科濟藥業-B(02171.HK):CT041獲批用於CLDN18.2表達陽性的胰腺癌術後輔助治療
格隆匯4月19日丨科濟藥業-B(02171.HK)宣佈,CT041,一種靶向Claudin18.2(CLDN18.2)蛋白的自體CAR-T細胞候選產品,已獲得國家藥品監督管理局的IND批准用於CLDN18.2表達陽性的胰腺癌術後輔助治療。
CT041是一種潛在全球同類首創的、靶向CLDN18.2蛋白的自體CAR-T細胞候選產品,用於治療CLDN18.2陽性實體瘤,主要治療胃癌╱食管胃結合部腺癌及胰腺癌。
科濟藥業正在進行的試驗包括在中國開展的研究者發起的試驗、一項針對晚期胃癌╱食管胃結合部腺癌和胰腺癌的Ib期臨牀試驗和針對晚期胃癌╱食管胃結合部腺癌的確證性II期臨牀試驗(CT041-ST-01,NCT04581473),以及在北美啟動了一項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CLDN18.2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。CT041在美國的2期臨牀試驗計劃於2023年上半年啟動。
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