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suizhemncyuguoneibiotechdebdjiaoyibuduanyongxian,tceliaofafuchushuimian,chengweiyiyaoxingyezhongdianyazhudesaidao。
10yue31ri,aiboweichushou14.65yimeiyuan,yazhutce,yuevolveimmune therapeuticsdachenghezuo,liyongqizhuanyoudetcepingtaigongtongkaifazhongliuyaowu。
10yue29ri,gskxuanbuheenmushengwudachengxieyi,jiangyi 3 yimeiyuandeyufukuanshougouenmushengwuchuyulinchuangjieduandebaxiang cd19 he cd20 deshuangzhong t xibaojieheqi (tce)cmg1a46。enmushengwujiangyouzigehuodezongji 5.5 yimeiyuancmg1a46kaifaheshangyelichengbeifukuan。
8yue9ri,moshadongtongguo13yimeiyuanshougoutongrunshengwuyiyaobxibaohaojieliaofazaiyantceyaowucn201:xiayidaicd19×cd3shuangkang。shoufukuandaojingrende7yimeiyuan,tongrunshengwuhaiyouzigehuodegaoda6yimeiyuandelichengbeifukuan。
huikan2024nianguoneiyaoqidehaiwaibdjiaoyi,duojiabiotechdechuhaiguanxiandouzhizhitceliaofa,chuleenmushengwuyutongrunshengwuwai,jiaheshengwu、anmaishengwu、kangnuoya、yaomingshengwudengjunshixianletceliaofadebdshouquan,jiaoyizongjineyigaoda30yimeiyuan。
xianxiangjishijianrengzaichuxian,haiwaichuangxinyaoqicandid therapeuticzai2024nian9yuezhongxunxuanbuwancheng3.7yirongzi,chuangxia2024nianlaishengwuyiyaoxingyezuigaomuzijinrongdejilu,qixialiangkuanhexinchanpindoushicongzhongguoyaoqigangchenglidehaiwainewcogongsimailaide,erqiedoushishixiaremendezimianjibingtceshuangkangpinzhong。
chulebdjiaoyiwai,anjindetceshuangkangyaowuimdelltrazaijinnian5yuehuodefdapizhunshangshi,chengweiquanqiushoukuanyongyuzhiliaoshitiliudetceliaofa。
congxueyeliudaoshitiliu,zaikuozhandaozimianjibing,tceliaofahuojiangchengweiyiyaoxingyezhongduowanjiazhengduodexiayikejinpingguo。
TCE双抗到底强在哪?
tce(t cell engager),jitxibaoxianjieqileiyaowu,tongguojiezhutxibaoduizhongliuxibaodeshashangzuoyonglaishixianaizhengzhiliao,muqianzaixueyeliulingyuyijingqudexianzhuchengxiao。
zaixueyeliuzhiliaozhong,tcetongguocd3yubutongbxibaobadian(rucd19、cd20hebcma)dejiehe,qudelexianzhudezhiliaoxiaoguo。tceshuangkangdeyiduantongguocd3yutxibaojiehe,lingyiduan(huoliangduan)yutaa(zhongliuxiangguankangyuan)jiehe,bangzhutxibaodingweibingjihuoqishashangnengli,congerdadaoduizhongliuxibaodeshashangmude。
tceyucar-tdoushijiezhutxibaodadaozhiliaojibingxiaoguo,bingqiecongxueyeliudaoshitiliuzaidaozimianjibingdekuozhanglujingyucar-txiangsi。jiyutceyucar-tzaizuoyongjizhifangmiandexiangsixing,xingyejingchangjiangliangzhongliaofajinxingbijiao,kansheinengzaishichangzhandexianji。neimeyucar-txiangbi,tcedaodichayihuazainali?
