阿斯利康(AZN.US)乳腺癌1類創新藥在中國獲批

智通財經

2025/04/18

智通財經APP獲悉，4月18日，中國國家藥監局(NMPA)官網最新公示，批准阿斯利康(AZN.US)的1類創新藥卡匹色替片(capivasertib)上市。該產品已於2023年11月獲美國FDA批准上市(商品名：Truqap)，用於治療激素受體(HR)陽性、人表皮生長因子受體2(HER2)陰性的晚期或轉移性乳腺癌成年患者。

截圖來源：NMPA官網

公開資料顯示，這是一款「first-in-class」AKT抑制劑。該藥適用於聯合氟維司羣用於轉移性階段至少接受過一種內分泌治療後疾病進展，或在輔助治療期間或完成輔助治療後12個月內復發的激素受體(HR)陽性、人表皮生長因子受體2(HER2)陰性且伴有一種或多種PIK3CA/AKT1/PTEN改變的局部晚期或轉移性乳腺癌成人患者。

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