整理 | GLP1减重宝典内容团队 「GLP-1俱乐部」覆盖数百位专业人士，构建了围绕GLP-1产业链上下游、覆盖多个板块的专家库，成为了业内顶尖专业人士获取行业真知灼见的首要选择。加入 专家库请添加下方「运营负责人」微信，并提供名片和必要的个人信息。 2025年10月30日，歌礼制药有限公司(香港联交所代码：1672，简称"歌礼")宣布，已选定一款有望成为同类最佳每月一次皮下注射胰淀 素(amylin)受体激动剂ASC36作为临床开发候选药物。歌礼预计将于2026年第二季度向美国食品药品监督管理局(FDA)递交ASC36治疗 肥胖症的新药临床试验申请(IND)。 ASC36是利用歌礼基于结构的AI辅助药物发现(Artificial Intelligence-Assisted Structure-Based Drug Discovery，AISBDD)和超长效药 物开发平台(Ultra-Long-Acting Platform，ULAP)技术自主研发的胰淀素受体激动剂多肽。经设计优化的ASC36实现了更长的表观半衰 期(以血药浓度降至Cmax的50%所需时间计)及更高的每毫克多肽生物利用度，从而支持每月一次皮 ...

消息面上，歌礼制药公布，已选定一款有望成为同类最佳每月一 次皮下注射胰淀素(amylin)受体激动剂 ASC36作为临床开发候选药物。歌礼预计将于2026年第二季度向美国食品药品监督管理局(FDA)递交 ASC36治疗肥胖症的新药临床试验申请(IND)。 智通财经APP获悉，歌礼制药-B(01672)现涨超4%，截至发稿，涨4.62%，报9.74港元，成交额1281.4万 港元。 据悉，ASC36是利用歌礼基于结构的AI辅助药物发现和超长效药物开发平台技术自主研发的胰淀素受体 激动剂多肽。经设计优化的ASC36实现更长的表观半衰期(以血药浓度降至Cmax的50%所需时间计)及更 高的每毫克多肽生物利用度，从而支持每月一次皮下给药，且注射体积不超过1毫升。这些经设计优化 的特性使其在规模化生产中成本更低。 ...

在头对头饮食诱导肥胖(DIO)大鼠研究中(DIO模型已被证实对人体中的疗效具有高度预测性)，给药相同 摩尔浓度的ASC36和petrelintide，ASC36减重达10.01%，petrelintide达5.25%，ASC36的减重效果相对提 升达91%。每毫克多肽的减重效果更优，也可能使ASC36在规模化生产中成本更低。 "我们始终致力於研发创新疗法，以丰富肥胖症及其他代谢性疾病的治疗选择，"歌礼创始人、董事会主 席兼首席执行官吴劲梓博士表示，"ASC36的临床前特性表明，其有望实现同类最佳疗效及每月一次的 给药频率，这些特点可能带来优越的减重效果和更简便、对患者更友好的剂量滴定(titration)方案。" 在头对头非人灵长类动物研究中，ASC36缓释皮下储库型(depot)制剂的平均表观半衰期(observed half- life)约为15天，比petrelintide长3倍，支持ASC36有望在人体中实现每月一次给药治疗肥胖症。 格隆汇10月30日丨歌礼制药-B(01672.HK)宣布，已选定一款有望成为同类最佳每月一次皮下注射胰淀素 (amylin)受体激动剂ASC36作为临床开发候选药物。歌礼 ...

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]

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].

Core Insights - The article highlights the recognition of HAPO Pharmaceutical and its subsidiary Nona Bio for their innovative human-derived heavy chain antibody (HCAb) technology, which addresses the challenges of long development cycles, high costs, and significant risks in the biopharmaceutical industry [1][2] - HAPO's HCAb technology is seen as a key to unlocking the next generation of biopharmaceuticals, with advantages in molecular size, antigen recognition, and tissue penetration [2][4] - The company has established a flexible and diverse business model that enhances its competitive edge, attracting partnerships with major pharmaceutical companies like AstraZeneca and Pfizer [4][5] Technology and Innovation - HAPO's proprietary Harbour Mice platform is a rare human antibody development platform capable of generating both dual light chain (H2L2) and heavy chain (HCAb) monoclonal antibodies [2] - The HCAb Plus™ platform has been developed to support the creation of complex molecules such as bispecific antibodies and antibody-drug conjugates (ADCs) [2][5] - The company has launched an AI-assisted drug discovery engine, Hu-mAtrIx™, to accelerate antibody discovery across various therapeutic areas [7] Business Model and Partnerships - HAPO has successfully engaged in over ten licensing agreements with major pharmaceutical companies, leveraging a License-out model [4] - The NewCo model allows HAPO to deepen collaborations through joint ventures, exemplified by its partnership with Boston Children's Hospital [4] - A notable partnership with AstraZeneca includes a $4.575 billion deal and a $105 million equity investment, marking a shift from single transactions to strategic partnerships [4] Financial Performance - HAPO has achieved profitability in 2023 and 2024, with a reported net profit of approximately 523 million yuan in the first half of the year, reflecting a 51-fold year-on-year increase [5][8] - The company aims to become a global leader in antibody drug development, targeting a growth trajectory similar to that of Regeneron [7][8] Future Goals - HAPO's strategic focus is on "platform monetization + pipeline breakthroughs," with plans to solidify its position as a "new infrastructure" in global antibody drug development [7] - The company has developed over 20 innovative products with differentiated competitive advantages, including the core product HBM9161, which received breakthrough therapy designation from the National Medical Products Administration [7][8]