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科倫藥業(002422.SZ):子公司核心產品蘆康沙妥珠單抗(sac-TMT)基於OptiTROP-Breast01研究治療2線及以上TNBC獲國家藥監局批准上市
格隆匯 11-27 11:50

格隆匯11月27日丨科倫藥業(002422.SZ)公佈,四川科倫藥業股份有限公司(以下簡稱"公司")近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司(以下簡稱"科倫博泰")首款用於既往至少接受過2種系統治療(其中至少1種治療針對晚期或轉移性階段)的不可切除的局部晚期或轉移性三陰性乳腺癌(TNBC)成人患者的國產靶向人滋養細胞表面抗原2(TROP2)的抗體偶聯藥物(ADC)蘆康沙妥珠單抗(sac-TMT,前稱SKB264/MK-2870)(佳泰萊®)獲國家藥品監督管理局(NMPA)批准在中國上市。

該項批准是基於一項用於既往至少接受過2種系統治療(其中至少1種治療針對晚期或轉移性階段)的不可切除的局部晚期或轉移性TNBC成人患者的隨機、對照3期OptiTROP-Breast01研究的積極結果。與化療相比,sac-TMT在無進展生存期(PFS)和總生存期(OS)方面均顯示出具有顯著統計學意義和臨牀意義的改善。該研究結果已在2024年5月舉行的美國臨牀腫瘤學會(ASCO)年會的新一代ADCs臨牀科學專題研討會上公佈。

此前,NMPA已經受理了兩項補充新藥申請(sNDA),分別是蘆康沙妥珠單抗(sac-TMT)單藥治療經EGFR-TKI治療後進展或經EGFR-TKI和含鉑化療治療後進展的局部晚期或轉移性EGFR突變非小細胞肺癌(NSCLC)患者的申請。

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