艾伯维为Humira找替补

医药魔方06-15

6月13日，一则“明济生物TL1A单抗17亿美元授权给艾伯维”的消息引爆朋友圈。对于与MNC达成授权不再稀缺的中国创新药行业，这样的交易金额放在肿瘤领域或许已经显得稀松平常，但放在自免领域仍足够吸睛。其爆点一方面在于，自免领域的国产创新药此前对外授权交易总金额的最高纪录为10.5亿美元（见：超10亿美元！恒瑞TSLP单抗授权出海），明济生物此次的交易大幅抬高了纪录；另一方面在于，TL1A是一个较为...

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Humira","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CD":1,"ABBV":0.9},"content_text":"6月13日，一则“明济生物TL1A单抗17亿美元授权给艾伯维”的消息引爆朋友圈。对于与MNC达成授权不再稀缺的中国创新药行业，这样的交易金额放在肿瘤领域或许已经显得稀松平常，但放在自免领域仍足够吸睛。其爆点一方面在于，自免领域的国产创新药此前对外授权交易总金额的最高纪录为10.5亿美元（见：超10亿美元！恒瑞TSLP单抗授权出海），明济生物此次的交易大幅抬高了纪录；另一方面在于，TL1A是一个较为新颖的自免靶点，重大的基础研究成果均来自海外，而且在研药物屈指可数（11款），该赛道此前发生过3起大额交易，皆是自海外Biotech达成向MNC巨头的授权，国产创新药能够在这个靶点上吸引MNC的目光实属难得。于明济生物而言，与艾伯维的交易证明了其研发实力；于中国药企而言，此番交易为自免领域的创新药研发和商业想象空间再度注入信心（见：从创新药临床研究趋势看内卷中成长的中国药企）。于艾伯维而言，引进TL1A单抗的动作又有何意义？首先看一下TL1A靶点的机制和潜力。TL1A即肿瘤坏死因子（TNF）样配体1A，属于TNF超家族的一员，TNFSF15是其另一名字。显而易见，TL1A与更为人熟知的经典靶点TNF-α（又称TNFSF1A）是“兄弟”关系。从机制上也可看出来，二者有相似之处，前者通过与死亡受体3（DR3）结合继而激活TNFR相关死亡结构域蛋白（TRADD）介导的信号通路，而后者通过与I型TNFR（TNFR1）结合继而激活TRADD介导的信号通路，以此达到促进促炎性细胞因子的分泌或诱导细胞凋亡的一致目的。左为TL1A靶点机制[1]，右为TNF-α靶点机制[2]TNF-α靶点在炎症性疾病上的商业价值已无需多言，明星产品修美乐（阿达木单抗）上市以来累计销售额已超2000亿美元即是强有力的证明。机制与其类似的TL1A靶点即便达不到这样的高度也比较值得期待。布局TL1A的企业并不多，国内仅有明济生物和智翔金泰两家。全球范围内开发进度靠前的TL1A项目tulisokibart（Prometheus Biosciences公司）和RG6631（Telavant公司）也已相继被默沙东和罗氏以高价引进。从这两款产品的临床数据来看，无论是克罗恩病（CD）还是溃疡性结肠炎（UC），其疗效均与阿达木单抗接近。在研TL1A项目与阿达木单抗II期数据疗效注：*安慰剂组数据为历史对照；TEV-48574未有相关数据披露。在全球TL1A项目并不多的情况下，AbbVie通过与明济生物交易获得一款临床前阶段的TL1A单抗，显然是出于巩固自免领域领先优势的考虑，同时也是在TNF-α生物类似药都已泛滥的情况下，为专利保护到期的Humira寻觅一款有潜力的补位产品。艾伯维目前凭借修美乐（阿达木单抗，TNF-α）、Rinvoq（乌帕替尼，JAK）和Skyrizi（利生奇珠单抗，IL-23）的多靶点产品组合雄居自免领军企业“王座”。但修美乐去年已彻底失去市场独占，2023年销售额同比暴跌32%（144 vs. 212亿美元），让艾伯维切实感受到了市场份额流失的寒气。为巩固地位，艾伯维正竭力探索Rinvoq和Skyrizi的临床和商业潜力，希望将其打造为撑起公司营收的百亿美元产品，但这两款产品也都面临着充分且激烈的市场竞争。自免市场足够大，但是再诞生修美乐这样200亿美元级别产品难度也较大。对于具有优势的业务，扩大产品组合，通过以量取胜来占领和保有市场份额是必然选择。TL1A单抗算是对修美乐专利到期的补位，这样的靶点也符合艾伯维在自免领域多样化布局的战略。从另一个角度而言，TL1A靶点优先开发的炎症性肠病领域也是艾伯维的“优势区”。修美乐分别于2007年和2012年在美国获批CD和UC适应症，艾伯维借此在炎症性肠病领域已积累了十多年的研发经验和商业化经验，而这些经验也已被运用到Rinvoq和Skyrizi身上。2020-2023年Rinvoq和Skyrizi全球销售额（单位：亿美元）相较而言，抢先买下TL1A产品的默沙东、罗氏和赛诺菲在炎症性肠病领域还只能算是“新手”，艾伯维虽没有抢得先机但胜在经验老道和过往优势雄厚，尤其是自免疾病的新药临床开发、堪比市场渗透都是马拉松式的长跑比赛。TL1A赛道目前吸引了数家制药巨头的聚首，我们可以期待强者的碰撞和比拼，也继续关注该赛道是否还会有其他交易的发生。- 上下滑动查看参考资料 -[1] Role of TL1A in Inflammatory 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