mRNA癌症疫苗点燃默沙东想象力 “后K药时代”找到新解法？

每日经济新闻08-20 23:34

美东时间8月19日盘前，一则临床消息搅动整个美股生物医药板块——Moderna（莫德纳）与默沙东对外公布INTerpath-001Ⅲ期临床试验核心结果。双方联合开发的个性化mRNA癌症疫苗intismeran autogene，搭配K药（Keytruda），在1137名已经完成手术切除的高危IIB-IV期黑色素瘤受试者身上，同时拿下主要终点无复发生存期（RFS），以及关键次要终点无远处转移生存期（...

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era\"?","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"RXL":0.6,"MRNA":1.91,"IHE":0.6,"LGHT":0.6,"FTXH":0.6,"JDOC":0.6,"PAWZ":0.6,"XLV":0.6,"IDNA":0.6,"GNOM":0.6,"PPH":0.6,"IXJ":0.6,"MRK":1.98,"HRTS":0.6,"FHLC":0.6,"VHT":0.6,"MRNX":0.6,"GDOC":0.6,"MRNY":0.6,"WDNA":0.6,"TRUH":0.6,"IYH":0.6,"BMED":0.6},"content_text":"美东时间8月19日盘前，一则临床消息搅动整个美股生物医药板块——Moderna（莫德纳）与默沙东对外公布INTerpath-001Ⅲ期临床试验核心结果。双方联合开发的个性化mRNA癌症疫苗intismeran autogene，搭配K药（Keytruda），在1137名已经完成手术切除的高危IIB-IV期黑色素瘤受试者身上，同时拿下主要终点无复发生存期（RFS），以及关键次要终点无远处转移生存期（DMFS），两项指标均达到统计学显著差异。　　这是全球首款Ⅲ期试验取得阳性结果的mRNA癌症疗法，个体化新抗原肿瘤治疗拿到首个大型Ⅲ期确证证据。　　资本市场反应强烈。莫德纳当日股价大涨近177%，默沙东同步大涨近13%，整个mRNA板块也随之出现明显行情。对莫德纳而言，疫情相关业务消退后，癌症疫苗一直是资本市场重点关注的管线方向，本次结果提供了新冠疫苗之外重要的管线验证。　　而对默沙东来说，该临床进展的意义并不局限于黑色素瘤单一适应证，它为K药应对未来的多重压力，提供了一条新的可能性路径。 K药困局：三重压力压向2028年 　　站在默沙东经营层面，不难理解资本市场对该临床数据的重视程度。　　根据2026年上半年财报，K药实现164亿美元销售额，占默沙东总营收的49.9%。单一产品贡献接近半数收入，也意味着企业需要直面产品集中度较高带来的经营风险，多项外部压力的时间窗口高度集中在2028年前后。 　　第一重压力是专利悬崖。K药静脉剂型美国核心专利将于2028年到期，届时多款生物类似药预计将集中上市。机构测算，专利到期后的数年内，默沙东或将面临百亿美元级别销售额流失，K药单药的市场份额和价格将直接受到仿制药冲击。　　第二重压力来自临床端的同业竞争。PD-1/VEGF双抗等新一代免疫药物陆续公布临床数据，已经在部分适应证开展与K药的头对头研究，试图挑战其现有标准治疗地位，分流临床使用场景。　　第三重压力来自政策层面的药价管控。依据美国《通胀削减法案》，市场普遍预期K药将在2026年被纳入药价谈判清单，谈判确定的约束性价格将于2028年1月生效。　　此前默沙东已经布局多项应对举措。如推进K药皮下注射剂型Qlex，希望借助给药形式的变化缓解专利到期冲击；通过外部收购引进ADC（一种靶向抗癌药）管线，寄望新产品承接后续营收。　　但这些方案均存在不确定性。皮下剂型面临专利诉讼纠纷；引进的ADC管线现有积极数据主要来自部分区域临床，全球Ⅲ期试验结果尚未落定。更为关键的是，上述举措都没有改变K药作为独立单药的产品属性，专利到期之后依旧要面对生物类似药的直接竞争。　　而“mRNA癌症疫苗+K药”的联合方案则给出另一种思路。若该组合获批成为标准治疗方案，K药的临床定位将发生变化：不再是一款可被生物类似药直接替换的单药，而是联合治疗方案中的必要组成部分。　　生物类似药可以复刻K药分子本身，但无法复制整套联合疗法积累的完整临床证据。