China NMPA Accepts New Drug Application for Ascletis Pharma's Denifanstat for Acne Treatment

Reuters12-10

China NMPA Accepts New Drug Application for Ascletis Pharma's Denifanstat for Acne Treatment

Ascletis Pharma Inc. announced that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, for the treatment of moderate-to-severe acne vulgaris. The NDA acceptance follows successful Phase III clinical trial results in which denifanstat met all primary and key secondary efficacy endpoints compared to placebo. The company recently completed a pre-NDA consultation with positive feedback from the NMPA. No grant or funding involving multiple organizations is mentioned.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ascletis Pharma Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20251210-11950995), on December 10, 2025, and is solely responsible for the information contained therein.

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