我国埃博拉疫苗新药注册获批

2017-10-21 佚名 健康报

0月20日,国家食品药品监督管理总局发布消息称,我国首个重组埃博拉病毒病疫苗已于近日获得新药注册申请批准。

10月20日,国家食品药品监督管理总局发布消息称,我国首个重组埃博拉病毒病疫苗已于近日获得新药注册申请批准,该疫苗是由我国独立研发、具有完全自主知识产权的创新性重组疫苗产品,此前全球仅有美国和俄罗斯两个国家具有可供使用的埃博拉病毒病疫苗。

据悉,我国此次批准的埃博拉病毒病疫苗采用了国际先进的复制缺陷型病毒载体技术和无血清高密度悬浮培养技术,可同时激发人体细胞免疫和体液免疫,在保证安全性的同时,具备良好的免疫原性。此外,该疫苗还突破了病毒载体疫苗冻干制剂的技术瓶颈,与国外的液体剂型埃博拉疫苗相比,我国的冻干剂型埃博拉病毒病疫苗具备更为优良的稳定性,特别适宜在非洲等高温地区运输和使用。

该产品的研发得到了国家大力支持,在国家传染病重大专项资助下建立了烈性病原体复制缺陷型重组腺病毒载体应急疫苗关键技术,并在重大新药创制专项经费的支持下开展了相关临床研究课题。其临床试验获得受理后,国家食药监管总局启动了特别审批程序,同年2月即批准了相关临床试验。世界卫生组织多次邀请我国药品监管部门及研发团队赴日内瓦参加埃博拉疫情防控的专题讨论,并将该疫苗列入世卫组织关于埃博拉病毒病疫苗质量、安全和有效性指南。

专家表示,我国首个重组埃博拉病毒病疫苗的获批,不仅为国家对涉及重大公共卫生事件的防控提供了有力保障,还将对我国重大传染病疫苗的研发起到推动和引领作用。它展示了我国生物医药领域科技创新的实力跃升,对国家生物安全具有重要的战略意义。

此次批准注册的重组埃博拉病毒病疫苗由军事医学科学院生物工程研究所、康希诺生物股份公司联合研发。

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1460070, encodeId=edbd14600e047, content=<a href='/topic/show?id=d44f415583a' target=_blank style='color:#2F92EE;'>#埃博拉疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41558, encryptionId=d44f415583a, topicName=埃博拉疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78136234994, createdName=yourmama, createdTime=Mon Oct 23 14:08:00 CST 2017, time=2017-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556780, encodeId=c7381556e8026, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Mon Oct 23 14:08:00 CST 2017, time=2017-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=255003, encodeId=48a42550034a, content=了解了解.继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Sun Oct 22 07:10:16 CST 2017, time=2017-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254987, encodeId=76c725498ec8, content=注意检测有无副作用, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/21/9461f3b3c9f14e1d844256cdd08f2cf3.jpg, createdBy=a30f1426910, createdName=swfzhanggui, createdTime=Sun Oct 22 06:07:55 CST 2017, time=2017-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254950, encodeId=9f0c254950af, content=很好!感谢研究人员的努力, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM6DGOvNrRdcib3UmzMgpEQplCaQGBmjHytXQqvsuocO2uV2lOAaJibzDafJudKToVfU12LzwArHDb4TSrmU2hk5Qxzc6icoicBK3Dg/0, createdBy=a7901968505, createdName=明心见性, createdTime=Sat Oct 21 23:26:58 CST 2017, time=2017-10-21, status=1, ipAttribution=)]
    2017-10-23 zhyy93
  3. [GetPortalCommentsPageByObjectIdResponse(id=1460070, encodeId=edbd14600e047, content=<a href='/topic/show?id=d44f415583a' target=_blank style='color:#2F92EE;'>#埃博拉疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41558, encryptionId=d44f415583a, topicName=埃博拉疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78136234994, createdName=yourmama, createdTime=Mon Oct 23 14:08:00 CST 2017, time=2017-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556780, encodeId=c7381556e8026, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Mon Oct 23 14:08:00 CST 2017, time=2017-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=255003, encodeId=48a42550034a, content=了解了解.继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Sun Oct 22 07:10:16 CST 2017, time=2017-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254987, encodeId=76c725498ec8, content=注意检测有无副作用, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/21/9461f3b3c9f14e1d844256cdd08f2cf3.jpg, createdBy=a30f1426910, createdName=swfzhanggui, createdTime=Sun Oct 22 06:07:55 CST 2017, time=2017-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254950, encodeId=9f0c254950af, content=很好!感谢研究人员的努力, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM6DGOvNrRdcib3UmzMgpEQplCaQGBmjHytXQqvsuocO2uV2lOAaJibzDafJudKToVfU12LzwArHDb4TSrmU2hk5Qxzc6icoicBK3Dg/0, createdBy=a7901968505, createdName=明心见性, createdTime=Sat Oct 21 23:26:58 CST 2017, time=2017-10-21, status=1, ipAttribution=)]
    2017-10-22 1dd8c52fm63(暂无匿称)

