"这些数据展现了ASC50良好的安全性特征，以及呈剂量依赖性且具有差异化的药代动力学特征，"歌礼 创始人、董事会主席兼首席执行官吴劲梓博士表示，"ASC50作为我们首个通过基于结构的AI辅助药物 发现(ArtificialIntelligence-assisted Structure-Based Drug Discovery，AISBDD)技术开发的免疫学领域口服 小分子候选药物，这些数据令我们感到鼓舞。这些发现突显了ASC50作为同类最佳口服小分子IL-17抑 制剂的潜力。" 格隆汇12月15日丨歌礼制药-B(01672.HK)宣布，ASC50在美国开展的一项随机、双盲、安慰剂对照的I 期临床试验(NCT07024602)取得积极顶线结果，该试验是在健康受试者中进行的单剂量递增(SAD)研 究，旨在评估ASC50的安全性、耐受性、药代动力学及外周循环的白细胞介素-17A(IL-17A)靶向结合特 征。46名健康受试者接受了10毫克、30毫克、100毫克、200毫克、400毫克或600毫克ASC50，或匹配的 安慰剂给药。该研究的目标包括评估安全性、耐受性、药代动力学和靶向结合效果。 ...

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]

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 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 Viewpoint - The company, Gilead Sciences-B (01672), has selected ASC36 as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection amylin receptor agonist for obesity treatment, with plans to submit an IND to the FDA by Q2 2026 [1] Group 1: Product Development - ASC36 is developed using Gilead's AI-assisted drug discovery and long-acting drug development platform technology [1] - The optimized design of ASC36 allows for a longer apparent half-life and higher bioavailability per milligram of peptide, supporting monthly subcutaneous administration with an injection volume not exceeding 1 milliliter [1] - These optimized characteristics are expected to reduce costs in large-scale production [1] Group 2: Market Reaction - Following the announcement, Gilead's stock rose over 4%, specifically by 4.62%, reaching HKD 9.74, with a trading volume of HKD 12.814 million [1]

Core Insights - The company has selected ASC36 as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection amylin receptor agonist for obesity treatment [1][2] - ASC36 is developed using the company's AI-assisted drug discovery and ultra-long-acting drug development platforms, featuring optimized properties for longer half-life and higher bioavailability [1] - The company plans to submit an Investigational New Drug (IND) application to the FDA in Q2 2026 [1] Drug Development and Efficacy - ASC36 has an observed half-life of approximately 15 days in non-human primate studies, which is three times longer than petrelintide, supporting the potential for monthly dosing in humans [2] - In diet-induced obesity rat studies, ASC36 demonstrated a weight reduction of 10.01%, compared to 5.25% for petrelintide, indicating a 91% relative improvement in weight loss efficacy [2] - The optimized characteristics of ASC36 may lead to lower manufacturing costs and improved dosing regimens for patients [2]

Core Viewpoint - The company has selected ASC36 as a promising candidate for clinical development, expected to be submitted for FDA approval in Q2 2026 for obesity treatment [1] Group 1: Product Development - ASC36 is an amylin receptor agonist developed using AI-assisted structure-based drug discovery and ultra-long-acting platform technologies [1] - The optimized design of ASC36 allows for a longer apparent half-life and higher bioavailability per milligram, supporting monthly subcutaneous administration with a volume not exceeding 1 milliliter [1] - The scalability advantages in manufacturing are highlighted, indicating lower production costs for ASC36 [1] Group 2: Clinical Research Findings - 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, supporting its potential for monthly dosing in humans [2] - In diet-induced obesity rat studies, ASC36 achieved a weight reduction of 10.01%, compared to 5.25% for petrelintide, indicating a relative improvement of 91% in weight loss effectiveness [2] - The superior weight loss effect per milligram of peptide may further enhance the cost-effectiveness of ASC36 in large-scale production [2]