智通财经APP获悉，12月16日，中国国家药监局药品审评中心(CDE)网站最新公示，武田制药(TAK.US)1类新药mezagitamab注射剂获得一项新的临床试验默示许可，拟开发治疗原发性免疫性血小板减少症(ITP)。公开资料显示，Mezagitamab是一种全人源免疫球蛋白IgG1单克隆抗体(mAb)，对表达CD38的细胞(包括浆母细胞、浆细胞和自然杀伤细胞)具有高亲和力，导致它们的耗竭。Mezagitamab治疗旨在提供快速且持续的血小板应答改善，并恢复血小板计数至功能水平。

截图来源：CDE官网

根据ClinicalTrials官网，武田已经于今年12月启动了mezagitamab治疗成人慢性ITP患者的国际多中心3期临床研究。在中国，武田已经完成该产品治疗持续性/慢性原发性免疫性血小板减少症的2期临床研究。本次该产品再次获得临床试验默示许可，意味着在中国迎来新的进展。

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