ASCLETIS-B (01672) announced that the company's board of directors has recently completed pre-New Drug Application (Pre-NDA) communication with China's National Medical Products Administration (NMPA) regarding denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris, and plans to submit the new drug application in the near future.

The Pre-NDA communication began in June 2025 and concluded in October 2025. Ascletis has completed both Phase II (NCT05104125) and Phase III (NCT06192264) studies of denifanstat (ASC40) for treating moderate-to-severe acne vulgaris.

In the Phase III study, denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints (intention-to-treat analysis), demonstrating significant improvement in moderate-to-severe acne vulgaris compared to placebo. Denifanstat (ASC40) exhibited favorable safety and tolerability characteristics.

All treatment-emergent adverse events (TEAEs) related to denifanstat (ASC40) were mild (Grade 1) or moderate (Grade 2). There were no Grade 3 or 4 TEAEs related to denifanstat (ASC40), and no serious adverse events (SAEs) related to denifanstat (ASC40). No permanent treatment discontinuation or trial withdrawal related to denifanstat (ASC40) was observed.

On September 17, 2025, at the 2025 European Academy of Dermatology and Venereology (EADV) Annual Meeting held in Paris, France, Ascletis presented the Phase III study results in an oral presentation.

Ascletis has obtained exclusive licensing rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. (NASDAQ: SGMT).