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Chi-Med公司开始向美国FDA递交Surufatinib治疗晚期神经内分泌肿瘤的申请

2020-12-29 Allan MedSci原创

神经内分泌肿瘤是起源于神经内分泌细胞的肿瘤。神经内分泌细胞是机体内具有神经内分泌表型,可以产生多种激素的一大类细胞。

神经内分泌肿瘤是起源于神经内分泌细胞的肿瘤。神经内分泌细胞是机体内具有神经内分泌表型,可以产生多种激素的一大类细胞。和记中国医疗科技有限公司(Chi-Med)今天宣布,已开始向美国食品药品监督管理局(FDA)提交Surufatinib治疗胰腺和非胰腺神经内分泌肿瘤的新药申请(NDA)。Chi-Med计划在2021年上半年完成NDA提交,这将是该公司在美国的第一个NDA。

NDA是基于中国的两项积极的III期研究数据以及来自美国非胰腺和胰腺神经内分泌肿瘤患者的研究数据。根据人用药品委员会(CHMP)的科学建议,该数据包还将用于向欧洲药品管理局(EMA)提交销售授权申请(MAA)。

Chi-Med首席医疗官Marek Kania博士说:“Surufatinib在晚期肿瘤患者中已显示出显著的临床益处,向美国FDA提出的NDA申请标志着我们朝着将surufatinib和其他新型疗法商业化的目标迈出了重要一步”。

 

原始出处:

https://www.firstwordpharma.com/node/1786940?tsid=4

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