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国内首款,双重机制嗜睡新药申报上市
12 月 10 日,CDE 官网显示,Axsome Therapeutic 和翼思生物 (Ignis Therapeutics)等公司联合申报的 索安非托片 (Solriamfetol)新药上市申请获受理 。 根据临床试验进展,推测适应症为阻塞型睡眠呼吸暂停综合征(OSA) 相关的日间过度嗜睡(EDS)。 这是国内首个申报上市的双重机制嗜睡新药。
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