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 | | | 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12月2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 | | 700,000 | 本月底法定/註冊股本總額： USD 700,000 FF ...

整理 | GLP1减重宝典内容团队 据了解，歌礼制药计划于2026年第二季度向美国FDA提交ASC37口服片用于治疗肥胖症的新药临床试验申请。 11月30日，歌礼制药宣布其首款口服GLP-1R/GIPR/GCGR三靶点激动剂多肽ASC37正式进入临床开发阶段。 在非人灵长类动物的直接对比研究中，ASC37口服片展现出显著的药代动力学优势：平均绝对口服生物利用度达到4.2%，分别是采用 口服SNAC制剂技术的司美格鲁肽、替尔泊肽和retatrutide的约9倍、30倍和60倍。 ASC37的研发得益于歌礼的两大核心技术平台：基于结构的AI辅助药物发现体系和口服多肽递送增强技术。体外实验数据显示，在激 活GLP-1R、GIPR和GCGR三大受体方面，ASC37的活性水平分别较retatrutide提升约5倍、4倍和4倍。 此外，ASC37口服片在非人灵长类动物研究中的平均表观半衰期约为56小时，支持每日一次甚至更低频率的口服给药。在同类对照研 究中，口服给药后ASC37的药物暴露量（以药时曲线下面积衡量）约为retatrutide的57倍。更高的暴露量意味着更多活性物质进入全身 循环，从而实现更充分的药效。 *本 ...

Core Insights - The company has selected ASC37 oral tablets as its first clinical development candidate for obesity treatment, with plans to submit an IND application to the FDA in Q2 2026 [1] - ASC37 is developed using the company's proprietary Peptide Oral Transport Enhancement Technology (POTENT) and is a multi-target peptide agonist for GLP-1R, GIPR, and GCGR [1] - The CEO emphasized the company's commitment to addressing unmet needs in obesity treatment through its advanced research capabilities and differentiated pipeline [2] Summary by Sections - **Product Development** - ASC37 oral tablets are the first candidate utilizing the POTENT technology [1] - The drug shows approximately 5 times, 4 times, and 4 times stronger agonistic activity on GLP-1R, GIPR, and GCGR compared to retatrutide [1] - **Pharmacokinetics** - In non-human primate studies, ASC37 achieved an average absolute oral bioavailability of 4.2%, outperforming semaglutide, tirzepatide, and retatrutide by 9 times, 30 times, and 60 times respectively [2] - The drug exposure (AUC) of ASC37 was about 57 times that of retatrutide in the same studies [2] - The average apparent half-life of ASC37 was approximately 56 hours, supporting once-daily or less frequent dosing [2] - **Strategic Vision** - The selection of ASC37 reflects the company's strong R&D capabilities and commitment to addressing the unmet needs in obesity treatment [2] - The company aims to establish a highly competitive and diversified pipeline to meet various treatment needs for obesity and other metabolic diseases [2]

Core Insights - The company has selected ASC37 oral tablets as its first clinical development candidate for obesity treatment, expected to submit an IND to the FDA in Q2 2026 [1] - ASC37 is developed using the proprietary Peptide Oral Transport Enhancement Technology (POTENT) and is a multi-target peptide agonist for GLP-1R, GIPR, and GCGR [1] - The CEO emphasized the company's commitment to addressing unmet needs in obesity treatment through its advanced research capabilities and diverse pipeline [2] Summary by Sections Drug Development - ASC37 oral tablets are the first candidate utilizing the company's POTENT technology for oral peptide delivery [1] - The drug was discovered and optimized using Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) technology [1] Efficacy and Bioavailability - In vitro studies show that ASC37 has approximately 5 times, 4 times, and 4 times stronger agonistic activity on GLP-1R, GIPR, and GCGR compared to retatrutide [1] - In non-human primate studies, ASC37 achieved an average absolute oral bioavailability of 4.2%, outperforming semaglutide, tirzepatide, and retatrutide by 9 times, 30 times, and 60 times respectively [2] - The drug exposure (AUC) of ASC37 was about 57 times greater than that of retatrutide in the same studies [2] - The average apparent half-life of ASC37 in non-human primates was approximately 56 hours, supporting once-daily or less frequent dosing [2] Strategic Vision - The selection of ASC37 for clinical development reflects the company's strong R&D capabilities and commitment to addressing obesity treatment needs [2] - The company aims to build a highly competitive and differentiated pipeline to meet various treatment demands for obesity and other metabolic diseases [2]

