于近期完成的该第二项III期研究是一项在中国开展的开放标签的多中心研究，旨在评估地尼法司他 (ASC40)在240例中重度寻常性痤疮患者中的长期安全性。这240例患者均接受了40周的每日一次地尼法 司他(ASC40)治疗，且此前均接受过12周的地尼法司他(ASC40)或安慰剂治疗。主要终点包括：(1)治疗 期间发生的不良事件(treatment-emergent adverse event，TEAE)的发生率；(2)严重不良事件(SAE)的发生 率；及(3)因不良事件(AE)导致停药的发生率。地尼法司他(ASC40)显示出良好的安全性和耐受性特徵。 大部分治疗期间发生的不良事件为轻度(1级)和中度(2级)。没有与地尼法司他(ASC40)相关的3级或4级不 良事件，没有与地尼法司他(ASC40)相关的严重不良事件。未有报告死亡病例。 格隆汇1月29日丨歌礼制药-B(01672.HK)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)在中重度寻常性痤疮患者中的III期开放标签研究(NCT06248008) 取得积极顶线结果。 ...

智通财经APP讯，歌礼制药-B(01672)发布公告，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)在中重度寻常性痤疮患者中的III期开放标签研究(NCT06248008) 取得积极顶线结果。 公司于2025年6月4日的公告中宣布地尼法司他 (ASC40)在480例患者中开展的治疗中重度寻常性痤疮的 随机、双盲、安慰剂对照的III期临床研究(NCT06192264)达到所有主要、关键次要和次要终点。 地尼法司他(ASC40)治疗痤疮的作用机制是通过抑制人皮脂细胞的脂肪酸从头合成(DNL)，直接抑制皮 脂生成;和通过减少细胞因子分泌和Th17分化来抑制炎症。皮脂分泌过剩是导致痤疮的主要诱因之一， 地尼法司他(ASC40)独特的作用机制可直接减少皮脂分泌过剩，这使得地尼法司他(ASC40)独树一帜， 而其他大多数痤疮治疗药物并不针对痤疮的根本原因。 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。 于近期完成的该第二项III期研究是一项在中国开展的开放标签 ...

Core Viewpoint - The announcement of the New Drug Application (NDA) acceptance for denifanstat (ASC40), a first-in-class oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate to severe acne, marks a significant milestone for the company in providing a potentially groundbreaking therapy for acne treatment [1][2]. Group 1 - The NDA for denifanstat (ASC40) has been accepted by the National Medical Products Administration (NMPA) of China [1]. - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) in treating moderate to severe acne [1]. - The Phase III study demonstrated that denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints, significantly improving moderate to severe acne compared to placebo [2]. Group 2 - Denifanstat (ASC40) exhibited 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 were there any serious adverse events (SAEs) associated with the treatment [2]. - The company has received positive feedback from the NMPA following recent pre-NDA communications regarding the new drug application for denifanstat (ASC40) [2]. Group 3 - The company has obtained exclusive rights for denifanstat (ASC40) in the Greater China region 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 [2].

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]