樂普生物-B(02157.HK)：CDE授予MRG003突破性治療藥物認定用於治療複發性╱轉移性鼻咽癌(R/MNPC)
格隆匯9月29日丨樂普生物-B(02157.HK)宣佈，於2022年9月29日，國家藥監局藥品審評中心(“CDE”)授予MRG003突破性治療藥物認定用於治療複發性或轉移性鼻咽癌(“R/M NPC”)。MRG003是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。
此前，MRG003已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。
突破性治療藥物認定指用於防治嚴重危及生命或者嚴重影響生存質量的疾病，且尚無有效防治手段或者與現有治療手段相比有足夠證據表明具有明顯臨牀優勢的創新藥或者改良型新藥等。根據《藥品註冊管理辦法》及《國家藥監局關於發佈＜突破性治療藥物審評工作程序(試行)＞等三個文件的公吿》(2020年第82號)，CDE對納入突破性治療藥物程序的藥物優先配置資源進行溝通交流，加強指導並促進藥物研發。突破性治療藥物認定把藥品上市的加速起點提前到臨牀試驗階段，並有助於加快遞交新藥申請及縮短藥物審評時間。
公司表示，MRG003是目前中國進度領先的處於臨牀研究階段的靶向EGFR的ADC藥物，其有望搶佔市場機遇。突破性治療藥物認定有助於加快CDE對該藥物的開發及審評，對MRG003的推廣及公司開發市場差異化管線的戰略而言是一個令人鼓舞的信號。
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