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 歌禮選定其首款口服GLP-1R/GIPR/GCGR三靶點激動劑 多肽ASC37進行臨床開發 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」）宣布已選定其首款口服GLP-1R/GIPR/GCGR[1] 三靶點激動劑多肽ASC37口服片作為臨床開發候選藥物。歌禮預計將於2026年第 二季度向美國食品藥品監督管理局(FDA)遞交ASC37口服片治療肥胖症的新藥臨 床試驗申請(IND)。 1 － 在非人靈長類動物的頭對頭研究中，通過利用歌禮口服多肽遞送增強技術 (POTENT)，ASC37口服片的平均絕對口服生物利用度達4.2%，分別約為採 用口服SN ...

开源证券发布研报称，随着未来越来越多临床数据的披露，超长效管线与技术平台的价值将逐步凸显， 我们预计超长效新疗法将成为减重降糖赛道最有差异化的竞争方向。该行指出，抗体偶联、脂肪酸端基 修饰、皮下储库缓控释等多项技术能实现超长效给药，其中，歌礼制药已布局皮下储库ULAP技术平 台，利用该平台已开发了多款超长效减肥药管线。 歌礼制药-B(01672)现涨超6%，截至发稿，涨6.25%，报14.46港元，成交额3959.18万港元。 消息面上，11月13日，辉瑞宣布已成功完成对Metsera公司的收购，交易总价值约92亿美元；通过本次 收购，辉瑞将获得Metsera核心资产MET-097i与MET-233i。礼来与诺和诺德也积极布局超长效平台， 2025年已分别与Camurus与Ascendis完成战略合作，将利用它们的FluidCrystal与TransCon皮下储库缓控 释技术开发超长效减重降糖类产品。 ...

消息面上，11月13日，辉瑞宣布已成功完成对Metsera公司的收购，交易总价值约92亿美元；通过本次 收购，辉瑞将获得Metsera核心资产MET-097i与MET-233i。礼来与诺和诺德也积极布局超长效平台， 2025年已分别与Camurus与Ascendis完成战略合作，将利用它们的FluidCrystal与TransCon皮下储库缓控 释技术开发超长效减重降糖类产品。 智通财经APP获悉，歌礼制药-B(01672)现涨超6%，截至发稿，涨6.25%，报14.46港元，成交额3959.18 万港元。 开源证券发布研报称，随着未来越来越多临床数据的披露，超长效管线与技术平台的价值将逐步凸显， 我们预计超长效新疗法将成为减重降糖赛道最有差异化的竞争方向。该行指出，抗体偶联、脂肪酸端基 修饰、皮下储库缓控释等多项技术能实现超长效给药，其中，歌礼制药已布局皮下储库ULAP技术平 台，利用该平台已开发了多款超长效减肥药管线。 ...

Group 1 - The Hong Kong stock market saw a collective decline in the innovative drug sector, with notable drops in several companies [1] - Three-Sixty Pharmaceutical experienced a decline of over 7% [1] - Other companies such as King’s Ray Biotechnology, CSPC Pharmaceutical Group, and Galenica also reported declines [1]

