-Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial.
HONG KONG, Dec. 10, 2025 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, has been accepted by the China National Medical Products Administration (NMPA).
"Acceptance of this NDA is an important milestone in our efforts to provide a potentially groundbreaking therapeutic approach for the treatment of moderate-to-severe acne," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "We are excited denifanstat (ASC40) is only one step away from the commercialization."
Ascletis has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies of denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris.
In the Phase III study, denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo. Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. All denifanstat (ASC40)-related treatment-emergent adverse events (TEAEs) were mild (Grade 1) or moderate (Grade 2). There were no denifanstat (ASC40)-related Grade 3 or 4 TEAEs and no denifanstat (ASC40)-related serious adverse events (SAEs). There were no denifanstat (ASC40)-related permanent treatment discontinuations or withdrawals observed.
The Phase III study results were presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France on September 17, 2025 (link).
The Company recently completed the pre-NDA consultation with the China NMPA for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and received positive feedback from NMPA.
Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China.
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, an oral GLP-1R/GIPR/GCGR triple peptide agonist for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
For more information, please visit www.ascletis.com.
Contact：
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (China)
pr@ascletis.com
ir@ascletis.com
