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全球大复方中药获批在美国进行二期临床研究

2015-12-26 记者 齐雷杰 新华网

河北石家庄以岭药业股份有限公司24日晚发布公告称,这家公司的美国全资子公司接到美国食品药品监督管理局(简称美国FDA)批复,公司生产的治感冒抗流感专利中药连花清瘟胶囊,获批在美国进行二期临床研究。这是我国第一个进入美国FDA临床研究的治疗流感的中药,也是全球第一个大复方中药的药品临床试验申报正式获得美国FDA批准。据以岭药业负责人介绍,近年来,中国中医科学院、广州医学院呼吸疾病国家重点实验室等多家

日前,中国生产的治感冒、抗流感药物连花清瘟胶囊,获得美国食品药品监督管理局(简称美国FDA)批复在美国进行二期临床研究。据了解,这是中国第一个进入美国FDA临床研究的治疗流行性感冒的中药,也是全球第一个大复方中药的药品临床试验申报正式获得美国FDA批准(FDA送大复方中药连花清瘟的圣诞礼物,在美国开展II期临床试验)。

此次申报美国FDA二期临床的连花清瘟胶囊,是用于治疗普通感冒和病毒性流感的专利新药,也是中国唯一获得国家科技进步二等奖的治疗流感的中成药。该药是2003年“非典”期间通过国家绿色通道审批的治感冒、抗流感中药,是专家团队在中医络病理论指导下,汲取古代中医药智慧,结合现代抗病毒、抑菌、提高免疫等研究成果创制而成的。

近年来,中国中医科学院、广州医学院第一附属医院呼吸疾病国家重点实验室等多家科研机构对连花清瘟胶囊进行了大量科学研究,证明了它的广谱抗病毒作用,尤其对甲型流感病毒(H1N1、H3N2)、禽流感病毒(H5N1、H9N2)、乙型流感病毒、腺病毒、疱疹病毒等有较强抑制杀灭作用。2015年,该药被列入国家卫计委《中东呼吸综合征病例诊疗方案》推荐用药。

美国FDA是国际公认的药品审批与监管权威机构,中药在美国FDA的注册是中医药进入国际主流医药市场的重要关口。连花清瘟胶囊是复方中药,目前复方中药的美国FDA注册尚无成功经验。若连花清瘟胶囊最终能通过美国FDA注册,将为中国传统医药走向国际市场打下坚实基础。

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    2016-11-16 小康子70

    可喜可贺,中药加油

    0

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  3. [GetPortalCommentsPageByObjectIdResponse(id=156009, encodeId=3bae156009bc, content=可喜可贺,中药加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83ep3KyYH7kyqVwUwK81ibQRkWMqRMVwerlwD2Ie9byeRp2RL9wKmLgoNwShDTdTNL8RQHfhDsAt0N9A/132, createdBy=99b61684657, createdName=小康子70, createdTime=Wed Nov 16 06:08:41 CST 2016, time=2016-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1940392, encodeId=e272194039242, content=<a href='/topic/show?id=3ec023929ce' target=_blank style='color:#2F92EE;'>#二期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23929, encryptionId=3ec023929ce, topicName=二期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sun Jul 31 16:49:00 CST 2016, time=2016-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59909, encodeId=3e2b59909e4, content=是一篇不错的文章, beContent=null, objectType=article, channel=null, level=null, likeNumber=203, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 17:10:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59908, encodeId=a6845990805, content=这篇文章有一定深度, beContent=null, objectType=article, channel=null, level=null, likeNumber=199, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 17:10:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59557, encodeId=e7695955e05, content=期待中国市场, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 15:00:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=58032, encodeId=07815803289, content=好消息, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da3d1626631, createdName=1dd7d1dam20(暂无匿称), createdTime=Sat Jan 16 22:23:00 CST 2016, time=2016-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49398, encodeId=76d94939815, content=太棒啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=194, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e3601615208, createdName=dearluodi, createdTime=Sun Dec 27 15:54:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49331, encodeId=2ccb4933172, content=很值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Sun Dec 27 12:39:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49289, encodeId=9e7549289e5, content=赞一个, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=95791668951, createdName=1de0837dm52(暂无匿称), createdTime=Sun Dec 27 12:16:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49241, encodeId=ffcd49241ca, content=支持中药!, beContent=null, objectType=article, channel=null, level=null, likeNumber=174, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6b0d1671629, createdName=1de11f7fm56(暂无匿称), createdTime=Sun Dec 27 11:19:00 CST 2015, time=2015-12-27, status=1, ipAttribution=)]
    2016-01-26 doctording1

