康方生物(09926):奇佑康®(古莫奇单抗,AK111)的新药上市申请获得国家药品监督管理局批准

智通财经
Jun 12

智通财经APP讯,康方生物(09926)发布公告,奇佑康®(古莫奇单抗,AK111)已获得中华人民共和国国家药品监督管理局(NMPA)批准上市,用于治疗中度至重度斑块状银屑病。

本次古莫奇单抗获批治疗中度至重度斑块状银屑病,基于1项关键Ⅲ期临床研究(AK111-301)和3项支持性研究。

古莫奇单抗是本公司自主研发的新型人源化IL-17(白介素-17)自身免疫疾病治疗药物,旨在治疗银屑病、强直性嵴柱炎等自身免疫性疾病。

目前,古莫奇单抗治疗中、重度斑块状银屑病及治疗强直性嵴柱炎的注册性Ⅲ期临床研究均已达到全部疗效终点。基于此,目前古莫奇用于治疗中度至重度斑块型银屑病已获批上市,以及治疗活动性强直性嵴柱炎的新药上市申请获得NMPA 药品审评中心受理审评中。

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