诺和诺德、诺华、强生、默沙东等“集体豪赌”，口服生物药这么难还要砸？

MedTrend医趋势02-27

一周之内，两笔跨国大交易，把同一个赛道推到了聚光灯下。2月25日，诺和诺德宣布与麻省理工学院传奇科学家Robert Langer实验室分拆公司Vivtex达成深度合作，交易总额最高达21亿美元，共同开发下一代代谢类药物的口服递送技术。几天前的2月18日，诺华以1亿美元首付款、潜在总金额超17亿美元，与加州生物科技公司Unnatural Products（UNP）签约，押注其AI驱动的大环肽平台，...

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Products（UNP）签约，押注其AI驱动的大环肽平台，用于心血管疾病口服新药研发。金额合计近40亿美元，两家MNC巨头，在同一周内押注同一方向——口服生物药。长期以来，蛋白和多肽类药物因易被胃酸降解、肠道吸收率极低，只能通过注射给药。谁能解决吸收率问题，谁就可能重构整个生物药市场的入口逻辑。2019年，诺和诺德Rybelsus（索马鲁肽）在美获批上市，成为全球首个口服GLP-1受体激动剂。截至2025年底，其累计销售额已突破百亿美元量级，足以证明口服生物药的巨大潜力。但Rybelsus并非完美产品。仅约1%的生物利用度、必须空腹服用、每日一次且严格限水的用药方式，使其在体验层面始终无法与“一周一针”的注射剂型竞争。这或许也是诺和诺德愿意为下一代递送技术支付21亿美元的根本原因——如何将吸收率从1%提升至5%甚至10%从技术演进周期来看，2026年或许正处在口服生物药“规模化爆发前夜”。中国并未缺席，当前国内已有至少15家企业布局口服GLP-1制剂研发，从分子改造到吸收增强剂再到新型递送系统，不再只是简单的跟随者。01口服生物药的诱人果实从“必须注射”到“可以吞服”“生物药”通常指由复杂大分子构成的治疗产品，包括治疗性蛋白、多肽、单克隆抗体、抗体偶联药物以及反义寡核苷酸等。它们是过去二十年创新药产业的核心引擎，也支撑起糖尿病、自身免疫病、肿瘤和心血管等多个万亿级慢病市场。但它们有一个共同的局限——几乎都依赖注射。自20世纪20年代胰岛素被发现以来，科学家一直梦寐以求将其制成口服药片。然而，人体的消化系统从进化之初就是为了“分解蛋白质”而存在的。第一道屏障来自胃部。pH值1–2的强酸环境，加上大量蛋白酶，会像处理食物一样迅速分解生物大分子，使其在到达吸收位点之前就失去活性。第二道屏障更为顽固。即便部分分子幸存进入小肠，巨大的分子量也几乎无法穿透肠上皮细胞之间的紧密连接结构进入血液循环。人体本能地阻止大分子进入体内，这是生理保护机制。因此，口服生物药长期面临一个残酷现实：生物利用度通常不足1%。例如，目前已经上市的Rybelsus的系统吸收率约为1%；Mycapssa（口服奥曲肽）甚至不足0.7%。在药代动力学的语境下，这几乎意味着“绝大多数药物被浪费”。技术演进方面，过去十年，行业的突破并非来自单点创新，而是一条逐渐清晰的路径。第一阶段：制剂工程的“妥协式”突破2019年，诺和诺德首度将口服司美格鲁肽Rybelsus推向市场，其关键在于SNAC吸收增强技术，通过在胃部形成局部微环境，提高多肽穿透能力。为了彻底锁定这一核心递送平台，诺和诺德在2021年斥资约18亿美元收购Emisphere Technologies。然而这一阶段的本质是工程优化，而非范式改变。吸收率仍低，服用条件严格，剂量成本高。行业开始寻找更底层的解决方案。第二阶段：分子层面的重构——大环肽崛起与其在制剂层面“保护”分子，不如从源头设计“更适合口服”的分子。大环肽（Macrocycle）因此成为新一代热点。它们在结构上兼具抗体的高特异性与小分子的部分通透性潜力，尺寸恰到好处，比小分子大，又比抗体小，理论上可以穿透细胞膜实现口服。