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歌礼制药-B(1672.HK):创新管线登上ADA大会 公司后续发展值得期待
Ge Long Hui· 2025-06-27 00:23
Core Viewpoint - The company's ASC30 and ASC47 drugs showcased at the ADA conference have promising future prospects, with ASC30 demonstrating good pharmacokinetic characteristics and safety, while ASC47 shows potential for fat reduction and muscle gain in preclinical studies [1][2]. Event Summary - On June 18, the company announced the completion of the first dosing of subjects in the U.S. Phase I clinical trial for ASC50, an oral small molecule IL-17 inhibitor for psoriasis [1]. - On June 23, ASC30 and ASC47 were presented at the ADA conference, highlighting their clinical research data [1]. ASC30 Insights - The SAD study for ASC30 included 30 subjects divided into five groups with doses of 2mg, 5mg, 10mg, 20mg, and 40mg, showing a half-life of 30-55 hours for the 5-40mg groups, indicating favorable pharmacokinetic properties [1][2]. - The study reported that all side effects were mild to moderate, with no vomiting in the 2mg and 5mg groups, confirming the drug's controllable safety profile [2]. ASC47 Insights - Preclinical studies of ASC47 indicated its potential for fat reduction, muscle gain, and weight loss, particularly when combined with semaglutide in mouse models, showing a greater weight loss trend compared to the semaglutide-only group [2]. ASC50 Potential - ASC50 is positioned as a promising oral treatment for psoriasis, currently undergoing Phase I clinical trials in the U.S. The preclinical data suggest higher oral exposure, longer half-life, and strong efficacy, supporting its potential as a best-in-class oral medication [2]. Future Development Outlook - The company plans to continue advancing its core pipeline, with ASC30's oral Phase IIa study and ASC40's Phase III study expected to be completed by 2025, alongside the publication of ASC30's subcutaneous Phase Ib results [3]. - The focus remains on ASC30 and ASC47, with multiple pipeline developments anticipated in the coming years [3]. Financial Forecast - The core drugs ASC30 and ASC47 are in early development stages, showing excellent safety and efficacy in early clinical results. The company estimates a reasonable market value of HKD 19.29 billion, raising the target price to HKD 19.93, maintaining a "buy" rating [3].
港股异动 | 歌礼制药-B(01672)再涨超18% 地尼法司他数据亮眼 公司将公布ASC30及ASC47研究结果
智通财经网· 2025-06-16 03:31
消息面上,歌礼制药近日公布,同类首创、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)治疗中重度寻常性痤疮的III期临床试验(NCT06192264)达到所有主要、关键次要及次要终 点。东吴证券指出,目前痤疮疗法治标不治本,而地尼法司他III期临床达到所有终点,疗效数据优秀, 未来有望成为疗效显著、患者依从性高、安全性好的BIC痤疮药物。随着地尼法司他III临床期顺利结 束,公司预计将在2025年提交药监局申报上市,2026年贡献收入。 此外,歌礼制药将在美国芝加哥举行的美国糖尿病协会(ADA)第85届科学会议上,以壁报形式报告口服 小分子GLP-1受体(GLP-1R)激动剂ASC30,以及脂肪靶向、减重不减肌候选药物ASC47的早期研究数 据。东吴证券指出,ASC30是目前唯一一款既可每天口服,也可每月一次皮下注射的GLP-1小分子,满 足了不同市场人群的需求,具备稀缺性;ASC47是靶向脂肪细胞THRβ靶点的小分子药物,每月一次皮 下注射,有减脂不减肌潜力,是首个THRβ靶点的小分子减肥药。目前I期SAD研究数据已读出,在美国 联合司美格鲁肽临床研究已经完成首例患者给药。 智通财 ...
