科倫藥業(002422.SZ):主要產品A140注射液(西妥昔單抗注射液)上市申請獲NMPA受理
格隆匯9月10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”)開發的A140注射液(西妥昔單抗注射液,商品名稱:達泰萊)的上市申請獲得國家藥品監督管理局藥品審評中心受理。
本品用於治療RAS基因野生型的轉移性結直腸癌:與FOLFOX或FOLFIRI方案聯合用於一線治療;與伊立替康聯合用於經含伊立替康治療失敗後的患者。本品用於治療頭頸部鱗狀細胞癌:與鉑類和氟尿嘧啶化療聯合用於一線治療復發和/或轉移性疾病;與放療聯合用於治療局部晚期疾病。
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