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 ...

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。 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，同類首創(first-in-class)、每日一次口服 小分子脂肪酸合成酶(FASN)抑制劑地尼法司他(ASC40)在中重度尋常性痤瘡患者 中的III期開放標籤研究(NCT06248008)取得積極頂線結果。 於近期完成的該第二項III期研究是一項在中國開展的開放標籤的多中心研究， 旨在評估地尼法司他(ASC40)在240例中重度尋常性痤瘡患者中的長期安全性。 這240例患者均接受了40周的每日一次地尼法司他(ASC40)治療，且此前均接受 過12周的地尼法司他(ASC40)或安慰劑治療。主要終點包括：(1)治療期間發生的 不良事件（treatment-emergent adverse event，TEAE）的發生率； ...

每经AI快讯，歌礼制药-B(01672.HK)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。 （文章来源：每日经济新闻） ...

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 4% in the afternoon, currently up 3.85% at HKD 13.76, with a trading volume of HKD 12.1855 million. The company announced the completion of the first patient dosing in a Phase II clinical trial in the U.S. for its oral GLP-1 receptor agonist ASC30, aimed at treating type 2 diabetes, with plans to recruit approximately 100 patients across multiple centers in the U.S. The primary data from this 13-week study is expected to be released in Q3 2026 [1]. Group 1 - Gilead Sciences has initiated a Phase II clinical trial for ASC30, targeting type 2 diabetes treatment [1]. - The trial will involve around 100 patients and is set to take place in multiple centers across the U.S. [1]. - The company plans to announce the primary data from the trial in Q3 2026 [1]. Group 2 - The CEO of Gilead Sciences, Dr. Wu Jinzi, emphasized the strategic expansion into the diabetes treatment market with ASC30 [1]. - The company aims to showcase ASC30 as a potential best-in-class oral treatment option, administered once daily [1]. - The upcoming trial results are anticipated to provide significant insights into the efficacy of ASC30 for diabetes patients [1].

Core Viewpoint - The announcement of the completion of the first patient dosing in the Phase II clinical trial of ASC30 for type 2 diabetes treatment has positively impacted the stock price of the company, leading to a rise of over 4% [1] Company Developments - The company, Songlei Pharmaceutical, has initiated a Phase II clinical trial in the United States for its oral small molecule GLP-1 receptor agonist ASC30, targeting approximately 100 type 2 diabetes patients across multiple centers [1] - The primary data from this 13-week Phase II study is expected to be released in the third quarter of 2026 [1] - The founder and CEO, Dr. Wu Jinzi, emphasized the strategic importance of expanding ASC30's clinical development into the large diabetes treatment market, highlighting its potential as a best-in-class oral treatment option [1]

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。 ...

Group 1 - The company announced that its oral small molecule GLP-1 receptor agonist ASC30 for the treatment of type 2 diabetes has completed the first dosing of participants in a 13-week Phase II study in the U.S., with top-line data expected in Q3 2026 [1] - The company recently completed a 13-week Phase II study evaluating ASC30 for obesity treatment, enrolling 125 obese or overweight participants with at least one weight-related comorbidity across multiple centers in the U.S. [2] - At the primary endpoint of the 13-week study, ASC30 doses of 20 mg, 40 mg, and 60 mg achieved statistically significant and clinically meaningful weight reductions of 5.4%, 7.0%, and 7.7% respectively, with a dose-dependent effect observed [2] Group 2 - The overall discontinuation rate due to adverse events in the Phase II study for ASC30 was 4.8%, indicating a favorable safety profile [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 once monthly to quarterly, targeting obesity, diabetes, and other metabolic diseases [2] - The company's strategy to expand ASC30's clinical development into the large diabetes treatment market is seen as a logical next step, providing an opportunity to showcase ASC30 as a best-in-class oral therapy option for patients [3]

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].

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 ...