Core Viewpoint - The financial markets are experiencing volatility due to mixed signals from the Federal Reserve regarding interest rate policies, geopolitical tensions, and sector-specific performance in both U.S. and international markets [3][4][11]. Market Performance - U.S. stock indices showed mixed results with the Dow Jones down 0.65%, S&P 500 down 0.05%, and Nasdaq up 0.13% [4][8]. - European indices faced declines, with Germany's DAX30 down 0.69%, UK's FTSE 100 down 1.11%, and the Euro Stoxx 50 down 0.85% [4][8]. - Hong Kong's Hang Seng Index fell 1.85%, closing at 26,572.46 points, with significant declines in technology stocks [5][8]. - A-shares also declined, with the Shanghai Composite Index down 0.97%, closing below 4,000 points [6][9]. Commodity Prices - WTI crude oil prices rose by 2.13%, closing at $59.82 per barrel, while Brent crude increased by 0.22% to $63.95 per barrel [4][8]. - Gold prices fell by 2.2%, ending at $4,079.58 per ounce, and silver dropped by 3.4% to $50.56 per ounce [8][9]. Federal Reserve Signals - Federal Reserve officials, including Logan and Schmidt, issued strong hawkish signals, indicating that further rate cuts may not be appropriate at this time [11]. - The market is reacting to these signals, with expectations of interest rate stability impacting various asset classes [11]. Corporate Developments - Berkshire Hathaway disclosed a rare technology stock position, having built a stake in Alphabet, Google's parent company, during Q3 [11]. - Huawei is expected to announce breakthrough technologies in the AI sector, which could enhance computational resource efficiency [17].

Market Performance - The Hang Seng Index increased by 1.26% this week, closing at 26,572.46 points, while the Tech Index decreased by 0.42% to 5,812.80 points, and the National Enterprises Index rose by 1.41% to 9,397.96 points [2][4]. Market Dynamics - The fluctuations in the Hong Kong stock market are closely related to external environments, particularly the impact of the U.S. government shutdown, which temporarily locked nearly one trillion dollars in liquidity, raising the cost of dollar funds and pressuring risk assets like U.S. and Hong Kong stocks [4]. - A recent report from Western Securities suggests that the end of the U.S. government shutdown may release previously "frozen" dollar liquidity, potentially leading to a liquidity-driven rally in the Hong Kong stock market [4]. Capital Inflows - Southbound capital has provided strong support, with net purchases through the Stock Connect exceeding HKD 1.3 trillion this year, totaling over HKD 5 trillion, indicating a shift towards a "semi-onshore market" where domestic capital plays a more significant role in pricing [4]. Sector Performance - Pharmaceutical stocks have seen renewed interest, with notable gains: - Gilead Sciences (01672.HK) up 45.40% - Clover Biopharmaceuticals (02197.HK) up 29.95% - Yummy (02589.HK) up 18.81% - The positive performance is attributed to strong Q3 results in innovative drugs and life sciences sectors [5]. - Other notable performers include: - HuShang Ayi (02589.HK) up 31.44% due to a new ten-year H-share incentive plan and reaching over 10,739 stores [5]. - Lee & Man Paper (00746.HK) up 17.37% benefiting from rising paper prices [5]. - Conversely, companies like Sanhua Intelligent Control (02050.HK) and Legend Holdings (06683.HK) faced declines of 10.93% and 19.82%, respectively, due to market risk aversion and concerns over equity dilution from a recent share placement [5]. Gold and Automotive Sectors - Gold stocks weakened following hawkish comments from Federal Reserve officials, with China Gold International (02099.HK) down 3.94% and Zijin Mining (02899.HK) down 2.94% [6][7]. - The automotive sector also faced declines, with Xpeng Motors (09868.HK) down 6.80% amid a drop in retail sales of passenger cars by 19% year-on-year for the first nine days of November [10][11]. Brokerage and Semiconductor Stocks - Chinese brokerage stocks adjusted, with major firms like GF Securities (01776.HK) and China Galaxy (06881.HK) experiencing declines due to a significant drop in new account openings [13]. - Semiconductor stocks also fell, influenced by a broader sell-off in U.S. tech stocks, with Shanghai Fudan (01385.HK) down 5.92% and SMIC (00981.HK) down 2.78% [14][16]. Individual Stock Movements - Lehua Entertainment (02306.HK) rose nearly 8% amid speculation regarding a contract renewal with a prominent artist [18]. - Zhonghui Biopharmaceuticals (02627.HK) increased by over 6% after announcing the initiation of Phase I clinical trials for its flu vaccines [19].