智通财经APP获悉，科济药业-B(02171)再涨超3%，近一个月累计涨幅超一倍。截至发稿，涨2.55%，报22.15港元，成交额1134.65万港元。
消息面上，5月20日，中国国家药监局药品审评中心(CDE)官网公示，科济药业全资子公司恺兴生命科技申报的舒瑞基奥仑赛注射液拟纳入优先审评，拟用于治疗CLDN18.2表达阳性、至少二线治疗失败的晚期胃/食管胃结合部腺癌。此次优先审评将有助于缩短其上市时间，使患者能够更快地受益于这一创新疗法，为胃癌患者带来了新的希望，也标志着中国CAR-T细胞疗法在实体瘤治疗领域取得了重大进展。
据介绍，舒瑞基奥仑赛注射液拟用于治疗的适应症为CLDN18.2表达阳性、至少二线治疗失败的晚期胃/食管胃结合部腺癌。这一适应症涵盖了经过至少两种前线治疗方案失败后的晚期患者群体，为这些患者提供了新的治疗选择。
舒瑞基奥仑赛注射液此次拟纳入优先审评，是基于其在多项临床试验中展现出的显著疗效和良好安全性。此前，该药物已获得CDE纳入突破性治疗品种，并被美国FDA授予再生医学先进疗法(RMAT)认定和孤儿药资格。这些资格认定不仅体现了舒瑞基奥仑赛在治疗胃癌领域的潜力，也为其加速审批提供了支持。
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