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新諾威(300765.SZ):控股子公司藥物CPO301獲得美國FDA快速通道資格
格隆匯 10-08 15:58

格隆匯10月8日丨新諾威(300765.SZ)公佈,公司的控股子公司石藥集團巨石生物製藥有限公司(以下簡稱"巨石生物")於近日收到美國食品藥品監督管理局(以下簡稱"美國FDA")通知,由巨石生物申報的注射用CPO301獲得美國FDA授予的用於治療表皮生長因子受體(EGFR)高表達的,接受含鉑化療和抗PD-(L1)治療期間或之後出現進展的復發或轉移性鱗狀非小細胞肺癌(Sq-NSCLC)患者的快速通道資格(Fast Track designation,FTD)。

CPO301是一款靶向EGFR腫瘤相關抗原的抗體藥物偶聯物(ADC),通過與腫瘤細胞表面的靶抗原結合,使得藥物被內吞進入細胞後釋放小分子毒素殺傷腫瘤細胞。目前,該藥物在中國和美國均已獲得臨牀試驗許可,均在開展I期臨牀試驗中。

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