GLP-1这次真的“卷到头了”

药渡2025-07-16

全球超过30亿超重或肥胖人群构成的庞大市场，让GLP-1类药物成为医药行业最炙手可热的赛道。然而刚落幕的美国糖尿病协会年会（ADA 2025）上，各大药企亮虽然纷纷亮出了自己的家底，却仍然抵不住一个显而易见的事实：GLP-1的时代的故事好像正在走向结尾。MNC竞速时刻MNC在GLP-1减重降糖领域的布局呈现加速态势，核心策略正围绕着技术迭代、靶点创新和全球化合作展开。诺和诺德（Novo ...

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Nordisk）核心产品：司美格鲁肽（注射剂Wegovy/口服版Rybelsus）口服剂型：全球首个提交减重适应症上市申请的口服GLP-1药物，68周减重17.4%。多靶点布局：CagriSema（司美格鲁肽+胰淀素类似物卡格列肽）：III期数据显示68周减重20.4%，计划2026年初提交FDA申请；口服Amycretin（GLP-1R/AMYR双靶点）：I期12周减重13.1%，皮下制剂36周减重24.3%。合作拓展：收购联邦生物“三重激动剂”UBT251全球权益（交易额达20亿美元）。礼来（Eli Lilly）核心产品：替尔泊肽（GLP-1R/GIP双靶点），2025Q1销售额50亿美元。创新组合：Eloralintide（胰淀素类似物）联用替尔泊肽：I期12周减重11.3%，恶心率仅8%；口服小分子Orforglipron：III期40周减重近8%，计划2025年底提交减重申请。肌肉保护：开发bimagrumab（肌肉保留药物），联用替尔泊肽减少肌肉流失。安进（Amgen）超长效制剂：MariTide（胰淀素类似物+GLP-1R激动剂），每4周给药一次（Q4W），旨在解决频繁注射痛点。默沙东（Merck）口服小分子：引进翰森制药HS-10535（临床前阶段），交易总额超20亿美元，瞄准肥胖及心血管代谢疾病。罗氏（Roche）靶向肌肉保护：53亿美元引进Zealand Pharma胰淀素类似物Petrelintide，联合GLP-1药物减少肌肉流失。阿斯利康（AstraZeneca）合作开发：与诚益生物等中国药企合作，布局口服GLP-1小分子药物。中国力量改写全球GLP-1竞争格局中国创新力量正在改写全球GLP-1竞争格局。今年6月，信达生物的玛仕度肽（商品名：信尔美）获国家药监局批准上市，成为全球首款GCG/GLP-1双受体激动剂减重药。华东医药则选择另一条技术路线——口服小分子GLP-1激动剂。7月7日，该公司登记启动HDM1002片的III期临床研究，针对二甲双胍治疗后血糖控制不佳的2型糖尿病患者。这款自主研发的口服制剂已完成体重管理III期首例患者入组，预计明年6月底完成主要指标评估。银诺医药的依苏帕格鲁肽α凭借204小时的全球最长半衰期惊艳ADA 2025舞台（超越司美格鲁肽（168小时）、替尔泊肽（120小时）等国际产品）。在超重/肥胖患者中，其半衰期更延长至256-287小时，支持双周给药方案。临床数据显示，高剂量治疗4周后患者体重下降达8.6公斤，且胃肠道反应未随剂量增加而加剧。除此之外，恒瑞医药、箕星药业、德睿智药等等中国药企在GLP-1减重/降糖领域都有布局。“卷”不动了GLP-1市场的“内卷”已触及天花板，市场饱和度提升与销售增速下滑的迹象日益显著。随着市场饱和（存量用户争夺）、支付限制（医保退潮）、价格血拼（净价持续走低）三重压力下，GLP-1赛道已从“高速扩张”转入“存量厮杀”。随着2026年专利到期以及生物类似药的上市，行业或许面临更残酷的洗牌。诺和诺德2025年Q1整个GLP-1产品线销量环比下降6.2%，主力减肥药Wegovy环比增速从2024年Q3的48.4%骤降至2025年Q1的-12.6%，首次出现负增长。礼来的替尔泊肽（Tirzepatide）虽同比增165%，但环比增速仅为13%，且增长主要依赖新上市产品Zepbound，糖尿病用药Mounjaro在美国本土增长已然处于停滞状态。美国PBM（药品福利管理机构）主导的“独家替代”策略激化竞争，CVS宣布2025年7月起将礼来Zepbound剔除优先目录，仅保留诺和诺德Wegovy；而麻州Medicaid则反向排除Wegovy，仅覆盖Zepbound。根据2025年初数据显示，目前全球处于临床试验阶段的GLP-1相关管线高达179个，仅中国申报临床的GLP-1类新药就已超过了50个。与此同时，国产仿制药定价预计比原研低30%-50%，更加挤压了利润空间。总结当“周制剂”与“口服版”的迭代速度超过患者增长的速度，当“药王”之争从实验室烧到医保目录，GLP-1赛道终究走到了自己的“诺曼底时刻”。GLP-1从来不缺乏争议，但争议的焦点早已从“谁能颠覆胰岛素”变成了“谁还能留在牌桌”。药渡媒体商务合作媒体公关 | 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