ASCLETIS-B(01672) has completed pre-communication with the National Medical Products Administration for the marketing application of Despirostatin (ASC40).

ASCLETIS-B (01672) announces that the board of directors of the company has recently completed pre-new drug application (Pre-NDA) communication with the China National Medical Products Administration on Denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris, and plans to submit a new drug application soon. The Pre-NDA communication for this new drug began in June 2025 and ended in October 2025. Gilead has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies on Denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris. In the Phase III study, Denifanstat (ASC40) met all major, key secondary, and secondary efficacy endpoints (intention-to-treat (ITT) analysis), significantly improving moderate to severe acne vulgaris compared to placebo. Denifanstat (ASC40) showed good safety and tolerability characteristics. All treatment-emergent adverse events (TEAE) 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 (SAE) related to Denifanstat (ASC40) were observed. There were no cases of permanent discontinuation of treatment or withdrawal from the trial related to Denifanstat (ASC40). On September 17, 2025, at the 2025 European Academy of Dermatology and Venereology (EADV) Annual Meeting in Paris, Gilead presented the results of this Phase III study verbally. Gilead has obtained exclusive rights for Denifanstat (ASC40) in the Greater China region from Sagimet Biosciences Inc. (NASDAQ: SGMT).