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歌礼制药-B高开逾22% ASC30治疗肥胖症的13周II期研究取得积极的顶线结果
Xin Lang Cai Jing· 2025-12-09 01:39
热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 歌礼制药宣布,评估口服小分子GLP-1受体(GLP-1R)激动剂ASC30治疗肥胖症的13周II期研究 (NCT07002905)取得积极的顶线结果。除了实现具有统计学显著性和临床意义的体重下降外,ASC30 也达到了次要和探索性终点。ASC30在所有剂量组中均降低了多项已知的心血管风险标志物,包括总胆 固醇、低密度脂蛋白胆固醇(LDL-C)、甘油三酯以及收缩压和舒张压。在稳态下,ASC30的血药浓度 随剂量增加而增加。 歌礼制药-B(01672)早盘高开,截至发稿,股价上涨22.26%,现报17.52港元,成交额1.23亿港元。 歌礼制药宣布,评估口服小分子GLP-1受体(GLP-1R)激动剂ASC30治疗肥胖症的13周II期研究 (NCT07002905)取得积极的顶线结果。除了实现具有统计学显著性和临床意义的体重下降外,ASC30 也达到了次要和探索性终点。ASC30在所有剂量组中均降低了多项已知的心血管风险标志物,包括总胆 固醇、低密度脂蛋白胆固醇(LDL-C)、甘油三酯 ...
港股医药股走强 歌礼制药涨近15%
Mei Ri Jing Ji Xin Wen· 2025-12-09 01:37
Group 1 - Hong Kong pharmaceutical stocks showed strong performance on December 9, with notable gains in several companies [2] - Gilead Sciences-B (01672.HK) experienced a significant increase of 14.93% [2] - Tigermed (03347.HK) rose by 2.91%, while WuXi AppTec (02268.HK) saw a modest increase of 0.97% [2]
港股异动 | 歌礼制药-B(01672)高开近15% ASC30治疗肥胖症的13周II期研究取得积极的顶线结果
智通财经网· 2025-12-09 01:31
Core Viewpoint - The stock of Gilead Sciences-B (01672) opened nearly 15% higher, reaching a price of HKD 16.47, following positive results from a Phase II study of the oral small molecule GLP-1 receptor agonist ASC30 for obesity treatment [1] Group 1: Study Results - Gilead Sciences announced that the 13-week Phase II study (NCT07002905) of ASC30 achieved positive topline results, demonstrating statistically significant and clinically meaningful weight loss [1] - ASC30 also met secondary and exploratory endpoints, indicating its potential effectiveness beyond primary weight loss [1] Group 2: Cardiovascular Risk Markers - ASC30 reduced several known cardiovascular risk markers across all dosage groups, including total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, systolic and diastolic blood pressure [1] - The blood concentration of ASC30 increased with dosage, suggesting a dose-dependent relationship [1]
歌礼制药-B高开近15% ASC30治疗肥胖症的13周II期研究取得积极的顶线结果
Zhi Tong Cai Jing· 2025-12-09 01:28
消息面上,歌礼制药宣布,评估口服小分子GLP-1受体(GLP-1R)激动剂ASC30治疗肥胖症的13周II期研 究(NCT07002905)取得积极的顶线结果。除了实现具有统计学显著性和临床意义的体重下降外,ASC30 也达到了次要和探索性终点。ASC30在所有剂量组中均降低了多项已知的心血管风险标志物,包括总胆 固醇、低密度脂蛋白胆固醇(LDL-C)、甘油三酯以及收缩压和舒张压。在稳态下,ASC30的血药浓度随 剂量增加而增加。 歌礼制药-B(01672)高开近15%,截至发稿,涨14.93%,报16.47港元,成交额1073.84万港元。 ...
港股开评:恒生指数涨0.06% 歌礼制药涨近15%
人民财讯12月9日电,港股开盘,恒生指数涨0.06%,恒生科技指数跌0.11%,歌礼制药涨近15%,泰达 生物涨超10%。 ...
