智通财经APP获悉，5月14日，CDE官网显示，强生(JNJ.US)达雷妥尤单抗注射液(皮下注射)新适应症上市申请获受理。本次产品申报注册分类为3.1类，即境外生产的境外已上市、境内未上市的生物制品申报上市。根据公开资料和临床进展，Insight数据库推断本次申报上市的适应症为：联用硼替佐米、来那度胺和地塞米松(VRd)，用于新诊断适合造血干细胞移植的多发性骨髓瘤患者。
达雷妥尤单抗是全球首款获批的CD38单抗，2015年11月，达雷妥尤单抗首次获FDA批准上市，与来那度胺和地塞米松，或者硼替佐米和地塞米松联用，适用于曾接受至少一种治疗的多发性骨髓瘤患者。2019年7月首次在国内附条件批准上市，单药用于治疗复发或难治性多发性骨髓瘤成年患者。
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