中国NMPA接受Envafolimab(KN035)治疗MSI-H / dMMR晚期实体瘤的NDA

2020-12-31 Allan MedSci原创

生物制药公司TRACON今天宣布,中国国家药品监督管理局(NMPA)已经接受Envafolimab(KN035)治疗MSI-H / dMMR晚期实体瘤的新药申请(NDA)。

生物制药公司TRACON今天宣布,中国国家药品监督管理局(NMPA)已经接受Envafolimab(KN035)治疗MSI-H / dMMR晚期实体瘤的新药申请(NDA)。

TRACON首席执行官Charles Theuer博士说:“Envafolimab的NDA被中国监管机构接受审查,突显了Envafolimab的先进性。除了中国MSI-H / dMMR晚期实体瘤的注册试验外,Envafolimab还正在另外两项注册试验阶段,其中一项是在中国进行的胆道癌III期试验,另外一项则是在美国进行的肉瘤试验”。

Envafolimab(KN035)是一种针对PD-L1的新型单域抗体。

微卫星(MS)是指细胞基因组中以少数几个核苷酸(多为1~6个)为单位串联重复的DNA序列。DNA错配修复(MMR)功能出现异常时,微卫星出现的复制错误得不到纠正并不断累积,使得微卫星序列长度或碱基组成发生改变,称为微卫星不稳定性(MSI)。微卫星高度不稳定(MSI-H)/错配修复缺陷(dMMR)实体瘤患者的临床治疗需求尚未被满足。

 

原始出处:

https://www.firstwordpharma.com/node/1787529?tsid=4

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    2021-05-29 snf701207
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    2021-01-02 vividelife
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    2021-01-02 小几洁

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