ASCLETIS(01672)
Search documents
歌礼制药-B:每月一次新一代胰淀素受体激动剂ASC36和每月一次新一代GLP-1R/GIPR双靶点激动剂ASC35的复方制剂进入临床开发阶段
Zhi Tong Cai Jing· 2025-11-12 23:44
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]
歌礼制药-B(01672):每月一次新一代胰淀素受体激动剂ASC36和每月一次新一代GLP-1R/GIPR双靶点激动剂ASC35的复方制剂进入临床开发阶段
Zhi Tong Cai Jing· 2025-11-12 23:41
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]
歌礼制药-B(01672.HK)宣布每月一次新一代胰淀素受体激动剂ASC36和每月一次新一代GLP-1R/GIPR双靶点激动剂ASC35的复方制剂进入临...
Ge Long Hui· 2025-11-12 23:35
Core Viewpoint - The company, Gilead Sciences-B (01672.HK), has announced the initiation of clinical development for its next-generation amylin receptor agonist ASC36 and the dual-target agonist ASC35, both designed for monthly administration, targeting obesity treatment [1] Group 1: Clinical Development - ASC36 and ASC35 are expected to enter clinical trials, with the company planning to submit an Investigational New Drug (IND) application to the FDA in the second quarter of 2026 [1] - The company believes that ASC36 and ASC35 have the potential to achieve more significant weight loss effects in obese populations compared to monotherapy, based on promising preclinical data [1] Group 2: Company Insights - Dr. Wu Jinzi, the founder, chairman, and CEO of the company, highlighted the increasing evidence supporting the company's platform technology in designing, optimizing, and developing multiple long-acting peptide formulations for monthly subcutaneous injection [1]
歌礼制药-B(01672.HK)宣布每月一次新一代胰淀素受体激动剂ASC36和每月一次新一代GLP-1R/GIPR双靶点激动剂ASC35的复方制剂进入临床开发阶段
Ge Long Hui· 2025-11-12 23:24
Core Viewpoint - The company, Gilead Sciences-B (01672.HK), has announced the initiation of clinical development for its next-generation amylin receptor agonist ASC36 and the dual-target GLP-1R/GIPR agonist ASC35 combination formulation, both designed for monthly administration. The company plans to submit an Investigational New Drug (IND) application to the FDA for these treatments aimed at obesity in the second quarter of 2026 [1]. Group 1 - The ASC36 and ASC35 combination formulations are expected to provide more significant weight loss effects in obese populations compared to monotherapy [1]. - The founder and CEO of the company, Dr. Wu Jinzi, highlighted the encouraging preclinical data supporting the potential of these formulations [1]. - The company has demonstrated its capability in designing, optimizing, and developing multiple long-acting peptide injections for monthly subcutaneous administration [1].
歌礼制药(01672) - 自愿性公告 - 歌礼宣布每月一次新一代胰淀素受体激动剂ASC36和每月一...
2025-11-12 23:15
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。 (股份代號:1672) 自願性公告 歌禮宣布每月一次新一代胰淀素受體激動劑ASC36和每月一次新一代 GLP-1R/GIPR雙靶點激動劑ASC35的複方製劑進入臨床開發階段 1 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) - 在非人靈長類動物的頭對頭研究中,每月一次皮下給藥的胰淀素(amylin)受 體激動劑多肽ASC36和每月一次皮下給藥的GLP-1R/GIPR雙靶點激動劑多肽 ASC35複方製劑的藥代動力學特徵與ASC36和ASC35單獨給藥時相當。該複 方製劑利用歌禮專有的超長效藥物開發平台(ULAP)技術開發而成。 - 在頭對頭飲食誘導肥胖 (DIO) 大鼠研究中,ASC36 單藥的減重效果較 eloralintide單藥相對提升約32%,而在頭對頭DIO小鼠研究中,ASC35單藥的 減重效果較替爾泊肽單藥相對提升約71%。 - 在頭對頭 DIO ...
港股歌礼制药-B尾盘涨超7%
Mei Ri Jing Ji Xin Wen· 2025-11-11 07:36
每经AI快讯,歌礼制药-B(01672.HK)尾盘涨超7%,截至发稿,涨7.05%,报11.08港元,成交额5993.81 万港元。 ...
