Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration

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

Insights

Clinical development & regulatory analyst

Positive Phase III results and completion of pre-NDA consultation support an imminent NDA filing in China.

Ascletis completed a pre-NDA consultation with the NMPA from June 2025 to October 2025 and plans to submit an NDA for denifanstat (ASC40) soon. The Phase III trial met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and showed a favorable safety and tolerability profile with no Grade 3/4 related TEAEs or related SAEs.

The regulatory path now depends on the NDA dossier content and the NMPA review process; the consultation completion is a procedural milestone but not an approval. Important monitorable items include the formal NDA submission date, NMPA acceptance/clock start, and any reported review outcomes; expect those updates to appear after the planned filing.

- 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.)
Peter.vozzo@icrhealthcare.com

Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (China)
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.

FAQ

What did Ascletis announce about denifanstat (ASC40) on October 14, 2025?

Ascletis completed a pre-NDA consultation with China NMPA and plans to submit an NDA for denifanstat (ASC40) soon.

Did denifanstat (ASC40) meet Phase III endpoints in Ascletis' NCT06192264 study?

Yes; the Phase III met all primary, key secondary and secondary efficacy endpoints (ITT) and was statistically significant versus placebo.

What safety profile did Ascletis report for denifanstat (ASC40) in the Phase III trial?

All related TEAEs were Grade 1–2 with no related Grade 3–4 TEAEs, no related SAEs, and no related permanent discontinuations or withdrawals.

When were Ascletis' Phase III results for ASC40 presented and where?

Phase III results were presented orally at the EADV Congress in Paris on Sept 17, 2025.

What regulatory step did Ascletis complete before filing an NDA for ASC40?

Ascletis completed a pre-New Drug Application consultation with China NMPA conducted from June to October 2025.

Who holds commercial rights for denifanstat (ASC40) in Greater China?

Ascletis licensed exclusive Greater China rights from Sagimet (Nasdaq: SGMT).