    是一篇不错的文章

    0

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    2016-01-26 doctording1

    这篇文章有一定深度

    0

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    2016-01-26 doctording1

    期待中国市场

    0

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    2016-01-16 1dd7d1dam20(暂无匿称)

    好消息

    0

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    2015-12-27 dearluodi

    太棒啦

    0

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    2015-12-27 忠诚向上

    很值得学习

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=156009, encodeId=3bae156009bc, content=可喜可贺,中药加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83ep3KyYH7kyqVwUwK81ibQRkWMqRMVwerlwD2Ie9byeRp2RL9wKmLgoNwShDTdTNL8RQHfhDsAt0N9A/132, createdBy=99b61684657, createdName=小康子70, createdTime=Wed Nov 16 06:08:41 CST 2016, time=2016-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1940392, encodeId=e272194039242, content=<a href='/topic/show?id=3ec023929ce' target=_blank style='color:#2F92EE;'>#二期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23929, encryptionId=3ec023929ce, topicName=二期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sun Jul 31 16:49:00 CST 2016, time=2016-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59909, encodeId=3e2b59909e4, content=是一篇不错的文章, beContent=null, objectType=article, channel=null, level=null, likeNumber=203, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 17:10:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59908, encodeId=a6845990805, content=这篇文章有一定深度, beContent=null, objectType=article, channel=null, level=null, likeNumber=199, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 17:10:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59557, encodeId=e7695955e05, content=期待中国市场, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 15:00:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=58032, encodeId=07815803289, content=好消息, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da3d1626631, createdName=1dd7d1dam20(暂无匿称), createdTime=Sat Jan 16 22:23:00 CST 2016, time=2016-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49398, encodeId=76d94939815, content=太棒啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=194, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e3601615208, createdName=dearluodi, createdTime=Sun Dec 27 15:54:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49331, encodeId=2ccb4933172, content=很值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Sun Dec 27 12:39:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49289, encodeId=9e7549289e5, content=赞一个, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=95791668951, createdName=1de0837dm52(暂无匿称), createdTime=Sun Dec 27 12:16:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49241, encodeId=ffcd49241ca, content=支持中药!, beContent=null, objectType=article, channel=null, level=null, likeNumber=174, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6b0d1671629, createdName=1de11f7fm56(暂无匿称), createdTime=Sun Dec 27 11:19:00 CST 2015, time=2015-12-27, status=1, ipAttribution=)]
    2015-12-27 1de0837dm52(暂无匿称)

    赞一个

    0

  10. [GetPortalCommentsPageByObjectIdResponse(id=156009, encodeId=3bae156009bc, content=可喜可贺,中药加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83ep3KyYH7kyqVwUwK81ibQRkWMqRMVwerlwD2Ie9byeRp2RL9wKmLgoNwShDTdTNL8RQHfhDsAt0N9A/132, createdBy=99b61684657, createdName=小康子70, createdTime=Wed Nov 16 06:08:41 CST 2016, time=2016-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1940392, encodeId=e272194039242, content=<a href='/topic/show?id=3ec023929ce' target=_blank style='color:#2F92EE;'>#二期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23929, encryptionId=3ec023929ce, topicName=二期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sun Jul 31 16:49:00 CST 2016, time=2016-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59909, encodeId=3e2b59909e4, content=是一篇不错的文章, beContent=null, objectType=article, channel=null, level=null, likeNumber=203, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 17:10:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59908, encodeId=a6845990805, content=这篇文章有一定深度, beContent=null, objectType=article, channel=null, level=null, likeNumber=199, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 17:10:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=59557, encodeId=e7695955e05, content=期待中国市场, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59121683644, createdName=doctording1, createdTime=Tue Jan 26 15:00:00 CST 2016, time=2016-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=58032, encodeId=07815803289, content=好消息, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da3d1626631, createdName=1dd7d1dam20(暂无匿称), createdTime=Sat Jan 16 22:23:00 CST 2016, time=2016-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49398, encodeId=76d94939815, content=太棒啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=194, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e3601615208, createdName=dearluodi, createdTime=Sun Dec 27 15:54:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49331, encodeId=2ccb4933172, content=很值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Sun Dec 27 12:39:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49289, encodeId=9e7549289e5, content=赞一个, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=95791668951, createdName=1de0837dm52(暂无匿称), createdTime=Sun Dec 27 12:16:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49241, encodeId=ffcd49241ca, content=支持中药!, beContent=null, objectType=article, channel=null, level=null, likeNumber=174, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6b0d1671629, createdName=1de11f7fm56(暂无匿称), createdTime=Sun Dec 27 11:19:00 CST 2015, time=2015-12-27, status=1, ipAttribution=)]
    2015-12-27 1de11f7fm56(暂无匿称)

    支持中药!

    0

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