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夺宝岛埃克替尼用于术后辅助治疗上市申请获受理
日期: 2020-09-22

        9YUE22RI,YANSUANAIKETINISHUHOUFUZHUZHILIAODEXINSHIYINGZHENGSHANGSHIXUKESHENQINGHUODEGUOJIAYAOPINJIANDUGUANLIJU(NMPA)SHOULI(SHOULIHAO:CXHS2000030GUO)。

        YANSUANAIKETINI(KAIMEINA®)SHI夺宝岛LISHIJINSHINIANZIZHUYANFA、WANQUANYONGYOUZIZHUZHISHICHANQUANDEGUOJIA1.1LEICHUANGXINYAO,YESHIZHONGGUODIYIGEZIZHUCHUANGXINDEXIAOFENZIBAXIANGKANGAIXINYAO。TASHIYIZHONGQIANGXIAO、GAOXUANZEXINGDEXIAOFENZIKOUFUBIAOPISHENGZHANGYINZISHOUTILAOANSUANJIMEIYIZHIJI(EGFR-TKI)。2011NIAN6YUE,YANSUANAIKETINIHUODEGUOJIASHIPINYAOPINJIANDUGUANLIZONGJU(CFDA)PIZHUNSHANGSHI,YONGYUFEIXIAOXIBAOFEIAI(NSCLC)ER/SANXIANDEZHILIAO,TIANBULEWOGUOXIAOFENZIBAXIANGKANGAIYAOWUDEKONGBAI,BEIYUWEIMINSHENGLINGYUDE“LIANGDANYIXING”。2014NIAN11YUE,CFDAPIZHUNDANYAOSHIYONGYUZHILIAOBIAOPISHENGZHANGYINZISHOUTI(EGFR)JIYINJUYOUMINGANTUBIANDEJUBUWANQIHUOZHUANYIXINGFEIXIAOXIBAOFEIAI(NSCLC)HUANZHEDEYIXIANZHILIAO。

AIKETINIZUOYONGJILITU

        BIAOPISHENGZHANGYINZISHOUTI(EGFR)GAOBIAODAYUDUOZHONGLEIXINGDEZHONGLIUXIBAO,YUQIPEITIBIAOPISHENGZHANGYINZI(EGF)JIEHEHOU,JIHUOEGFRXIBAOJIANGBUFENDEJIMEIHUOXING,TONGGUOBUTONGDEXINHAOCHUANDAOTUJINGDIAOJIEDUOZHONGJIYINDEZHUANLU,CONGERDIAOKONGXIBAODEZENGZHI、FENHUA、DIAOWANGDENG。EGFR-TKINENGTEYI、JINGZHENGXINGDIJIEHEEGFRJIMEIGONGNENGQUDEATP JIEHEWEIDIAN,YIZHIQIJIMEIHUOXINGCONGERZUDUANAIXIBAOZENGZHI、ZHUANYIDENGXIANGGUANXINHAODECHUANDAO。YANSUANAIKETINISHINENGGOUJINRUXIBAONEIDEXIAOFENZIHUAHEWU,YANJIUJIEGUOBIAOMING,DUIJIWANGJIESHOUGUOHUALIAOFANGANSHIBAIHOUDEJUBUWANQIHUOZHUANYIXINGFEIXIAOXIBAOFEIAI(NSCLC)JUYOUQUEQIEDEKANGZHONGLIUXIAOYING,ZHUYAOZHIBIAODENGTONGDUIZHAOJINKOUYAOWU,BULIANGFANYINGFASHENGLVMINGXIANDIYUDUIZHAOJINKOUYAOWU,ANQUANXINGGENGYOU。PINGJIETUCHUDELIAOXIAOHEANQUANXING,AIKETINISHANGSHIYILAIYIJINGYOUCHAOGUO26WANWANQIFEIAIHUANZHEFUYONG,MIANFEIYONGYAOXIANGMULEIJIFAYAO532WANYUHE,QIESHIJIANGDILEHUANZHEFUDAN。

