口服GLP-1成热门赛道！华东医药、信达生物、德睿智药、恒瑞医药等加速竞逐

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随着肥胖、2型糖尿病等代谢性疾病的高发，GLP-1(胰高血糖素样肽-1)受体激动剂凭借优势成为医药领域的热门赛道。相较于传统注射剂型，口服GLP-1药物因便利性更受市场青睐，成为药企布局的核心方向。当前，国产口服GLP-1研发势头强劲，全球在研国产药物超20款，多款产品推进至临床关键阶段，部分实现海外授权突破，中国创新药企正逐步打破海外垄断，在市场中抢占先机。在国产口服GLP-1管线中，华东医药、...

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Huadong Medicine, Innovent Biologics, Derui Zhiyao, Hengrui Medicine, etc. accelerate competition","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01276":1.5,"01801":1.5},"content_text":"随着肥胖、2型糖尿病等代谢性疾病的高发，GLP-1(胰高血糖素样肽-1)受体激动剂凭借优势成为医药领域的热门赛道。相较于传统注射剂型，口服GLP-1药物因便利性更受市场青睐，成为药企布局的核心方向。当前，国产口服GLP-1研发势头强劲，全球在研国产药物超20款，多款产品推进至临床关键阶段，部分实现海外授权突破，中国创新药企正逐步打破海外垄断，在市场中抢占先机。在国产口服GLP-1管线中，华东医药、信达生物、德睿智药、恒瑞医药等企业的产品进度较快。其中，华东医药口服小分子 GLP-1 受体激动剂 HDM1002片用于超重或肥胖人群的体重管理适应症的新药临床试验已进入临床II期阶段。资料显示，HDM1002片是华东医药自主研发并拥有全球知识产权的1类化药新药，是具有口服活性、强效、高选择性的 GLP-1 受体小分子完全激动剂。其糖尿病适应症已于2023年5月首获中美双IND批准，并于2023年6月初实现头例受试者用药(FIH)。肥胖适应症的中国IND申请最早于2023年9月获批，现已迈入临床II期阶段。而信达生物研发的创新口服小分子胰高血糖素样肽-1受体(GLP-1R)激动剂IBI3032的IND已经获得中国国家药品监督管理局(NMPA)受理和美国FDA批准。资料显示，IBI3032是一种新型口服小分子胰高血糖素样肽-1受体激动剂(GLP-1RA)。通过高效特异性靶向激活GLP-1R，引发级联信号转导，从而延缓胃排空、抑制食欲、促进胰岛素分泌，达到治疗肥胖、2型糖尿病等胰岛素相关代谢疾病的目的。IBI3032通过基于结构的药物设计(SBDD)策略开发，结合系统性的理化性质优化，临床前数据显示其具有同类更优的药代动力学和物理化学特性，在动物模型上，相同剂量下口服暴露量是同类产品的5至10倍，在GLP-1R KI DIO小鼠模型和肥胖食蟹猴中展现出更出色的疗效，且耐受性良好，更低剂量下即可达到同等效力。德睿智药已启动其自主研发的AI辅助设计小分子GLP-1受体激动剂MDR-001的Ⅲ期中国临床试验MOBILE，也是中国头个进入Ⅲ期临床的AI创新药。如果顺利，这款口服减肥新药，将于2028年底或2029年初上市。据悉，2025年6月，德睿智药公布了一项新药临床实验数据，MDR-001在为期24周的二期临床试验中，显示出减重效果。317名受试者，平均体重约90公斤。结果发现，用药24周后，受试者体重平均下降幅度达到10.3%。在医学上，通常将用药12周后体重下降超过5%作为药物有效的早期标志。这意味着，MDR-001的疗效已明显超过这一标准。值得一提的是，这是中国头一个人工智能设计(AIDD)的药物分子进入Ⅲ期确证性临床研究试验。在此之前，虽然AI新药设计的概念一直是行业热点，但是这个细分赛道的交付成果长期停留在临床前候选化合物(PCC)或早期临床阶段，一直面临着缺乏实质性的后期管线的尴尬。德睿智药的这款AI设计的小分子药物MDR-001，仅用时四年半，便推进至Ⅲ期临床，这不仅是德睿智药的关键里程碑，更是中国AI制药领域的重大突破，充分展现了德睿智药在AI新药研发方向的硬核实力。此外，恒瑞医药的口服小分子GLP-1受体激动剂HRS-7535片进度也较快，2026年1月28日其宣布，其子公司山东盛迪医药有限公司于近日收到国家药监局核准签发的《药品临床试验批准通知书》，同意公司自研1类创新口服小分子GLP-1受体激动剂HRS-7535片开展用于高血压合并超重或肥胖适应症的Ⅲ期临床研究。当前，全球GLP-1市场竞争日趋激烈，而国产药企凭借差异化研发，正逐步崛起。同时，已有多款国产GLP-1药物达成海外授权，彰显了国产创新药的国际认可度。随着临床研究的持续推进，国产口服GLP-1药物有望惠及更多代谢性疾病患者。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2610893956","isCrawlerRequest":true}