文｜动脉网

cengjingqingsongzuoyongshangyihuanzhedebolisuannadiyanye，yejikaishifubuzhule。shujuxianshi，2020nianyilai，bolisuannadiyanyezaiyuanneidexiaoshouechixuzoudi，youqishizaibeinaruyibaohou，bolisuannadiyanyedexiaoshouegengshijizhuanzhixia。

rujin，bolisuannadiyanyekeweineiyouwaihuan。yibianshihuanbaosudiyanyehengsaohaiwaiganyanbingshichanghou，kaishixijuandaoguonei。lingyibianshigedayaoqipinpinxiazhu，ganyanbingjihuchengweibingjiabizhengzhidi，xinjizhizhiliaoyaowubuduanqudelinchuangshiyandetupojinzhan。

一代神药

zaisuoyoudeganyanzhengyaowuzhong，bolisuannadiyanyeshirenmenzuishuxideyilei。

youyanjiushujuxianshi，bolisuannayanyongzhijishiwoguoyiyuanshichangxiaoshouguimozuidadeganyanzhengyanyaoshui，shichangzhanbichao25%。zaozai2018nian，bolisuannadiyanyezaiwoguozhongduanxiaoshouejiutupole10yiyuan，2019niandaodaxiaoshoufengzhi12yiyuan。qizhong，guoneibolisuannadiyanyeshichangzhangqibeideguowuzifamuyaoye、ribencantianzhiyaodenghaiwaiyaoqizhanju，fenezhanbichao8cheng。chucizhiwai，zhuhailianbang、qiluzhiyao、jiangxizhenshimingyaoyedengguoneiyaoqikaifadebolisuannadiyanye，yezhanyouyidingdeshichangfene。

2020nianyilai，bolisuannadiyanyedexiaoshouesuiranrengbaochizai10yiyuanyishang，danyijingchengxianmingxiandexiahuaqushi。2021nian5yue，bolisuannadiyanyeyaobeinarudisipijicaipinzhong。dao2022nianshangbannian，bolisuannadiyanyedezhongduanxiaoshouetongbixiahuachao30%。

bolisuannadiyanyeyidutongzhiganyanzhengyongyaoshichangdebeihou，shizailinchuangshijianzhong，ganyanzhengzhenliaodeguifanchengdurengyoudaitisheng。

suoweiganyanzheng，shizhiyanbiaoshiquleleimodebaohu，zhijiebaoluzaiwaijiecijixia，wangwanghuichanshengyanbugansegan、shaozhuogan、yiwugan、zhencigan、yanyang、weiguang、yanhong、shiwumohu、shilibodongdengzhengzhuang。zaiyanqiubiaomian，youyicengleimo，meicizhayan，jiuhuiyouxindeleimoxingcheng，junyunfugaizaiyanbiao。eryidanleimodezhihuolianghuoyetidonglixueyichang，jiukenenghuichuxiangezhongyanbubushizheng，shenzhishigongnengzhangai。

zuoweiyizhongmanxingyanbiaojibing，ganyanzhengxingchengdeyuanyinyouhenduo。zongtieryan，jianbanxiangongnengzhangaizaochengyouzhicengjianshao，daozhileimozhengfaguokuai，shizaochengganyanzhengzuizhiguandeyinsu。biru，zhangshijianningshidianzipingmu，huozheshenghuozaidafeng、kongqiguoyuganzaodehuanjingzhong，douyoukenengganyanzheng。

zaisuoyoudeyankejibingzhong，ganyanzhengshifabinglvdiergaodeyilei。fabinglvzuigaodeshijinshi，erjinshidezhiliaoshouduanyiqixieweizhu。shujuxianshi，ganyanzhenghuanzheyuezhanyankejiuzhenhuanzhede60%yishang，danyoulinchuangyishengbiaoshi，ganyanzhengjiuzhenlvhendi，jin5.38%。

linchuangshang，direngongyanyeshiganyanzhengzhiliaoshouxuandejiyaoxingshi。rendeyanjingshiyigefuzadewentaiqiguan，youyuxue-fangshuipingzhangdecunzai，yaowuhennantongguoquanshenjiyaojinruyanbiaozuzhi。yinci，xianjieduan，shichangshang90%deyanyongzhijijunshizhijiezuoyongyuyanbudejubujiyaoxingshi。erganyanzhengzuoweiyizhongyanbiaojibing，wangwangxuyaozhangqizhiliaocainengzhongjianheweichiyanbiaoxitongwentai。

