樂普生物-B(02157.HK):MRG003用於治療複發性╱轉移性鼻咽癌(R/M NPC)新藥上市申請獲國家藥監局受理並納入優先審評
格隆匯9月27日丨樂普生物-B(02157.HK)發佈公吿,公司已收到中國國家藥品監督管理局(“NMPA”)發出的《受理通知書》,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”)已獲受理。MRG003亦已獲NMPA藥品審評中心(“CDE”)納入優先審評(“優先審評”)。
此前,MRG003已獲CDE授予突破性治療藥物認定(“BTD”),並獲美國食品藥品監督管理局(“FDA”)授予BTD、孤兒藥資格認證(“ODD”)及快速通道資格(“FTD”),用於治療R/M NPC。
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