在Ib期研究中，未报告任何严重不良事件(SAE)，亦未观察到3级或以上不良事件(AE)。经100毫克 ASC30治疗的肥胖受试者中，GI相关AE较少且仅为1级。未出现肝酶(包括丙氨酸氨基转移酶(ALT)、天 冬氨酸氨基转移酶(AST)及总胆红素 (TBL))升高。实验室检查、生命体征、ECGs(心电图，包括按心率 校正的QT间期(QTc))和体格检查均未有异常。 ASC30超长效皮下注射储库型制剂展现出与剂量呈比例的药代动力学特征，可同时支持减重治疗和维持 疗法。同为利用歌礼ULAP开发的ASC30用于减重治疗的超长效皮下储库型制剂，作为每月一次减重治 疗疗法，目前正在美国开展IIa期研究 (NCT06679959)，受试者为肥胖人群(BMI ≥ 30 kg/m )或伴有至少 一种体重相关合并症的超重人群(27 kg/m2 ≤ BMI < 30 kg/m2 )。预计于2026年第一季度获得 ASC30减重 治疗制剂IIa期研究的顶线数据。ASC30减重治疗制剂在肥胖受试者中表现出46天的表观半衰期，支持 每月给药一次治疗肥胖症。 基于小分子、多肽和蛋白质╱抗体的特性，歌礼可通过其专有的ULAP技术设计皮下储库 ...

格隆汇9月9日｜歌礼制药-B公告，小分子GLP-1R激动剂ASC30用于减重维持的超长效皮下储库型制剂 在美国Ib期临床研究中，在肥胖受试者中显示出75天的表观半衰期。8名肥胖受试者单次皮下注射 ASC30减重维持制剂(100毫克)后，达到ASC30血药峰浓度的时间为给药后17天(中位数)。给药约75天 后，ASC30血药浓度降至Cmax值的百分之五十，即表观半衰期为75天。良好耐受性支持每季度给药一 次。ASC30是临床进展最快的每季度一次的肠促胰素药物，有望成为长期体重管理的维持疗法。 ...

在Ib期研究中，未报告任何严重不良事件(SAE)，亦未观察到3级或以上不良事件(AE)。经100毫克 ASC30治疗的肥胖受试者中，GI相关AE较少且仅为1级。未出现肝酶(包括丙氨酸氨基转移酶(ALT)、天 冬氨酸氨基转移酶(AST)及总胆红素 (TBL))升高。实验室检查、生命体征、ECGs(心电图，包括按心率 校正的QT间期(QTc))和体格检查均未有异常。 ASC30超长效皮下注射储库型制剂展现出与剂量呈比例的药代动力学特征，可同时支持减重治疗和维持 疗法。同为利用歌礼ULAP开发的ASC30用于减重治疗的超长效皮下储库型制剂，作为每月一次减重治 疗疗法，目前正在美国开展IIa期研究 (NCT06679959)，受试者为肥胖人群(BMI ≥ 30 kg/m²)或伴有至少 一种体重相关合并症的超重人群(27 kg/m2 ≤ BMI < 30 kg/m2 )。预计于2026年第一季度获得 ASC30减重 治疗制剂IIa期研究的顶线数据。ASC30减重治疗制剂在肥胖受试者中表现出46天的表观半衰期，支持 每月给药一次治疗肥胖症。 基于小分子、多肽和蛋白质╱抗体的特性，歌礼可通过其专有的ULAP技术设计皮下储库 ...

ASC30是一款正在临床研究中的小分子GLP-1R偏向激动剂，具有独特和差异化性质，使得同一小分子 同时适用于口服片剂和皮下注射给药成为可能。ASC30是一种新化学实体(NCE)，拥有美国和全球化合 物专利保护，专利保护期至2044年(不含专利延期)。 8名肥胖受试者单次皮下注射ASC30减重维持制剂(100毫克)后，达到ASC30血药峰浓度(Cmax )的时间为 给药后17天(中位数)。给药约75天后，ASC30血药浓度降至Cmax值的百分五十(50%)，即表观半衰期为 75天。 格隆汇9月9日丨歌礼制药-B(01672.HK)公告，小分子GLP-1受体(GLP-1R)激动剂ASC30用于减重维持的 超长效皮下储库型(depot)制剂在美国Ib期临床研究(NCT06679959)的肥胖受试者(体重指数 (BMI)≥30kg/m)中显示出75天的表观半衰期(observedhalf-life)，该数据支持ASC30作为长期体重管理的维 持疗法，每季度给药一次。ASC30减重维持制剂利用歌礼超长效药物开发平台(Ultra-Long- ActingPlatform，ULAP)开发而成。 "减重维持疗法是长期体重管 ...