干眼症的分类及治疗方式 数据来源：动脉网根据公开资料整理

jinguanduiyubutongleixinghejieduandeganyanzheng，linchuangzhinanjichulemingquedechayihuazhiliaofangan，danzaiguoneidelinchuangshijianzhong，yuanbenbeidingyiweiqingduganyanzhenghuanzheyongyaoderengongleiye，jihubeiyongyurenhejieduandeganyanzhenghuanzhe。qizhong，zuichangjianderengongleiye，jibolisuannadiyanye。

tongchang，rengongleiyecaiyongdengshenhuodishendiyanyedexingshi，keyirunhuayanqiu、zengjiayanbiaorunshidu、xishiyanzhengyinzi、jiangdileimoshentouyadeng。buguo，baokuobolisuannadiyanyezaineiderengongleiye，liaoxiaodoushifenyouxian，huanzheyongyaodeyicongxingyebugao，duiyuganyanzhengliuxingdekongzhixiaoguobingbumingxian。

闯入者席卷而来

jinnianlai，bolisuannabolisuannadiyanyedeshichangdiweijijikewei。qizhong，zuidadeweixielaizihuanbaosudiyanye。

yubolisuannadiyanyezhuyaotongguorunhuayanqiu，laihuanjieganyanzhengzhengzhuangbutong，huanbaosudiyanyedezuoyongyuanli，cujinleiyedeshengcheng。jutieryan，huanbaosudiyanyeshiyizhonggaidiaoshenjinglinsuanmeiyizhijimianyiyizhiji，xuanzexingjikenixingdiyizhitlinbaxibaodegongneng，bingnengyizhibaokuobaixibaojiesu-2zaineidelinbayinzideshengchengheshifang，yizhinkxibaodeshashanghuoli，kezuoweijubumianyidiaojiejiyongyuganzaoxingjiaomojiemoyanyinqideyanyanzhengshideleiyefenmishoudaoyizhidehuanzhe，congercujinleiyedeshengcheng。huanbaosudiyanyezhiliaoganyandeyaowunongduwei0.05%~1.00%，shiyongpinlvduoweimeitian2ci。zaiguowai，huanbaosushizuichangjiandeganyanzhengyaowu。

2002nian，quanqiushoukuanhuanbaosudiyanyehuopishangshi。meiguoaierjian(allergan)yanfadehuanbaosudiyanyerestasis，beifdapizhunyongyuzhongzhongduganyanbingzhiliaodeyaowushi。zairestasisshangshihoudeshiyunianjian，yizhimeiyouganyanzhengxinyaohuopishangshi。restasisdexiaoshoueyeyiluzougao，2019nian，restasiszaimeiguoxiaoshouedadao11.88yimeiyuan，cihoudefengzhinianxiaoshouegengshidadaojin15yimeiyuan，chengweiyankeyongyaozhongyigexianxiangjidecunzai。

restasisdedamai，jianghuanbaosudiyanyedekaifatuixianggaochao。

2015nian，ribencantianweikasi （huanbaosudiyanye（iii）），zaiouzhoushangshi。2022nian5yue，zheikuanyaowuhuodezhongguoguojiayaopinjianduguanliju（nmpa）dezhengshipizhun，zaiguoneishangshi，yongyuzhiliao4suijiyishangertongheqingshaoniandeyanzhongxingchunjijiaojiemoyan。2018nian，yindutaiyangyaoyekaifadehuanbaosucequazaimeiguohuopishangshi，chengweifdapizhundeshoukuanjiaoshuxingdiyanye。2023nian6yue8ri，novaliqxuanbufdapizhun0.1%devevye （cyclasol）yongyuzhiliaoganyanbingdetizhenghezhengzhuang，vevye shidiyizhongyeshiweiyiyizhongyongyuzhiliaoganyanzhengtizhenghezhengzhuangdehuanbaosurongye。

fangzhiyaofangmian，huanbaosudekaifajingzhengyeshifenjilie。2022nian2yue，fdapizhunshangshilerestasisdeshougefangzhiyao，jimylandehuanbaosuyanyongruji0.05%。ciwai，tiwazhiyao、huirui、akorndeng9jiayaoqidouzaituijinrestasisfangzhiyaoshangshi。

