樂普生物-B(02157.HK):MRG003用於治療複發性╱轉移性鼻咽癌(R/M NPC)完成關鍵註冊性IIb期臨牀試驗受試者入組
格隆匯12月29日丨樂普生物-B(02157.HK)發佈公吿,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”)候選藥物以及公司的核心產品)近期已順利完成關鍵註冊性IIb期臨牀試驗的全體受試者入組,用於治療複發性或轉移性鼻咽癌(“R/M NPC”)。
該試驗為隨機、開放、多中心關鍵註冊性IIb期臨牀研究,於2023年4月啟動受試者入組,截至本公吿日期,173名受試者已順利完成入組。此前,MRG003已獲中國國家藥品監督管理局藥品審評中心授予突破性治療藥物認定,獲美國食品藥品監督管理局(“FDA”)孤兒藥資格認證(用於治療R/M NPC)及獲FDA授予快速通道資格。
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