智通财经APP获悉，乐普生物-B(02157)早盘涨超4%，截至发稿，涨4.11%，报7.34港元，成交额3016万港元。
消息面上，9月19日，CDE官网公示，乐普生物旗下EGFR靶向ADC药物MRG003拟被纳入突破性疗法认定，适应症为联合普特利单抗（PD-1单抗）治疗既往接受过铂类及PD-1/PD-L1抑制剂治疗失败的复发或转移性鼻咽癌。
据悉，MRG003是目前全球研发进展领先的EGFR ADC药物，此前已获得CDE授予的突破性治疗药物认定与优先审评资格，以及FDA授予的孤儿药资格、快速通道资格和突破性疗法认定。2024年9月，乐普生物首次提交该药用于鼻咽癌的上市申请，后因需补充资料主动撤回，并于今年3月重新提交，目前已被纳入优先审评程序，单药用于特定复发/转移性鼻咽癌患者治疗。
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