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海正藥業(600267.SH):子公司依維莫司原料藥獲得《化學原料藥上市申請批准通知書》
格隆匯 07-10 17:28

格隆匯7月10日丨海正藥業(600267.SH)公佈,公司全資子公司海正藥業(杭州)有限公司(稱“海正杭州公司”)收到國家藥品監督管理局核准簽發的依維莫司原料藥的《化學原料藥上市申請批准通知書》。

依維莫司適用於既往接受舒尼替尼或索拉非尼治療失敗的晚期腎細胞癌成人患者;不可切除的、局部晚期或轉移性的、分化良好的(中度分化或高度分化)進展期胰腺神經內分泌瘤成人患者;無法手術切除的、局部晚期或轉移性的、分化良好的、進展期非功能性胃腸道或肺源神經內分泌腫瘤(NET)成人患者;需要治療干預但不適於手術切除的結節性硬化症(TSC)相關的室管膜下鉅細胞星形細胞瘤(SEGA)成人和兒童患者;用於治療不需立即手術治療的結節性硬化症相關的腎血管平滑肌脂肪瘤(TSC-AML)成人患者。依維莫司臨牀上還可用於預防腎移植和心臟移植手術後的排斥反應。

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