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高钾血症新药利倍卓中国获批

美通社2020年1月8日 4:41 点击:212

2020年1月6日,阿斯利康中国正式宣布其新型口服降钾药物利倍卓获得中国国家药品监督管理局的上市批准,用于治疗成人高钾血症。

上海2020年1月6日 /美通社/ -- 今日,阿斯利康中国正式宣布其新型口服降钾药物利倍卓®(通用名:环硅酸锆钠散)获得中国国家药品监督管理局(NMPA)的上市批准,用于治疗成人高钾血症。高钾血症药物治疗领域经历了近60年的空白期[1],作为中国首个上市的创新型药物[2],环硅酸锆钠散的获批标志着高钾血症治疗在中国迎来新时代。

革新机制填补治疗空白

不用本金就能赚钱的方法HUANGUISUANGAONASHIYIZHONGBURONGYUSHUI、BUBEIXISHOUDEHUAHEWU,DUIJIALIZIJUYOUGAOQINHELI,NENGKUAISUJIANGJIABINGWEICHIXUEJIAWENDINGZAIANQUANYUZHI。CIQIAN,ZHONGGUOSHANGWUYOUXIAOZHILIAOYAOWUKEZAIKUAISUKONGZHIXUEJIADETONGSHIZHANGQIWEICHIXUEJIAWENDING。 

此次获批是基于全球临床试验结果和一项中国药效学研究。研究数据显示:环硅酸锆钠散服药1小时后即开始起效,达到正常血钾水平的中位时间是2.2小时,48小时内98%的患者达到正常血钾水平[3,4,5]。近九成患者治疗1年维持血清钾<5.1mmol/L[6]且在28天持续治疗期间,安全性与安慰剂无差异,治疗1年耐受性良好[3,4,7]

2019NIANSHANGBANNIAN,HUANGUISUANGAONASANYINDUTEDEZUOYONGJIZHIYULINCHUANGLIAOXIAO,KEBANGZHUGAOJIAXUEZHENGHUANZHEJIEJUEWEIBEIMANZUDEZHILIAOXUQIU,BEIGUOJIAYAOPINJIANDUGUANLIJUYAOPINSHENPINGZHONGXIN(CDE)NARUDIERPI《LINCHUANGJIXUJINGWAIXINYAOMINGDAN》,YUYIYOUXIANSHENPINGSHENPI。

快速获批满足巨大临床需求

作为慢性肾脏病和心力衰竭的重要并发症之一,高钾血症(血清钾水平>5.0mmol/L)的发病率随着疾病进展逐渐升高,且反复发作、发生间隔逐渐缩短。若未进行长期规范化管理,患者将面临更高心律失常及猝死风险,影响患者整体预后和生存率。数据显示,近 40%[8]慢性肾脏病4-5期患者因为心律失常/心脏骤停而面临死亡风险。而目前,我国慢性肾脏病的发病率已高达10.8%[9],患者人数超过1亿,更是目前增长最快的第六大死因。这意味着众多患者正面临严峻的并发症和死亡考验。

不用本金就能赚钱的方法SUIZHEHUANGUISUANGAONASANDEHUOPI,YISHENGWUFANGKESHI、HUANZHEWUYAOKEYONGDEKUNJINGDEYIGAISHAN,WOGUOGAOJIAXUEZHENGJIBINGGUANLITIXIYEJIANGZHUJIANQIANJIN。

GUANGDONGSHENGRENMINYIYUANYUANZHANGYUXUEQINGJIAOSHOUBIAOSHI:“GAOJIAXUEZHENGSHIMANXINGSHENBINGYOUQISHIZHONGMOQISHENBINGZUICHANGJIANDEBINGFAZHENGZHIYI,YANZHONGWEIXIEBINGRENDESHENGMINGANQUAN,YINCI,YOUXIAO、WENDING、QIEANQUANXINGGAODEJIANGJIAYAOWUFEICHANGZHONGYAO。 ZUOWEIZHONGGUOSHOUGESHANGSHIDEGAOJIAXUEZHENGCHUANGXINXINGYAOWU,HUANGUISUANGAONASANDELIAOXIAOYUANQUANXINGZAIGUOJISHANGHUODELEGUANGFANRENKE,QIDAIHUANGUISUANGAONASANSHANGSHIHOUKEYIWEIZHONGGUODESHENBINGHUANZHEDAILAIFUYIN。”

