Group 1 - The Hong Kong biotechnology sector experienced a widespread decline, with notable drops in several companies' stock prices [1] - Specifically, Gilead Sciences-B fell over 13%, while Sanofi-B dropped more than 10% [1] - Other companies such as Crystal Technology Holdings and Hualing Pharmaceutical-B also saw declines exceeding 6% [1] Group 2 - Gilead Sciences-B's latest price is 11.750, with a market capitalization of 116.56 billion and a year-to-date increase of 290.37% [2] - Sanofi-B's latest price is 7.000, with a market capitalization of 7.44 billion and a year-to-date increase of 102.31% [2] - Crystal Technology Holdings has a latest price of 9.330, a market capitalization of 401.48 billion, and a year-to-date increase of 56.02% [2] - Hualing Pharmaceutical-B's latest price is 3.230, with a market capitalization of 34.13 billion and a year-to-date increase of 121.23% [2] - Other companies like Wangshan Wangshui-B and Sanleaf Biotech-B also reported significant declines, with year-to-date increases of 123.25% and 920.75% respectively [2]

Group 1 - The Hong Kong biotechnology sector is experiencing a decline, with notable drops in stock prices for several companies [1] - Gilead Sciences (01672.HK) has seen a decrease of over 13% [1] - Other companies such as Clover Biopharmaceuticals (02197.HK), WuXi AppTec (02359.HK), BeiGene (06160.HK), and CanSino Biologics (06185.HK) also reported declines, with Clover down over 4% [1]

Core Viewpoint - The Hong Kong pharmaceutical stocks experienced a significant downturn, with notable declines in several companies' stock prices [1] Group 1: Company Performance - Gilead Sciences (歌礼制药-B) saw a drop of over 8% in its stock price [1] - Sanofi (圣诺医药-B) experienced a decline of more than 6% [1] - Deciphera Pharmaceuticals (德琪医药-B) fell by over 4% [1] - Other companies such as Innovent Biologics (复宏汉霖) and Antengene Corporation (药捷安康-B) also followed the downward trend [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 | | | 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 ...

Core Insights - The article highlights the clinical development of ASC37, a novel oral GLP-1R/GIPR/GCGR triagonist peptide by Gilead Sciences, showcasing its significant pharmacokinetic advantages over existing treatments [5][7]. Group 1: Drug Development - ASC37 has entered clinical development as of November 30, with a notable oral bioavailability of 4.2%, which is approximately 9 times, 30 times, and 60 times higher than semaglutide, tirzepatide, and retatrutide, respectively [5]. - The drug's development leverages Gilead's two core technology platforms: AI-assisted drug discovery and enhanced oral peptide delivery technology [5]. - In non-human primate studies, ASC37 demonstrated an average apparent half-life of about 56 hours, supporting once-daily or even less frequent dosing [7]. Group 2: Efficacy and Exposure - ASC37 exhibited a drug exposure level (measured by area under the curve) approximately 57 times greater than that of retatrutide, indicating a higher amount of active substance entering systemic circulation for enhanced efficacy [7]. - The drug's activity levels in activating GLP-1R, GIPR, and GCGR receptors were approximately 5 times, 4 times, and 4 times higher than retatrutide, respectively [5]. Group 3: Regulatory Plans - Gilead plans to submit a new drug clinical trial application for ASC37 to the FDA for obesity treatment in the second quarter of 2026 [7].

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 ...

Group 1 - The core point of the article highlights the significant acquisition by Pfizer of Metsera for approximately $9.2 billion, which includes key assets MET-097i and MET-233i [1] - The article mentions that Eli Lilly and Novo Nordisk are also actively developing long-acting platforms, with strategic collaborations established with Camurus and Ascendis by 2025 to utilize their FluidCrystal and TransCon subcutaneous depot technologies for developing long-acting weight loss and glucose-lowering products [1] - Open Source Securities reports that as more clinical data is disclosed, the value of long-acting pipelines and technology platforms will become increasingly evident, predicting that new long-acting therapies will represent the most differentiated competitive direction in the weight loss and glucose-lowering market [1] Group 2 - The article notes that various technologies such as antibody-drug conjugates, fatty acid end-group modifications, and subcutaneous depot controlled-release can achieve long-acting administration, with Singularity Pharmaceuticals having developed multiple long-acting weight loss drug pipelines using its subcutaneous depot ULAP technology platform [1]

Core Viewpoint - Pfizer has successfully completed the acquisition of Metsera for approximately $9.2 billion, gaining access to key assets MET-097i and MET-233i, indicating a strategic move in the long-acting weight loss and diabetes treatment market [1] Company Developments - The stock price of Gilead Sciences-B (01672) has increased by 6.25%, reaching HKD 14.46, with a trading volume of HKD 39.59 million [1] - Gilead has developed a subcutaneous reservoir technology platform (ULAP) for long-acting weight loss drugs, positioning itself in the competitive landscape of obesity and diabetes treatments [1] Industry Trends - Eli Lilly and Novo Nordisk are also actively pursuing long-acting platforms, having formed strategic partnerships with Camurus and Ascendis to develop long-acting weight loss and diabetes products by 2025 [1] - Open Source Securities predicts that the value of long-acting pipelines and technology platforms will become more apparent as clinical data is disclosed, suggesting that long-acting therapies will be a key differentiator in the weight loss and diabetes treatment market [1] - Various technologies such as antibody-drug conjugates, fatty acid end-modification, and subcutaneous reservoir sustained-release methods are expected to enable long-acting drug delivery [1]