科倫博泰生物-B(06990.HK)核心產品蘆康沙妥珠單抗(SAC-TMT)新增適應症上市申請獲國家藥監局受理
格隆匯5月22日丨科倫博泰生物-B(06990.HK)發佈公吿,公司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,亦稱SKB264/MK-2870)(佳泰萊®)的一項新增適應症上市申請已獲中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)受理,用於治療既往接受過內分泌治療且在晚期或轉移性階段接受過其他系統治療的不可切除的局部晚期或轉移性激素受體陽性(HR+)且人表皮生長因子受體2陰性(HER2-)乳腺癌(BC)成人患者。本次受理是基於OptiTROP-Breast02註冊3期研究的積極結果。該申請是蘆康沙妥珠單抗(sac-TMT)獲NMPA受理的第四個適應症上市申請。
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