        AIKETINISHANGSHIHOUKAIZHANLE80DUOXIANGLINCHUANGXUESHUYANJIU,BAOKUOYIXIANZHILIAOYANJIU、FEIAIBANNAOZHUANYIYANJIU、EGFRZHUANGTAIBUMINGHUANZHEYANJIU、EGFR21L858RWAIXIANZIMINGANTUBIANJIALIANGYANJIU、YUHUALIAOLIANHEDEYANJIUDENG,BINGZAIASCO、WCLC、ESMODENGGUOJIXUESHUHUIYISHANGBAOGAO,ZHANSHIZHULIZHONGGUOFEIAIYANJIUZOUSHANGGUOJIWUTAI。

        EVIDENCEYANJIUSHIZHENDUIII-IIIAQIFEIAIEGFRTUBIANHUANZHESHUHOUFUZHUZHILIAODEDUIZHAOSHIYAN,SHIYANZUWEIAIKETINIZHILIAO,DUIZHAOZUWEIBIAOZHUNFUZHUHUALIAO。GAIXIANGMUYU2014NIAN12YUEHUODELINCHUANGSHIYANPIJIAN,YOUSHANGHAISHIFEIKEYIYUANZHOUCAICUNJIAOSHOUHEGUANGZHOUYIKEDAXUEFUSHUDIYIYIYUANHEJIANXINGJIAOSHOUGONGTONGQIANTOUKAIZHAN。2015NIAN6YUERUZUSHOULIHUANZHE,2019NIAN8YUEWANCHENG322LIHUANZHERUZU,2020NIAN6YUEWANCHENGSHUJUKUSUODING。JIEGUOXIANSHI:ZAILIAOXIAOFANGMIAN,AIKETINIZHILIAOZUDUIBIBIAOZHUNFUZHUHUALIAOZU,HUANZHEZHONGWEIWUBINGSHENGCUNQI(DFS)WEI46.95GEYUE vs 22.11GEYUE,(P<0.0001);3NIANDFSLVWEI63.88% vs 32.47%;ZAIANQUANXINGFANGMIAN,AIKETINIZHILIAOZUBULIANGFANYINGFASHENGLVMINGXIANDIYUBIAOZHUNFUZHUHUALIAOZU;3JIJIYISHANGBULIANGFANYINGFASHENGLVWEI4.49% ,BIAOZHUNHUALIAOZUWEI59.71%。ZONGHELAIKAN,YANSUANAIKETINIPIANYONGYUEGFRJIYINMINGANTUBIANDENSCLCHUANZHESHUHOUFUZHUZHILIAODELIAOXIAOYOUYUBIAOZHUNFUZHUHUALIAO,NENGXIANZHUYANZHANGHUANZHEWUBINGSHENGCUNQI,TONGSHIANQUANXINGGENGYOU。2020NIAN9YUE,ZENGJIAXINSHIYINGZHENGDESHANGSHIXUKESHENQINGHUODESHOULI。

