樂普生物-B(02157.HK)MRG003補充資料後重申NDA,力爭加速上市進程
格隆匯3月4日丨樂普生物-B(02157.HK)發佈公告,有關公司的候選藥物MRG003(一種表皮生長因子受體(“EGFR”)靶向抗體藥物偶聯物(“ADC”)候選藥物,用於治療複發性或轉移性鼻咽癌(“R/M NPC”))的新藥上市申請(“NDA”)。 如此前公告所披露,公司已於2024年9月收到中國國家藥品監督管理局(“NMPA”)發出的《受理通知書》,內容有關MRG003的NDA已獲受理,並已獲NMPA藥品審評中心(“CDE”)納入優先審評(“優先審評”)。
監管機構目前正有序進行MRG003的臨牀及藥學審覈。根據公司與監管機構的最新溝通,爲補充提交相關資料,公司主動撤回前次MRG003的NDA。公司已就申報材料進行補充並製備完成eCTD申報文件,將於2025年3月4日重新提交MRG003的NDA,並將盡最大努力與監管機構合作完成後續審評程序,以獲得NDA的上市批準。對於因補充提交相關資料重新遞交NDA,對MRG003的上市獲批進程可能帶來的延遲,公司深表歉意。
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