葛兰素史克(GSK.US)美泊利珠单抗注射液在中国申报新适应症COPD上市

智通财经
11 Feb

智通财经APP获悉,今日(2月11日),中国国家药监局(CDE)官网最新公示显示,葛兰素史克(GSK.US)以生物制品2.2类申报的抗IL-5单抗美泊利珠单抗注射液上市申请获得受理。根据GSK官网及公开资料推测,本次美泊利珠单抗在中国申报上市的适应症可能为慢性阻塞性肺疾病(COPD)。针对该适应症,美泊利珠单抗尚未在全球范围内获得批准。

截图来源:CDE官网

白细胞介素-5(IL-5)是一种细胞因子,能够调节嗜酸性粒细胞的生长、活化、存活,并为嗜酸性粒细胞从骨髓迁移至肺部及其他器官提供重要信号。

公开资料显示,美泊利珠单抗(mepolizumab)是全球首个获批上市的抗IL-5单抗,其通过与IL-5结合,阻断IL-5与嗜酸粒细胞表面受体结合,抑制嗜酸粒细胞的生物活性并使其数量持续降低至正常水平,从而减少嗜酸性粒细胞的生长,以及嗜酸粒细胞所介导的炎症和组织损伤,维持健康状态

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