JIABANJIADIANBAOZHANGAIKETINIEVIDENCESHENBAO

        ZUOWEIGONGSISHOUGEANNDA(HUAXUEYAOPIN2.4LEI)SHENBAODEZENGJIAXINSHIYINGZHENGDESHANGSHIXUKESHENQING,ZHUCESHIWUZONGJIANHEWEIZHICHU,CICIZHUCESHENBAOQIAFENG《YAOPINZHUCEGUANLIBANFA》DENGFAGUIZHINANGANGGANGSHIXING,ZILIAOXINGSHIHEJISHUYAOQIUYOUJIAODABIANHUA,YUYIWANGYOUHENDACHAYI,WEICIDAJIARENZHENYANDUXINZHENG,TIZAOZHUNBEI,ZHIDINGLEQIESHIKEXINGDEZHUCECELVE,WEISHUNLISHENBAOTIGONGLEBAOZHANG。BENCISHANGSHIXUKESHENQINGZILIAODUO、SHIJIANJIN、RENWUZHONG、YAOQIUGAO,YIXUE、ZHUCE、ZHIGUANDENGBUMENGONGTONGLIANDONG,XIANGMUZUCHENGYUANTUANJIEHEZUO,BUMENZHIJIANJINMIGOUTONG,ZUODAOLEGONGZUOWUFENGXIANJIE,QUANLIKUAISUTUIJIN,GAOXIAOWANCHENGLESHENBAO。GONGSILINCHUANGYANJIUZHUGUANZHANGDANDANGANKAIDAO:“EVIDENCEXIANGMULIJINGLE5NIANDUOSHIJIAN,KANDAOSHANGSHIXUKESHENQINGBEIZHENGSHISHOULIDEPIJIANSHI,GANDAOSHUOBUCHUDEXINWEI,XIANGMUZUTONGSHIMENDOUHENKAIXIN,JUEDEHANSHUIMEIYOUBAILIU,YIQIEXINLAODOUSHIZHIDEDE,JIEXIALAIYIDINGNULIZUOHAOHOUXUHECHADENGGONGZUO,FENZHANDAODI,ZHENGQUGENGDASHENGLI。”

        FUZONGCAIMAYONGBINBIAOSHI:“AIKETINIEVIDENCEYANJIUTIGONGLEZHONGYAODEXUNZHENGYIJU,JINYIBUZHENGSHILEBAXIANGZHILIAOZAIEGFRMINGANTUBIANFEIXIAOXIBAOFEIAIHUANZHESHUHOUFUZHUZHILIAOZHONGDEDIWEI。ZHEICISHANGSHIXUKESHENQING,NINGJIELEGONGSIGEGEBUMENDEXINXUEHEHANSHUI,WOMENJIANGJIXUNULIZUOHAOHOUXUGONGZUO,ZHENGQUZAORIHUOPISHANGSHI,TIGONGYIZHONGYOUXIAODIDUDEXINDEZHILIAOTUJING,ZAOFUGUANGDAHUANZHE。”

关于夺宝岛

夺宝岛GUFENYOUXIANGONGSI(GUPIAODAIMA:)SHIYIJIAYOUHAIGUIGAOCENGCIRENCAITUANDUICHUANGBANDE,YIZIZHUZHISHICHANQUANCHUANGXINYAOWUYANJIUHEKAIFAWEIHEXIN,JIYANFA、SHENGCHAN、YINGXIAOYUYITIDEGAOXINZHIYAOQIYE。ZIZHUYANFALEZHONGGUODIYIGEXIAOFENZIBAXIANGKANGAIYAO——YANSUANAIKETINI(SHANGPINMING:KAIMEINA),BEIYUWEIMINSHENGLINGYUDE“LIANGDANYIXING”,LIANGHUOZHONGGUOZHUANLIJINJIANG,RONGHUOZHONGGUOGONGYEDAJIANG,ZHANHUOWOGUOHUAXUEZHIYAOXINGYEDIYIGEGUOJIAKEJIJINBUYIDENGJIANG。JIEZHI2020NIANSHANGBANNIAN,AIKETINIYIHUIJI26WANMINGWANQIFEIAIHUANZHE,LEIJIXIAOSHOUTUPO80YIYUAN。GONGSIJIANLILEWANZHENGDEXINYAOYANFATIXI,ZAIHANGZHOU、BEIJINGFENBIESHEYOUYANFAZHONGXIN,ZAIYANCHUANGXINYAO30YUXIANG,HANGAILEFEIAI、SHENAI、RUXIANAIDENGDUOGEZHONGLIUSHIYINGZHENG。GONGSIYUAmgen、Xcovery、Tyrogenex、Merus、Agenus、TIANGUANGSHI、YIFANGSHENGWUDENGGUONEIWAILINGXIANDEZHIYAOQIYEDACHENGZHANLVEHEZUO,WEICUJINQUANRENLEIDEJIANKANGFUZHIERGONGTONGNULI。


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