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 Insights - The company reported significant results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne at the 2025 EADV annual meeting in Paris, highlighting its innovative mechanism of action and clinical significance [1] - Denifanstat (ASC40) demonstrated statistically significant improvements in all primary and secondary endpoints compared to placebo, along with good safety and tolerability profiles [1] - The company is in communication with the National Medical Products Administration (NMPA) in China regarding the pre-New Drug Application (Pre-NDA) process, with positive feedback received [1] Company Developments - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

Core Viewpoint - The company reported positive results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne, demonstrating significant efficacy compared to placebo and good safety and tolerability profiles [1] Group 1: Study Results - Denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints in the intent-to-treat (ITT) analysis, showing significant improvement in moderate to severe acne compared to placebo [1] - The incidence of treatment-emergent adverse events (TEAEs) was comparable between the denifanstat (ASC40) group and the placebo group, at 58.6% versus 56.3% respectively [1] - Most TEAEs were mild (Grade 1) or moderate (Grade 2) [1] Group 2: Regulatory Communication - The company is in pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration (NMPA) in China regarding denifanstat (ASC40) [1] - Feedback from the NMPA has been positive, and the company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne following the completion of pre-application communications [1]

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） 自願性公告 歌禮在2025年歐洲皮膚病與性病學會(EADV)年會最新突破性研究專場 報告了同類首創脂肪酸合成酶(FASN)抑制劑地尼法司他(ASC40) 治療痤瘡的III期研究結果 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」）宣佈，在2025年9月17日於法國巴黎舉 行的2025年歐洲皮膚病與性病學會(EADV)年會最新突破性研究專場上口頭 報告了地尼法司他（denifanstat，ASC40）治療中重度尋常性痤瘡的III期研究 (NCT06192264)結果。 口頭報告細節 標題：同類首創脂肪酸合成酶(FASN)抑制劑地尼法司他治療尋常性痤瘡達到所有 ...

Group 1 - Company Gilead Sciences-B (01672) saw a significant stock increase of over 18%, currently trading at 10.96 HKD with a transaction volume of 79.907 million HKD [1] - Gilead announced that its oral small molecule fatty acid synthase (FASN) inhibitor, ASC40, achieved all primary, key secondary, and secondary endpoints in a Phase III clinical trial for moderate to severe acne [1] - Dongwu Securities highlighted that ASC40's clinical trial results are promising, indicating it may become an effective, patient-compliant, and safe treatment for acne, with plans to submit for regulatory approval in 2025 and potential revenue contribution in 2026 [1] Group 2 - Gilead will present early research data on its oral small molecule GLP-1 receptor agonist ASC30 and fat-targeting weight loss candidate ASC47 at the 85th American Diabetes Association (ADA) Scientific Sessions in Chicago [2] - ASC30 is noted as the only GLP-1 small molecule that can be administered both orally daily and via monthly subcutaneous injection, catering to diverse market needs [2] - ASC47 targets the THRβ receptor in fat cells and has potential for fat loss without muscle loss, being the first small molecule weight loss drug targeting THRβ, with Phase I SAD study data already released [2]