2月28日,根据中国国家药品监督管理局(NMPA)官网显示,本日为全球首款实体瘤CAR-T细胞产品科济药业(02171)舒瑞基奥仑赛注射液(CT041)突破性治疗药物认定程序公示期最后一日,获批在即。
据智通财经了解到,CT041是主要针对至少二线治疗失败的Claudin18.2表达阳性的晚期胃/食管胃结合部腺癌的创新疗法。若最终获批,不仅在于其针对特定肿瘤标志物的精准打击能力,更在于它代表了CAR-T疗法在实体瘤治疗领域的一次重大飞跃。而这一突破,不仅是对科济药业研发实力的肯定,更是对整个生物医药行业的巨大鼓舞,预示着未来CAR-T疗法在实体瘤治疗领域将有更多可能,为实体瘤患者带来了新的希望。
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