GLP-1竞争新动向：礼来后来居上？

健识局2025-04-21

就在替尔泊肽与司美格鲁肽减肥药在市场缠斗之际，礼来再放“大招”。4月17日，礼来公布在研小分子口服GLP-1受体激动剂Orforglipron积极的Ⅲ期临床试验结果：在最高剂量下，每日一次的治疗中实现了平均减重7.3kg（7.9%），已达到主要终点。这意味着礼来的首款口服减肥药研发获得初步成功，全球两大GLP-1生产企业都要开始进入口服药的竞争中。当天礼来美股盘中一度涨近17%，收盘涨14.30%...

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4研究完成，至今没有申报等后续进展。这才是礼来新药获得市场强烈关注的根本原因。礼来预计今年年底前将向多个国家的监管机构提交体重管理的上市申请，Ⅱ型糖尿病的治疗适应症则预计在2026年提交申请。先报减重，后报降糖，礼来可能会抄了诺和诺德的后路。GLP-1尽管看来已经接近完美，但依然有很大的不足。在生产上，注射版GLP-1严重依赖专业灌装厂，诺和诺德甚至收购了CDMO公司Catalant，以满足产能；运输储存上，现有GLP-1注射液还不能脱离冷链；使用时候也需要专业医务人员的指导，否则旋钮式的注射笔很容易弄错剂量。口服药就完全规避了以上所有劣势，从诺和诺德、礼来的开发劲头可以看出，今后GLP-1药物的竞争会逐渐从注射剂转到口服制剂上。礼来当然想到了这一层，没有把鸡蛋都放在双靶点、三靶点等注射版的篮子里，部署了很多口服减肥药的管线。2024年，礼来的替尔泊肽的营收达164.7亿美元，只有司美格鲁肽几个版本总营收的一半左右。但替尔泊肽起速很快，正在快速追赶，但要找到新的引爆点就没那么容易了。口服减肥GLP-1可能会成为礼来反超的一张王牌。国际上，辉瑞、阿斯利康、罗氏等都在开发GLP-1类药物，从一天三次，每日一次，到周制剂、月制剂，投资热情不减。国内药企中恒瑞医药、信达生物、华东医药等也都纷纷跟进。目前公开信息显示，恒瑞在3月31日，登记了一款口服GLP-1药物HRS-7535片减重适应症的III期临床研究，算是挤进了口服减肥药的决赛圈。谁能笑到最后？现在还不知道。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"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 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