不用本金就能赚钱的方法ASILIKANGQUANQIUZHIXINGFUZONGCAI,GUOJIYEWUJIZHONGGUOZONGCAIWANGLEIBIAOSHI:“HUANGUISUANGAONASANDEHUOPISHANGSHIYIYIFEIFAN,WEIGAOJIAXUEZHENGHUANZHETIGONGLEQUANXINDEZHILIAOXUANZE,YEZAICIYINZHENGLEASILIKANGSHIZHONGYIHUANZHEWEIZHONGXINDECHENGNUO。MIANDUIZHONGGUOJISHUJUDA、JIXUCHUANGXINZHILIAOHEGUANLIFANGANDEMANXINGSHENZANGBINGHUANZHE,ASILIKANGJIANGCHIXUJIADATOURU,BUDUANSHENGENGSHENZANGBINGLINGYU,WEIZHONGGUOHUANZHEDAILAIGENGDUOQUANQIUCHUANGXINYAOWU,BINGZHILIYUTONGGUOCHUANGXINYAOWUTUIDONGBINGCHENGGUANLI,QUANFANGWEIZHULITISHENGMANXINGSHENZANGBINGDEZHENLIAOSHUIPING,GENGHAODIJIANXING‘JIANKANGZHONGGUO2030’ZHANLVE。”

[1] Sterns RH, et al. Kidney Int. 2016 Mar;89(3):546-54.

[2] Palmer BF et al. Mayo Clin Proc. 2019 Oct 23. pii S0025-6196(19)30486-0.

[3] AstraZeneca. Lokelma Prescribing Information. December 2019.

[4] Fishbane S, et al. Clin J Am Soc Nephrol. 2019 Jun 7;14(6):798-809. doi: 10.2215/CJN.12651018. Epub 2019 May 20.

[5] National Kidney Foundation. Clinical Update on Hyperkalemia. 2014. Accessed 17 December 2019. 

[6] Spinowitz BS et al.Clin J Am SocNephrol.2019:14:798-809

[7] Ash S, et al. A Phase 2 Study on the Treatment of Hyperkalemia in Patients with Chronic Kidney Disease Suggests that the Selective Potassium Trap, ZS-9, is Safe and Efficient. Kidney Int. 2015; 88, 404-411.

[8] Kashihara N, et al. Kidney Int Rep. 2019; 4(9): 1248-1260. doi:10.1016/j.ekir.2019.05.018

[9] 张路霞,王芳,王莉等,中国慢性肾脏病患病率的横断面调查,中华内科杂志,2012,51:570

关于高钾血症

GAOJIAXUEZHENG(XUEQINGJIASHUIPING>5.0mmol/L)SHIYIZHONGYIXUEYEZHONGJIAHANLIANGSHENGGAOWEITEZHENGDEYANZHONGJIBING,GAOFAYUWANQISHENZANGBINGHE/HUOXINLISHUAIJIEHUANZHEZHONG,XUEYETOUXIHUANZHEHUOSHIYONGCHANGGUIXINZANGBINGYAOWU(RUSHENSU-XUEGUANJINZHANGSU-QUANGUTONGXITONGYIZHIJI)DEHUANZHELIHUANGAOJIAXUEZHENGDEFENGXIANGENGGAO。ZAIWOGUOYUE1.3YIDEMANXINGSHENZANGBING(CKD)HUANZHEZHONG,CKD4-5QIHUANZHEBINGFAGAOJIAXUEZHENGDEHUANBINGLVDA40% YISHANG,ZHEIXIEHUANZHEMIANLINGENGGAOXINLVSHICHANGJICUSIFENGXIAN。SHUJUXIANSHI,JIN40%CKDHUANZHEYINWEIXINLVSHICHANG/XINZANGZHOUTINGERSIWANG。