港股异动 | 歌礼制药-B(01672)尾盘涨超7% ASC36进入临床开发阶段 明年二季度将递交IND申请
Zhi Tong Cai Jing· 2025-11-11 07:29
Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a significant stock increase of over 7% following the announcement of its potential "best-in-class" monthly subcutaneous injection amylin receptor agonist, ASC36, as a clinical development candidate [1] Group 1: Company Developments - Gilead has selected ASC36 as a candidate for clinical development, with plans to submit a new drug clinical trial application to the FDA in the second quarter of 2026 for obesity treatment [1] - ASC36 is designed to have a longer apparent half-life and higher bioavailability per milligram of peptide, enabling monthly subcutaneous administration [1] - The CEO, Dr. Wu Jinzi, indicated that ASC36's preclinical characteristics suggest it may achieve best-in-class efficacy and a more patient-friendly dosing titration scheme [1]
歌礼制药-B尾盘涨超7% ASC36进入临床开发阶段 明年二季度将递交IND申请
Zhi Tong Cai Jing· 2025-11-11 07:26
Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 7% following the announcement of a new clinical development candidate, ASC36, which is a potential "best-in-class" once-monthly subcutaneous amylin receptor agonist for obesity treatment [1] Company Summary - Gilead Sciences has selected ASC36 as a clinical development candidate, with plans to submit a new drug clinical trial application to the FDA in the second quarter of 2026 [1] - ASC36 is designed to have a longer apparent half-life and higher bioavailability per milligram of peptide, enabling once-monthly subcutaneous administration [1] - The CEO, Dr. Wu Jinzi, indicated that ASC36's preclinical characteristics suggest it may achieve best-in-class efficacy and a more convenient dosing regimen, potentially leading to superior weight loss effects and a patient-friendly titration scheme [1] Market Activity - As of the report, Gilead Sciences-B's stock increased by 7.05%, reaching HKD 11.08, with a trading volume of HKD 59.9381 million [1]
从突围到引领 18A第一股歌礼制药开启发展2.0时代
Zheng Quan Shi Bao Wang· 2025-11-10 10:18
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]
恒生指数早盘涨0.61% 中国中免大涨超13%
Zhi Tong Cai Jing· 2025-11-10 04:05
Market Overview - The Hang Seng Index rose by 0.61%, gaining 161 points to close at 26,406 points, while the Hang Seng Tech Index increased by 0.12%. The morning trading volume in Hong Kong reached 114.1 billion HKD [1]. Company Highlights - China Duty Free Group (601888) (01880) saw a surge of over 13% as the new duty-free policy in Hainan shows positive effects, with institutions suggesting a potential industry turning point [1]. - Pop Mart (09992) increased by over 6% due to gradual capacity expansion, with management expecting stronger sales performance in Q4 [1]. - Dongyang Sunshine Pharmaceutical (600673) (06887) rose by over 4% as flu activity is on the rise, and institutions are optimistic about the company's innovative pipeline development [1]. - China Liansu (02128) gained over 5% as the company is expected to benefit significantly from urban pipeline upgrades under the 14th Five-Year Plan [1]. - Hou Shang Ayi (02589) increased by over 8% after the company proposed adopting an H-share incentive plan, successfully entering the "10,000-store club" [1]. - Education stocks performed well, with institutions noting overall good performance in the education sector and the potential for AI+ education to enhance valuation. China Education Holdings (00839) rose by 8%, Thinking Academy (01769) by 3.3%, and New Oriental-S (09901) by 3.25% [1]. - Ruipu Lanjun (00666) increased by over 6% as global demand for energy storage remains strong, with the company reporting over 50 GWh of energy storage battery shipments in the first three quarters [1]. - Gilead Sciences-B (01672) rose by over 6% after being included in the MSCI Global Small Cap Index, with significant weight loss effects from ASC30 [1]. - Goldwind Technology (002202) (02208) fell by over 5% as a major shareholder, Harmony Health, plans to further reduce its stake by up to 1%, following a previous reduction at the end of last month [1]. - Robotics concept stocks declined, with DCH Holdings (00179) dropping over 4% and Sanhua Intelligent Controls (002050) (02050) falling over 3% [1].