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艾力斯(688578.SH):伏美替尼新增適應症獲得藥物臨牀試驗批准通知書
格隆匯 07-08 17:44

格隆匯7月8日丨艾力斯(688578.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,甲磺酸伏美替尼片(簡稱“伏美替尼”)新增適應症的臨牀研究獲得藥物臨牀試驗批准。伏美替尼是一種表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI),為公司自主研發的1類小分子靶向藥。伏美替尼屬於高選擇性、不可逆第三代EGFR-TKI,主要用於EGFR突變的非小細胞肺癌治療,具有“腦轉強效、療效優異、安全性佳、治療窗寬”差異化的競爭優勢,其二線適應症、一線適應症均已被納入《國家基本醫療保險、工傷保險和生育保險藥品目錄(2023年)》。

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