3e3b89356ea0d21f59c381949bb6af25"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/AmJDa7oTdvowtNmgiL7OTw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE1NDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/3e3b89356ea0d21f59c381949bb6af25","width":300,"height":110}},"lazy":false},{"type":"text","content":"SAN MATEO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that Ascletis Pharma Inc. issued a December 10 statement that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne. Sagimet has granted an exclusive license to denifanstat for China to Ascletis Bioscience Co. Ltd. (Ascletis), of which Ascletis Pharma Inc. is the parent company.","length":626,"tagName":"p"},{"type":"text","content":"Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis for acne in China as ASC40, and by Sagimet for metabolic dysfunction associated steatohepatitis (MASH) in the rest of world. The NDA is based on data from Ascletis’ successful Phase 3 clinical trial of denifanstat for the treatment of moderate to severe acne vulgaris, in which denifanstat met all primary and secondary endpoints and was generally well tolerated.","length":496,"tagName":"p"},{"type":"text","content":"About Sagimet Biosciences ","length":25,"tagName":"p"},{"type":"text","content":"Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. Denifanstat, an oral, once-daily pill, met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial in MASH as well as all primary and secondary endpoints in Sagimet’s license partner for China’s Phase 3 clinical trial in moderate-to-severe acne. A combination of denifanstat a...