艾力斯(688578.SH)：甲磺酸伏美替尼片EGFR20外显子插入突变NSCLC二线治疗适应症拟纳入优先审评程序

智通财经2025-07-09

智通财经APP讯，艾力斯(688578.SH)发布公告，公司产品甲磺酸伏美替尼片(以下简称“伏美替尼”)拟用于“既往经含铂化疗治疗时或治疗后出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体(EGFR)20外显子插入突变的局部晚期或转移性NSCLC成人患者的治疗”的药品上市许可申请近日被国家药品监督管理局药品审评中心(CDE)纳入拟优先审评品种公示名单，公示期为2025年7月8日至...

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SH): Fumetinib mesylate tablets EGFR20 exon insertion mutation NSCLC second-line treatment indications are to be included in the priority review process","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"688578":1},"content_text":"智通财经APP讯，艾力斯(688578.SH)发布公告，公司产品甲磺酸伏美替尼片(以下简称“伏美替尼”)拟用于“既往经含铂化疗治疗时或治疗后出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体(EGFR)20外显子插入突变的局部晚期或转移性NSCLC成人患者的治疗”的药品上市许可申请近日被国家药品监督管理局药品审评中心(CDE)纳入拟优先审评品种公示名单，公示期为2025年7月8日至2025年7月15日。甲磺酸伏美替尼片是一种表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)，为公司自主研发的1类新药，属于小分子靶向药，是目前公司的核心产品，用于晚期NSCLC的治疗，伏美替尼用于EGFR20外显子插入突变NSCLC的二线治疗适应症已获得CDE突破性治疗品种的认定。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.43.1","shortVersion":"4.43.1","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2550363868","isCrawlerRequest":true}