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美国FDA授予BioCryst的BCX7353快速通道资格

2018-08-06 MedSci MedSci原创

BioCrystBCX7353FDA
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BioCryst是一家专注于罕见疾病疗法开发和商业化的制药公司，BioCryst近日宣布该公司的BCX7353已被美国食品和药物管理局（FDA）授予快速通道资格，用于预防遗传性血管性水肿（HAE）患者的血管神经性水肿。快速通道资格旨在为候选药物与FDA的频繁交互提供机会。

BioCryst是一家专注于罕见疾病疗法开发和商业化的制药公司，BioCryst近日宣布该公司的BCX7353已被美国食品和药物管理局（FDA）授予快速通道资格，用于预防遗传性血管性水肿（HAE）患者的血管神经性水肿。快速通道资格旨在为候选药物与FDA的频繁交互提供机会。

遗传性血管性水肿系常染色体显性遗传性皮肤病，可发生于任何年龄，而多见于儿童期和少年期，常有家族史。HAE由C1酯酶抑制物减少或功能缺陷所致，临床表现为反复发作的局限性、非凹陷性皮肤黏膜肿胀。

BioCryst总裁兼首席执行官Jon P. Stonehouse说：“美国食品和药物管理局的快速通道指定是BCX7353在美国满足HAE患者医疗需求的里程碑。我们将专注于完成第三阶段计划，并准备在2019年下半年提交NDA申请”。BCX7353是一种新型、口服、每日一次的血浆激肽释放酶选择性抑制剂，目前正在开发用于预防和治疗诊HAE患者的血管性水肿。在II期APeX-1临床试验中，BCX7353具有良好的安全性和耐受性。


原始出处：

http://www.firstwordpharma.com/node/1583141?tsid=4#axzz5NCMJrdAy

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    2018-08-27 sunylz

    #Bio#

    0

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    2018-08-08 Eleven14

    #快速通道资格#

    0

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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Aug 06 22:59:22 CST 2018, time=2018-08-06, status=1, ipAttribution=)]
    2018-08-08 10518098zz

    #美国FDA#

    0

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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Aug 06 22:59:22 CST 2018, time=2018-08-06, status=1, ipAttribution=)]
    2018-08-07 liumin1987

    嗯嗯，学习学习。

    0

  5. 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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Aug 06 22:59:22 CST 2018, time=2018-08-06, status=1, ipAttribution=)]
    2018-08-07 牛顿爱吃苹果

    学习了

    0

  6. 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    2018-08-07 太阳系小猪

    很有趣的一个公司~

    0

  7. 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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Aug 06 22:59:22 CST 2018, time=2018-08-06, status=1, ipAttribution=)]
    2018-08-07 yjs木玉

    好好好好好好好好

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1918226, encodeId=09a5191822691, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Mon Aug 27 01:54:00 CST 2018, time=2018-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1495265, encodeId=d5dd149526505, content=<a href='/topic/show?id=9b035208633' target=_blank style='color:#2F92EE;'>#快速通道资格#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52086, encryptionId=9b035208633, topicName=快速通道资格)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ebf79160797, createdName=Eleven14, createdTime=Wed Aug 08 13:54:00 CST 2018, time=2018-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551412, encodeId=ec1e1551412ed, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Wed Aug 08 13:54:00 CST 2018, time=2018-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337037, encodeId=eb4e33e037fe, content=嗯嗯，学习学习。, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/07/16/3b24606172648eea459125cb74754afe.jpg, createdBy=6c022216608, createdName=liumin1987, createdTime=Tue Aug 07 12:28:58 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337017, encodeId=428333e01706, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20230214/f9a4c33015ad4f8c8421eeb2fef26ab3/8f194fc039fc48afa071caaab4eff3ab.jpg, createdBy=98072077561, createdName=牛顿爱吃苹果, createdTime=Tue Aug 07 10:36:07 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336959, encodeId=510f3369593b, content=很有趣的一个公司~, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d7e71713450, createdName=太阳系小猪, createdTime=Tue Aug 07 06:55:28 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336948, encodeId=281933694879, content=好好好好好好好好, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/29/bbc5cc0eed9b8d17623d2fd49dbdf19a.jpg, createdBy=79522135794, createdName=yjs木玉, createdTime=Tue Aug 07 05:41:28 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336930, encodeId=2bef33693028, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Mon Aug 06 23:52:20 CST 2018, time=2018-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336910, encodeId=6ad7336910b4, content=学习了，谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Mon Aug 06 23:11:56 CST 2018, time=2018-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336900, encodeId=12883369005d, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Aug 06 22:59:22 CST 2018, time=2018-08-06, status=1, ipAttribution=)]
    2018-08-06 清风拂面

    谢谢分享学习

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1918226, encodeId=09a5191822691, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Mon Aug 27 01:54:00 CST 2018, time=2018-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1495265, encodeId=d5dd149526505, content=<a href='/topic/show?id=9b035208633' target=_blank style='color:#2F92EE;'>#快速通道资格#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52086, encryptionId=9b035208633, topicName=快速通道资格)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ebf79160797, createdName=Eleven14, createdTime=Wed Aug 08 13:54:00 CST 2018, time=2018-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551412, encodeId=ec1e1551412ed, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Wed Aug 08 13:54:00 CST 2018, time=2018-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337037, encodeId=eb4e33e037fe, content=嗯嗯，学习学习。, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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authenticateStatus=null, createdAvatar=, createdBy=d7e71713450, createdName=太阳系小猪, createdTime=Tue Aug 07 06:55:28 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336948, encodeId=281933694879, content=好好好好好好好好, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/29/bbc5cc0eed9b8d17623d2fd49dbdf19a.jpg, createdBy=79522135794, createdName=yjs木玉, createdTime=Tue Aug 07 05:41:28 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336930, encodeId=2bef33693028, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Mon Aug 06 23:52:20 CST 2018, time=2018-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336910, encodeId=6ad7336910b4, content=学习了，谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Mon Aug 06 23:11:56 CST 2018, time=2018-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336900, encodeId=12883369005d, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Aug 06 22:59:22 CST 2018, time=2018-08-06, status=1, ipAttribution=)]
    2018-08-06 惠映实验室

    学习了，谢谢分享。

    0

  10. 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createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Mon Aug 06 23:52:20 CST 2018, time=2018-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336910, encodeId=6ad7336910b4, content=学习了，谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Mon Aug 06 23:11:56 CST 2018, time=2018-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336900, encodeId=12883369005d, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Aug 06 22:59:22 CST 2018, time=2018-08-06, status=1, ipAttribution=)]
    2018-08-06 医者仁心5538

    学习了

    0

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