阿斯利康(AZN.US)“本瑞利珠单抗”新适应症在中国申报上市

智通财经
03 Apr

智通财经APP获悉,4月3日,中国国家药监局药品审评中心(CDE)官网最新公示,阿斯利康(AZN.US)申报的本瑞利珠单抗注射液一项新适应症上市申请获得受理,具体适应症尚未披露。公开资料显示,本瑞利珠单抗(benralizumab)是阿斯利康开发的一款靶向IL-5受体的单克隆抗体,此前已经在中国获批用于成人和12岁及以上青少年重度嗜酸粒细胞性哮喘的维持治疗。在美国,该产品还已经获FDA批准用于治疗嗜酸性肉芽肿性多血管炎(EGPA)的成年患者。

截图来源:CDE官网

根据阿斯利康近期新闻稿介绍,本瑞利珠单抗重度嗜酸粒细胞性哮喘(SEA)适应症目前已在美国、欧盟、日本、中国等80多个国家和地区获批。嗜酸性肉芽肿病伴多血管炎(EGPA)适应症也已经在美国、欧盟和日本等全球35多个国家和地区获批。阿斯利康也在对该产品的其它适应症进行开发,包括慢性阻塞性肺疾病(COPD)和嗜酸粒细胞增多综合征。本次本瑞利珠单抗新适应症在中国申报上市,意味着其有望在不久的将来惠及更多患者。

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