shouxianzaixueyeliulingyu,muqiantcejicar-tjunyouduokuanchanpinshangshi,car-tdeliaoxiaogengjuyoushi,danyishangshidecar-tdoushizitichanpin,chengbengao、shengchanzhouqizhang、jiageanggui。xiangbizhixia,tceyaowuzuowei“xianhuo”yaowu,gengrongyituiguangshiyong。
zaishitiliulingyu,suizheanjindetarlatamab(cd3/dll3)yujinnian5yuehuodefdapizhunshangshizhiliaoxiaoxibaofeiai,tcezhiliaoshitiliuyijingqudechubutupo。jinguangpc3 car-tjiclaudin 18.2 car-tzailinchuangshangyijingkandaoyidingdeliaoxiao,danlihuopishangshihaiyouxiangdangdejuli。yinci,yujizaishitiliuzhiliaofangmiantcehuilingxiancar-tyiduanshijian。
zaizimianjibinglingyu,anquanxingfangmiancar-tkenengyinqixibaoyinzifengbao(crs),ertceyaowutongguodiaojiejiliangnenggenghaodikongzhifengxian,liruteclistamabzaizhiliaozhongtongguojiliangpapo,xianshichulianghaodeanquanxing,wushenjingduxinghuogusuiyizhi,jinyoudijibiecrs。
ciwai,zimianjibingzuoweimanbing,huanzheduiyuzhangqiliaoxiao、anquanxing、jiyaobianyixingxiangjiaoyuzhongliuyougenggaodeyaoqiu。car-tzhibeiguochengfuza,zhiliaoguochengyibaokuodancai、qinglindengduogebuzhou,huishuhouhuanzhehaixuzhuyuanguancha。ertcekeyizuochengpixiajiyao,zaijiyao、huanzheyicongxingfangmiandouyouzhehendayoushi。
juxingyezishenrenshijieshao,tcedejiligenadchenxiangsi,doujuyousangejiegouyu,yigejiegouyuyutxibaoshoutidezufenjiehe,yigejiegouyuyuzhongliuxiangguankangyuanjiehe,disangejiegouyutigongewaidegongneng,ruyanzhangbanshuaiqi。congjilishanglaikan,yuchangguideiggxiangbi,tcebeirenweibifcjiedaodeadcgengyouxiao。ciwai,youyushashangzhongliuxibaodeguochengshikaozishentxibaowanchengde,yinciyoubiadcdeduxinggengdi。
zhengshijiyuzhuduoyoushi,tceshuangkangyouqishibaxiangcd3+txibaozhongdingxiangshuangteyixingkangti,chengweijinnianlaishuangkangdeyanjiuredian,yebeichengweijiebangadcdeqianliyaowu。
血液瘤治疗成效显著,实体瘤研究迎新突破
tongchanglaishuo,xingyejiangtceshuangkangdefazhanfenweisangejieduan,fenbieduiyingxueyeliu、shitiliu、zimianjibingzheisangezhiliaolingyu。
zaixueyeliulingyu,tceshuangkangchixuqudejinzhan。jumordor inteligenceshuju,yuji2024nianquanqiuxueyeliushichangguimoyue670yimeiyuan,2029nianyue980yimeiyuan,nianfuhezengzhanglv7.8%。
muqianquanqiugongyou10kuantceshuangkanghuopishangshi,xueyeliuzhanle7kuan,zhuyaolaizianjin、luoshi、aibowei,fugaibcma、gprc5d、cd20hecd19dengbadian,huopiduofaxinggusuiliu、mimandabxibaolinbaliudengduogexueyeliushiyingzheng。qizhongzhongguohuopi2kuanchanpin,fenbieweianjin/baijishenzhoudebeilintuooudankangheluoshidegeluofeituodankang。
已上市的10款TCE药物
ciwai,qiangshengyu2022nianhe2023nianfenbiehuopiletceshuangkangyaowu,suizhehouxuyaowulianyongyijicongmoxiandaoqianxianhuanzhedequanfugai,qiangshengduiqiliangkuantalquetamabheteclistamabtceshuangkangyaowudeyuqixiaoshouejunjiejin50yimeiyuan。
zhideyitideshi,tceshuangkangdegaoxingjiabiweimoxianduofaxinggusuiliu(mm)huanzhetigonglexindezhiliaoxuanze。quanqiuduofaxinggusuiliuhuanzherenshuyue45wanren,dangxiachangyongyaowubaokuodanbaimeitiyizhiji,mianyidiaojiejiyijikangcd38kangtideng,danshifufahenaiyaoxingyizhishinanyijiejuedewenti,yeshidemoxianmmhuanzheshouyibujia。
