Intra-Cellular Therapies（ICT）SHIYIJIAZHUANZHUYUKAIFACHUANGXINLIAOFAZHIZHONGSHUSHENJINGXITONG（CNS）JIBINGDESHENGWUZHIYAOGONGSI。JINRI，GAIGONGSIGONGBULEIIIQILINCHUANGSHIYAN（Study 401，401YANJIU）DEYANGXINGDINGXIANJIEGUO，GAIYANJIUPINGGULECaplyta（lumateperone）ZUOWEILIYANHUOBINGWUSUANYANDEFUZHULIAOFA，YONGYUZHILIAOYUSHUANGXIANGIXINGHUOSHUANGXIANGIIXINGZHANGAIXIANGGUANZHONGXINGYIYUFAZUO（major depressive episode）。JIEGUOXIANSHI，YUANWEIJIXIANGBI，MEIRIYICIlumateperone 42mgXIANZHUGAISHANLEYIYUZHENGZHUANG，ZAIZHUYAOZHONGDIAN（GAISHANYIYUZHENG，p=0.0206）HEGUANJIANCIYAOZHONGDIAN（GAISHANYIYUYANZHONGCHENGDU，p=0.0082）JUNQUDELETONGJIXUESHANGYIYIDEJIEGUO。

　　SHUJUFABUHOU，ICTGONGSIGUJIABAOZHANG74%。CaplytaYU2019NIAN12YUEHUODEMEIGUOSHIPINHEYAOWUGUANLIJU（FDA）PIZHUN，YONGYUJINGSHENFENLIEZHENGCHENGRENHUANZHEDEZHILIAO。GENJU401YANJIUJIEGUO，YIJIZHIQIANGONGBUDEDANYAOZHILIAOIIIQI404YANJIUJIEGUO，ICTGONGSIJIHUAZAI2020NIANDIHUO2021NIANCHUXIANGMEIGUOFDATIJIAOYIFENBUCHONGXINYAOSHENQING（sNDA），JIANGCaplytaZUOWEIDANYAOLIAOFAHEFUZHULIAOFA，YONGYUZHILIAOSHUANGXIANGIXINGHUOIIXINGZHANGAIHUANZHEDESHUANGXIANGYIYUZHENG。

　　402HAOYANJIUZAIQUANQIU5GEGUOJIAJINXING，BAOKUOMEIGUO。YANJIUZHONG，529LIBANYOUSHUANGXIANGIXINGHUOSHUANGXIANGIIXINGZHANGAIDEZHONGDUZHIZHONGDUZHONGXINGYIYUFAZUOHUANZHEYI1：1：1DEBILISUIJIFENPEI，FENBIEMEIRIYICIFUYONGlumateperone 42mg、28mg、ANWEIJI，TONGSHIJIXUSHIYONGLIYANHUOBINGWUSUANYANZUOWEIQINGXUWENDINGJI。

　　JIEGUOXIANSHI，lumateperone 42mgDADAOLEZHUYAOZHONGDIAN：ZAIZHILIAODI6ZHOU（SHIYANZHONGDIAN），CAIYONGMENGGEMALIHEASIBOGEYIYUZHENGDENGJILIANGBIAO（MADRS）ZONGPINGFENXIANGDUIJIXIANDEBIANHUAJINXINGPINGJIA，YUANWEIJIZUXIANGBI，lumateperone 42mgZUZAIGAISHANYIYUZHENGFANGMIANBIAOXIANCHUTONGJIXUEYIYIDEXIANZHUGENGDAGAISHAN。ZAIYIXIANGXINGZHILIAO（ITT）YANJIUQUNTIZHONG，lumateperone 42mgZUXIANGDUIJIXIANDEZUIXIAOERCHENGFA（LS）PINGJUNXIAJIANGZHIWEI16.9FEN，ANWEIJIZUWEI14.5FEN（LSPINGJUNCHAYI=2.4FEN，XIAOYINGDAXIAO=0.27，p=0.0206）。

　　CIWAI，lumateperone 42mgZUYEDADAOLEGUANJIANCIYAOZHONGDIAN：JILINCHUANGZONGTIYINXIANG-SHUANGXIANGZHANGAIBANJIBINGYANZHONGCHENGDULIANGBIAO（CGI-BP-S）YIYUPINGFENYOUTONGJIXUEYIYIDEGAISHAN（p=0.0082；XIAOYINGDAXIAO=0.31）。

　　GAIYANJIUZHONG，YUANWEIJIZUXIANGBI，lumateperone 28mgZUZAIYIYUZHENGZHUANGFANGMIANXIANSHIJILIANGXIANGGUANGAISHANQUSHI，DANJIEGUOMEIYOUTONGJIXUEYIYI。RANER，YUANWEIJIZUXIANGBI，lumateperone 28mgZUZAICGI-BS-SSHANGYUANWEIJIZUXIANGBIYOUTONGJIXUEYIYIDEXIANZHUGAISHAN。

