乐普生物(02157.HK) 公布,已于去年9月收到国家药监局(NMPA)发出的《受理通知书》,内容有关MRG003的新药上市申请(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。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,将于今日(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。
MRG003为一种表皮生长因子受体(EGFR)靶向抗体药物偶联物(ADC)候选药物,用于治疗复发性或转移性鼻咽癌。(jl/w)(港股报价延迟最少十五分钟。沽空资料截至 2025-03-03 16:25。)
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