歌礼制药-B:ASC30治疗肥胖症的13周II期研究取得积极的顶线结果
Zhi Tong Cai Jing· 2025-12-08 09:41
歌礼制药-B(01672)公布,评估口服小分子GLP-1受体(GLP-1R)激动剂ASC30治疗肥胖症的13周II期研究 (NCT07002905)取得积极的顶线结果。该研究在美国多个中心开展,共入组125名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。研究共评估了三个剂量的ASC30口服片(20毫克、40毫克和60毫 克)。在第13周时,与安慰剂相比,三个剂量的ASC30均达到了主要终点,显示出具有统计学显著性(20 毫克、40毫克和60毫克对比安慰剂的p值<0.0001)和临床意义的体重下降。在主要终点(第13周时体重相 对基线的平均百分比变化)上,60毫克ASC30的经安慰剂校正后的平均体重下降高达7.7%。 在第13周的主要终点上,每日一次ASC30片的经安慰剂校正后的平均体重下降呈剂量依赖性,20毫克、 40毫克和60毫克产生的体重下降分别达5.4%、7.0%和7.7%。未观察到减重平台期。受试者的基线平均 体重和体重指数(BMI)分别为107.3kg和38.6kg/m2。 该ASC30II期研究因不良事件导致的总体停药率为4.8%。在各剂量组中,ASC30片因不良事件导致的停 药率分别为7 ...
歌礼制药-B(01672):ASC30治疗肥胖症的13周II期研究取得积极的顶线结果
智通财经网· 2025-12-08 09:40
Core Insights - The Phase II study of ASC30, an oral GLP-1 receptor agonist for obesity treatment, has shown positive topline results, demonstrating statistically significant and clinically meaningful weight loss compared to placebo [1][2] Group 1: Study Results - The study involved 125 participants with obesity or overweight with at least one weight-related comorbidity, assessing three doses of ASC30 (20 mg, 40 mg, and 60 mg) [1] - At week 13, the average weight loss relative to baseline was 5.4%, 7.0%, and 7.7% for the 20 mg, 40 mg, and 60 mg doses respectively, all showing statistical significance (p < 0.0001) [1] - 80.0% of participants receiving 60 mg ASC30 experienced a weight loss of ≥5%, compared to 4.2% in the placebo group [2] Group 2: Secondary and Exploratory Endpoints - ASC30 also achieved secondary and exploratory endpoints by reducing cardiovascular risk markers, including total cholesterol, LDL-C, triglycerides, systolic and diastolic blood pressure across all dose groups [2] Group 3: Safety and Tolerability - The overall discontinuation rate due to adverse events was 4.8%, with gastrointestinal adverse events being the primary cause [4] - No severe gastrointestinal adverse events were reported, and the tolerability of ASC30 was comparable to orforglipron, with a lower incidence of vomiting [3][4] - No liver safety signals were observed, and laboratory tests showed no significant abnormalities [4] Group 4: Future Plans - The company plans to submit data to the FDA and request an End-of-Phase II meeting in Q1 2026, anticipating further improvements in gastrointestinal tolerability in Phase III studies [4]
歌礼制药-B(01672.HK):口服小分子GLP-1药物ASC30在肥胖或超重受试者中进行的美国13周II期研究显示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
Ge Long Hui· 2025-12-08 09:39
Core Viewpoint - The company has announced positive topline results from a 13-week Phase II study of the oral small molecule GLP-1 receptor agonist ASC30 for the treatment of obesity, indicating significant weight loss compared to placebo [1][2] Group 1: Study Results - The Phase II study involved 125 obese or overweight participants with at least one weight-related comorbidity, conducted across multiple centers in the United States [1] - All three doses of ASC30 (20 mg, 40 mg, and 60 mg) achieved the primary endpoint, showing statistical significance (p-values < 0.0001) and clinical relevance in weight reduction compared to placebo [1] - The average weight loss at week 13, adjusted for placebo, was as high as 7.7% for the 60 mg dose of ASC30 [1] Group 2: Future Plans - The CEO expressed optimism about the Phase II results, highlighting ASC30's potential for weight loss and gastrointestinal tolerance, suggesting it may be best-in-class [2] - The company anticipates further improvement in gastrointestinal tolerance during the Phase III study, where dosing will shift to every four weeks [2] - Plans are in place to submit data and request an End-of-Phase II meeting with the FDA in the first quarter of 2026 [2]
歌礼制药(01672) - 自愿性公告 - 歌礼口服小分子GLP-1药物ASC30在肥胖或超重受试者...