在这一方向上，2025年多个项目进入审批上市阶段：强生从Protagonist授权的IL-23R拮抗肽icotrokinra已完成三期临床，结果显示，治疗第16周，相比于安慰剂组，Icotrokinra组患者银屑病面积及严重指数至少改善90%比例更高（49.6% vs. 4.4%），实现研究者总体评估评分为0分或1分（IGA 0/1）的比例也更高（64.7% vs. 8.3%）。默沙东开发的口服PCSK9抑制剂Enlicitide治疗高血脂症的两项 III 期研究达到了主要终点，该药不仅能在24周内显著降低“坏胆固醇”约60%，且疗效在一年观察期内持续稳定。超过67.5%的患者达到指南推荐的严格降脂目标。与此同时，AI分子设计平台成为资本追逐的新核心。2025年7月，Argenx与UNP达成超过15亿美元的合作，旨在攻克免疫领域“不可成药”的靶点。今年2月，诺华与UNP达成了总额最高超17亿美元的协议，专注研发心血管疾病的大环肽口服药；同月，诺和诺德再度出手，与Vivtex签署最高21亿美元的合同，继续强化递送平台。这些交易的核心逻辑已经非常清晰：利用AI筛选具备高通透性的“原生口服分子”，从而规避传统蛋白药物易被酶解和吸收率低的顽疾。第三条路径：物理学解法——可吞服注射器除了化学结构创新，还有一条更加“硬核”的路径——机械递送。例如Rani Therapeutics开发的RaniPill机器人胶囊，患者吞服后，胶囊完整通过胃部，在小肠内通过内置微型“机器人”结构完成一次无痛经肠壁注射，将生物药直接注入肠壁组织，从而绕开胃酸和消化酶的破坏。临床前和早期临床数据显示，其生物利用度可接近或优于皮下注射。来源：Rani Therapeutics总体而言，口服制剂无需冷链运输，不依赖医疗机构给药，在患者依从性与供应链成本上对注射剂形成天然优势。基于诺和诺德口服减重药的获批，IQVIA已将2026年定义为“The Year of Orals”。高盛预测，到2030年口服减重药将占据接近四分之一的市场份额。但更大的潜力在慢病领域。注射的不便显著限制了渗透率，若口服剂型获批，市场扩容并非简单增长，而可能出现结构性跃升。02中国：从“跟跑仿制”到“平台输出”的拐点时刻当全球巨头通过大环肽、AI分子设计和创新递送系统重塑竞争格局时，中国创新药产业也在发生一次更深层的位移。从“热门靶点”到“新兴模态”：买平台，而不是买单品今年3月，北京元思生肽宣布与阿斯利康达成战略合作。交易结构包括7500万美元首付款、最高34亿美元的里程碑金额以及股权投资，授权其Synova™大环肽高通量筛选平台。这笔交易的意义，并不在某一个具体项目，本质是一次“平台能力输出”。其底层思路与UNP高度相似——利用AI贯穿大环肽的设计、筛选、优化全流程，专门针对传统小分子和抗体难以触达的“不可成药”靶点。摩熵医药数据显示，国内多家制药企业在布局环肽平台，包括一些初创新药公司GLP-1 赛道的“大分子口服”实战当前最现实的口服生物药竞技场仍然是GLP-1。在代谢赛道，中国企业正围绕“吸收率”“成本结构”“给药便利性”展开一场工程学竞争。其中，先为达是国内最早推进口服GLP-1临床的企业之一。其OralVantage™平台通过增强分子稳定性解决酶解问题，在一期数据中实现6周减重6.8%。更关键的是，其未简单复制SNAC钠盐路线，而探索PNAC钾盐及递送协同体系。这意味着中国企业已不再停留在“复制方案”，而是在做系统优化。此外，2024年11月，北京质肽生物口服GLP-1多肽ZT006获得国内I期临床批件，其口服多肽技术平台名为QLOral， 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