Core Insights - The company, Gilead Sciences, has announced the initiation of clinical development for its next-generation amylin receptor agonist ASC36 and the dual-target GLP-1R/GIPR agonist ASC35, both designed for monthly administration [1][2] - Gilead plans to submit an Investigational New Drug (IND) application to the FDA for ASC36 and ASC35 in the second quarter of 2026 for obesity treatment [1] Group 1 - ASC36 and ASC35 are developed using Gilead's AI-assisted drug discovery and ultra-long-acting drug development platforms, enabling proprietary formulations for monthly subcutaneous administration [2] - The formulations demonstrate superior physicochemical stability, avoiding aggregation and precipitation issues commonly seen with other amylin receptor agonists at neutral pH [2] Group 2 - In head-to-head studies, ASC36 showed a 32% greater weight loss effect compared to eloralintide in diet-induced obesity (DIO) rats, while ASC35 demonstrated a 71% greater effect compared to tirzepatide in DIO mice [3] - The combination of ASC36 and ASC35 resulted in a 51% greater weight loss effect compared to the combination of eloralintide and tirzepatide in DIO rat studies [3] - The CEO of Gilead expressed optimism about the potential of ASC36 and ASC35 to achieve more significant weight loss effects in obese populations compared to monotherapy, highlighting the company's capabilities in developing long-acting peptide therapies [3]

Core Insights - The company, Gilead Sciences, has announced the clinical development of its next-generation amylin receptor agonist ASC36 and the GLP-1R/GIPR dual-target agonist ASC35, both designed for monthly administration [1][2] - Gilead plans to submit an Investigational New Drug (IND) application to the FDA for ASC36 and ASC35 by the second quarter of 2026 for obesity treatment [1] Group 1 - ASC36 and ASC35 are developed using Gilead's AI-assisted drug discovery and ultra-long-acting drug development platforms, enabling proprietary formulations for monthly subcutaneous administration [2] - The formulations demonstrate superior physicochemical stability, avoiding aggregation and precipitation issues that can weaken efficacy and increase immunogenicity risks [2] Group 2 - In head-to-head studies, ASC36 showed a 32% greater weight loss effect compared to eloralintide in diet-induced obesity (DIO) rats, while ASC35 demonstrated a 71% greater effect compared to teriparatide in DIO mice [3] - The combination of ASC36 and ASC35 resulted in a 51% greater weight loss effect compared to the combination of eloralintide and teriparatide in DIO rat studies [3] - The CEO of Gilead expressed optimism about the potential of ASC36 and ASC35 to achieve more significant weight loss effects in obese populations compared to monotherapy [3]

Core Insights - The article highlights the transformative journey of Gilead Sciences (1672.HK) in the Chinese biotech industry, showcasing its resilience and strategic decision-making in the face of challenges [2][11] - Gilead's shift towards a differentiated pipeline in weight loss drugs has led to a significant market re-evaluation and recovery in its stock price [4][9] Group 1: Company Development - Gilead Sciences was listed on the Hong Kong Stock Exchange in August 2018 at an initial price of 14 HKD, reaching a market capitalization of 16 billion HKD, but faced a decline due to setbacks in its core hepatitis C drug [3][4] - By August 2024, the company's stock price had plummeted to 0.76 HKD, resulting in a market value reduction of over 95% [3][4] - The founder, Dr. Wu Jinzi, demonstrated strategic foresight by pivoting the company's focus to the metabolic disease sector, particularly the weight loss drug market, starting in 2022 [3][5] Group 2: Strategic Shift and Market Response - Following the strategic shift, Gilead's stock price surged from 0.76 HKD in August 2024 to 18.75 HKD by August 2025, representing an increase of over 20 times and restoring its market capitalization to the billion HKD level [4][9] - The market's positive response reflects recognition of Gilead's research team's capabilities and strategic execution [4][9] Group 3: R&D and Competitive Advantage - Gilead has adopted a differentiated approach in drug development, focusing on oral small molecule GLP-1 receptor agonists and ultra-long-acting formulations, rather than following mainstream peptide drug development paths [5][8] - The core pipeline, ASC30, has shown promising clinical results, with a maximum weight reduction of 6.5% in U.S. Phase Ib trials, and is expected to complete Phase IIa trials by the end of the year [5][6] - Gilead is also developing ASC35 and ASC36, which are expected to provide significant advantages in terms of dosing frequency and efficacy compared to existing treatments [6][7] Group 4: Global Competitiveness and Valuation - Despite the stock price recovery, Gilead's current market capitalization is still considered undervalued compared to global peers, as evidenced by recent acquisition bids for similar companies [9][10] - Gilead's diverse pipeline, including multiple formulations with the potential for monthly and quarterly dosing, positions it favorably in the competitive landscape [9][10] Group 5: Lessons and Implications for the Industry - Gilead's successful transformation underscores the importance of strong R&D leadership and strategic vision in navigating industry challenges [11] - The case of Gilead serves as a valuable reference for other Chinese biotech companies seeking to innovate and compete on a global scale [11]

