默沙东(MRK.US)抗艾滋病口服新药在中国申报上市

智通财经08-06 21:10

【默沙东(MRK.US)抗艾滋病口服新药在中国申报上市】智通财经APP获悉，8月5日，中国国家药监局药品审评中心(CDE)官网公示显示，默沙东(MRK.US)申报的多拉韦林伊拉曲韦片(doravirine/islatravir，DOR/ISL)上市申请已获得受理。根据CDE官网，该产品此前已经被纳入优先审评，拟定适应症为：作为治疗成人HIV-1感染的完整双药治疗方案，适用于正接受稳定抗逆转录病毒治疗方案达到病毒学抑制(HIV-1 RNA<；50拷贝/ml)、无抗病毒治疗失败史且无已知与多拉韦林耐药相关突变的患者，替代其当前的抗逆转录病毒治疗方案。

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