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和黄医药:索凡替尼第二项中国新药上市申请已获受理
阿思达克 09-18 12:16
和黄医药宣布,中国国家药品监督管理局已受理索凡替尼(surufatinib)用於治疗晚期胰腺神经内分泌瘤的新药上市申请。

是次新药上市申请是基於成功的SANET-p临床研究数据。SANET-p是一项索凡替尼以晚期胰腺神经内分泌瘤为适应症的III期关键性研究,而这些患者目前尚无有效的治疗方法。

此前,国家药监局於2019年11月受理了索凡替尼的首个新药上市申请用於治疗非胰腺神经内分泌瘤,并於2019年12月将该新药上市申请纳入优先审评。

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