"地尼法司他(ASC40)是痤疮治疗领域的创新性疗法，具有潜在的临床重要意义。我们非常荣幸能在本 届EADV年会上向皮肤病学界展示这些结果。"歌礼创始人、董事会主席兼首席执行官吴劲梓博士表 示，"地尼法司他(ASC40)采用痤疮治疗新作用机制，在III期研究中所有主要和次要终点较安慰剂均显 示出高度具有统计学意义且临床意义显著的改善，同时显示出良好的安全性和耐受性特征。" 歌礼正与中国国家药品监督管理局(NMPA)进行地尼法司他(ASC40)的上市申请前(Pre-NDA)沟通， NMPA目前反馈良好。歌礼计划在完成上市申请前沟通后向NMPA提交地尼法司他(ASC40)用于治疗中 重度寻常性痤疮的新药上市申请 (NDA)。 智通财经APP讯，歌礼制药-B(01672)发布公告，在2025年9月17日于法国巴黎举行的2025年欧洲皮肤病 与性病学会(EADV)年会最新突破性研究专场上口头报告了地尼法司他(denifanstat，ASC40)治疗中重度 寻常性痤疮的III期研究 (NCT06192264)结果。 歌礼已从Sagimet Biosciences Inc.(纳斯达克股票代码：SGMT)获得地尼法司他 ( ...

歌礼制药-B(01672)发布公告，在2025年9月17日于法国巴黎举行的2025年欧洲皮肤病与性病学会 (EADV)年会最新突破性研究专场上口头报告了地尼法司他(denifanstat，ASC40)治疗中重度寻常性痤疮 的III期研究(NCT06192264)结果。 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。 "地尼法司他(ASC40)是痤疮治疗领域的创新性疗法，具有潜在的临床重要意义。我们非常荣幸能在本 届EADV年会上向皮肤病学界展示这些结果。"歌礼创始人、董事会主席兼首席执行官吴劲梓博士表 示，"地尼法司他(ASC40)采用痤疮治疗新作用机制，在III期研究中所有主要和次要终点较安慰剂均显 示出高度具有统计学意义且临床意义显著的改善，同时显示出良好的安全性和耐受性特征。" 歌礼正与中国国家药品监督管理局(NMPA)进行地尼法司他(ASC40)的上市申请前(Pre-NDA)沟通， NMPA目前反馈良好。歌礼计划在完成上市申请前沟通后向NMPA提交地尼法司他(ASC40)用于治疗中 重度寻常性痤疮的新药上市申请( ...

歌礼正与中国国家药品监督管理局(NMPA)进行地尼法司他(ASC40)的上市申请前(Pre-NDA)沟通， NMPA目前反馈良好。歌礼计划在完成上市申请前沟通后向NMPA提交地尼法司他(ASC40)用于治疗中 重度寻常性痤疮的新药上市申请(NDA)。 格隆汇9月18日丨歌礼制药-B(01672.HK)宣布，在2025年9月17日于法国巴黎举行的2025年欧洲皮肤病与 性病学会(EADV)年会最新突破性研究专场上口头报告了地尼法司他(denifanstat，ASC40)治疗中重度寻 常性痤疮的III期研究(NCT06192264)结果。 根据披露，地尼法司他(denifanstat，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痤疮。地尼法司他(ASC40)显示出了良好的安全性与耐受性特征。 地尼法司他(ASC40)组和安慰剂组的治疗期间发生的不良事件(TEAE)发生率相当：58.6%对比56.3%。大 部分TEAE为轻度(1级)或中度(2级)。 ...

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 ...

Core Insights - The company reported results from its ASC30 oral small molecule GLP-1 receptor agonist study at the 61st EASD Annual Meeting, indicating promising weight loss outcomes in obese subjects [1][5] Study Results - The Ib phase MAD study was randomized, double-blind, and placebo-controlled, assessing the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ASC30 in obese participants (BMI: 30-40 kg/m²) [1] - In MAD cohort 2, ASC30 showed a 6.5% average weight reduction after 28 days of treatment, while cohort 1 showed a 4.5% reduction, both adjusted for placebo [1] - No signs of weight loss plateau were observed by day 29 [1] Pharmacokinetics - ASC30 at 20 mg and 40 mg demonstrated superior oral PK characteristics at steady state, with a positive correlation between higher drug exposure (AUC) and significant weight loss [2] - Key PK metrics for MAD cohorts are summarized, showing differences in Tmax, Cmax, AUCo-24h, and half-life (T1/2) between the two cohorts [3] Safety and Tolerability - ASC30 exhibited good safety and tolerability, with only mild to moderate gastrointestinal adverse events reported [5] - No vomiting was reported in cohort 1, while cohort 2 experienced vomiting primarily during the 10 mg dose escalation week [5] - No serious adverse events (SAE) were reported, and liver enzymes remained stable throughout the study [5]