xibaoliaofahetceshuangkangdechuxian,zair/r mmhuanzhezhongzhanxianchugaohuanjielv,xinbanbennccnzhinanjianyijieshouguo≥4xianzhiliaodehuanzhekeyijiangcar-thetceshuangkangzuoweiyouxuanliaofa。
xiangjiaoyucd38dankang,zaimoxianmmhuanzhezhong,teclistamabheelranatamabdanyaozhiliaorrmmzhanxianchugenggaodekeguanhuanjielv(orr:61-63% vs31%),qiebiaoxianqianzaifanbeideshengcunhuoyi(mpfs:11.3 vs 3.7,mos 18.3 vs 9.3)。suiranxiangjiaoyucar-tliaofa,bcma/cd3shuangkangdeliaoxiaolvecha(orr:98% vs 61-63%),danshianquanxinggengjia(crs:95% vs 58%-72%),qiezhiliaochengbengengdi。tceyouxiudekejixingjilezheixiehuanzhelingwaiyigexuanze。
zaishitiliulingyu,ciqiantceshuangkangzaishitiliuzhongxiangjiaoyuxueyeliudeyanjiujinzhanhuanman,zheizhuyaojiyujidayinsu。yifangmian,zaoqizhenduishitiliukaifadebadianbiruher2、egfr、trop2yijimuc1dengyezaizhengchangzuzhizhongbiaoda,youyutceshuangkanghuoxingjiaogao,daozhitxibaozaigongjimubiaoshirongyi“wushang”。ertigaojiliangyouhuixishenganquanxing,xuyaozailiaoxiaoheanquanxingzhijianzhaodaopinghengdian。
lingyifangmian,zhongliuweihuanjingdemianyiyizhishiyigezhongyaoyinsu,taxianzhiletxibaodehuoxinghexiaoguo。bujinruci,txibaojinrunshuipingyouxianyexianzhiletceshuangkangzaishitiliudezhiliaoliaoxiao。
suizheduizheixietiaozhandeshenrulejiehexincelvedekaifa,tceshuangkangzaishitiliuzhiliaozhongdeqianlizhengzaizhububeiwajueheshixian。biru,xinyidaizhenduishitiliudetceshuangkangyaowuzaishejishangzhubudakaisilu。shouxianzaibadiandexuanzeshangpianxiangyuzhongliuteyixingbiaodagengqiang,rudll3hepsmadengbadian。tongshi,youhuakangyuanshibiebeidexiaojiaheqinheliyitigaoduiyuzhongliuzuzhidexuanzexing。zuihou,tongguoyaowulianyonglaitupomianyiyizhi。
jinnian5yue,anjindetalatuodankangbeifdajiasupizhunyongyuzhiliaosanxianxiaoxibaofeiai,yechengweishoukuanzhiliaoshitiliudetceyaowu,jitcezaishitiliulingyudafangyicaitanmingledaolu。ciwai,zhenduipsma,steap-1dengbadiandetceshuangkang,yezaibuduanshichuzhenduiqianliexianaidezaoqiyouyishuju。weilai,tceyaowuzaishitiliulingyudebaofashimukedai。
20余款自免产品在研,有望开辟下一个千亿市场
duiyuyeneizuijinrucimijishougoutceshuangkangzichan,youxingyerenshibiaoshi,zheizaiyidingchengdushangshiyouyumnckandaoletcezaizimianjibinglingyudeyingyong,zhuruxitongxinghongbanlangchuang、qiangzhixingjizhuyanyijiyinxiebingdengzimianleijibing,xiangguanzhiliaoyaowuweilaihuiyuelaiyuechengweigedayaoqibingjiabizhengzhidi。
zhongsuozhouzhi,bxibaozaiduozhongzimianjibingzhongbanyanguanjianjiaose,shenduqingchubxibaonenggouzhiliaoduozhongzimianjibing。tceshuangkangyouyubenshenshizaimianyixibaoshangzuowenzhang,zirannengbeikaifachengzishenmianyidiaokongdechanpin。yeyouguandianrenwei,weilaigaisaidaohuojiangjiebangzhongliulingyu,chengweixiayigeqianyishichangdechaojisaidao。
shishishang,zaizhongliushenrutansuodetongshi,bufenyaoqiyequeshijiangmuguangmiaoxiangzimianshichang。
muqianquanqiugongyou20yukuanchuyuhuoyuezhuangtaide tceyaowukaizhanlezimianxiangguandelinchuangyanjiu,badianzuheleixingzhuyaojizhongzai cd3×cd19、cd3×cd20、cd3×bcmadeng。
全球在研的针对自免疾病的TCE双抗
