两种制剂均已在ASC30口服Ia期单剂量递增(SAD)研究(NCT06680440)中进行了评估。制剂2相较制剂1 显示出更平缓的药代动力学特征。 歌礼制药-B(01672)发布公告，评估小分子口服GLP-1受体(GLP-1R)激动剂ASC30治疗肥胖症的美国13周 IIa期研究(NCT07002905)已完成入组。125例受试者均为肥胖人群或伴有至少一种体重相关合并症的超 重人群。 "我们很高兴宣布这一重要里程碑，这标志着ASC30在有望成为治疗肥胖症的独特差异化疗法的道路上 又迈进一步。"歌礼创始人、董事会主席兼首席执行官吴劲梓博士表示，"完成125名受试者入组仅用时 一个多月，凸显了肥胖症市场迫切需要更多治疗选择。我们热切期待在2025年第四季度获得这项IIa期 研究的顶线数据。作为一种小分子药物，如获批，ASC30有望提供每日一次口服和每月一次皮下注射两 种给药选择治疗肥胖症。" 这项IIa期研究是一项13周、随机、双盲、安慰剂对照和多中心的研究，旨在评估ASC30在肥胖受试者 (体重指数(BMI)≥30kg/m2)或伴有至少一种体重相关合并症的超重受试者(27kg/m2≤BMI<30kg/m2)中的 ...

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 歌禮完成小分子口服GLP-1R激動劑ASC30美國IIa期研究 肥胖或超重受試者入組 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，評估小分子口服GLP-1受體(GLP-1R) 激動劑ASC30治療肥胖症的美國13周IIa期研究(NCT07002905)已完成入組。125 例受試者均為肥胖人群或伴有至少一種體重相關合併症的超重人群。 「我們很高興宣佈這一重要里程碑，這標誌着ASC30在有望成為治療肥胖症的獨 特差異化療法的道路上又邁進一步。」歌禮創始人、董事會主席兼首席執行官吳 勁梓博士表示，「完成125名受試者入組僅用時一個多月，凸顯 ...

Group 1 - The Hong Kong biotechnology stocks collectively rose, with notable increases in several companies' stock prices [1][2] - Beihai Kangcheng-B saw a rise of nearly 19%, while other companies like Gilead Sciences-B and Ascentage Pharma-B also experienced significant gains of over 15% and 9% respectively [1][2] - The overall trend indicates a positive sentiment in the biotechnology sector, with multiple companies achieving gains of over 5% [1][2] Group 2 - Specific stock performance includes: Beihai Kangcheng-B at 18.99% increase, Gilead Sciences-B at 15.30%, and Ascentage Pharma-B at 9.48% [2] - The market capitalization of these companies varies significantly, with Gilead Sciences-B at approximately 11.477 billion and Ascentage Pharma-B at about 29.86 billion [2] - Other notable performers include Jiahua Bio-B and Beikang Medical-B, both showing increases of over 7% [1][2]

Group 1 - The Hong Kong biotechnology sector experienced a rise on August 5, with notable increases in stock prices for several companies [1] - Gilead Sciences (歌礼制药) saw a surge of over 15% in its stock price [1] - Ascentage Pharma (亚盛医药) increased by more than 9% [1] - Other companies such as Jiahe Biopharma (嘉和生物) and Innovent Biologics (复宏汉霖) rose by over 8% [1] - CanSino Biologics (康希诺生物) and Zai Lab (再鼎医药) experienced increases of over 5% [1]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | | --- | | 狀態: 新提交 | | 2025年7月31日 | 致：香港交易及結算所有限公司 公司名稱: 歌禮製藥有限公司 呈交日期: 2025年8月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01672 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 7,000,000,000 | USD | | 0.0001 | USD | | 700,000 | | 增加 / 減少 (-) | | | 0 | | | | USD | | 0 | | 本月底結存 | | | 7,000,000,000 | USD | | 0.0001 | USD | | ...

