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基因细胞治疗CDMO行业研究:新兴赛道,蓬勃
- 2020-3-2

1 、xibaozhiliao:xinyidaiyaowu,chuyukuaisuzengzhangjieduan

细胞治疗是新一代肿瘤治疗方式

xibaozhiliaoyouchengweijiyuxibaodejiyinzhiliao(cell based gene therapy),muqianzhuliudexibaozhiliaoshizhijiangxibaojingjiyingongchenggai zaohouhuishuyongyujibingzhiliaodefangfa。jingjiyingongchenggaizaohoudexibaokenengjubeiduozhonggongneng,rubaxiangxing、mianyizengqiangdeng。suizhe2017nian lianggecar-tchanpinhuopishangshi,xibaozhiliaojinrushangyehuadexinshiqi。

细胞治疗与常规疗法在形式、递送、治疗上有较大区别

jiyinyuxibaoliaofayuchuantongyaowuzaiyaowuxingshishangyoujiaodaqubie,yaowuxingshishidna、rnahuozhexibao。qubieyuchuantongliaofa,jiyin xibaozhiliaogengqingxiangyuyizhenjiejuewenti。chuantongliaofazhuyaozhiliaomubiaoshihuanjiezhengzhuanghuozheyanzhangshouming,jiyinxibaozhiliaozeshiqianzaizhiyu liaofa。

细胞治疗经历30年临床探索,有望进入快速发展期

jiyinxibaozhiliaoyu1990niankaishikaizhanlinchuangshiyan,2005nianshoukuanrongliubingdushangshi,2017nianshoukuancar-tchanpinshangshi。jinru kuaisufazhanjieduan。

CAR-T疗法采用个性化制备及治疗流程

car-t,chimeric antigen receptor t-cell immunotherapy,jiqianhekangyuanshoutit xibaomianyiliaofa。tongguojiang shibiezhongliuxiangguankangyuandescfv hebaoneixinhaoyu(tongchangweicd3ζ huofcεriγ)zaitiwaijinxingjiyinzhongzu,tongguobingduqinranqianhe daohuanzhet xibao,shihuanzhet xibaobiaodazhongliukangyuanshouti,jingguochunhuahedaguimokuozenghoudet xibao,yejicar-t xibao。

CAR-T:优势与挑战并存,技术仍处于升级阶段

car-txibaoliaofadeyoushishiliaoxiaozhijieqiechijiu,tiaozhanfenbielaizisangefangmian:①fufanyingguanliyaoqiugenggao(xibaoyinzifengbao、tuo baduxing、shenjingduxing);②shitiliuzhiliaoxiaoguoshouzhiyuweihuanjing;③gexinghuadingzhidaozhichengbengaoang;④yunshubanjingxiao、zibentouru da。muqianxibaoliaofadejishurengchuyushengjijieduan。

2、 yanfaxuqiuheyingyongtongdiangongtongcuishengjiyinxibaozhiliaocdmoxingyefanrong

细胞基因治疗临床热情持续,带来CDMO行业需求

 evaluate pharmayuji,jiyinxibaozhiliaoshichangcong 2017 niande 10 yimeiyuanfazhandao 2024 niande 440 yimeiyuan,fuhenianzengzhanglvdadao 65%。congjiyinxibaozhiliaoxiangmushuliangkan,yezhujianchengweizhuyaoyanjiufangxiangzhiyi。2020 niandi,quanqiuleijizaiyanjiyinzhiliaolinchuangshiyanchaoguo 1,300 xiang。jiezhi 2020 niandi,meiguoshikaizhanjiyinzhiliaolinchuangshiyanshuliangzuiduodeguojia,leijichaoguo 650 xiang;qiciweizhongguo,leijichaoguo 300 xiang。

细胞治疗CDMO帮助降低治疗成本

降低细胞疗法生产成本:T细胞肿瘤免疫疗法通过从患者或者捐献者外周血分离获得特定亚群的T细胞,进一步激活、基因修饰获得CAR-T细 胞,扩增培养从而到达治疗级别的细胞数,再经过洗涤浓缩回输患者体内进行治疗。

car-tzhizuoguochengdewujuncaozuo、chundu、zhibeijieguodeanquanxingdengzhiliangkongzhiduihouqideliaoxiaoyouzhezhongyaoyingxiang,suoyiquebaoshengchanguocheng debiaozhunhuahezidonghua,zuodaoyaoxiaohefengxiankekongshishouyaorenwu。

