港股异动 | 乐普生物-B(02157)尾盘涨超10% 治疗鼻咽癌药物临床研究结果以LBA形式于ASCO年会公布

智通财经网
Jun 06, 2025

智通财经APP获悉,乐普生物-B(02157)尾盘涨超10%,截至发稿,涨10.22%,报5.07港元,成交额1.78亿港元。

消息面上,乐普生物近日公布,自主研发的候选药物MRG003(一种表皮生长因子受体靶向创新型抗体药物偶联物(ADC)候选药物,用于治疗复发性或转移性鼻咽癌(R/M NPC))的关键注册性临床研究结果于2025年美国临床肿瘤学会(ASCO)年会上以“重磅研究摘要(LBA)”形式公布,并于会上作口头报告。

今年3月,公司公告称已于2024年9月收到中国国家药品监督管理局发出的《受理通知书》,监管机构目前正有序进行MRG003的临床及药学审核。根据公司与监管机构的最新沟通,为补充提交相关资料,公司主动撤回前次MRG003的NDA。公司已就申报材料进行补充并制备完成eCTD申报文件,将于2025年3月4日重新提交MRG003的NDA,并将尽最大努力与监管机构合作完成后续审评程序,以获得NDA的上市批准。

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