zaihaiwaimnczhong,luoshidecd20/cd3shuangkang、anjinbcma/cd3shuangkangluxukaizhanletceshuangkangzaizimianshiyingzhengdelinchuangshiyan,zheiyeyiweizhe,tceshuangkangyoukenengdakaizimianzheiyiguangkuodeshichangkongjian。
ciqianmoshadongchizi13yimeiyuanshougoutongrunshengwudecd3xcd19shuangkangcn201,yeshiyouyukanzhonglecn201zaizimianlingyutuweidekeneng。zhengshizaizheiyiluojixia,gengduodemncweilieguochanfenzi,xiwangwajuetceduokangzaizimianshichangdeqianli。
muqianguoneizaitcezimianyingyonglingyu,baxiangcd3/bcmadeshuangkangzhong,chuledachengjiaoyideanmaishengwu、kangnuoyazhiwai,zhixiangjintai、zhengdatianqing、xinshidaiyaoye、yikesiteyeyoutongleichanpinjinrulinchuangyanjiujieduan。
baxiangcd3/cd19deshuangkangzhong,chutongrunshengwuwai,yikesite、yiyishengwu、lvzhushengwu、xinshidaiyaoyedetongleichanpinyeyijinrulinchuangyanjiujieduan。
baxiangcd3/cd20deshuangkangzhong,aisimai、kangnuoya、yitengjiahe、tianguangshi、zhengdatianqing、junshishengwu、shenzhouxibaodetongleichanpinyeyijinrulinchuangyanjiujieduan。
ciwai,xindashengwudecd3/cldn18.2shuangkangyijinruiiqilinchuangjieduan,yanfajinduzaiquanqiufanweineidoushulingxian。
国产TCE研发独辟蹊径,多种适应症中崭露头角
suizhetcepingtaidezhubuchengshu,guoneiqiyeyekaishibujutcepingtai。womenyefaxian,yuguowaizhuyaoyixueyeliudaoshitiliuzaidaozimianjibingdeyanfaluxianxiangbi,guoneizaitceyaowudeyanfabujufangmianzeyousuobutong,henduoqiyeshenzhitiaoguolezhongliulingyu,zhijiekaishizimianlingyudeyanjiu。
duibizhixia,guowaitceyanfachuqizhuyaojizhongzaixueyeliulingyu,ruduofaxinggusuiliuhemimandabxibaolinbaliu,bingzaibufenxueyeliuzhiliaozhongzhanxianchuxianzhudeliaoxiao,shichangxiangduichengshu。guoneisuiranyezaijijituijintceyaowudeyanfa,danyouyushichangxiangduijiaoxiao,qiedabufenchuyulinchuangzaoqijieduan,yincishichangjinzhanjiaoweihuanman。
guoneizaichuqigengduoguanzhudeshishitiliulingyu,danyouyushitiliudefuzaxingheanquanxingtiaozhan,zhengzaizhubujiaqiangzimianlingyudetceyaowuyanjiu。
zaianquanxingfangmian,tceyaowudeshejimianlindetiaozhanzhiyishiruhepinghengliaoxiaoheanquanxing,tebieshizaikongzhixibaoyinzifengbaofangmian,guowaigongsizaizheifangmiandejishuyanjiujiaoweishenru。guoneigongsizaikaifatceyaowushizaijijitansuojiangdicd3qinhelidesheji,yitigaoyaowudeanquanxing。
zongtilaishuo,guoneiwaizaitceyanfashanggeyoucezhonghetiaozhan,dansuizhejishudebuduanjinbuhelinchuangshujudejilei,tceyaowuyouwangzaigengduoaizhengzhiliaozhongfahuizhongyaozuoyong。
muqianguoneilaikan,zejingzhiyaozaishitiliuyousuobuju,qishoukuanzhenduidll3desankangjinduquanqiuzuiyou,qianlijuda。zuoweixiaoxibaofeiailingyuanjinshengwutarlatamab(dll3/cd3)guoneiduibiaopin,bingqiexiangjiaoyuanjinyouzhegenggaodehuoxing,nenggenggaodejiehezhongdibiaodaweidian。
zhixiangjintaizaixueyeliuyousuobuju,hexinchanpingr1803delinchuangshujuxianshi,qiduiyusuiwaibingbianhuanzhezhanxianchu100% orr,shujuyouyi。
ciwai,xindashengwuzaishitiliujixueyeliujunyoubuju;tongrunshengwudecn201yijiqitagongsiyouwangzaizimianshiyingzhengjinxingbuju;anmaishengwuyongyouyikuancd3/ror1shuangkang;youzhiyoushengwubaxiangcd3/epcamdeshuangkangjinzhanjiaokuai,yiburuiiiqilinchuangjieduandengdeng。
