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艾力斯(688578.SH):已與Arrivent合作啟動了伏美替尼20外顯子插入突變一線治療適應症的III期臨牀研究
格隆匯 06-19 17:16

格隆匯6月19日丨有投資者向艾力斯(688578.SH)提問,“在之前的業績交流會中,艾力斯説近期美國FDA會有新進展,除了溝通伏美替尼20插入適應症外,也在積極溝通其他適應症的綜合研究。自艾力斯與ARRIVENT合作,已經有兩年時間了,海外進展一直未見披露,每次調研及答覆都是寥寥幾句。請公司認真回覆。”

艾力斯回覆稱,伏美替尼海外註冊臨牀研究項目進展順利,公司已經與Arrivent合作啟動了伏美替尼20外顯子插入突變一線治療適應症(即用於一線治療EGFR20外顯子插入突變的局部晚期或轉移性非小細胞肺癌患者的治療)的III期臨牀研究,這是一項全球、III期、多中心、隨機、開放標籤研究。中國境內臨牀研究由公司實施,境外臨牀研究由ArriVent實施,該研究已在美國、法國、日本等多個國家獲批進入臨牀,目前正處於患者入組階段,並且已於近期完成了海外的首例患者入組。

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