科濟藥業-B(02171.HK)：舒瑞基奧侖賽注射液獲國家藥品監督管理局納入優先審評
格隆匯5月28日丨科濟藥業-B(02171.HK)宣佈，舒瑞基奧侖賽注射液(產品編號：CT041，一款靶向Claudin18.2蛋白的自體CAR-T細胞治療候選產品)已被國家藥品監督管理局藥品審評中心納入優先審評，用於治療Claudin18.2表達陽性、至少二線治療失敗的晚期胃╱食管胃結合部腺癌的患者。
舒瑞基奧侖賽注射液是一款潛在全球同類首創的、靶向Claudin18.2蛋白的自體CAR-T細胞治療候選產品，用於治療Claudin18.2陽性實體瘤，主要治療胃╱食管胃結合部腺癌及胰腺癌。已開展的試驗包括在中國開展的研究者發起的臨牀試驗(CT041-CG4006, NCT03874897)，在中國開展的針對晚期胃╱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Ib期臨牀試驗(CT041-ST-05, NCT05911217)，在中國開展的用於胃╱食管胃結合部腺癌患者術後輔助治療後鞏固治療的研究者發起的臨牀試驗(CT041-CG4010，NCT06857786)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)。2025年3月，舒瑞基奧侖賽注射液獲得了中國國家藥品監督管理局藥品審評中心授予的突破性治療藥物品種認定，擬定適應症為既往接受過至少二線治療失敗的Claudin18.2表達陽性的晚期胃╱食管胃結合部腺癌。2022年1月，舒瑞基奧侖賽注射液被美國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╱食管胃結合部腺癌。2020年9月，舒瑞基奧侖賽注射液被美國FDA授予「孤兒藥」認定用於治療胃╱食管胃結合部腺癌。
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