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创伤性脑损伤的治疗：FDA批准了MR-301的研究性新药申请

2019-08-29 Allan MedSci原创

FDA创伤性脑损伤MR-301
关注

SHINKEI是一家专注于开发治疗中枢神经系统（CNS）疾病治疗药物的制药公司，近日宣布FDA已接受MR-301治疗严重创伤性脑损伤（sTBI）的研究性新药申请（IND）。

SHINKEI是一家专注于开发治疗中枢神经系统（CNS）疾病治疗药物的制药公司，近日宣布FDA已接受MR-301治疗严重创伤性脑损伤（sTBI）的研究性新药申请（IND）。

在美国，sTBI是致残的一个主要原因，约有1350万病例。许多幸存者遗留明显的残疾，造成了巨大社会经济负担。在2010年，估计sTBI对美国经济的影响为765亿美元的直接和间接成本。SHINKEI表示，目前尚无批准的药物可用于逆转sTBI并改善患者的认知功能。该项IND的获批是一个重要的里程碑，SHINKEI表示将推进临床计划，预计健康志愿者的初始剂量研究将在接下来的30天内开始。


原始出处：

http://www.firstwordpharma.com/node/1662398#axzz5xwhWnSXE

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#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1744190, encodeId=a6ad1e441903c, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Wed Oct 23 17:11:00 CST 2019, time=2019-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839715, encodeId=b9911839e15d4, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Jan 21 16:11:00 CST 2020, time=2020-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2077236, encodeId=3b6020e72364f, content=<a href='/topic/show?id=c5341218477' target=_blank style='color:#2F92EE;'>#MR-301#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12184, encryptionId=c5341218477, topicName=MR-301)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf1d2500084, createdName=1249884fm87暂无昵称, createdTime=Fri Mar 20 20:11:00 CST 2020, time=2020-03-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2025498, encodeId=18a72025498e8, content=<a href='/topic/show?id=66f93204223' target=_blank style='color:#2F92EE;'>#创伤性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32042, encryptionId=66f93204223, topicName=创伤性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=325a197, createdName=amyloid, createdTime=Thu Aug 06 20:11:00 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335271, encodeId=964513352e121, content=<a href='/topic/show?id=e7cc32022c7' target=_blank style='color:#2F92EE;'>#创伤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32022, encryptionId=e7cc32022c7, topicName=创伤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=aa5a2500103, createdName=ms920641618706883, createdTime=Sat Aug 31 00:11:00 CST 2019, time=2019-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1397814, encodeId=e212139e81463, content=<a href='/topic/show?id=8bee565436d' target=_blank style='color:#2F92EE;'>#损伤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56543, encryptionId=8bee565436d, topicName=损伤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sat Aug 31 00:11:00 CST 2019, time=2019-08-31, status=1, ipAttribution=)]
    2019-10-23 wangbingxhy

    #新药申请#

    0

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    2020-01-21 bugit

    #FDA批准#

    0

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    2020-03-20 1249884fm87暂无昵称

    #MR-301#

    0

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    2020-08-06 amyloid

    #创伤性#

    0

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    2019-08-31 ms920641618706883

    #创伤#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1744190, encodeId=a6ad1e441903c, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Wed Oct 23 17:11:00 CST 2019, time=2019-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839715, encodeId=b9911839e15d4, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Jan 21 16:11:00 CST 2020, time=2020-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2077236, encodeId=3b6020e72364f, content=<a href='/topic/show?id=c5341218477' target=_blank style='color:#2F92EE;'>#MR-301#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12184, encryptionId=c5341218477, topicName=MR-301)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf1d2500084, createdName=1249884fm87暂无昵称, createdTime=Fri Mar 20 20:11:00 CST 2020, time=2020-03-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2025498, encodeId=18a72025498e8, content=<a href='/topic/show?id=66f93204223' target=_blank style='color:#2F92EE;'>#创伤性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32042, encryptionId=66f93204223, topicName=创伤性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=325a197, createdName=amyloid, createdTime=Thu Aug 06 20:11:00 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335271, encodeId=964513352e121, content=<a href='/topic/show?id=e7cc32022c7' target=_blank style='color:#2F92EE;'>#创伤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32022, encryptionId=e7cc32022c7, topicName=创伤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=aa5a2500103, createdName=ms920641618706883, createdTime=Sat Aug 31 00:11:00 CST 2019, time=2019-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1397814, encodeId=e212139e81463, content=<a href='/topic/show?id=8bee565436d' target=_blank style='color:#2F92EE;'>#损伤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56543, encryptionId=8bee565436d, topicName=损伤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sat Aug 31 00:11:00 CST 2019, time=2019-08-31, status=1, ipAttribution=)]
    2019-08-31 仁者大医

    #损伤#

    0

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