Core Insights - Company announced multiple reports at the 2025 ObesityWeek in Atlanta, Georgia, showcasing the efficacy and safety of its obesity treatment pipeline, including ASC30, ASC31, and ASC47 [1] Group 1: Clinical Research - The complete analysis of the ASC30 oral tablet in Phase Ib trials was presented [1] - A Phase Ib study of ASC30 as a monthly injection was also reported [1] - Preclinical studies on the combination of ASC31 and ASC47 were highlighted [1] Group 2: Technology and Development - The reports emphasize the promising efficacy and safety characteristics of the company's small molecules and peptides for obesity treatment [1] - The proprietary AI-assisted drug discovery platform (AISBDD) and ultra-long-acting drug development platform (ULAP) were validated through these studies [1] Group 3: Strategic Focus - The company is committed to advancing the clinical development of ASC30, ASC31, and ASC47 while engaging closely with strategic partners [1] - The goal is to better meet the treatment needs of obesity patients globally [1]

Core Viewpoint - The announcement highlights the promising efficacy and safety characteristics of the diverse obesity pipeline of the company, showcasing its proprietary AI-assisted drug discovery and ultra-long-acting drug development platforms [1] Group 1: Clinical Research Updates - The company presented multiple reports at the 2025 ObesityWeek in Atlanta, Georgia, including a complete analysis of the ASC30 oral tablet Phase Ib study and the ASC30 monthly injection Phase Ib study [1] - Additionally, the company reported on preclinical studies involving ASC31 and ASC47 combination therapy [1] Group 2: Strategic Focus - The CEO emphasized the ongoing clinical development of ASC30, ASC31, and ASC47 while maintaining close consultations with strategic partners to better meet the treatment needs of global obesity patients [1]

Core Viewpoint - The article discusses the development of ASC36, a novel amylin receptor agonist by the company, which is expected to be a leading candidate for obesity treatment with a monthly subcutaneous injection regimen. The company plans to submit an IND application to the FDA in the second quarter of 2026 [5]. Group 1: Product Development - ASC36 is developed using AI-assisted structure-based drug discovery and ultra-long-acting drug development platforms, resulting in a longer apparent half-life and higher bioavailability per milligram of peptide, supporting monthly administration [5][6]. - The optimized characteristics of ASC36 lead to lower production costs, making it a competitive option in the market [6]. Group 2: Efficacy Studies - In head-to-head studies with diet-induced obesity (DIO) rats, ASC36 demonstrated a weight loss of 10.01%, compared to 5.25% for petrelintide, indicating a 91% relative improvement in weight loss efficacy [7]. - The superior weight loss effect per milligram of peptide may further enhance ASC36's cost-effectiveness in large-scale production [7].

Core Insights - The company has selected ASC36 as a promising monthly subcutaneous injection amylin receptor agonist for clinical development, with plans to submit an IND to the FDA by Q2 2026 [1] Group 1: Product Development - ASC36 is developed using the company's AI-assisted structure-based drug discovery and ultra-long-acting platform technologies, achieving a longer apparent half-life and higher bioavailability per milligram of peptide [1] - The optimized characteristics of ASC36 support monthly subcutaneous administration with an injection volume not exceeding 1 milliliter, leading to cost advantages in manufacturing [1] Group 2: Clinical Research - In head-to-head studies with non-human primates, ASC36 demonstrated an average observed half-life of approximately 15 days, three times longer than petrelintide, indicating potential for monthly dosing in humans [2] - In diet-induced obesity rat studies, ASC36 resulted in a weight reduction of 10.01%, compared to 5.25% for petrelintide, representing a 91% relative improvement in weight loss efficacy [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 歌禮選定同類最佳每月一次皮下注射胰淀素受體激動劑 ASC36進入臨床開發階段 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，已選定一款有望成為同類最佳每月一 次皮下注射胰淀素(amylin)受體激動劑ASC36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ASC36治療肥胖症的 新藥臨床試驗申請(IND)。 | 組別 | 給藥方案 | 相對基線的 | 較petrelintide的 | | --- | --- | --- | --- | | | | 總體重變化 | 減重效果相對提升 | | 服 ...