细胞治疗CDMO:质粒、病毒载体和CMC

CAR-T生产流程复杂,高额的成本限制了应用:zaixibaojiyinzhiliaolishishang,2017nianshiguanjiandeyinian。suizhenuohuazhiyaokymriah(tisagenlecluecel)deshangshi、jiliedezhiyao (kite pharma)yescarta(axicabatgene ciloleucel)deshangshihespark therapeuticsdeluxturna(voretigene neparvovec rzyl)deshangshipizhun,xibaohejiyinliaofazhongyuzhanlutoujiao。jinguankaipilexinfangxiang,dangaoedeshengchanchengbenxianzhileyingyong。zaituichukymriahqianhekangyuanshouti(car)txibaoliaofahou,nuohuayinqi 47.5wanmeiyuandebiaojiaershoudaopiping。yescarta car-tliaofadebiaojialvedi,wei37.3wanmeiyuan,luxturnajiyinliaofadebiaojiaweimeizhiyanjing42.5wanmeiyuan。

quanqiuhezhongguojiyinzhiliaocroxingyekuaisuzengzhang。genjufuruositeshaliwenyuce:2016 nianzhi 2020 nian,quanqiujiyinzhiliao cro shichangguimocong 4.0 yimeiyuanzengzhangzhi 7.1 yimeiyuan。suizhejiyinzhiliaoxingyedekuaisufazhan,wei laiquanqiujiyinzhiliao cro shichangguimojiangchixuwenbuzengzhang,yujiyu 2025 nianzengzhi 17.4 yimeiyuan。2016 nianzhi 2020 nian,zhongguojiyinzhiliao cro shichangguimocong 1.7 yiyuanzengzhangzhi 3.1 yiyuan,yujijiangyu 2025 nianzengzhi 12.0 yiyuan。

3、 jiyinxibaozhiliaocrojicdmozhuyaogongsi

中国基因细胞治疗CRO/CDMO公司快速崛起

zhongguojiyinxibaozhiliaocro/cdmogongsikuaisujueqi。qizhong,yaomingkangdejubeizonghefuwunengli,jinsiruiyizhiliweitese,heyuanshengwu yimanbingduweitese,zhaoyanxinyaozaijiyinxibaozhiliaoanpinglingyuyoushimingxian,junweixifenlingyulongtou。

金斯瑞生物(蓬勃生物):基因细胞治疗CDMO龙头

jinsiruipengboshengwu(genscript probio)shinanjingjinsiruishengwukejiyouxiangongsiqixiadeshengwuyiyaocdmoyewu。mugongsijinsiruisheng wukejichigu82.75%,gaolingzibenchigu17.25%。shangyilunrongzi1.5yimeiyuan,touhouguzhiyue10yimeiyuan。 muqianjinsiruipengboshengwuyijianlizhenghedechuangxinshengwuyaocdmopingtai,zhuyaobaokuoliangdafuwulingyu:zhiliaoxingkangtiyaohejiyinyuxibaozhiliao。 tigongzhuanyedejiejuefanganhekekongdezhiliangliuchengzhudongtigongduandaoduanfuwu(faxiandaoshangyehua),yijiakuaiweikehukaifayaowudeguocheng。jinsiruipengboshengwudejiyinxibaozhiliaozhengtijiejuefanganhangaileindshenbaoziliaozhuanxie,linchuangyangpinshengchanheshangyehuashengchan。gongyikaifazhiliang tixiquebaoleheguixing,shujuwanzhengxinghekezhuisuxing,suoyoudeshiyanpianchadoubeiyangeyanjiuhejilu。

药明康德(无锡生基):赋能全球基因细胞治疗客户

wuxishengjiyiyaokejiyouxiangongsishiyaomingkangdequanzizigongsi,zhuanyecongshixibaozhiliaoyongchanpin、jiyinzaitideyanfa、shengchanjiqitaxiangguanfu wu。zhiliyufunengquanqiukehu、jiasuxibaohejiyinzhiliaochanpinyanfashengchanjincheng,shengjiyiyaoxianyizaishanghaihewuxijianchengzongmianjiyu18,000 pingfangmidechanpinyanfajigmpshengchanjidi,dazaoquanmianfugaijiyin、xibaoliaofachanpinleixing,jiyanfa、shengchan、chanpinbaopidengyuyitideyi zhanshifuwupingtai。jiezhi2021nianyijidu,wei36gelinchuangjieduanxiangmutigongfuwu; 14geii/iiiqilinchuangshiyanxiangmu;22geiqilinchuangshiyanxiangmu。yuji2021 nianyou2-3gexiangmu,baokuozitixibaoliaofaheyitixibaoliaofachanpin,jiangjinrubla jieduan。2020nianshouruguimoyuewei8-10yiyuan。

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