Ascletis Announces Poster Presentations on the Study Results of ASC30 and ASC47 at the 85th Scientific Sessions of American Diabetes Association (ADA)
Prnewswire· 2025-06-09 00:15
Core Insights - Ascletis Pharma Inc. is set to present preliminary studies on its oral GLP-1 receptor agonist ASC30 and weight loss drug candidate ASC47 at the 85th Scientific Sessions of the American Diabetes Association in Chicago [1][5] Group 1: ASC30 - ASC30 is an investigational GLP-1 receptor biased small molecule agonist that can be administered both orally and via subcutaneous injection [3] - It is a new chemical entity with patent protection in the U.S. and globally until 2044 [3] - The first-in-human single ascending dose study will be presented under poster number 750-P on June 22, 2025 [2] Group 2: ASC47 - ASC47 is an adipose-targeted, ultra-long-acting small molecule agonist that selectively targets thyroid hormone receptor beta [4] - It is designed to achieve high drug concentrations in adipose tissue, demonstrating unique properties for obesity treatment [4] - The ongoing Phase I clinical trial in combination with semaglutide for obesity treatment began dosing participants in May 2025 [4][2] Group 3: American Diabetes Association (ADA) - The ADA is a leading nonprofit organization focused on diabetes prevention, cure, and improving the lives of those affected by diabetes [5] - The 85th Scientific Sessions will take place from June 20 to 23, 2025, in Chicago, setting the agenda for clinical practice and research innovation [5] Group 4: Ascletis Pharma Inc. - Ascletis is an innovative R&D-driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases [6] - The company covers the entire value chain from drug discovery and development to GMP manufacturing [6] - Ascletis has multiple clinical-stage drug candidates in its metabolic disease pipeline, addressing unmet medical needs globally [7]
东吴证券晨会纪要-20250606
Soochow Securities· 2025-06-06 01:35
证券研究报告 东吴证券晨会纪要 东吴证券晨会纪要 2025-06-06 [Table_Tag] 宏观策略 [Table_MacroStrategy] 宏观深度报告 20250603:复盘 200 年,贸易战何去何从? 通过复盘自 1800 年至今 200 余年的全球贸易历史,以及结合近期东部沿 海省份"造船厂-船东-船公司-货代及外贸公司-实体制造业"外贸产业链 调研反馈,我们的研究表明: 首先,复盘全球贸易历史看,汇率、非关 税壁垒可能取代关税成为更加关键的"贸易交锋"工具。 其次,国内多 数外贸企业认为由于在根本矛盾上的冲突,中美贸易谈判过程未来或将 "一波三折",企业可能需要持续控制对美出口风险敞口。 再次,如果加 征关税无法实现美方贸易竞争的主要目的,那么参考过去 200 年全球贸 易历史特别是 1970s-1990s 美日德贸易竞争阶段的美方举措,未来美国政 府可能在非关税壁垒、汇率等方面发起更多挑战。 最后,在控制对美出 口风险敞口的过程中,拓展非美出口、"出口转内销"、"出海"等关键手 段仍待企业端摸索落地方式,年内外贸前景仍面临高度不确定性。 宏观深度报告 20250602:人民币汇率:会否升 ...
歌礼制药-B:ASC40痤疮适应症III期临床达到所有终点,疗效数据优秀-20250605
Soochow Securities· 2025-06-05 00:23
歌礼制药-B(01672.HK) ASC40痤疮适应症 III期临床达到所有终点, 疗效数据优秀 证券研究报告·海外公司点评·药品及生物科技(HS) 买入(维持) | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入(百万元) | 56.69 | 1.28 | 0.00 | 40.00 | 100.00 | | 同比(%) | 4.81 | (97.74) | (100.00) | | 150.00 | | 归母净利润(百万元) | (144.72) | (300.94) | (454.44) | (469.72) | (445.21) | | 同比(%) | 54.04 | (107.95) | (51.01) | (3.36) | 5.22 | | EPS-最新摊薄(元/股) | (0.15) | (0.31) | (0.47) | (0.48) | (0.46) | | P/E(现价&最新摊薄) | (54.06) | (26.00) | ...
Ascletis Announces First Participants Dosed in a U.S. Clinical Study Combining Adipose-Targeted, Once-Monthly Injectable Small Molecule THRβ Agonist, ASC47, and Semaglutide for the Treatment of Obesity
Prnewswire· 2025-05-20 10:00
Core Insights - Ascletis Pharma Inc. is conducting a randomized, double-blind, placebo-controlled study (ASC47-103) to evaluate the safety and preliminary efficacy of ASC47 in combination with semaglutide for obesity treatment [3][6] - ASC47 is an adipose-targeted, ultra-long-acting small molecule agonist with a half-life of up to 40 days, showing promising results in preclinical studies [4][6] - The combination of low-dose ASC47 and semaglutide resulted in a 56.7% greater reduction in body weight with muscle preservation compared to semaglutide alone in a mouse model [2][4] Study Design - The ASC47-103 study includes three cohorts receiving single ascending doses of ASC47 (10 mg, 30 mg, and 60 mg) or placebo, along with four doses of semaglutide (0.5 mg, once weekly) [3][6] - Topline data from the ASC47-103 study are anticipated in the fourth quarter of 2025 [5] Company Overview - Ascletis Pharma Inc. is a biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases and addressing unmet medical needs globally [7]
港股概念追踪|传闻世卫组织计划将减肥药纳入基本目录 减肥药研发进展加速(附概念股)
智通财经网· 2025-05-07 07:16
对此,世界卫生组织独家回应《人民财讯》称,自2022年以来,世卫组织一直在针对不同年龄组制定一 套关于肥胖预防、护理和治疗的新指南。 有传闻称"世卫组织计划首次将减肥药纳入基本药物目录以治疗成人肥胖症"。 目前,关于使用GLP-1 RA和GLP-1 RA/GIP双受体激动剂治疗成年肥胖患者的指南,正按照指南审查委 员会的程序进行全面制定,预计在2025年8月或9月会出台最终方案。 该指南的目的在于明确GLP 1 RAs的临床适应症、应用以及规划方面的考量,包括这类药物如何以及在 何时能够作为包括临床干预和生活方式干预的慢性病管理模式的一部分加以应用。 另外,上述药物目前正由世界卫生组织基本药物选择与使用专家委员会进行评审。该专家委员会的评审 流程独立于指南制定程序,旨在评估多种药物是否应纳入《世界卫生组织基本药物标准清单》和《世界 卫生组织儿童基本药物标准清单》。 这两份清单为国家或地区采购机构提供指导,帮助其选择符合人群优先健康需求的药物。 中信证券研报认为,海外巨头的业绩持续超预期以及国内研发进展的加速,减肥药的产业趋势有望进一 步明确。预计后续海外巨头业绩预期指引&重磅药物销售数据超预期、海外GLP-1 ...