Core Viewpoint - The company has selected ASC35, a dual-target GLP-1R/GIPR agonist, as a clinical development candidate, expected to submit an IND application to the FDA by Q2 2026 for obesity treatment [1] Group 1: Drug Development and Characteristics - ASC35 is developed using the company's AI-assisted structure-based drug discovery and ultra-long-acting drug development platforms, showing approximately 4 times stronger agonistic activity on GLP-1R and GIPR compared to Tirzepatide [2] - ASC35 has a longer apparent half-life and higher bioavailability per milligram compared to Tirzepatide, allowing for monthly subcutaneous administration with a volume not exceeding 1 milliliter [2] - In non-human primate studies, ASC35's observed half-life is about 14 days, which is 6 times longer than that of FDA-approved Tirzepatide, indicating a potential human half-life of at least 30 days [3] Group 2: Efficacy and Comparative Studies - In diet-induced obesity mouse studies, ASC35 achieved a weight reduction of 33.6%, compared to 19.6% for Tirzepatide, representing a 71% relative improvement in weight loss [4][5] - ASC35 demonstrates superior in vitro agonistic activity, apparent half-life, subcutaneous bioavailability, and weight loss effects compared to Tirzepatide, suggesting it may become a best-in-class obesity therapy [5] Group 3: Strategic Development Plans - The company plans to develop ASC35 as a monotherapy and in combination with other agents for treating metabolic diseases, including obesity and diabetes [6] - ASC35 is intended to be combined with ASC36, an amylin receptor agonist, and ASC47, a THRβ agonist, for treating obesity and metabolic dysfunction-related fatty liver disease [6][7] - The proprietary ULAP technology allows the company to design various release rates for subcutaneous peptides, enhancing clinical efficacy and patient compliance [7]

Core Viewpoint - The company has selected ASC35, a potential best-in-class monthly subcutaneous injection GLP-1R/GIPR dual agonist peptide, as a clinical development candidate, with plans to submit an IND to the FDA by Q2 2026 for obesity treatment [1]. Group 1: Product Development - ASC35 is developed using the company's AI-assisted structure-based drug discovery (AISBDD) and ultra-long-acting platform (ULAP) technologies, showing approximately 4 times stronger agonistic activity on GLP-1R and GIPR compared to Tirzepatide [2]. - ASC35 has a longer apparent half-life and higher bioavailability per milligram compared to Tirzepatide, enabling monthly subcutaneous administration with a volume not exceeding 1 milliliter, which also supports cost-effective large-scale production [2]. Group 2: Preclinical Data - In non-human primate studies, ASC35's depot formulation has an average observed half-life of about 14 days, which is 6 times longer than that of FDA-approved Tirzepatide [3]. - ASC35 demonstrated approximately 80% and 70% higher drug exposure compared to Tirzepatide via intravenous and subcutaneous administration, respectively, suggesting a potential human half-life of at least 30 days based on preclinical data [3]. - In diet-induced obesity (DIO) mouse studies, ASC35 resulted in a weight reduction of 33.6%, compared to 19.6% for Tirzepatide, indicating a relative improvement of 71% in weight loss efficacy [4][5]. Group 3: Strategic Vision - The development of ASC35 reflects the company's commitment to innovation and complements its small molecule drug pipeline for treating obesity and other metabolic diseases [6]. - ASC35 is being developed as both a monotherapy and in combination with other agents, including ASC36 and ASC47, for treating obesity, diabetes, and metabolic dysfunction-related fatty liver disease [6]. Group 4: Technological Advantages - The company's AISBDD and ULAP technologies allow for the design and optimization of multiple long-acting peptides for monthly subcutaneous injection, enhancing clinical efficacy by precisely controlling the release rates of the peptides [7].