界面新闻记者 |
界面新闻编辑 | 谢欣
10yue8ri,gangguchuangxinyaogongsixindashengwuyuagushangshigongsiaosaikangyaoyegongtongxuanbu,shuangfangjiulietinipian(shangpinming:aoyixin)dachengdujiashangyehuahezuo。
qizhong,aosaikangweilietinideshangshixukechiyouren,fuzegaichanpindeshangyehuashengchanhegonghuo,bingxiangxindashengwuzhifuxiaoshoutuiguangfuwufei。xindashengwuzequdelietinizaizhongguodaludiqudedujiatuiguangxiaoshouquan,bingxiangaosaikangzhifushoufukuan、zhucelichengbeihexiaoshoulichengbeikuanxiang。buguo,shuangfangweipilubencihezuodejutijiaoyijine。
shijishang,jinsanniandexingyehandongshiguoneichuangxinyaolingyufengongquyumingque,yuelaiyueduoguochanchuangxinyaodeshangyehuahuanjiebeijiaojiyouxiaoshoutuanduihejingyande“dachang”laizuo。houzheyejiecijiangzijideshangyehuanenglibianxian,bingfengfuzishendechanpinzuhe。bencixindashengwuheaosaikangdehezuoyeshiruci。
jutidaochanpinshang,lietinishiyikuandisandaiegfr tki(biaopishengzhangyinzishoutilaoansuanjimeiyizhiji)baxiangyao,yeshiaosaikangjinzhanzuikuaide1leixinyao。
muqian,gaiyaoyiyouliangxiangxinyaoshangshishenqing(nda)zaiguojiayaojianju(nmpa)shenpingzhong,fenbieweiegfr tkinaiyaobingcunzaiegfr t790mtubianyangxing、huoyuanfaxingegfr t790mtubianyangxingdefeixiaoxibaofeiai(nsclc)erxianzhiliao,yijiegfrwaixianzi19queshi(19del)huowaixianzi21zhihuantubian(l858r)densclcyixianzhiliao。
qizhong,qianzheyu2021nian11yuehuoshouli,bingyibuchongdijiaoziliao;houzheyu2024nian8yuehuoshouli。aosaikangyujigaiyaojiangyu2024nianhuopi。
zuoweihuanzheduo、shichangdadedaaizhong,wanqinsclcsulaishizhongduoyaoqide“bizhengzhidi”。
zheileihuanzhedexitongxingquanshenzhiliaofenzuoqudongjiyinyinxingheyangxinglianglei。qianzhedangxiadeyixianbiaozhunliaofashipd-1+hualiao。houzhezhong,egfr、krastubianjunshichangjiandequdongjiyintubian,liangzhezainsclchuanzhezhongdexiedailvjunyuewei30%。
zaiegfrtubiannsclczhong,egfr tkiyishiyixianbiaozhunliaofa。youyinweijiejueleqiandaichanpindenaiyaoxingwenti,disandaiegfr tkichengweizhuliuyongyao。2021nian,shoukuansandaichanpinaoxitini(asilikang)jichuangxiachao50yimeiyuandequanqiuxiaoshoue。
zaizheiyishiyingzhengshang,guoneiduojiayaoqidekaifasilujunshiconghouxianwangyixianzhiliaoshangtuijin、jinyibaofangliang,bingtansuolianheyongyao,lietiniyebuliwai。
buguodangxia,gailingyuyixiangdangyongji。zailietiniqian,yiyou6kuandisandaiegfr tkizaiguoneihuopi。
其中,先行者阿美替尼(翰森)、伏美替尼(艾力斯)shangshihouxunsuqiangshiaoxitinishichang,2023nianxiaoshouefenbiechao30yiyuan、yue20yiyuan。
随后,贝福替尼(贝达/益方)、瑞齐替尼(倍而达药业)、瑞厄替尼(圣和药业)先后进场。该品种的价格较量也成为2024年国谈的看点之一。
换而言之,利厄替尼上市即面临激烈竞争。由此,对以消化领域产品起家、zhengzaichuangxinzhuanxing、weiyouzhongliuxinyaoxiaoshoujingyandeaosaikangeryan,jiangqijiaojixindashengwulaimaibunanlijie。yuzhileisidehaiyou,beierdayejiangruiqitiniguoneideshangyehuaquanyishouyulelaopaiyaoqishiyao。
erduixindashengwulaishuo,jieqianjiniandechuangxinyaozibenrelang,gongsiyizhujiancongbiotech(shengwukejigongsi)fazhanchengbiopharma(shengwuzhiyaogongsi)。muqian,qiyongyouyue3000rendexiaoshoutuandui,qieshangyehuanenglizaiguoneiyizhongchuangxinyaogongsizhongpoweituchu。
youci,bang“xinren”maiyaoyeshuidaoqucheng。erchuleshangyehuashouyi,lietiniyebuchonglexindazijizaifeiailingyudebuju。
shijishang,xindashengwuzaizhenggefeiaishangluozipoduo,baokuoyihuopidexindilidankang(pd-1,kuohaoneiweibadian,xiatong)、beifazhudankang(vegr)、saiputini(ret)、fuzeleisai(kras g12c),yijindazhengzaishenpingzhongdetaleitini(ros1)。
qizhong,zaiqudongjiyinyinxingdensclcshang,jishixingchanpinxindilidankangyihuopiyuhualiaolianyong,yongyuyixianzhiliaolinzhuanghefeilinzhuangnsclc。beifazhudankangyuhualiaolianyongyehuopiyongyufeilinzhuangnsclcdeyixianzhiliao。
qudongjiyinyangxingdensclczhong,xindabenshenzaiegfrtubianshangyiyouliaofahuopi,jixindili+beifazhu+hualiaosiyaolianyong,yongyuegfrtubiannsclcdeerxianzhiliao。
不过,相较于后来的新疗法如PD-1/VEGF双抗(依沃西单抗,康方)、egfr/c-metshuangkang(aiwantuodankang,qiangsheng)、trop2 adcdengyaowuyongyuegfrtubiannsclchouxianzhiliao,xindadelianyongfanganzailiaoxiao、yongyaofudandengfangmiandouxianyouyoushi。
lingwai,aiwantuodankangyudisandaiegfr tkilazetinilianyong,zaiquanqiu3qilinchuangtouduitoushiyanzhongjibaiaoxitini,yu2024nian8yuezaimeihuopiyongyuegfrtubiannsclcyixianzhiliao,yexianshichuegfr tkidelianyongqianli。
zheihuodouchengweixindaxuyaoyikuanjijianghuopideegfr tki,laiweichizijizaigailingyudiweideyuanyin。
ciwai,fuzeleisaishiguoneishougehuopidekrasbaxiangyao,zheilingxindazailingyichangjiandequdongjiyinkrastubianshangzhanjuxianfayoushi。retheros1tubianzainsclchuanzhezhongzejiaoweihanjian。
lingwai,lietinibingfeiaosaikangzaifeiailingyubujudeweiyixinyao,qihaiyouyikuanxiaofenzic-metyizhijiaskc202,niyulietinilianyong,zhiliaoegfr-tkinaiyaoqiecunzaimetjiyinyichanghuodanbaiguobiaodadensclchuanzhe。muqian,gailianyongfanganzhengchuyulinchuang1qijieduan。
zheihuoyeshibencixindajinqudelietinishangyehuaquanyi,erfeimaiduangaichanpindeyuanyin。weilai,aosaikanghexindashengwuzaifeiaishangdehezuoshifouhuigengjinyibuhaiyoudaiguancha。
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