永安期货每日报告-20250507
Xin Yong An Guo Ji Zheng Quan· 2025-05-07 03:37
2025年5月7日星期三 ➢ 中美贸易谈判将启;中国重磅政策发 布会。A股节后走强。上证指数涨 1.13%报3316.11点,深证成指涨1.84%, 创业板指涨1.97%。可控核聚变、算力、 人脑工程涨幅居前。港股维持强势, 全日拉升 。 恒 生 指 数 涨 0.7% 报 22662.71点,恒生科技指数跌0.09%, 恒生中国企业指数涨0.37%。油气、贵 金属、能源涨幅居前。大市成交额 2134亿港元。外盘方面,欧洲三大股 指收盘涨跌不一。美国三大股指全线 收跌,道指跌0.95%,标普500指数跌 0.77%报5606.91点,纳指跌0.87%。中 美高层本周末将启动贸易谈判。中国 央行、证监会等金融官员将于上午召 开新闻发布会,讨论稳市场举措。 | 22662.71 | 0.70 | 12.97 | | --- | --- | --- | | 8261.61 | 0.37 | 13.33 | | 5239.50 | -0.09 | 17.26 | | 135.25 | 0.91 | -5.42 | | 3316.11 | 1.13 | -1.06 | | 10082.33 | 1.84 | -3.19 ...
整理:每日港股市场要闻速递(5月7日 周三)
news flash· 2025-05-07 01:13
4. 透云生物(01332.HK):附属拟1300万元出售威道国际70%股权。 5. 歌礼制药(01672.HK):将在第32届欧洲肥胖症大会(ECO 2025)上以口头和壁报形式报告脂肪靶向、减 重不减肌的肥胖症候选药物ASC47的早期研究。 金十数据整理:每日港股市场要闻速递(5月7日 周三) 1. 正荣地产(06158.HK):控股股东委任联合清盘人,股份自周三上午9时起恢复买卖。业务运作一切如 常。 2. 小鹏汽车(09868.HK)拟5月21日举行董事会会议批准一季度业绩。 3. 协合新能源(00182.HK):前4个月权益发电量为3330.69GWh,同比跌2.24%;4月权益发电量为 809.84GWh,同比跌6.48%。 6. 远大医药(00512.HK):全球创新产品 STC3141 在中国开展的用于治疗脓毒症的 II 期临床研究成功达 到临床终点。 7. 山高新能源(01250.HK):前2个月累计总营运发电量约101.96万兆瓦时,同比增长约13.1%。 ...
智通港股早知道 | 央行等部门将介绍一揽子金融政策支持稳市场稳预期 港交所推出“科企专线”
Zhi Tong Cai Jing· 2025-05-06 23:36
【今日头条】 香港金管局日内两度出手 再沽出127.88亿港元 今年4度注资共1294亿港元 智通财经APP获悉,港元长时间触及7.75强方兑换保证,5月6日,香港金管局两度入市维持港元联系汇 率,继香港时间清晨宣布已沽出605.43亿港元(相当于78.12亿美元),香港金管局于下午宣布,香港交易 时段亦向市场出售127.88亿港元(相当于16.50亿美元),香港银行体系结余将升至1741亿港元。 香港金管局总裁余伟文表示,港元需求持续上升,港元走强主要受股票相关的需求推动,没有看到港元 出现异常活动。预计未来几个月港元/美元将出现套利交易,将对不确定性保持警惕。金管局一直在减 少持有的美国国债的期限;香港的外汇基金一直在多元化投资非美国资产;一直在分散投资组合中的货币 敞口以管理风险。 【大势展望】 现货黄金时隔两周再次站上3400美元 隔夜美股截至收盘,道指跌389.83点,跌幅为0.95%,报40829.00点;纳指跌154.58点,跌幅为0.87%,报 17689.66点;标普500指数跌43.47点,跌幅为0.77%,报5606.91点。大型科技股多数下跌,Meta跌2%,特 斯拉、英特尔跌超1%, ...