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石藥集團(01093.HK):CPO301獲美國FDA授予第三項快速通道資格用於治療NSCLC成年患者

格隆匯5月19日丨石藥集團(01093.HK)公告,集團開發的一款首創表皮生長因子受體(EGFR)抗體偶聯藥物(ADC)CPO301(於中國亦稱爲SYS 6010)已獲美國食品藥品監督管理局(FDA)授予第三項快速通道資格,用於治療不伴有EGFR突變或其他驅動基因改變(AGA),且既往經含鉑化療和抗PD-(L)1抗體治療後出現疾病進展的晚期或轉移性非鱗狀非小細胞肺癌(Nsq-NSCLC)成年患者。

此前,CPO301已獲FDA授予兩項快速通道資格:第一項於2023年6月獲授予,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,或不適合EGFR靶向治療的EGFR突變轉移性非小細胞肺癌(NSCLC)患者;第二項於2024年9月獲授予,用於治療EGFR過度表達而在接受含鉑化療和抗PD-(L)1治療或之後出現疾病進展的復發或轉移性鱗狀非小細胞肺癌(Sq-NSCLC)患者。

肺癌是全球發病率及死亡率最高的癌症,估計全球每年新增病例約250萬,死亡病例約180萬。活化性EGFR基因突變及EGFR蛋白過度表達是肺癌的驅動因素,不僅見於EGFR突變陽性患者,也見於不伴有EGFR突變但高表達野生型EGFR蛋白的組織學亞型,包括鱗狀細胞癌及腺癌。

CPO301於所有NSCLC亞型中的快速通道資格,均基於其令人鼓舞的臨牀療效數據,顯示出較現有NSCLC及其他腫瘤類型治療方案更具潛力的活性。CPO301是一款人源化單克隆抗體,由西妥昔單抗優化而來,並與拓撲異構酶I抑制劑偶聯。目前,該藥物正在中國及美國同步開展臨牀研究。FDA授予的快速通道資格將有助於CPO301於美國及全球範圍內的開發與註冊進程。

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