首药控股(688197.SH)：RET抑制剂索特替尼片(SY-5007)新药上市申请获得受理

智通财经

10/22

智通财经APP讯，首药控股(688197.SH)发布公告，公司于近日收到国家药品监督管理局下发的《受理通知书》，公司完全自主研发的索特替尼片(SY-5007，申报商品名：首亦泽®)单药适用于转染重排(RET)基因融合阳性的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者治疗的新药上市申请(NDA)获得受理。

SY-5007在RET融合阳性非小细胞肺癌初治及经治患者中均展现出显著且持久的疗效，同时具备良好的安全性与耐受性，充分验证了其作为高选择性RET抑制剂的临床潜力，有望为我国RET融合驱动的非小细胞肺癌患者提供新的治疗选择。

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