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科濟藥業-B(02171.HK)於2024年ASCO年會上口頭報吿CT041試驗數據更新
格隆匯 04-11 18:29

格隆匯4月11日丨科濟藥業-B(02171.HK)公吿,CT041(一種靶向Claudin18.2自體CAR-T細胞候選產品)的摘要已被接收於2024年美國臨牀腫瘤學會(ASCO)年會進行口頭報吿。

CT041是一種潛在全球同類首創的、靶向Claudin18.2蛋白的自體CAR-T細胞候選產品,用於治療Claudin18.2 陽性實體瘤,主要治療胃癌╱食管胃結合部腺癌及胰腺癌。正在進行的試驗包括在中國開展的研究者發起的臨牀試驗(CT041-CG4006, NCT03874897),針對晚期胃癌╱食管胃結合部腺癌的確證性II期臨牀試驗(CT041-ST-01, NCT04581473),在中國開展的針對胰腺癌輔助治療的I期臨牀試驗(CT041-ST-05, NCT05911217),以及在北美開展的針對晚期胃癌或胰腺癌的1b/2期臨牀試驗(CT041-ST-02, NCT04404595)。2022年1月,CT041被美國FDA授予“再生醫學先進療法”(RMAT)認定用於治療Claudin18.2陽性的晚期胃癌╱食管胃結合部腺癌。2021年11月,CT041被歐洲藥品管理局(EMA)授予優先藥品(PRIME)資格治療晚期胃癌。2020年和2021年,CT041分別被美國FDA授予孤兒藥認定用於治療胃癌 ╱ 食管胃結合部腺癌和EMA授予孤兒藥產品認定用於治療晚期胃癌。

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