Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration
Ascletis (HKEX:1672) completed a pre-NDA consultation with China NMPA for denifanstat (ASC40) for moderate-to-severe acne vulgaris, initiated in June 2025 and completed in October 2025, and plans to submit an NDA soon.
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Rhea-AI Summary
Ascletis (HKEX:1672) completed a pre-NDA consultation with China NMPA for denifanstat (ASC40) for moderate-to-severe acne vulgaris, initiated in June 2025 and completed in October 2025, and plans to submit an NDA soon.
Ascletis completed Phase II (NCT05104125) and Phase III (NCT06192264) studies; the Phase III met all primary, key secondary and secondary efficacy endpoints (ITT) and showed statistically significant improvement versus placebo. Denifanstat demonstrated a favorable safety and tolerability profile: all related TEAEs were Grade 1–2, with no related Grade 3–4 TEAEs, SAEs, permanent discontinuations, or withdrawals. Phase III results were presented at EADV Congress on Sept 17, 2025. Ascletis holds exclusive Greater China rights via license from Sagimet (Nasdaq: SGMT).
Positive
- Phase III met all primary and key secondary endpoints (ITT)
- Favorable safety: only Grade 1–2 related TEAEs; no related Grade 3–4 TEAEs or SAEs
- Completed pre-NDA consultation with China NMPA (June–Oct 2025); NDA planned soon
- Exclusive Greater China license from Sagimet (Nasdaq: SGMT)
Negative
- NDA not yet submitted; regulatory approval remains pending
- No numeric efficacy or complete statistical data disclosed in the announcement
Details
News Market Reaction – SGMT
On Oct 14, the day this news came out, SGMT closed 1.18% below the previous close.
Data tracked by StockTitan Argus for the Oct 14 session.
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- 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.
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
Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in
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 (
Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (
pr@ascletis.com
ir@ascletis.com
View original content:https://www.prnewswire.com/news-releases/ascletis-completes-denifanstat-asc40-pre-nda-consultation-with-china-national-medical-products-administration-302583127.html
SOURCE Ascletis Pharma Inc.
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