Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration
- 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 Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial.
HONG KONG, Oct. 14, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that it recently completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon. The pre-NDA consultation was initiated from June 2025 and completed in October 2025.
Ascletis has completed the 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).
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, Ascletis has developed multiple drug candidates in-house, including 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. 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.)
[email protected]
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (China)
[email protected]
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SOURCE Ascletis Pharma Inc.
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