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新諾威(300765.SZ):控股子公司SYS6010(CPO301)抗體偶聯藥物獲得美國FDA快速通道資格
格隆匯 05-19 15:45

格隆匯5月19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(簡稱“巨石生物”)所研發的SYS6010(CPO301)藥物於近日獲得美國食品藥品監督管理局(簡稱“美國FDA”)授予用於治療不伴有表皮生長因子受體(以下簡稱“EGFR”)突變或其他驅動基因改變(AGA)的,且既往經含鉑化療和抗PD-(L)1治療後疾病進展的晚期或轉移性非鱗非小細胞肺癌(Nsq-NSCLC)成年患者的快速通道資格認定(Fast Track Designation,FTD)。

SYS6010(CPO301)是一款靶向EGFR腫瘤相關抗原的抗體偶聯藥物(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。該藥物在中國和美國均已獲得臨牀試驗許可,相關臨牀試驗正在開展中。此為該藥物獲得美國FDA授予的第三項快速通道資格認定,第一次於2023年6月被授予用於治療經EGFR靶向治療(包括奧希替尼在內的第三代EGFR抑制劑)後復發/難治的,或者不適合EGFR靶向治療的EGFR突變轉移性NSCLC患者;第二次於2024年9月被授予用於治療EGFR高表達的,接受含鉑化療和抗PD-(L)1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。

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