自免领域频频“加码”，艾伯维再花2.5亿美元寻合作

新京报网07-04

艾伯维在自身免疫性疾病（以下简称自免疾病）领域又出手了，近日收购了私营生物科技公司Celsius Therapeutics（以下简称Celsius），收购后者所有流通股股权花费2.5亿美元。Celsius致力于为炎症性疾病患者开发创新疗法，其主要研究药物CEL383目前已完成针对炎症性肠病（IBD）的1期临床研究。上月，艾伯维还就共同开发用于治疗炎症性肠病的下一代TL1A抗体，与本土企业明济生物...

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Therapeutics（以下简称Celsius），收购后者所有流通股股权花费2.5亿美元。Celsius致力于为炎症性疾病患者开发创新疗法，其主要研究药物CEL383目前已完成针对炎症性肠病（IBD）的1期临床研究。上月，艾伯维还就共同开发用于治疗炎症性肠病的下一代TL1A抗体，与本土企业明济生物达成合作，合作金额可能高达17.1亿美元。2023年，艾伯维自免领域知名产品修美乐的全球销售规模被默沙东的帕博利珠单抗（俗称K药）超越，失去其蝉联了多年的全球“药王”位置。自免领域频出手根据收购协议的相关条款，艾伯维以2.5亿美元的现金收购了Celsius公司的所有流通股股权，最终支付金额将视行业惯例做出相应调整。Celsius总部位于美国马萨诸塞州剑桥市，是一家临床阶段的生物科技公司，致力于研发在炎症性疾病领域的创新药物，目前的研发重点是针对IBD的抗TREM1抗体药物，其主要研究药物CEL383，便是一种潜在的一流抗TREM1药物。TREM1是IBD领域中一个已证实的关键致病基因，在炎症性单核细胞和中性粒细胞中均有表达。在这些细胞类型和其他细胞类型中，TREM1处于多条已知炎症通路的上游位置，起着加剧炎症反应的作用。在临床前试验中，CEL383已证实能够抑制TREM1的信号传导，降低在炎症反应中起到关键作用的多种炎症介质的水平。目前，一项首次人体随机、双盲、安慰剂对照、单次给药递增的1期临床研究已经完成，旨在评估CEL383在健康志愿者中的安全性、耐受性以及药代动力学特性。近期，艾伯维在自免疾病领域还有其他动作。上月，公司与本土企业明济生物达成合作，双方就共同开发一种用于治疗炎症性肠病的下一代TL1A抗体。艾伯维将获得明济生物在研产品FG-M701在全球进行开发、生产和商业化的独家许可权。明济生物将获得1.5亿美元的首付款和近期里程碑付款，并有资格获得后续高达15.6亿美元的临床开发、监管注册和商业化里程碑付款，以及高达净销售额低两位数比例的分级特许权使用费。FG-M701是一种用于治疗炎症性肠病的下一代TL1A抗体，目前正处于临床前开发阶段。FG-M701是靶向TL1A的全人源单克隆抗体，该靶点在炎症性肠病中已获得临床验证。与第一代TL1A抗体相比，FG-M701通过独特的工程化改造，旨在为炎症性肠病治疗提供更高的疗效并减少给药频率，具备成为同类最佳的潜力。修美乐失去“药王”地位2013年，艾伯维从雅培公司中拆分，正式成为一家独立的公司，免疫学一直是其重点布局的领域，尤其是旗下重磅药物修美乐高企的销售业绩，让艾伯维成为自免疾病领域的龙头。2002年，修美乐（阿达木单抗）首次获得美国食药监局（FDA）批准，是全球首个获批上市的全人源抗肿瘤坏死因子%u3B1（TNF-%u3B1）单抗隆抗体。上市以来，已获批用于治疗包括类风湿关节炎、强直性脊柱炎、银屑病（包括儿童斑块状银屑病）等17种疾病。2012年之后，修美乐一直雄居全球处方药销售额榜首，取代辉瑞旗下立普妥，成为新的“药王”。作为全球最畅销药物，过去20多年来，修美乐已经为艾伯维带来超过2000亿美元的收入。不过，随着修美乐的组合物/活性成分专利分别于2016年和2018年在美国和欧盟到期，制药企业纷纷加入阿达木单抗的研发。修美乐在全球多个市场遭遇“围堵”，销售额较峰值期也开始下降。在蝉联全球“药王”十年后（不考虑新冠药物及疫苗），修美乐迎来了对手，该药2023年全球销售规模下滑至144.04亿美元，被默沙东旗下帕博利珠单以250.11亿美元的销售额超越。虽然失去了全球“药王”的位置，修美乐销售额依然可观。2023年，该药销售规模领先度普利尤单抗（赛诺菲与再生元共同研发）近30亿美元。艾伯维方面，也在为了避免修美乐专利到期带来的业绩大幅波动而大举并购，包括相继收购全球医美巨头艾尔建、创新药公司Mavupharma等。新京报记者 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