weilaisuizheguoneiqiyezaitceshangdeyanjiurijianchengshu,womenyekanhaohouxugezhongleixingdetceleiyaowuzaiduozhongshiyingzhengshangyinglaitupo。
BD、融资、并购、NewCo……TCE多点开花
2024nian,tceshuangkanglingyuwuyichengweileshichangshangdejiaodian,zhongbangjiaoyi、daerongzi、binggouhaishinewcomoshi……tcedouzhanxianchulefeifandehuoliheredu,wuluncongnagefangmianlaikandoukeweishifenhuobao。
2024年TCE交易情况(不完全统计)
zaijiaoyifangmian,judongmaiwangbuwanquantongji,2024niangongfashenglejiangjin20bijiaoyi,zongjinechao85yimeiyuan。zaizheixiejiaoyizhong,shejiguoneixiangmujinezuigaodeliangbijiaoyifenbieweitongrunshengwuyumoshadongdachengdecd3/cd19shuangkangtcejiaoyi(13yimeiyuan),yijienmushengwuyugskdachengdecd3/cd19/cd20sankangtcejiaoyi(8.5yimeiyuan)。
zaitcelingyu,newcodezibenyunzuomoshiyeyuelaiyueshouhuanying。birujinnian9yueanmaishengwudebcma×cd3shuangkangemb-06chuhai,bianshiyinewcomoshiwanchengde,gaibijiaoyizhong6000wanmeiyuandeshoufukuanyouxiangdangyibufenjiangyiguquanxingshizhifu。julejie,cicijiaoyishourangfangvignette bioyouforesite capitalfuhua,qimingchuangtouyecanyuleqirongzi。jinnian9yue,zaigaibibdfashengqian,gaigongsibeicandid therapeuticsshougou。
zhideyitideshi,rongzifangmian,yeshizaijinnian9yue,cicijiaoyizhihou,candid therapeuticshuodele3.7yimeiyuanalunrongzi,yongyuzhiliaozishenmianyijibing,yechuangxialejinnianoumeishengmingkexuelingyujinezuidadanlunrongzijilu。
shougoufangmian,jinnian1yue,moshadongxuanbuyimeigu23meiyuandejiage,gongji6.8yimeiyuanshougouleharpoon。tongguozheicishougou,moshadongbujinhuodelemuqianlinchuangzhongjuyouqianjingdedll3/cd3kangti,erqiehuodedeharpoonduogesanteyikangtipingtai,baokuoxiayidaiduoteyikangtipingtai——zaizhongliuweihuanjingzhongteyixingjihuodeprotritachetritac-xrsanteyikangtipingtai,congerkuaisuqierutcesaidao。
wulunshicongbd、rongzi、binggouhaishinewcomoshigefangmianlaikan,tcesaidaochengxianchuduodiankaihuadejumian,yushizhegailingyudepengbofazhanheweilaiqianli。
dangran,duiyuyikuanyaowulaishuo,zuihexindehaishiqilinchuangjingzhengli。congzheigefangmianlaishuo,tcebulunshizaixueyeliu、shitiliuhuoshizimianlingyu,douyouzhewuqiongdeqianlihexiangxiangkongjian。
zaiduofaxinggusuiliulingyu,duokuantceshuangkangzaiquanqiuyubiaozhunliaofajinxingtouduitoudeyixianheerxianlinchuangshiyan,xiwangzaiweilaichengweiduofaxinggusuiliudexinyidaijishiyaowu。zaidlbcllingyu,cd20/cd3shuangkangxiwangwanchengcongsanxianzouxiangerxian、yixiandeyueqian。ruguonenggouzailinchuangshangzhengmingqihuoyi,tceshuangkangbiranhuiyucar-t、adcdengxingchengjingzheng。
muqian,yucar-txiangbi,tceshuangkangsuiranzailiaoxiaoshangjiaoruo,danzaianquanxinghebianlixingshangyouzhegenghaodebiaoxian。mianduihuoredeadc,tceshuangkangyeyouzhexianzhudechayihua,yifangmianduibadianbiaodaliangyaoqiujiaodi,danduizhongliuteyixingyaoqiugenggao,huokeyiyuzhixingchengcuoweijingzheng。
keyiyujiandeshi,tceshuangkangzaiweilaijiangjixuyinlingxingyerechao,cuishenggengduojuyoulichengbeiyiyidezhongbangjiaoyi。zheibujinweiyiyaoqiyedailailenixidejiyu,erqieyouwangzaichanpinkaifaheshichangbujushangyinfayichangchuangxinhedianfudegeming。
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