信達生物(01801.HK)「泰萊替尼」新藥上市申請獲授予優先審評資格
信達生物(01801.HK)與葆元醫藥共同宣布,旗下新一代ROS1酪氨酸激(酉每)抑制劑「泰萊替尼」(他雷替尼)的新藥上市申請,已獲得中國國家藥監局藥品審評中心授予優先審評資格,用於經ROS1-TKI治療失敗的ROS1陽性局部晚期或轉移性非小細胞肺癌成人患者的治療。
集團高級副總裁周輝表示,獲納入優先審評程序,進一步顯示泰萊替尼作為新一代精準療法的同類最佳潛力,未來會繼續配合監管機構的審評。
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