Ascletis Announces Positive Topline Results from Its Phase III Open-Label Study of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne [Accessibility Statement] Skip Navigation- Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated favorable safety and tolerability in a Phase III open-label study- The exceptional efficacy of denifanstat (ASC40) observed in the Company's previously reported placebo-controlled Phase III trial coupled with a favora ...

歌礼制药创始人、董事长兼首席执行官吴劲梓博士表示："将ASC30的临床开发扩展至庞大的糖尿病治 疗市场，是符合逻辑的下一步。这为我们提供了另一个机会，来展现ASC30作为每日一次口服治疗方 案，其潜在的最佳同类药物特性。我们期待在2026年第三季度分享针对糖尿病患者的II期研究主要数 据。" 歌礼制药-B(01672)午后涨超4%，截至发稿，涨3.85%，报13.76港元，成交额1218.55万港元。 消息面上，歌礼制药发布公告，其口服小分子胰高血糖素样肽-1(GLP-1)受体激动剂ASC30用于治疗2型 糖尿病的美国II期临床试验已完成首例患者给药。计划在美国多中心招募约100名2型糖尿病患者。公司 计划在2026年第三季度公布这项为期13周的II期研究的主要数据。 ...

歌礼制药创始人、董事长兼首席执行官吴劲梓博士表示："将ASC30的临床开发扩展至庞大的糖尿病治 疗市场，是符合逻辑的下一步。这为我们提供了另一个机会，来展现ASC30作为每日一次口服治疗方 案，其潜在的最佳同类药物特性。我们期待在2026年第三季度分享针对糖尿病患者的II期研究主要数 据。" 智通财经APP获悉，歌礼制药-B(01672)午后涨超4%，截至发稿，涨3.85%，报13.76港元，成交额 1218.55万港元。 消息面上，歌礼制药发布公告，其口服小分子胰高血糖素样肽-1（GLP-1）受体激动剂ASC30用于治疗2 型糖尿病的美国II期临床试验已完成首例患者给药。计划在美国多中心招募约100名2型糖尿病患者。公 司计划在2026年第三季度公布这项为期13周的II期研究的主要数据。 ...

在肥胖或超重受试者中开展的13周研究显示，ASC30的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，未观察到肝脏安全性信号。该研究共入组125例肥胖受试者或伴有至少一种体重相关合 并症的超重受试者。 在第13周的主要终点上，ASC30片的每日一次20毫克、40毫克和60毫克分别实现了5.4%、7.0%和7.7% 的体重下降，且体重下降具有统计学显著性和临床意义。因不良事件导致的总停药率为4.8%。 1月26日，歌礼制药发布公告称，公司完成了口服小分子GLP-1R激动剂ASC30治疗糖尿病的美国II期研 究首批受试者给药。预计将于2026年第三季度获得该项研究的顶线数据。 ...

Core Viewpoint - The company has initiated clinical trials for its oral small molecule GLP-1 receptor agonist ASC30, targeting type 2 diabetes and obesity, with significant data expected by Q3 2026 [1][3]. Group 1: Clinical Trials and Results - The company announced the completion of the first dosing of ASC30 in a 13-week Phase II study for type 2 diabetes in the U.S., with top-line data anticipated in Q3 2026 [1]. - A recent 13-week Phase II study for ASC30 in treating obesity involved 125 participants, showing statistically significant and clinically meaningful weight loss of 5.4%, 7.0%, and 7.7% for daily doses of 20 mg, 40 mg, and 60 mg respectively [2]. - The overall discontinuation rate due to adverse events in the obesity study was reported at 4.8%, indicating a favorable safety profile [2]. Group 2: Strategic Implications - The expansion of ASC30's clinical development into the diabetes treatment market is viewed as a logical strategic move, providing an opportunity to establish ASC30 as a best-in-class oral therapy option for patients [3].

