财中社12月30日电科济药业-B(02171)发布自愿公告,宣布其关键II期临床试验CT041-ST-01(NCT04581473)取得初步阳性结果。该试验旨在评估舒瑞基奥仑赛注射液治疗Claudin18.2表达阳性的晚期胃/食管胃结合部腺癌的有效性和安全性。试验结果显示,舒瑞基奥仑赛注射液组的无进展生存期(PFS)相比于研究者选择治疗组有统计学意义上的显著改善,表明该产品的有效性。
舒瑞基奥仑赛注射液是一种靶向Claudin18.2蛋白的自体CAR-T细胞候选产品,目前在中国和北美进行多项临床试验。该产品在2022年获得美国FDA的“再生医学先进疗法”认定,并在2020年获得“孤儿药”认定。公司致力于研发创新的CAR-T细胞疗法,目标是解决现有疗法面临的挑战,提高治疗安全性和有效性。
(文章来源:财中社)
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