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 5% following the announcement of positive results from its ASC30 oral GLP-1R agonist study, indicating significant weight loss and good safety profile [1] Company Summary - Gilead Sciences reported a 5.02% increase in stock price, reaching HKD 10.88, with a trading volume of HKD 92.59 million [1] - The company announced results from a 28-day multiple ascending dose study of ASC30, showing a maximum average weight loss of 6.5% compared to baseline after treatment [1] - ASC30 demonstrated superior efficacy due to higher oral drug exposure, with good safety and tolerability, experiencing only mild to moderate gastrointestinal adverse events [1] Industry Summary - Dongwu Securities highlighted that Gilead Sciences has several catalysts in the second half of the year, with multiple important clinical data releases expected [1] - The firm anticipates that by Q4 2025, Gilead will report top-line data for ASC30 oral Phase II, ASC47 Phase I, and ASC50 Phase I trials, with ASC30 subcutaneous Phase II data expected in Q1 2026 [1] - The company plans to submit 2-3 new IND applications to the FDA within the next 6-9 months, including a dual-target peptide weight loss pipeline [1]

Core Viewpoint - The stock of Gilead Sciences-B (01672) increased by over 5%, currently trading at 10.88 HKD with a transaction volume of 92.59 million HKD, following the announcement of positive results from its ASC30 oral GLP-1R agonist study [1] Group 1: Clinical Trial Results - Gilead announced that at the 61st European Association for the Study of Diabetes (EASD) conference in Vienna, it reported results from its ASC30 oral GLP-1R agonist 28-day multiple dose escalation study [1] - The ASC30 oral tablet showed an average weight loss of up to 6.5% after 28 days of treatment, adjusted for placebo [1] - The efficacy of ASC30 is attributed to its higher oral drug exposure, with good safety and tolerability, experiencing only mild to moderate gastrointestinal adverse events [1] Group 2: Future Catalysts - Dongwu Securities noted that Gilead has several catalysts in the second half of the year, with multiple important clinical data expected to be disclosed [1] - The firm anticipates that by Q4 2025, Gilead will read out phase II topline data for ASC30 oral, phase I data for ASC47, and phase I data for ASC50, with phase II topline data for ASC30 subcutaneous expected in Q1 2026 [1] - The company plans to submit 2-3 new IND applications to the FDA for its pipeline, including a dual-target peptide weight loss program, within the next 6-9 months [1]

Core Viewpoint - The company reported positive results from its ASC30 oral GLP-1 receptor agonist in a 28-day multi-dose escalation study, indicating significant weight loss in obese subjects [1][5]. Group 1: Study Results - In MAD cohort 2, ASC30 showed a 6.5% average weight loss after 28 days of treatment, adjusted for placebo [1]. - In MAD cohort 1, ASC30 demonstrated a 4.5% average weight loss after 28 days of treatment, adjusted for placebo [1]. - No signs of weight loss plateau were observed by day 29 [1]. Group 2: Pharmacokinetics - ASC30 at 20 mg and 40 mg showed superior oral pharmacokinetic characteristics at steady state, with a positive correlation between higher AUC and significant weight loss [2]. - Key pharmacokinetic parameters for MAD cohorts are summarized, showing Tmax of 8 hours for both cohorts, with Cmax of 272±101 ng/mL for cohort 1 and 397±274 ng/mL for cohort 2 [3]. Group 3: Safety and Tolerability - ASC30 exhibited good safety and tolerability, with only mild to moderate gastrointestinal adverse events reported [5]. - No vomiting was reported in cohort 1, while cohort 2 experienced vomiting primarily during the 10 mg dose escalation week [5]. - No serious adverse events were reported, and liver enzymes remained stable throughout the treatment [5].

Core Viewpoint - The company reported positive results from its ASC30 oral small molecule GLP-1 receptor agonist in a clinical trial, highlighting its efficacy and safety for obesity treatment [1] Group 1: Clinical Trial Details - The ASC30 study is a Phase Ib multi-dose escalation (MAD) trial conducted in the United States, focusing on safety, tolerability, pharmacokinetics, and preliminary efficacy in obese subjects with a BMI of 30-40 kg/m² [1] - The trial is randomized, double-blind, and placebo-controlled, ensuring robust data collection and analysis [1] Group 2: Future Expectations - The company anticipates reporting the top-line results of the 13-week Phase IIa study of ASC30 in the fourth quarter of this year [1] - The CEO emphasized the strong research and development capabilities of the company, aiming to provide differentiated treatment options for obesity [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 歌禮在第61屆歐洲糖尿病研究協會(EASD) 年會上報告其ASC30口服小分子GLP-1R激動劑 28天多劑量遞增研究隊列1和隊列2的結果 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」）宣布，在2025年9月16日在奧地利維也納舉 行的第61屆歐洲糖尿病研究協會(EASD)年會上的簡短口頭討論專場會議A中報告 了其ASC30口服小分子GLP-1受體(GLP-1R)激動劑28天多劑量遞增(MAD)研究 (NCT06680440)隊列1和隊列2的結果。 該Ib期MAD研究是一項在美國開展的隨機、雙盲、安慰劑對照的研究，旨在評估 ASC30每日一次 ...