乐普生物-B(02157)发布公告,公司已于2024年9月收到中国国家药品监督管理局(NMPA)发出的《受理通知书》,内容有关MRG003的NDA已获受理,并已获NMPA药品审评中心(CDE)纳入优先审评。
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。
据悉,MRG003是一种由EGFR靶向单克隆抗体与强效的微管抑制有效载荷一甲基澳瑞他汀E分子通过缬氨酸-瓜氨酸链接体偶联而成的ADC。
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