    了解了解.继续关注

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1460070, encodeId=edbd14600e047, content=<a href='/topic/show?id=d44f415583a' target=_blank style='color:#2F92EE;'>#埃博拉疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41558, encryptionId=d44f415583a, topicName=埃博拉疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78136234994, createdName=yourmama, createdTime=Mon Oct 23 14:08:00 CST 2017, time=2017-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556780, encodeId=c7381556e8026, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Mon Oct 23 14:08:00 CST 2017, time=2017-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=255003, encodeId=48a42550034a, content=了解了解.继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Sun Oct 22 07:10:16 CST 2017, time=2017-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254987, encodeId=76c725498ec8, content=注意检测有无副作用, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/21/9461f3b3c9f14e1d844256cdd08f2cf3.jpg, createdBy=a30f1426910, createdName=swfzhanggui, createdTime=Sun Oct 22 06:07:55 CST 2017, time=2017-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254950, encodeId=9f0c254950af, content=很好!感谢研究人员的努力, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM6DGOvNrRdcib3UmzMgpEQplCaQGBmjHytXQqvsuocO2uV2lOAaJibzDafJudKToVfU12LzwArHDb4TSrmU2hk5Qxzc6icoicBK3Dg/0, createdBy=a7901968505, createdName=明心见性, createdTime=Sat Oct 21 23:26:58 CST 2017, time=2017-10-21, status=1, ipAttribution=)]
    2017-10-22 swfzhanggui

    注意检测有无副作用

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1460070, encodeId=edbd14600e047, content=<a href='/topic/show?id=d44f415583a' target=_blank style='color:#2F92EE;'>#埃博拉疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41558, encryptionId=d44f415583a, topicName=埃博拉疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78136234994, createdName=yourmama, createdTime=Mon Oct 23 14:08:00 CST 2017, time=2017-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556780, encodeId=c7381556e8026, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Mon Oct 23 14:08:00 CST 2017, time=2017-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=255003, encodeId=48a42550034a, content=了解了解.继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Sun Oct 22 07:10:16 CST 2017, time=2017-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254987, encodeId=76c725498ec8, content=注意检测有无副作用, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/21/9461f3b3c9f14e1d844256cdd08f2cf3.jpg, createdBy=a30f1426910, createdName=swfzhanggui, createdTime=Sun Oct 22 06:07:55 CST 2017, time=2017-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254950, encodeId=9f0c254950af, content=很好!感谢研究人员的努力, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM6DGOvNrRdcib3UmzMgpEQplCaQGBmjHytXQqvsuocO2uV2lOAaJibzDafJudKToVfU12LzwArHDb4TSrmU2hk5Qxzc6icoicBK3Dg/0, createdBy=a7901968505, createdName=明心见性, createdTime=Sat Oct 21 23:26:58 CST 2017, time=2017-10-21, status=1, ipAttribution=)]
    2017-10-21 明心见性

    很好!感谢研究人员的努力

    0

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