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。 8名肥胖受試者單次皮下注射ASC30減重維持製劑（100毫克）後，達到ASC30血藥 峰濃度(Cmax)的時間為給藥後17天（中位數）。給藥約75天後，ASC30血藥濃度降 至Cmax值的百分之五十(50%)，即表觀半衰期為75天。 「減重維持療法是長期體重管理中一個重大未滿足的醫療需求，」歌禮創始人、董 事會主席兼首席執行官吳勁梓博士表示，「例如，患者在使用每周一次腸促胰素 （incretin）藥物治療一段時間實現減重目標後，更傾向於轉換為每季度給藥一次 的療法以維持體重。基於包括超長半衰期在內的優越的藥代動力學參數以及良好 的安全性，我們相信ASC30每季度給藥一次的方案有望幫助患者維持體重且不反 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） （股份代號：1672） 自願性公告 歌禮宣佈小分子GLP-1R激動劑ASC30用於減重維持的超長效 皮下儲 ...

来源：滚动播报 香港恒生指数收跌1.12%，恒生科技指数跌1.85%。芯片股普跌，中芯国际、上海复旦跌超6%，华虹半 导体跌超5%；创新药概念股回调，歌礼制药跌超10%，恒瑞医药跌超6%；黄金板块下跌，灵宝黄金、 中国黄金国际跌超7%。 ...

港股创新药概念股持续走低，歌礼制药-B跌超7%，康龙化成、信达生物、凯莱英跌超5%，复星医药、 泰格医药、荣昌生物跌超4%。 ...

Core Viewpoint - The article discusses the upcoming 2025 Shanghai Leading Industries and the 14th Pharmaceutical CEO Forum, highlighting the focus on innovation and global expansion of Chinese pharmaceutical companies [1]. Summary by Sections Event Overview - The event will take place on September 4-5, 2025, at the Mandarin Oriental Hotel in Pudong, Shanghai, featuring nearly a hundred executives from listed companies, including chairpersons, CEOs, and industry leaders [4]. Morning Sessions - The morning session on September 4 will include a keynote speech and several roundtable discussions focusing on topics such as the global expansion of Chinese pharmaceutical companies and the search for the next billion-dollar drug [4][5]. - Notable discussions will include: - "From Local Innovation to Global Leadership: The Era of Chinese Pharmaceutical Companies Going Abroad" [4]. - "The Birth of Big Drugs is the Future of Pharmaceuticals: Finding the Next Billion-Dollar Bomb" [4]. Afternoon Sessions - The afternoon will feature discussions on future disease areas and technologies worth exploring for pharmaceutical assets going abroad, as well as the new cycle of Chinese innovative drugs under global competition [5][6]. - Additional topics will cover advancements in drug development platforms and the emerging field of brain-machine interfaces [6]. TMT Forum - The TMT (Technology, Media, and Telecommunications) forum will also take place, discussing AI's impact on various industries, including gaming and healthcare [7][8]. - Key topics will include AI innovations in mobile internet ecosystems and the future of AI in healthcare [7]. Pharmaceutical Sub-Forum - The pharmaceutical sub-forum will address topics such as ADC technology exploration, probiotic delivery systems, and the future development paths of dual antibodies and XDC [8]. - Discussions will also focus on the integration of medical insurance and the innovative practices in building a multi-level medical security system in China [8].

Core Viewpoint - The company is set to present clinical data for ASC30, an oral small molecule GLP-1 receptor agonist, at the 61st European Association for the Study of Diabetes (EASD) annual meeting in Vienna, Austria, highlighting its potential as a differentiated treatment for obesity [1] Group 1: Clinical Research and Development - ASC30 is currently undergoing a 28-day multiple ascending dose study (NCT06680440) [1] - The drug is characterized as a new chemical entity (NCE) with unique properties that allow for both oral and subcutaneous administration [1] - The compound is protected by patents in the U.S. and globally, with patent protection lasting until 2044, excluding any extensions [1] Group 2: Company Leadership and Vision - Dr. Wu Jinzi, the founder, chairman, and CEO of the company, expressed confidence that the efficacy and safety data presented will position ASC30 as a promising option for obesity treatment [1]

Core Viewpoint - The company, Gilead Sciences-B (01672.HK), will present data on ASC30, an oral small molecule GLP-1 receptor agonist, at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria [1] Summary by Relevant Sections Clinical Data Presentation - The presentation will include findings from a 28-day multiple ascending dose study (NCT06680440) of ASC30, highlighting its superior weight loss effects in obese subjects [1] - The abstract title for the discussion is "ASC30, an oral GLP-1R biased small molecule agonist shows superior weight loss effects in obese subjects: a 28-day multiple ascending dose study" [1] Event Details - The discussion will take place on September 16, 2025, from 12:00 to 13:00 (Central European Summer Time) [1] - The report number for this presentation is 827 [1] Company Perspective - Dr. Wu Jinzi, founder, chairman, and CEO of the company, expressed anticipation for showcasing the clinical data at the EASD meeting, believing that the efficacy and safety data will position ASC30 as a differentiated treatment option for obesity [1]