Core Insights - Ascletis Pharma Inc. is advancing its investigational drug ASC30, a GLP-1 receptor agonist, into a Phase II study for type 2 diabetes, with topline data expected in Q3 2026 [2][5] Group 1: ASC30 Development - ASC30 has shown a placebo-adjusted weight loss of up to 7.7% in a completed 13-week Phase II study for obesity, demonstrating better gastrointestinal tolerability compared to other treatments [1][3] - The Phase II study for diabetes will evaluate ASC30's efficacy, safety, and tolerability, focusing on changes in HbA1c and body weight among approximately 100 participants [5][6] - ASC30 is designed for once-daily oral administration and has been developed in-house by Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist [4][6] Group 2: Clinical Study Details - The obesity Phase II study involved 125 participants and reported a treatment discontinuation rate due to adverse events of 4.8% [3] - The study for diabetes is randomized, double-blind, and placebo-controlled, with participants assigned to different dosages of ASC30 [5] - The primary endpoint of the diabetes study is the mean change in HbA1c from baseline, with secondary endpoints including fasting blood glucose and body weight changes [5]

Group 1 - The core focus of the news is the progress of Ascletis Pharma's oral small molecule GLP-1 receptor agonist ASC30, which is undergoing clinical trials for the treatment of type 2 diabetes and obesity [1][2][3] - The Phase II study for ASC30 in treating type 2 diabetes has commenced dosing the first batch of participants, with top-line data expected in Q3 2026 [1] - A recent Phase II study for ASC30 in treating obesity involved 125 participants and demonstrated statistically significant weight loss of 5.4%, 7.0%, and 7.7% for doses of 20mg, 40mg, and 60mg respectively, with a dose-dependent effect [2] Group 2 - ASC30 is the first and only small molecule GLP-1 receptor agonist in clinical research that can be administered both orally once daily and via subcutaneous injection monthly to quarterly [2] - The overall discontinuation rate due to adverse events in the obesity study was 4.8%, indicating a favorable safety profile [2] - The CEO of Ascletis Pharma highlighted the strategic expansion of ASC30's clinical development into the large diabetes treatment market, emphasizing the potential for ASC30 to offer a best-in-class oral therapy option [3]

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） 歌禮已於近期完成一項評估ASC30治療肥胖症的13周II期研究(NCT07002905)。 該研究在美國多個中心開展，共入組125例肥胖受試者或伴有至少一種體重相關 合併症的超重受試者。在第13周的主要終點上，每日一次20毫克、40毫克和60毫 克ASC30片分別實現了5.4%、7.0%和7.7%的經安慰劑校正後平均體重下降，體 重下降具有統計學顯著性、臨床意義且呈劑量依賴性。未觀察到減重平台期。每 周滴定直至目標劑量的ASC30的嘔吐發生率約為已公布的每周滴定的orforglipron 中觀察到的嘔吐發生率的一半。每周滴定的ASC30的胃腸道耐受性與已公布的 orforglipron在III期ATTAIN-1研究中每四周滴定(titrated every four weeks)的結果 相當。在ASC30用於治 ...

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 5% following positive data from its oral GLP-1 drug ASC30 for obesity treatment in a Phase IIa study in the U.S. [1] Group 1: Stock Performance - Gilead Sciences-B's stock increased by 5.12%, reaching HKD 13.56, with a trading volume of HKD 13.2847 million [1]. Group 2: Research and Analyst Opinions - Citigroup released a report indicating that the data from ASC30 demonstrates its potential as a best-in-class treatment, enhancing confidence in future collaborations and predicting a positive stock price reaction; they reiterated a "Buy/High Risk" rating with a target price of HKD 32 [1]. - Orient Securities noted that ASC30's weight loss data is superior, with good safety profiles, and the molecular patent has been authorized in the U.S., indicating significant business development potential [1]. Group 3: Drug Development Insights - ASC30, developed on the Ultra-Long-Acting Platform (ULAP), has subcutaneous injection formulations with apparent half-lives of 46 days and 75 days, significantly longer than other ultra-long-acting GLP-1 drugs, while also demonstrating superior safety [1].

Core Viewpoint - Gilead Sciences-B (01672) experienced a significant stock increase of over 5%, reaching HKD 13.56, following positive data from its oral GLP-1 drug ASC30 for obesity treatment in a Phase IIa study in the U.S. [1] Group 1: Company Performance - Gilead's stock rose by 5.12%, with a trading volume of HKD 13.28 million [1] - Citigroup released a report indicating that the data from ASC30 demonstrates its potential as a best-in-class treatment, enhancing confidence in future collaborations [1] - The target price set by Citigroup is HKD 32, maintaining a "Buy/High Risk" rating [1] Group 2: Drug Development Insights - Oriental Securities noted that ASC30 shows superior weight loss data and good safety, with molecular patents already authorized in the U.S., indicating significant business development potential [1] - The subcutaneous formulation of ASC30, developed on Gilead's Ultra-Long-Acting Platform (ULAP), has a half-life of 46 days and 75 days for weight loss and maintenance treatment, respectively, surpassing other long-acting GLP-1 drugs while maintaining superior safety [1]