关于环硅酸锆钠

HUANGUISUANGAONASHIYIZHONGBURONGYUSHUI、BUBEIXISHOUDEJIALIZIJIEHEJI,SHIYONGYUZHILIAOCHENGRENGAOJIAXUEZHENG。HUANGUISUANGAONACAIYONGDECHUANGXINLIZIBUHUOJISHU,DUIJIALIZIJUYOUGAOXUANZEXING,YINERJUYOUGENGKUAIDEQIXIAOSHIJIANYUGENGHAODENAISHOUXING。WULUNHEZHONGGAOJIAXUEZHENGQIANZAIYOUYIN,QIEWULUNNIANLING、XINGBIE、ZHONGZU、SHIFOUYOUGONGBINGHUOSHIFOULIANHESHIYONGRAASi,HUANGUISUANGAONAJUNKEJIANGDIHUANZHEXUEJIASHUIPINGBINGJIANGQIWEICHIZAIZHENGCHANGSHUIPING。ZAIQUANQIUGAOJIAXUEZHENGHUANZHEDELINCHUANGSHIYANHEZHONGGUOYAOXIAOXUEYANJIUZHONG,YIDUIQILIAOXIAOYUANQUANXINGJINXINGLEGUANGFANDEZHENGSHI。

关于阿斯利康

不用本金就能赚钱的方法ASILIKANGSHIYIJIAKEXUEZHISHANGDEQUANQIUXINGSHENGWUZHIYAOQIYE,ZHUANZHUYUYANFA、SHENGCHANJIYINGXIAOCHUFANGLEIYAOPIN,ZHONGDIANGUANZHUZHONGLIU、XINXUEGUAN、SHENZANGJIDAIXIE、HUXISANDAZHUYAOJIBINGLINGYU。ASILIKANGDEYEWUBIANBU100DUOGEGUOJIA,CHUANGXINYAOWUHUIJIQUANQIUSHUBAIWANHUANZHE。GENGDUOXINXI,QINGFANGWEN。

关于阿斯利康中国

ZI1993NIANJINRUZHONGGUOYILAI,ASILIKANGJIANCHIKEXUEZHISHANG,ZHUZHONGCHUANGXIN,YIMANZUZHONGGUOBUDUANZENGZHANGDEJIANKANGXUQIU,SHIXIAN“KAITUOCHUANGXIN,ZAOFUBINGHUAN,CHENGWEIZHONGGUOZUIZHIDEXINLAIDEYILIAOHEZUOHUOBAN”ZHEIYIHONGWEIYUANJING。ASILIKANGDEZHONGGUOZONGBUWEIYUSHANGHAI,BINGFENBIEZAIHANGZHOU、GUANGZHOU、CHENGDOU、BEIJING、WUXIJIANLILEDONG、NAN、XI、BEI、ZHONGBUQUYUZONGBU,ZAIQUANGUOYONGYOUYU15,000MINGYUANGONG。GONGSIZAIJIANGSUWUXIHETAIZHOUTOUZIJIANYOUSHENGCHANJIDI,BINGZAIWUXIJIANLILEZHONGGUOWULIUZHONGXIN。ZAIZHONGGUO,ASILIKANGDEYEWUZHONGDIANZHUYAOJIZHONGZAIZHONGGUOHUANZHEXUQIUZUIPOQIEDEZHILIAOLINGYU,BAOKUOHUXI、XINXUEGUAN、DAIXIE、ZHONGLIU、XIAOHUA、SHENZANGJIBING。2017NIAN,ZHONGGUOJIANKANGWULIANWANGCHUANGXINZHONGXINZAIWUXILUODI,ZHIZAITANSUOCHUANGXINDEJIANKANGWULIANWANGZHENLIAOYITIHUAQUANBINGCHENGGUANLIJIEJUEFANGAN。TONGNIAN,ASILIKANGYUGUOTOUCHUANGXINHEZICHENGLIDIZHE(JIANGSU)YIYAOYOUXIANGONGSI,YIJIAKUAIBENTUXINYAOYANFABUFA。2019NIAN,ASILIKANGXUANBUYUWUXIHEZUOGONGJIANWUXIGUOJISHENGMINGKEXUECHUANGXINYUAN,HUIJUQUANQIUZHIHUI,ZAOFUZHONGGUOHUANZHE。TONGNIAN,ASILIKANGXUANBUZAISHANGHAISHELIQUANQIUYANFAZHONGXINBINGJIANLIAICHUANGXINZHONGXIN,BINGYUZHONGJINZIBENLIANHECHENGLIQUANQIUYILIAOJIANKANGCHANYEJIJIN。

消息来源:阿斯利康


(来源: 美通社


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