2025-12-08 09:30
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 在第13週的主要終點上,每日一次ASC30片的經安慰劑校正後的平均體重下降 呈劑量依賴性,20毫克、40毫克和60毫克產生的體重下降分別達5.4%、7.0%和 7.7%。未觀察到減重平台期。受試者的基線平均體重和體重指數(BMI)分別為 107.3 kg和38.6 kg/m2 。 該ASC30 II期研究因不良事件導致的總體停藥率為4.8%。在各劑量組中,ASC30 片因不良事件導致的停藥率分別為7.3%(20毫克)、7.5%(40毫克)和0.0%(60毫 克),安慰劑組為0.0%。導致停藥的不良事件僅為胃腸道不良事件(惡心、嘔吐和 便秘)。未觀察到肝臟安全性信號,且丙氨酸氨基轉移酶(ALT)、天冬氨酸氨基轉 移酶(AST)或總膽紅素(TBL)水平未有升高。此外,實驗室檢查、 ...
港股收盘 | 恒指收跌1.23% 券商、芯片股等逆市上涨 百度集团-SW领升蓝筹
Zhi Tong Cai Jing· 2025-12-08 08:51
Market Overview - The Hong Kong stock market faced pressure, with the Hang Seng Index dropping over 1%, closing at 25,965.36 points, down 1.23% or 319.72 points, with a total turnover of HKD 2,062.3 million [1] - The Hang Seng China Enterprises Index fell by 1.25% to 9,083.53 points, while the Hang Seng Tech Index remained flat at 5,662.55 points [1] Blue Chip Performance - Baidu Group-SW (09888) led blue-chip stocks, rising 3.45% to HKD 125.8, contributing 8.38 points to the Hang Seng Index [2] - Other notable performers included SMIC (00981) up 2.94%, China Ping An (02318) up 2.15%, while China Construction Bank (00939) fell 4.01%, dragging the index down by 54.39 points [2] Sector Highlights - Large tech stocks generally declined, with Alibaba down over 1% and Tencent down 0.82% [3] - Chinese brokerage stocks rose against the trend, with Huatai Securities (06886) up 5.17% and GF Securities (01776) up 3.1% [3] - The light communication sector saw significant gains, with Huiju Technology rising over 7% [4] - Lithium stocks mostly increased, with Ganfeng Lithium (01772) up 6.95% and CATL (03750) up 3.28% [5] Regulatory Developments - The Chairman of the China Securities Regulatory Commission (CSRC) emphasized the need to accelerate the development of top-tier investment banks and institutions, indicating a potential easing of regulations for quality institutions [4] - The CSRC plans to optimize risk control indicators and moderately open up capital space and leverage limits, which could benefit leading brokerages [4] New Listings and Stock Movements - Two new stocks were listed, with Zhuoyue Ruixin (02687) surging 87.26% and Naxinwei (02676) declining 4.31% [7] - Restructured Energy (02570) faced a significant drop of 27.33% on its first trading day after the lock-up period ended [8] - Silver Pharma-B (02591) saw a decline of 14.32% following its inclusion in the Hong Kong Stock Connect [9] - Sutech (02498) performed well, rising 5.23% after securing a major order from FAW Toyota [10] Pharmaceutical Sector Updates - The National Healthcare Security Administration announced the addition of 114 new drugs to the 2025 National Medical Insurance Drug List, with a success rate of 88%, up from 76% in 2024 [6]