復宏漢霖(02696.HK):注射用HLX42(靶向EGFR抗體-新型DNA拓撲異構酶I抑制劑偶聯藥物)獲FDA授予快速通道資格
格隆匯12月27日丨復宏漢霖(02696.HK)發佈公吿,近日,注射用HLX42(靶向EGFR抗體-新型DNA拓撲異構酶I抑制劑偶聯藥物)(“HLX42”)用於經第三代EGFR 酪氨酸激酶抑制劑治療後疾病進展的EGFR突變的晚期或轉移性非小細胞肺癌患者的治療獲美國食品藥品監督管理局(“FDA”)授予快速通道資格(Fast Track Designation,“FTD”)。
快速通道是FDA為用於治療嚴重疾病和解決未被滿足臨牀需求的藥物設置的一項助力開發及加速審評的程序,此次HLX42獲得FTD意味着其有資格獲得(1)與FDA更多會議討論、書面溝通的機會,從而在藥物研發、臨牀試驗設計等方面獲得更加密切的指導;(2)符合相關標準後可獲得優先審評和加速批准資格;及(3)滾動式審評,即分階段遞交生物製品上市申請(BLA)或新藥申請 (NDA)申報材料用於FDA審評,無需待所有材料全部完成後再提交審評。
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