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Back中新健康｜伏美替尼全球III期临床试验不达标？艾力斯市值蒸发超百亿
中新健康｜伏美替尼全球III期临床试验不达标？艾力斯市值蒸发超百亿
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中国新闻网2 hours agoHealth3 min readChinaView translation

中新健康｜伏美替尼全球III期临床试验不达标？艾力斯市值蒸发超百亿

艾力斯伏美替尼FURVENT

Quick Look

艾力斯发布公告称其核心产品伏美替尼全球III期临床试验(FURVENT)未达到主要研究终点，导致股票连续两日大跌，市值蒸发超100亿元。尽管国内销售占总营收98.7%，但海外临床失败冲击其出海叙事和里程碑付款预期，凸显创新药出海的不确定性。

AI-generated summary

Why It Matters

艾力斯是一家以伏美替尼为核心产品的创新药企，该药2021年获批上市，国内已获批三个适应症，2025年营收中伏美替尼占比达98.7%。公司曾将伏美替尼在大中华区以外的全球权益独家授权给美国ArriVent BioPharma，对价包括首付款和里程碑付款。

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中新网北京10月11日电(罗春昊)一纸公告，让一家药企市值蒸发超百亿元。

10月8日，上海艾力斯医药科技股份有限公司(下称：艾力斯)发布一则公告，其核心产品伏美替尼的一项全球III期临床试验(FURVENT)，“未达到主要研究终点”。

传导至资本市场，10月8日，艾力斯股票跌停(跌幅20%)，单日市值蒸发超100亿元。10月9日，艾力斯继续大跌7.57%，两个交易日市值减少130.86亿元。

反应如此剧烈，全球III期临床数据“未达标”，这对艾力斯来说，意味着什么？还要先从“伏美替尼”这一靶向药说起。

伏美替尼，是一款主要用于治疗表皮生长因子受体(EGFR)突变阳性非小细胞肺癌(NSCLC)的靶向药，由艾力斯自主研发，2021年上市，国内已获批三个适应症。根据艾力斯2025年年度报告，当年，公司实现营业总收入51.87亿元，其中伏美替尼销售收入51.20亿元，约占总营收的98.7%。

在创新药领域，当很多创新药企还在喊着商业化变现难，研发成本收不回来时，艾力斯凭借约1800人的营销团队，2026年上半年实现归母净利润15.41亿元。

当前，艾力斯的销售收入主要来自国内市场，海外市场开拓情况，还要取决于海外临床试验进展。数月前披露的艾力斯半年报显示，2026年上半年公司实现营收33.20亿元，而伏美替尼全年销售有望冲击65亿元。

然而这份临床试验结果，直接给艾力斯的出海叙事踩了脚刹车。

国内一年卖出几十亿，为何海外“未达标”？

从伏美替尼当前公布的适应症来看，此次海外“未达标”的是用于EGFR 20外显子插入突变NSCLC一线治疗的适应症，并不代表“伏美替尼”靶向药本身有问题。

艾力斯对这项研究一直寄予厚望，后续还要看完整数据集分析及与监管沟通的结果。

图：艾力斯核心产品及临床研发管线。来源：艾力斯2026半年报

艾力斯发布的公告显示，此次由盲态独立中心审评(BICR)评估的无进展生存期(PFS)是该临床试验的主要终点。在伏美替尼240mg高剂量组中，患者的中位PFS为11个月，而作为对照的化疗组为9.5个月，风险比(HR)为0.75。

公告同时称：在研究者评估的PFS和BICR评估的经确认客观缓解率(ORR)等次要终点上观察到了临床获益；尽管总生存期(OS)数据尚未成熟，已经观察到明显的改善趋势。

然而，BICR评估的PFS未达主要研究终点，这一结果对艾力斯仍是不小的冲击。

全球Ⅲ期数据“未达标”，对抗癌明星药企影响几何？

从竞争格局来看，迪哲医药的舒沃替尼已在中美推进商业化，并用一场成功的全球Ⅲ期抢下一线治疗指南席位；强生的双抗联合化疗早已拿到FDA一线正式批准，甚至可以交出成熟的总生存数据。对艾力斯来说，出海的希望曾押在FURVENT数据上。

其次是里程碑付款，最终能拿到多少的问题。

2021年6月，艾力斯便将“伏美替尼”在大中华区(中国大陆及港澳台)以外的全球权益独家授权给美国药企ArriVent BioPharma，对价包括4000万美元首付款、累计不超过7.65亿美元里程碑款加销售提成及部分股权。

截至2026年6月30日，艾力斯累计收到的里程碑付款为约1000万美元。据公开报道，这1000万美元只是协议中最高7.65亿美元里程碑付款里已兑现的部分，其余绝大部分都还没达到支付条件。

针对此临床试验数据，10月9日，上证报从艾力斯获悉，公司商业化推广及伏美替尼针对EGFR PACC突变一线治疗的全球Ⅲ期都在顺利推进。FURVENT研究数据有待深入分析，以确定后续开发及监管沟通方案。

与其他创新药出海案例相比，伏美替尼并非尚无营收的“新药”，而是已在国内完成商业化验证、持续贡献现金流的成熟产品；但即便“家底”更厚，新适应症在海外的III期数据“未达标”，仍让创新药出海的不确定性再次凸显。

医药魔方数据显示，2025年中国创新药BD出海交易总金额达1356.55亿美元。另据SRS Acquiom数据，截至2025年的生物制药BD交易中，到期的里程碑数量共609项，仅136项达成里程碑付款，达成率仅为22%。按金额计算，全球BD交易临床前里程碑的兑现率约为55%，到临床III期已降至12%，商业化阶段仅为5%左右。(完)

What to Watch

AI outlook — possibilities, not facts

  • 艾力斯将在未来几个月内公布FURVENT试验的完整数据集并与监管机构沟通，以确定后续开发方案

    Likely · Within months

  • 艾力斯股价在短期内将继续承压，但若后续数据显示有积极趋势或公司成功推进其他适应症，可能出现反弹

    Possible · Within weeks

Open Questions

  • 完整的FURVENT试验数据何时公布？
  • 艾力斯是否会就该临床试验结果与监管机构进行进一步沟通？
  • 此次未达标是否会影响艾力斯与ArriVent的合作协议？
  • 公司是否有其他备用适应症或产品来弥补海外市场的不足？

Related Topics

艾力斯
People罗春昊
Organizations上海艾力斯医药科技股份有限公司迪哲医药强生ArriVent BioPharma
Places北京上海中国美国
Topics伏美替尼FURVENTEGFR非小细胞肺癌临床试验市值蒸发
This article was originally published by 中国新闻网.

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