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 ...