intismeran autogene需要基于每位患者的肿瘤基因测序结果筛选突变，定制mRNA序列并单独生产。测序算法、定制化生产流程，共同构成较高的技术与专利壁垒。　　未来在黑色素瘤辅助治疗场景，K药的使用依附于mRNA疫苗的联合方案，即便市场出现低价K药生物类似药，也不能直接等同于可以照搬这套联合治疗方案。　　但同时也要看到现实约束。个性化疫苗的产能扩张存在客观难度，制造成本偏高；整套疗法定价预计处于高位，各国医保如何对个体化肿瘤治疗产品进行支付，目前仍缺少成熟机制。Ⅲ期临床只是完成关键一步，距离大规模商业化落地还有不少待解决问题。 十年伏笔：“后K药时代”的押注 　　默沙东和莫德纳的合作管线重心经历过多次调整。　　2016年mRNA整体产业尚处于早期阶段，默沙东与莫德纳正式签署战略合作协议。默沙东支付2亿美元首付款，同时布局感染性疾病mRNA疫苗，也同步关注mRNA技术在肿瘤领域的应用潜力。　　2018年双方更新战略合作协议，研发重心转向肿瘤赛道，启动莫德纳新抗原mRNA疫苗与K药的联合开发，也就是本次试验所用的intismeran autogene，同时布局KRAS靶点共享抗原肿瘤疫苗。这份协议构成双方肿瘤管线合作的基础，相关Ⅰ/Ⅱ期临床随之启动。　　2020年第四季度，莫德纳股价受新冠业务推动大幅上涨，默沙东出售全部直接持有的莫德纳股权，兑现早期投资收益。股权退出并未终止研发协作，肿瘤疫苗相关的联合开发工作继续向前推进，资本层面与管线研发层面完成切割。　　2022年，默沙东行使协议选择权并支付2.5亿美元，双方正式进入全球联合开发、共同商业化阶段。按照约定，个性化癌症疫苗项目全球研发成本双方对半分摊，产品上市后利润平分。分工上，莫德纳负责mRNA疫苗技术设计、定制化生产；默沙东提供K药，承担临床开发、全球注册以及商业化推广工作。　　自此，INTerpath项目下多项Ⅱ、Ⅲ期临床试验陆续启动，最终迎来INTerpath-001的Ⅲ期阳性结果。　　从合作逻辑来看，莫德纳需要打造新冠疫苗之外的核心管线；默沙东则在为K药的专利周期窗口寻找可行的解决方案，双方的诉求形成匹配。　　而黑色素瘤只是这套联合疗法的首个验证瘤种。选择黑色素瘤率先开展试验，客观原因在于该瘤种肿瘤突变负荷较高，更容易筛选出可用的肿瘤新抗原，便于验证mRNA疫苗的治疗效果。但双方的开发目标并不局限于此。　　默沙东与莫德纳搭建的INTerpath临床开发项目，一共包含9项Ⅱ期与Ⅲ期试验，核心目的是系统评估“mRNA个性化肿瘤疫苗+K药”组合，能否在更多实体瘤上复现黑色素瘤的临床结果。　　INTerpath-001已经完成终点，聚焦高危黑色素瘤术后辅助。非小细胞肺癌作为体量最大的实体瘤赛道之一，Ⅲ期试验INTerpath-002针对已完整手术切除的II-IIIB期患者，对比疫苗联合K药与安慰剂联合K药，目前处于受试者入组阶段；针对新辅助后未实现病理完全缓解的肺癌高危人群，Ⅲ期试验INTerpath-009同步推进。　　肾癌方向INTerpath-004为Ⅱ/Ⅲ期研究，探索术后高复发风险患者的辅助治疗价值；尿路上皮癌领域，Ⅱ 期试验 INTerpath-005正在招募高危膀胱癌受试者。　　需要客观区分的是，黑色素瘤取得阳性结果，并不代表这套组合可以直接复制到所有癌种。不同肿瘤的突变负荷差异较大，各瘤种现有治疗格局也十分复杂，后续多项跨癌种临床试验就是对这一联合疗法价值的持续检验。　　如果后续多项研究能够得到积极结果，K药有机会在多个癌种的辅助治疗领域建立新的治疗标准，其竞争边界将从单一药物延伸到肿瘤免疫治疗平台层面。默沙东近期日K线走势　　这或也是过去一年默沙东股价大幅上涨背后，市场重点交易的远期预期。　　对默沙东而言，行业现实并不简单是寻找一款“下一个K药”，而是依靠多条管线、多种联合疗法，对冲K药专利到期带来的营收缺口。但mRNA癌症疫苗的全部预期仍有待后续全球临床数据逐一验证。（文章来源：每日经济新闻）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":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 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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