　　GAISHIYANZHONG，lumateperoneDENAISHOUXINGLIANGHAO，ANQUANXINGLIANGHAO。BULIANGSHIJIANDUOWEIQINGDUZHIZHONGDU，YUYIWANGSHUANGXIANGYIYUHEJINGSHENFENLIEZHENGYANJIUZHONGSUOJIANXIANGSI，WEIGUANCHADAOXINDEBULIANGSHIJIAN。ZUICHANGJIANDEBULIANGSHIJIAN（FASHENGLV≥5%，QIEZHISHAOSHIANWEIJIDE2BEI）SHISHISHUI、TOUYUNHEEXIN。JINGZUOBUAN、ZHUITIWAIXIZHENGZHUANGHETIZHONGBIANHUADEFASHENGLVYUANWEIJIXIANGSI。ZHEIXIEFAXIANTIGONGLEJINYIBUDEZHENGJU，ZHICHIlumateperoneZAIBUTONGHUANZHEQUNTIZHONGDELIANGHAOANQUANXINGHENAISHOUXING。

　　SHUANGXIANGIXINGHESHUANGXIANGIIXINGQINGGANZHANGAISHIYANZHONGDE、GAODULIUXINGDEJINGSHENJIBING。ZHEIXIEJIBINGDETEDIANSHIFANFUFAZUODEZAOKUANGZHENGHUOQINGDUZAOKUANGZHENGJIAZAZHECHENGWEISHUANGXIANGYIYUDEZHONGXINGYIYUFAZUO。SHUANGXIANGIHESHUANGXIANGIIGEZHANSHUANGXIANGQINGGANZHANGAIHUANZHEZONGSHUDEYIBAN。SHUANGXIANGYIYUSHISHUANGXIANGQINGGANZHANGAIZUICHANGJIANDELINCHUANGBIAOXIAN。ZHEIXIEFAZUOWANGWANGCHIXUSHIJIANGENGZHANG，FUFALVGENGGAO，YUZAOKUANG/QINGDUZAOKUANGFAZUOXIANGBIYUHOUGENGCHA。SHUANGXIANGYIYURENGRANSHIYIGEYANZHONGBUZUDEYILIAOXUQIU，ZHIYOUJIGEFDAPIZHUNDELIAOFAKEYONG，ZHEIXIELIAOFATONGCHANGYUNAISHOUXINGWENTIYOUGUAN。

　　CaplytaDEHUOXINGYAOWUCHENGFENWEIlumateperone，ZHEISHIYIZHONGSHOUCHUANGDE（first-in-class）XIAOFENZIYAOWU，KEXUANZEXINGQIETONGSHIDIAOJIE5-QIANGSEAN、DUOBAANJIGUANSUANZHEI3ZHONGSHEJIYANZHONGJINGSHENJIBINGDESHENJINGDIZHITONGLU。YAOXIAOXUEYANJIUBIAOMING，lumateperoneZUOWEIYIZHONGQIANGXIAOJIEKANGJIZAI5-QIANGSEAN5-HT2ASHOUTISHANGJUYOUGAOJIEHEQINHELI、ZUOWEIYIZHONGJIEKANGJIZAITUCHUHOUD2SHOUTISHANGYOUZHONGDENGJIEHEQINHELI、ZUOWEIYIZHONG5-QIANGSEANZHUANYUNTI（SERT）ZAISHEQUYIZHIJIDUID1SHOUTIJUYOUZHONGDENGDEQINHELI（ZHEIKENENGYOUZHUYUAMPAHENMDASHOUTIDEJIANJIEJIHUO）。ZHEIXIESHOUTIBEIRENWEIZAIJINGSHENFENLIEZHENG、SHUANGXIANGQINGGANZHANGAI、YIYUZHANGAIHEQITASHENJINGJINGSHENJIBINGZHONGQIZHONGYAOZUOYONG。TIWAIYANJIUBIAOMING，YUD2SHOUTIXIANGBI，lumateperoneDUI5-HT2ASHOUTIDEQINHELIGAOCHUYUE60BEI。

　　ZAIMEIGUO，FDAYIYU2017NIAN11YUESHOUYUlumateperoneZHILIAOJINGSHENFENLIEZHENGDEKUAISUTONGDAODIWEI。CHULEJINGSHENFENLIEZHENGZHIWAI，ICTGONGSIYEZHENGZAIKAIFAlumateperoneZHILIAOSHUANGXIANGYIYU、YIYUZHENGHEQITASHENJINGJINGSHENHESHENJINGJIBING。

　　YEJIEDUICaplytaDEQIANJINGFEICHANGKANHAO，YIYAOSHICHANGDIAOYANJIGOUEvaluatePharmaYUCE，CaplytaZAI2026NIANDEXIAOSHOUEJIANGDADAO20YIMEIYUAN，QIZHONGYIBANJIANGLAIZIJINGSHENFENLIEZHENG，LINGYIBANJIANGLAIZISHUANGXIANGYIYUZHENG。（SHENGWUGUBioon.com）

　　YUANWENCHUCHU：Intra-Cellular Therapies Announces Positive Topline Results from Study 402 Evaluating Lumateperone as Adjunctive Therapy in Patients with Bipolar Depression