歌礼制药-B(01672)公布，董事会认为公司现时股价被低估，并于2025年12月15日决议将股份购回资金 由最多3亿港元增至最多5亿港元。 公告称，回购资金增加此乃经考虑公司取得的重要里程碑的重大成就，包括但不限于：(1)歌礼口服小 分子GLP-1激动剂ASC30在肥胖或超重受试者中进行的美国13周II期研究显示经安慰剂校正后的体重下 降高达7.7%，且胃肠道耐受性更佳;(2)脂肪靶向甲状腺受体β(THRβ)选择性小分子激动剂ASC47与司美 格鲁肽联用在肥胖受试者中较司美格鲁肽单药减重效果相对提升高达56.2%;(3)有望成为同类最佳口服 小分子白细胞介素-17(IL-17)抑制剂ASC50美国I期研究取得积极的顶线结果;及(4)同类首创脂肪酸合成酶 (FASN)抑制剂地尼法司他(ASC40)治疗痤疮的新药上市申请获中国国家药品监督管理局受理。 公司现时的财务状况稳健。董事会认为股份现时的成交价未能反映其内在价值。董事会相信，经更新建 议股份购回可提升股份的价值，从而提高股东的回报。此外，董事会相信，经更新建议股份购回反映公 司对自身的长远业务前景及公司的增长潜力充满信心，且最终将可惠及公司，并符合公司及 ...

格隆汇12月10日｜歌礼制药(1672.HK)公告，公司同类首创FASN抑制剂地尼法司他(ASC40)治疗痤疮的 新药上市申请获中国国家药品监督管理局受理。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。地尼法司他(ASC40)显示出了良好的安全性与耐受性特征。 ...

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。 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。 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)，与安慰剂相比显着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 ...

Core Viewpoint - The announcement of the acceptance of the New Drug Application (NDA) for the first-in-class oral small molecule fatty acid synthase (FASN) inhibitor, ASC40, by the National Medical Products Administration (NMPA) of China marks a significant milestone in providing a potential groundbreaking therapy for moderate to severe acne [1] Company Summary - The company, Gilead Sciences-B (01672.HK), is advancing its innovative treatment for moderate to severe acne with the drug ASC40, which is a first-in-class FASN inhibitor [1] - The CEO, Dr. Wu Jinzi, expressed excitement about the NDA acceptance, indicating that ASC40 is just one step away from commercialization [1]

Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a stock increase of over 4% following the announcement of its new drug application progress for ASC40, aimed at treating moderate to severe acne, and the selection of ASC35 as a clinical development candidate for obesity treatment [1] Group 1: Drug Development Updates - Gilead has completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding ASC40 for treating moderate to severe acne, with plans to submit the new drug application soon [1] - The Pre-NDA communication for ASC40 began in June 2025 and concluded in October 2025 [1] Group 2: Future Clinical Trials - Gilead has selected ASC35, a GLP-1R/GIPR dual agonist peptide, as a candidate for clinical development, expected to be submitted for an Investigational New Drug (IND) application to the FDA in the second quarter of 2026 [1] - ASC35 is being developed for use as a monotherapy and in combination therapy for treating cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [1]

Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a stock increase of over 4% following the announcement of its new drug application progress for ASC40, aimed at treating moderate to severe acne [1] Group 1: New Drug Application - Gilead Sciences has completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding ASC40 for treating moderate to severe acne [1] - The Pre-NDA communication took place from June 2025 to October 2025, with plans to submit the new drug application soon [1] Group 2: Clinical Development Candidates - Gilead Sciences has selected ASC35, a GLP-1R/GIPR dual agonist peptide, as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection [1] - The company plans to submit an Investigational New Drug (IND) application to the FDA for ASC35 in the second quarter of 2026, targeting obesity treatment [1] - ASC35 is being developed as both a monotherapy and combination therapy for treating cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [1]

Core Insights - The company has completed Pre-NDA communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne and plans to submit a New Drug Application soon [1][2] - Denifanstat (ASC40) has successfully met all primary, key secondary, and secondary efficacy endpoints in the Phase III study, showing significant improvement compared to placebo [2] - The safety profile of denifanstat (ASC40) is favorable, with all treatment-emergent adverse events being mild or moderate, and no severe adverse events reported [2] Company Developments - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) [1] - The results of the Phase III study were presented at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

Core Insights - The company, Gilead Sciences-B (01672.HK), has recently completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris [1][2] - Gilead plans to submit the New Drug Application shortly, following the completion of Phase II (NCT05104125) and Phase III studies (NCT06192264) for denifanstat [1] Group 1 - In the Phase III study, denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints, significantly improving moderate to severe acne vulgaris compared to placebo [2] - Denifanstat (ASC40) demonstrated good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2) [2] - There were no Grade 3 or 4 TEAEs related to denifanstat (ASC40), nor any serious adverse events (SAEs) associated with the treatment [2] Group 2 - Gilead reported the results of the Phase III study at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2]

Core Viewpoint - The company has completed pre-NDA communication with the National Medical Products Administration of China regarding the new drug application for denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris, with plans to submit the application soon [1][2] Group 1: Drug Development Progress - Denifanstat (ASC40) has successfully completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for treating moderate to severe acne vulgaris [1] - In the Phase III study, denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints, showing significant improvement compared to placebo [2] - The drug demonstrated good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2), and no Grade 3 or 4 TEAEs reported [2] Group 2: Licensing and Presentation - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2] - The results of the Phase III study were presented orally at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris on September 17, 2025 [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 本公告乃歌禮製藥有限公司（「本公司」或「歌禮」，連同其附屬公司稱為「本集 團」）自願作出，以使本公司股東及潛在投資者了解本集團的最新業務發展。 本公司董事（「董事」）會（「董事會」）宣布，已於近期與中國國家藥品監督管理局 就地尼法司他（denifanstat，ASC40）治療中重度尋常性痤瘡完成新藥上市申請前 (Pre-NDA)溝通，並計劃於近日遞交新藥上市申請。該新藥上市申請前(Pre-NDA) 溝通自2025年6月開始，並於2025年10月結束。 歌禮已完成地尼法司他(ASC40)治療中重度尋常性痤瘡的II期(NCT05104125)和III 期研究(NCT06192264)。 在該III期研究中，地尼法司他(ASC40)達到所有主要、關鍵次要及次要療效終點 （意向治療集(ITT)分 ...