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科倫藥業(002422.SZ)子公司核心產品TROP2 ADC蘆康沙妥珠單抗(sac-TMT)聯合PD-L1單抗塔戈利單抗一線治療無驅動基因突變的局部晚期或轉移性非鱗狀非小細胞肺癌獲國家藥品監督管理局突破性療法認定

格隆匯6月11日丨科倫藥業(002422.SZ)公佈,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”)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)(佳泰萊®)聯合抗程序性細胞死亡配體 1(PD-L1)單克隆抗體塔戈利單抗(科泰萊®)一線治療無驅動基因突變的局部晚期或轉移性非鱗狀非小細胞肺癌(NSCLC)獲中國國家藥品監督管理局(NMPA)藥品評審中心(CDE)授予突破性療法認定。突破性療法認定是針對與現有治療手段相比具有明顯臨牀優勢的藥物,旨在加速滿足臨牀急需醫療需求的創新藥的研發和產品上市。

這是蘆康沙妥珠單抗(sac-TMT)獲 NMPA 授予的第五項突破性療法認定。此前,蘆康沙妥珠單抗(sac-TMT)分別在 2022 年 7 月就治療局部晚期或轉移性三陰性乳腺癌(TNBC), 2023 年 1 月就治療表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI)治療後疾病進展的局部晚期或轉移性 EGFR 突變 NSCLC, 2023 年6 月就治療既往接受過至少二線系統化療的局部晚期或轉移性激素受體陽性(HR+)及人類表皮生長因子受體 2 陰性(HER2-)乳腺癌(BC)患者,以及 2024 年 3月就一線治療不可手術切除的局部晚期、復發或轉移性 PD-L1 陰性 TNBC,獲得突破性療法認定。

蘆康沙妥珠單抗(sac-TMT)聯合塔戈利單抗一線治療晚期或轉移性非鱗狀NSCLC 患者的 2 期 OptiTROP-Lung01 臨牀研究結果在 2025 年美國臨牀腫瘤學會(ASCO)年會上的壁報環節公佈。

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