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君实生物(01877.HK)向FDA提交鼻咽癌生物制品许可申请
阿思达克 03-04 03:53
君实生物(01877.HK)公布,子公司TopAlliance Biosciences, Inc.已向FDA(美国食品药品监督管理局)滚动提交了特瑞普利单抗(项目代号TAB001/JS001)用於治疗复发或转移性鼻咽癌的生物制品许可申请。

特瑞普利单抗是中国首个批准上市的以PD-1为靶点的国产单抗药物。去年12月,特瑞普利单抗注射液成功通过国家医保谈判,被纳入新版国家医保目录。

滚动审评是指药企在申请新药上市许可时,可以将申报文件分批次提交FDA进行审评,而无需等待申报文件全部完成後才向FDA提交申请,此举可缩短新药的审评周期。

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