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康諾亞-B(02162.HK):CMG901治療復發╱難治性胃癌及胃食管結合部腺癌獲FDA授予快速通道資格
格隆匯 04-19 08:29

格隆匯4月19日丨康諾亞-B(02162.HK)發佈公吿,其在研新藥CMG901(“Claudin 18.2抗體偶聯藥物”)用於治療復發╱難治性胃癌及胃食管結合部腺癌已於近日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”)。此前,集團已於2021年3月就CMG901在美國進行胃癌及胃食管結合部腺癌的臨牀試驗獲得FDA批准,並於2022年4月獲FDA孤兒藥資格認定。

根據披露,FTD的設立旨在促進和加快藥物的臨牀開發與審評過程,以期滿足嚴重疾病的未竟醫療需求。根據規定,獲得FTD資格的候選藥物意味着有機會通過各種形式加快審評進程,包括但不限於(1)與FDA進行更加頻繁地溝通、開展會議等,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;(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,無需待所有資料全部完成後再提交審評。 

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