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Vericiguat有望在中国获得批准,用于治疗慢性心衰

2020-08-29 Allan MedSci原创

拜耳近日宣布,已提交监管申请,以寻求Vericiguat在中国获得批准。Vericiguat是一种研究性可溶性鸟苷酸环化酶(sGC)刺激物。

拜耳近日宣布,已提交监管申请,以寻求Vericiguat在中国获得批准。Vericiguat是一种研究性可溶性鸟苷酸环化酶(sGC)刺激物,用于治疗有症状、射血分数低于45%的先前曾出现过恶化的心力衰竭患者。

拜耳执行委员会Joerg Moeller博士说:“可悲的是,约有50%的心力衰竭患者会在30天之内再次住院,每次住院会使死亡风险加倍。尽早确诊和改变治疗方法可以降低这些风险。在中国,大约有1370万心力衰竭患者,迫切需要新的治疗方案来减轻这种疾病的负担”。

新药申请已提交至中国国家药品监督管理局(NMPA)药品评审中心(CDE),并基于VICTORIA研究的III期阳性数据。Vericiguat也已在欧盟、日本以及世界其他多个国家提交了上市申请。此外,美国FDA已于2020年7月对新药申请(NDA)进行了优先审查。

Vericiguat(BAY1021189/MK-1242)是一种研究性可溶性鸟苷酸环化酶(sGC)酶的直接刺激剂。sGC对血管和心脏的功能都很重要,但在心力衰竭患者中sGC刺激不足,导致心肌和血管功能异常。

 

原始出处:

https://www.firstwordpharma.com/node/1752990?tsid=4

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    2021-08-19 与狼共舞

    希望能够早点使用

    0

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    2021-08-10 Doctoryangbai

    超赞

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    2021-06-20 ms7000001124466419

    实用

    0

  4. 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createdBy=9cba5468764, createdName=ms8000001004052089, createdTime=Sat Mar 13 21:36:20 CST 2021, time=2021-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924225, encodeId=e3589242259c, content=是个好消息吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Feb 12 07:08:41 CST 2021, time=2021-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1811418, encodeId=f5c7181141810, content=<a href='/topic/show?id=26ae8803219' target=_blank style='color:#2F92EE;'>#获得批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88032, encryptionId=26ae8803219, topicName=获得批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=838d2500169, createdName=12498cb5m13暂无昵称, createdTime=Tue Mar 23 02:13:48 CST 2021, time=2021-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881461, encodeId=a34888146162, content=在中国,大约有1370万心力衰竭患者,迫切需要新的治疗方案来减轻这种疾病的负担。Vericiguat有望在中国获得批准,用于治疗慢性心衰。这对于心力衰竭患者真的是个好消息!, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Mon Aug 31 18:16:59 CST 2020, time=2020-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881338, encodeId=fba9881338ff, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200819/64fbd2072f9a45e4ab1d483ac903cef2/6094007d789849e39a3a1f25435a6f41.jpg, createdBy=72732561091, createdName=杀无敌战神, createdTime=Mon Aug 31 14:23:39 CST 2020, time=2020-08-31, status=1, ipAttribution=)]
    2021-05-02 随梦飞扬

    学习

    0

  5. 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topicList=[TopicDto(id=88032, encryptionId=26ae8803219, topicName=获得批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=838d2500169, createdName=12498cb5m13暂无昵称, createdTime=Tue Mar 23 02:13:48 CST 2021, time=2021-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881461, encodeId=a34888146162, content=在中国,大约有1370万心力衰竭患者,迫切需要新的治疗方案来减轻这种疾病的负担。Vericiguat有望在中国获得批准,用于治疗慢性心衰。这对于心力衰竭患者真的是个好消息!, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Mon Aug 31 18:16:59 CST 2020, time=2020-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881338, encodeId=fba9881338ff, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200819/64fbd2072f9a45e4ab1d483ac903cef2/6094007d789849e39a3a1f25435a6f41.jpg, createdBy=72732561091, createdName=杀无敌战神, createdTime=Mon Aug 31 14:23:39 CST 2020, time=2020-08-31, status=1, ipAttribution=)]
    2020-08-29 lovetcm

