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科倫藥業(002422.SZ):創新藥SKB264治療晚期三陰性乳腺癌III期臨牀獲批開展
格隆匯 04-07 15:45

格隆匯4月7日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司科倫博泰開發的創新藥物TROP2抗體偶聯藥物SKB264(TROP2-ADC)治療至少經二線治療失敗的晚期或轉移性三陰性乳腺癌(TNBC)患者以隨機對照試驗(RCT)支持上市申請的III期臨牀試驗獲得國家藥品監督管理局藥品審評中心(以下簡稱“CDE”)同意開展。

SKB264為科倫博泰擁有自主知識產權的TROP2抗體偶聯藥物(TROP2-ADC),於2020年4月獲得國家藥品監督管理局的默示許可,為首家獲批IND的國產TROP2-ADC。

乳腺癌是嚴重威脅全世界女性健康的第一大惡性腫瘤,其中TNBC佔所有乳腺癌病理類型的10%-20%,預後較其他類型乳腺癌差,對於蒽環類和紫杉類治療失敗的患者,目前並無標準療法,具有較大的未滿足臨牀需求。SKB264已完成TNBC的II期拓展入組,並獲得階段性臨牀數據。

基於II期拓展臨牀試驗的數據,科倫博泰向CDE提交了SKB264針對至少經二線治療失敗的晚期或轉移性TNBC患者開展III期臨牀試驗前的溝通交流申請,並於近日收到CDE的回覆意見。科倫博泰將結合監管要求啟動註冊臨牀研究,首例患者入組時會按照要求及時披露。

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