zaiguonei，baokuohuanbaosuzaineideganyanzhengxinyao，yijingduibolisuannadiyanyexingchengleweijiaozhishi。

xianjieduan，guoneihuopishangshidehuanbaosudiyanyezhiyou2kuan。chuleqianwentidaoderibencantianweikasi wai，2020nian6yue，xingqiyanyaoyanfadeganyanzhengzhiliaoyaowu0.05%huanbaosudiyanye（ii）（zirun ）huoguojiayaojianjupizhunshangshi，yongyuyujiaojiemoganzaozhengxiangguandeyanbuyanzhengsuodaozhideleiyeshengchengjianshaozhengzhuang，chengweiguoneishoujiahuopishangshideganyanzhengyanyongzhiji。

ciwai，gengduodeguoneiyaoqi，zetongguoshouquanhezuodefangshi，zhengdaliyinjinhaiwaichangxiaodeganyanzhengxinyao。

2019nian6yue，taiyangzhiyaojiangcequa zaidazhonghuaqudekaifaheshangyehuashouquanjilekangzheyaoye。buguo，zai2021nian5yue，taiyangzhiyaozaimeiguozhudongzhaohuiyipi0.09%huanbaosudiyanye，jiyuci，kangzheyaoyejuedingzhudongzantingzhongguoiiiqiqiaojieshiyan，daishoudaofuhegongsizhiliangyaoqiudexinpicishiyanyongchanpinhou，zaiqidongqiaojieshiyan。

2019nian11yue，hengruiyiyaocongnovaliqgongsihuodecyclasolzhongguodujiashouquan，daihaoweishr8028。2021nian3yuezaizhongguojinxing3qiyanjiu。2024nian3yue20ri，hengruiyiyaoxuanbu，shr8028deyaopinshangshixukeshenqingyihuonmpashouli，shenqingshangshideshiyingzhengwei：zhiliaoganyandetizhenghezhengzhuang，xiwangnenggouzaorizaiguoneishangshi。

guochanfangmian，zhaokeyankedehuanbaosuayanyongningjiaoweigongsiziyande2.2leigailiangxingxinyao，muqianxinyaoshangshishenqingyiyu2022nian6yue8rihuoguojiayaojianjucdeshouli。gaiyao2023nian1yueluxutongguoguojiayaojianjudeyaopinzhucejilinchuangshiyanxianchanghecha，bingtongguoguangdongshengyaopinjianduguanlijudegmpfuhexingjiancha，xiangzhezuizhongzhucejishangyehuamaijin。gaiyaoruguoshangshi，yejiangshixingqiyanyaodeqiangshijingzhengduishou。

zaihuanbaosudiyanyedeheweizhixia，bolisuannadiyanyedeshichangdiweiyiranjijikewei。neime，huanbaosudiyanyeyoukeyiwenzuoganyanzhengyaowudejiangshanma？

等待新霸主

shijishang，haimeiyouyikuanyaowu，keyizhangqizhanjuganyanzhengyongyaodebangshou。zheiyeshiyuelaiyueduomnc、biotechdouyuanyizaizheiyisaidaoluozidezhongyaoyuanyin。

qianwentidao，quanqiuganyanzhenghuanzherenshuzhongduo。suizhedianzichanpinzairichangshenghuozhongdeyingyongpuji，ganyanzhengdefabinglvhaizaichixushangsheng，zheizhongyuanbenbeirenweishilaonianbingdeyanji，yijingkaishizaizhongqingnianrenqunzhongbaofa。

ganyanzhengliuxingbingxuediaochaxianshi，quanqiuganyanzhenghuanzhe3.44yi，zhanyankemenzhenrencide30%，meinian10%zengzhang。zaiguonei，genju《zhongguoganyanzhuanjiagongshi（2020nian）》tongji，woguoganyanzhengfabinglvyuegaoda21%~30%。qizhong，genianlingduanrenqunjunyoujiaogaoganyanzhenghuanbinglv，qizhong21suizhi50suirenqunganyanzhengfabinglvwei22.5%，65suiyishangrenqunganyanzhengfabinglvwei33.75%。

