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Novo's Wegovy Gets Express Lane: 7.2mg Dose Could Reshape the Obesity Drug Wars

Novo Nordisk just dropped a power move—向FDA提交申请,要把Wegovy的剂量干到7.2mg。听起来没啥区别?但数据说话:STEP UP研究显示,打这个高剂量的人平均减重20.7%,而现有最高剂量(2.4mg)只有17.5%。更猛的是,33.2%的人减重超过25%,这在肥胖症治疗里是个不小的数字。

关键来了——Novo用了FDA的"Commissioner’s National Priority Voucher"(CNPV),直接把审查时间从10-12个月压到1-2个月。这个加急通道一般是留给救命药的,但肥胖症现在被列为高未满足需求疾病。同样的套路,Eli Lilly也给orforglipron(新一代GLP-1)搞到了CNPV。

市场现状:肥胖药市场预计2030年破百亿美元。Novo和Eli Lilly现在是两大巨头,Wegovy vs Zepbound就像新的iPhone vs Android战争。但竞争在升温——Pfizer花10亿美元买了Metsera,拿到四个在研肥胖症管线。Viking Therapeutics的VK2735也在跑后期临床。

坏消息是NVO股价今年暴跌43%,对标行业涨19%。另外联邦医保谈判砍了NVO的semaglutide系列产品价格71%,从list price降到每月274美元。

总结:Novo在押宝高剂量和口服版本(oral Wegovy有望年底前获批),Eli Lilly则全面布局下一代小分子GLP-1。这场肥胖症药物竞赛刚进入真正的加速期。

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