ASCLETIS-B (01672) announced that the New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small-molecule fatty acid synthase (FASN) inhibitor targeting moderate-to-severe acne vulgaris, has been accepted by China's National Medical Products Administration (NMPA).

"This NDA acceptance marks a significant milestone in our mission to deliver a potentially groundbreaking therapy for moderate-to-severe acne," said Dr. Jinzi Wu, Founder, Chairman, and CEO of ASCLETIS-B. "We are excited that denifanstat (ASC40) is now one step closer to commercialization."

ASCLETIS-B has completed Phase II (NCT05104125) and Phase III (NCT06192264) clinical trials for denifanstat (ASC40) in treating moderate-to-severe acne vulgaris. In the Phase III study, denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints (intent-to-treat, ITT analysis), demonstrating significant improvement over placebo. The drug also exhibited a favorable safety and tolerability profile, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2). No Grade 3 or 4 TEAEs, serious adverse events (SAEs), or treatment discontinuations related to denifanstat (ASC40) were observed.

On September 17, 2025, ASCLETIS-B presented the Phase III results orally at the European Academy of Dermatology and Venereology (EADV) Annual Congress in Paris, France. The company recently completed pre-NDA discussions with the NMPA and received positive feedback.

ASCLETIS-B holds exclusive rights to develop and commercialize denifanstat (ASC40) in Greater China under a licensing agreement with Sagimet Biosciences Inc. (NASDAQ: SGMT).