和鉑醫藥(02142.HK)HBM9161獲批展開對CIDP患者二期臨床試驗
和鉑醫藥(02142.HK)公布,國家藥監管局已批准就HBM9161(一種靶向新生兒Fc受體(FcRn)的全人源抗體)作出的新藥臨床試驗申請以對CIDP患者開展二期臨床試驗。此次IND批准是HBM9161在中國的第五次批准。
CIDP是一種由自身免疫介導破壞引起的外周神經及神經根慢性自身免疫性疾病。該疾病是一種慢性及漸進性的疾病,其特徵是腿部及手臂逐漸無力及感覺功能受損,並與格林-巴利綜合症密切相關。考慮到類固醇長期使用的不良反應及IVIg的可獲得性有限,在探索新的有效且方便的CIDP治療方法方面仍存在巨大且未能滿足的醫療需求。
至於巴托利單抗(HBM9161)是一種全人源抗FcRn單克隆抗體,可阻斷FcRn-IgG相互結合,加速自身抗體的清除,從而達到治療致病性IgG介導的自身免疫性疾病的效果。
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