A股異動 | 艾力斯升超12% 伏美替尼20外顯子插入突變NSCLC一線治療適應症III期臨牀獲批
格隆匯4月7日丨艾力斯(688578.SH)升超12%,報28.14元,總市值126億元。艾力斯公吿,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(“伏美替尼”)針對EGFR或HER2突變晚期NSCLC患者的Ib期臨牀試驗獲得藥物臨牀試驗批准。據悉,公司與ArriVent Biopharma Inc,(“ArriVent”)合作開展一項評估伏美替尼對攜帶EGFR或HER2激活突變的晚期或轉移性非小細胞肺癌患者的安全性、藥代動力學和抗腫瘤活性的Ib期劑量遞增和劑量擴展研究(該研究“FURMO-002”),中國境內臨牀研究由公司實施,境外臨牀研究由ArriVent實施,FURMO-002已在美國、西班牙、澳大利亞、日本等多個國家獲批進入臨牀階段,目前在上述地區正處於患者入組階段。

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