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

1. Denifanstat (ASC40) improved acne treatment efficacy in Phase III trials. 2. Ascletis completed pre-NDA consultation for ASC40 with Chinese authorities. 3. No serious adverse events reported in clinical trials for ASC40. 4. Ascletis has exclusive rights for ASC40 in Greater China. 5. Results presented at EADV Congress 2025 highlight ASC40's potential.

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Why Bullish?

Positive clinical results for ASC40 may boost investor confidence in SGMT, similar to previous biotech successes where early trial success led to increased stock value.

How important is it?

The article discusses significant developments for a key product related to SGMT, which could directly influence its stock price.

Why Short Term?

The upcoming NDA submission could lead to immediate market reactions, as seen with other biotech stocks after regulatory events.

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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. , /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 VozzoICR Healthcare443-231-0505 (U.S.)[email protected] Ascletis Pharma Inc. PR and IR teams+86-181-0650-9129 (China)[email protected][email protected] SOURCE Ascletis Pharma Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

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