Ascletis Pharma New Drug Application for Denifanstat Accepted by China National Medical Products Administration

Reuters01-29

Ascletis Pharma New Drug Application for Denifanstat Accepted by <a href="https://laohu8.com/S/688128">China National</a> Medical Products Administration

Ascletis Pharma Inc. announced that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, was recently accepted by the China National Medical Products Administration. The acceptance follows positive topline results from two Phase III studies, including a recently completed open-label multicenter study in China evaluating the long-term safety of denifanstat in 240 patients. Denifanstat (ASC40) is licensed from Sagimet Biosciences Inc. for exclusive rights in Greater China.

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-20260129-12004936), on January 29, 2026, and is solely responsible for the information contained therein.

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Ascletis Pharma Inc. published the original content used to generate this news brief via IIS, the Issuer Information S","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"01672":"歌礼制药-B","BK1161":"生物科技","BK1515":"抗疫概念","BK4139":"生物科技","BK1574":"生物医药B类股","SGMT":"Sagimet Biosciences Inc."},"translate_title":"歌礼制药Denifanstat新药申请获中国国家药品监督管理局受理","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SGMT":0.9,"01672":0.9},"content_text":"Ascletis Pharma New Drug Application for Denifanstat Accepted by China National Medical Products Administration\n    \n\nAscletis Pharma Inc. announced that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, was recently accepted by the China National Medical Products Administration. The acceptance follows positive topline results from two Phase III studies, including a recently completed open-label multicenter study in China evaluating the long-term safety of denifanstat in 240 patients. Denifanstat (ASC40) is licensed from Sagimet Biosciences Inc. for exclusive rights in Greater China.\n      \n\n\nDisclaimer: 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. 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