智通财经APP获悉，3月10日，艾伯维(ABBV.US)宣布其利生奇珠单抗注射液和利生奇珠单抗注射液（皮下注射）上市申请已获得中国国家药品监督管理局（NMPA）批准，用于治疗用于治疗对传统治疗或生物制剂治疗应答不足、失应答或不耐受的中重度活动性克罗恩病成年患者。
利生奇珠单抗是一种人源化、IgG1亚型的单克隆抗体，可以通过与IL-23的p19亚基结合而选择性地拮抗IL-23。IL-23是一种与炎症有关的细胞因子，被认为与许多慢性免疫疾病有关。利生奇珠单抗是艾伯维在自身免疫疾病领域的重磅产品，此次获批包括利生奇珠单抗注射液与利生奇珠单抗注射液（皮下注射）两种剂型，拥有随身给药器。
据艾伯维介绍，在两项诱导临床研究和一项维持治疗临床研究中，与安慰剂相比，利生奇珠单抗在诱导治疗和维持治疗在内镜应答（定义为克罗恩病简化内镜下评分[SES-CD] 较基线下降＞50%或对于患有孤立性回肠疾病且基线SES-CD为4的患者，较基线降低至少2分）和临床缓解（定义为克罗恩病活动指数[CDAI]<150）上均显示出显著改善。
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