ASC-30

-在一项随机、双盲、安慰剂对照、多中心的III期临床试验中，地尼法司他(ASC40)达到所有主要、关键次要及次要疗效终点(意向治疗集(ITT)分析)，与安慰剂相比显著改善中重度寻常性痤疮。 香港，2025年12月10日--歌礼制药有限公司(香港联交所代码：1672，简称“歌礼”)今日宣布同类首创(first-in-class)、每日一次口服小分子脂肪酸合成酶(FASN)抑制剂地尼法司他(ASC40)治疗中重度寻常性痤疮的新药上市申请(NDA)获中国国家药品监督管理局(国家药监局)受理。 吴劲梓博士 歌礼创始人、董事会主席兼首席执行官 此NDA获受理是我们在为中重度痤疮治疗提供潜在开创性疗法的道路上的重要里程碑。地尼法司他(ASC40)离商业化仅一步之遥，这令我们感到振奋。 歌礼已完成地尼法司他(ASC40)治疗中重度寻常性痤疮的II期(NCT05104125)和III期(NCT06192264)研究。 在该III期研究中，地尼法司他(ASC40)达到所有主要、关键次要及次要疗效终点(意向治疗集(ITT)分析)，与安慰剂相比显著改善中重度寻常性痤疮。地尼法司他(ASC40)显示出了良好的安全性与耐受性特征。所有与地尼法司他(ASC40)相关的治疗期间发生的不良事件(treatment-emergent adverse events，TEAE)均为轻度(1级)或中度(2级)。没有与地尼法司他(ASC40)相关的3级或4级TEAE，且没有与地尼法司他(ASC40)相关的严重不良事件(SAE)。未有观察到与地尼法司他(ASC40)相关的永久性终止治疗或退出试验的情况。 2025年9月17日，在法国巴黎举办的2025年欧洲皮肤病与性病学会(EADV)年会上，歌礼口头报告了该项III期研究结果(详见歌礼网站“科学研究”栏目下的“拓展性适应症”)。 本公司已于近期完成与中国国家药监局就地尼法司他(denifanstat，ASC40)治疗中重度寻常性痤疮的新药上市申请前(Pre-NDA)沟通并收到国家药监局的积极反馈。 歌礼已从Sagimet Biosciences Inc.(纳斯达克股票代码：SGMT)获得地尼法司他(ASC40)的大中华区独家授权。 关于歌礼制药有限公司 歌礼制药有限公司是一家全价值链整合型生物技术公司，聚焦有望成为治疗代谢疾病同类最佳(best-in-class)和同类首创(first-in-class)药物的开发和商业化。利用公司专有的基于结构的AI辅助药物发现(Artificial Intelligence-Assisted Structure-Based Drug Discovery，AISBDD)、超长效药物开发平台(Ultra-Long-Acting Platform，ULAP)技术以及口服多肽递送增强技术(Peptide Oral Transport ENhancement Technology，POTENT)，歌礼已自主研发多款小分子和多肽候选药物，包括其核心项目ASC30，一款在研小分子GLP-1R激动剂，既可每日一次口服也可每月一次至每季度一次皮下注射作为减重治疗疗法和减重维持疗法，用于长期体重管理；ASC36，一款每月一次皮下注射胰淀素受体激动剂多肽，ASC35，一款每月一次皮下注射GLP-1R/GIPR双靶点激动剂多肽，ASC37，一款口服GLP-1R/GIPR/GCGR三靶点激动剂多肽，用于长期体重管理。歌礼已在香港联交所上市(1672.HK)。 欲了解更多信息，敬请登陆网站：www.ascletis.com。 关于以下临床试验： NCT05104125 NCT06192264 可点击“阅读原文”查看详细信息！

-Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial. HONG KONG, Dec. 10, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that 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, has been accepted by the China National Medical Products Administration (NMPA). "Acceptance of this NDA is an important milestone in our efforts to provide a potentially groundbreaking therapeutic approach for the treatment of moderate-to-severe acne," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "We are excited denifanstat (ASC40) is only one step away from the commercialization." Ascletis has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies of denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris. In the Phase III study, denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo. Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. All denifanstat (ASC40)-related treatment-emergent adverse events (TEAEs) were mild (Grade 1) or moderate (Grade 2). There were no denifanstat (ASC40)-related Grade 3 or 4 TEAEs and no denifanstat (ASC40)-related serious adverse events (SAEs). There were no denifanstat (ASC40)-related permanent treatment discontinuations or withdrawals observed. The Phase III study results were presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France on September 17, 2025 (link). The Company recently completed the pre-NDA consultation with the China NMPA for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and received positive feedback from NMPA. Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China. About Ascletis Pharma Inc. Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, an oral GLP-1R/GIPR/GCGR triple peptide agonist for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK). For more information, please visit . Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR teams +86-181-0650-9129 (China) [email protected] [email protected] SOURCE Ascletis Pharma Inc. 21% more press release views with Request a Demo