yucitongshi，zhiliaoganyanzhengshangmeiyouyikuanzhangqixingzhiyouxiaodeyaowu。yixueshang，duiyuganyanzhengfabingjizhiyijingpowanshan，dannenggoucaiyongdeganyanzhengyaowu，zhiliaoxiaoguoquewangwangchaqiangrenyi，bolisuannadiyanye、huanbaosudiyanyedoushiruci。

beihoudeyuanyinhaishizaiyu，yanjingdeteshujiegouduiyaowuzhibeijishutichulegenggaoyaoqiu。shouxian，yanjingdezhayanfanshe、bileiguanyinliudengzuoyongshiyaowuzaiyanbiaodetingliushijianduan、daodabazuzhideyaowuliangdi。qici，leimo、jiaomodengteshugouzaojiangdileyaowudeshentouliang。disan，diyanyechufangdaozhidexianzhi，liruzengzhanjirongyichuxianshilimohu，fangfujirongyijiazhonghuanzhezhengzhuang，huanzheduibufenfuliaonaishouxingcha，jububuliangfanyingfashenglvzengjiadeng。

xianjieduan，zhenduiganyanzhengyongyaodetedian，duozhongyaowudisongxitongdeyaowuluxubeikaifachulai。tamentongchangjubeiyanbuzhiliushijiangengzhang、shengwuliyongdugenggao、anquangengzhangxiaodengtedian。

2016nian，wutianzhiyaokaifadelfa-1jiekangjixiidradiyanye，huofdapizhunshangshi，yongyuzhiliaoganyanzheng。2019nian5yue，nuohuacongwutianzhiyaoshouzhongshougouganyanzhengyaowuxiidradequanqiuquanyi。2022nian，xiidradexiaoshouedadao4.87yimeiyuan，zhijiedaozhizhuyaojingzhengduishourestasisdexiaoshouechuxianxiahua。zaiguonei，jixingyaoyeyinjindejiushisuanfanikelanbipenwuji，zai11yuemohuopishangshi，chengweiguoneishougehuodepizhundebiyongganyanzhiliaoyaowu，yejiangduiguoneichuantongdeganyanzhengyongyaoshichangxingchengchongji。

部分进展较快的干眼症新药 数据来源：动脉网根据公开渠道整理

dangran，gengzhongyaodeshi，yuelaiyueduobutongjizhideganyanzhengxinyaomijijinrulinchuangkaifadezhonghouqi。biru，regene rxekaifadekangyanleiganyanzhengyaowuxiongxiantaiβ4，alcon agekaifadecuzhandanbaifenmijiicomucrete、sylentis sakaifadeshengwuxinyaosyl1001、senjuekaifadesjp-0132deng，douyijingjinruiiiqilinchuangshiyanjieduan。qizhong，yanxiazuizhongbangdeganyanzhengxinyao，moguoyualdeyraekaifadereproxalap。

ganggangguoqude11yue，fdazhengshijienaaldeyrashenqingshenchaqiyongyuganyanzhengdexinyaoreproxalap，bingzhiding2025nian4yue2rizuoweiyaopinpingshendejiezhiriqi。zuoweizheikuanyaowuzaimeiguoshichangdeshouquanxukefang，gaixiaoxiyichu，aiboweigongsidegujiayinglailiulianzhang。

reproxalapshiyikuanyouqianlichengwei“first-in-class”dezaiyanxiaofenzicuyanxinghuoxingquanleiwuzhi（rasp）yizhiji，nengjiangdiraspshuiping，dadaoyizhiyanzhenghuanjiezhengzhuangdezuoyong。jubaodao，reproxalapyizai2000duominghuanzhezhongjinxingleyanjiu，weiguanchadaomingxiandelinchuanganquanwenti，qingduheduanzandedizhubuweicijishilinchuangshiyanzhongzuichangjiandebuliangshijian。ciqiandelinchuangshiyanxianshi，reproxalapyurongmeixiangbi，kejianshaoyanjingfahongbinggaishanleiyechansheng，yanzhenglelianghaodenaishouxingyuanquanxing。

bansuigengduoganyanzhengxinyaoshangshi，zuoweichuangruzhedehuanbaosudiyanye，huoxuyehenkuaijiangyinglaibeiweijiaodemingyun。danwomengengleyujiandaode，shizaizheigeguochengzhong，chixuzengzhangdequanqiuganyanzhengqunti，nengyougenghaodezhiliaofangan。