Investment Rating - The report maintains a positive outlook on the pharmaceutical and biotechnology industry, emphasizing the transition from "Made in China" to "Created in China" for innovative drugs [10]. Core Insights - The report highlights that domestic innovative drugs are gaining global competitiveness and are currently in the first and second stages of international expansion, primarily through licensing agreements and partnerships [10][12]. - The report identifies key areas of focus for investment, including PD-(L)1 plus, ADCs, and GLP-1 drugs, which are expected to drive future growth and business development (BD) opportunities [10][51]. Summary by Sections Section 1: Transition from "Manufacturing" to "Innovation" - The policy reforms initiated in 2015 have stimulated a shift from generic to innovative drug development in China, with significant increases in R&D investment since 2018 [19][21]. - The number of First-in-Class (FIC) drugs developed in China has risen from 9 in 2015 to 120 in 2024, indicating a substantial increase in innovation [25][26]. Section 2: Continued BD Opportunities - PD-(L)1 plus is identified as a cornerstone for next-generation cancer treatments, with significant demand and potential for new products [51]. - The report notes that ADCs are transitioning towards more differentiated targets, focusing on unmet clinical needs, with promising candidates like PD-L1, DLL3, and EGFR [51]. - The GLP-1 market is experiencing rapid growth, with a focus on multi-target, oral, combination, and long-acting formulations [51]. Section 3: Investment Recommendations - For PD-(L)1 plus, companies such as Kangfang Biotech, Shansheng Pharmaceutical, and Junshi Biosciences are recommended for investment due to their strong pipelines [5]. - In the ADC space, companies like Fuhong Hanlin and Zai Lab are highlighted for their potential in addressing unmet clinical needs [5]. - In the GLP-1 sector, firms such as Borui Pharmaceutical and Zai Lab are noted for their promising developments [5].

| 生物医药B类股 | | | | --- | --- | --- | | 1317.810↑+16.019 +1.23% | | 交易中 | | 图周日记 | | | | 最高价 1317.810 | 开盘价 1303.908 | 成交量 5819万 | | 最低价 1296.245 | 昨收价 1301.791 | 成交额 6.16亿 | | 市盈率 -26.663 | 换手率 0.17% | 总市值 3855.92亿 (1) | | 市净率 6.400 | 平均价 1307.028 | 流通值 3428.88亿 | | 上 涨 18 | 一带 9 | 下 跌 24 | | 52周最高 1330.898 历史最高 2139.662 | | | | 52周最低 404.425 历史最低 393.223 | | | 据国家医保局消息，7月28日，国家医保局副局长李滔在京会见新加坡政府投资公司（GIC），双方就 医保支持创新药发展有关情况进行了深入交流。 7月31日消息，港股B类股逆市走高，歌礼制药、中国抗体、乐普生物涨超5%，科伦博泰生物、百奥赛 图涨超4%，圣诺医药等涨超3%。 ...

港股创新药概念多股走强，歌礼制药(01672.HK)、石药集团(01093.HK)涨近3%，中国生物制药 (01177.HK)涨超2%，百济神州(06160.HK)、翰森制药(03692.HK)等跟涨。 ...

Group 1 - The company, Gilead Sciences, announced the completion of the first cohort of a 12-week Phase IIa study in the United States for its small molecule GLP-1R agonist ASC30, which is administered as a once-monthly subcutaneous depot formulation for overweight or obese subjects [1]

Market Performance - A-shares steadily advanced this week, with the ChiNext Index reaching a new high for the year and the Shenzhen Component Index hitting a four-month high, approaching its highest point of the year [1] - Weekly trading volume increased to 7.73 trillion yuan, marking the largest weekly trading volume in three months [1] Fund Inflows - Leverage funds actively entered the market, with most industries under the Shenwan first-level industry classification seeing net buying, particularly the computer industry with over 4.4 billion yuan and the electronics industry with over 3 billion yuan [2] - The electronic, biopharmaceutical, and automotive sectors each received over 20 billion yuan in net inflows, while the non-bank financial sector saw a net outflow of over 8.3 billion yuan [2] Rare Earth Demand - The rare earth sector performed strongly, with the rare earth permanent magnet index reaching a three-and-a-half-year high [3] - Demand for rare earths is expected to grow rapidly due to advancements in humanoid robots and electric vehicles, with estimates suggesting a demand of at least 70,000 tons of neodymium-iron-boron by 2025 [3] Energy Metals - The energy metals sector, including lithium and cobalt, reached a two-year high, with lithium carbonate futures breaking 70,000 yuan/ton, marking a 20% increase from recent lows [4] - Short-term lithium salt supply may decline due to reduced exports from Chile and domestic production halts, leading to a potential price stabilization [4] Biopharmaceutical Sector - The biopharmaceutical sector saw significant gains, with the innovative drug index hitting record highs multiple times this week [6] - Notable stocks in the sector, such as Lianhuan Pharmaceutical and Aosaikang, experienced consecutive trading halts, with some stocks showing year-to-date gains exceeding 200% [6][7] Earnings Forecasts - Several pharmaceutical companies have recently forecasted substantial profit increases for the first half of 2025, with estimates suggesting net profit growth exceeding 19 times for some firms [7]