    #心力衰竭#有可能成为心衰三驾马车:ARNI,SGLT2i,和GCa

    3

    展开3条回复
  6. 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GetPortalCommentsPageByObjectIdResponse(id=880718, encodeId=c6a1880e183d, content=<a href='/topic/show?id=072c5088466' target=_blank style='color:#2F92EE;'>#心力衰竭#</a>有可能成为心衰三驾马车:ARNI,SGLT2i,和GCa, beContent=null, objectType=article, channel=null, level=null, likeNumber=292, replyNumber=3, topicName=null, topicId=null, topicList=[TopicDto(id=50884, encryptionId=072c5088466, topicName=心力衰竭)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Aug 29 22:48:26 CST 2020, time=2020-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=947932, encodeId=ecc894e932e5, content=心衰患者倍受痛苦,希望能得到更多有质量的医疗护理手段来缓解, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9cba5468764, createdName=ms8000001004052089, createdTime=Sat Mar 13 21:36:20 CST 2021, time=2021-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924225, encodeId=e3589242259c, content=是个好消息吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Feb 12 07:08:41 CST 2021, time=2021-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1811418, encodeId=f5c7181141810, content=<a href='/topic/show?id=26ae8803219' target=_blank style='color:#2F92EE;'>#获得批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88032, encryptionId=26ae8803219, topicName=获得批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=838d2500169, createdName=12498cb5m13暂无昵称, createdTime=Tue Mar 23 02:13:48 CST 2021, time=2021-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881461, encodeId=a34888146162, content=在中国,大约有1370万心力衰竭患者,迫切需要新的治疗方案来减轻这种疾病的负担。Vericiguat有望在中国获得批准,用于治疗慢性心衰。这对于心力衰竭患者真的是个好消息!, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Mon Aug 31 18:16:59 CST 2020, time=2020-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881338, encodeId=fba9881338ff, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200819/64fbd2072f9a45e4ab1d483ac903cef2/6094007d789849e39a3a1f25435a6f41.jpg, createdBy=72732561091, createdName=杀无敌战神, createdTime=Mon Aug 31 14:23:39 CST 2020, time=2020-08-31, status=1, ipAttribution=)]
    2021-03-13 ms8000001004052089

    心衰患者倍受痛苦,希望能得到更多有质量的医疗护理手段来缓解

    0

  7. 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topicList=[TopicDto(id=88032, encryptionId=26ae8803219, topicName=获得批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=838d2500169, createdName=12498cb5m13暂无昵称, createdTime=Tue Mar 23 02:13:48 CST 2021, time=2021-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881461, encodeId=a34888146162, content=在中国,大约有1370万心力衰竭患者,迫切需要新的治疗方案来减轻这种疾病的负担。Vericiguat有望在中国获得批准,用于治疗慢性心衰。这对于心力衰竭患者真的是个好消息!, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Mon Aug 31 18:16:59 CST 2020, time=2020-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881338, encodeId=fba9881338ff, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200819/64fbd2072f9a45e4ab1d483ac903cef2/6094007d789849e39a3a1f25435a6f41.jpg, createdBy=72732561091, createdName=杀无敌战神, createdTime=Mon Aug 31 14:23:39 CST 2020, time=2020-08-31, status=1, ipAttribution=)]
    2021-02-12 易水河

    是个好消息吧

    0

  8. 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  9. 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level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200819/64fbd2072f9a45e4ab1d483ac903cef2/6094007d789849e39a3a1f25435a6f41.jpg, createdBy=72732561091, createdName=杀无敌战神, createdTime=Mon Aug 31 14:23:39 CST 2020, time=2020-08-31, status=1, ipAttribution=)]
    2020-08-31 Jessica

    在中国,大约有1370万心力衰竭患者,迫切需要新的治疗方案来减轻这种疾病的负担。Vericiguat有望在中国获得批准,用于治疗慢性心衰。这对于心力衰竭患者真的是个好消息!

    0

  10. 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GetPortalCommentsPageByObjectIdResponse(id=880718, encodeId=c6a1880e183d, content=<a href='/topic/show?id=072c5088466' target=_blank style='color:#2F92EE;'>#心力衰竭#</a>有可能成为心衰三驾马车:ARNI,SGLT2i,和GCa, beContent=null, objectType=article, channel=null, level=null, likeNumber=292, replyNumber=3, topicName=null, topicId=null, topicList=[TopicDto(id=50884, encryptionId=072c5088466, topicName=心力衰竭)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Aug 29 22:48:26 CST 2020, time=2020-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=947932, encodeId=ecc894e932e5, content=心衰患者倍受痛苦,希望能得到更多有质量的医疗护理手段来缓解, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9cba5468764, createdName=ms8000001004052089, createdTime=Sat Mar 13 21:36:20 CST 2021, time=2021-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924225, encodeId=e3589242259c, content=是个好消息吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Feb 12 07:08:41 CST 2021, time=2021-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1811418, encodeId=f5c7181141810, content=<a href='/topic/show?id=26ae8803219' target=_blank style='color:#2F92EE;'>#获得批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88032, encryptionId=26ae8803219, topicName=获得批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=838d2500169, createdName=12498cb5m13暂无昵称, createdTime=Tue Mar 23 02:13:48 CST 2021, time=2021-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881461, encodeId=a34888146162, content=在中国,大约有1370万心力衰竭患者,迫切需要新的治疗方案来减轻这种疾病的负担。Vericiguat有望在中国获得批准,用于治疗慢性心衰。这对于心力衰竭患者真的是个好消息!, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Mon Aug 31 18:16:59 CST 2020, time=2020-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881338, encodeId=fba9881338ff, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200819/64fbd2072f9a45e4ab1d483ac903cef2/6094007d789849e39a3a1f25435a6f41.jpg, createdBy=72732561091, createdName=杀无敌战神, createdTime=Mon Aug 31 14:23:39 CST 2020, time=2020-08-31, status=1, ipAttribution=)]
    2020-08-31 杀无敌战神

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