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君實生物(01877.HK)向FDA提交鼻咽癌生物製品許可申請
阿思達克 03-04 03:53
君實生物(01877.HK)公布,子公司TopAlliance Biosciences, Inc.已向FDA(美國食品藥品監督管理局)滾動提交了特瑞普利單抗(項目代號TAB001/JS001)用於治療復發或轉移性鼻咽癌的生物製品許可申請。

特瑞普利單抗是中國首個批准上市的以PD-1為靶點的國產單抗藥物。去年12月,特瑞普利單抗注射液成功通過國家醫保談判,被納入新版國家醫保目錄。

滾動審評是指藥企在申請新藥上市許可時,可以將申報文件分批次提交FDA進行審評,而無需等待申報文件全部完成後才向FDA提交申請,此舉可縮短新藥的審評周期。

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