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"PANDA"登陆悉尼！康柏西普全球多中心III期临床试验启动

2018-12-22 MedSci MedSci原创

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"PANDA"登陆悉尼！康柏西普全球多中心III期临床试验启动

"PANDA"登陆悉尼！康柏西普全球多中心III期临床试验启动

2018年11月3日，康柏西普眼用注射液治疗新生血管性年龄相关性黄斑变性患者的国际多中心III期临床试验（PANDA研究）亚太区研究者会议在澳大利亚悉尼威斯汀酒店顺利举行。

本次会议由成都康弘生物科技有限公司和Syneos Health 联合举办，来自亚太区的24家中心，64位研究者应邀参加了此次会议。包括有澳大利亚狮子眼科研究所，皇家维多利亚眼科医院/澳大利亚眼科研究中心，香港大学玛丽医院，奥克兰眼科有限公司，菲律宾圣卢克医疗中心，首尔国立大学医院，国立台湾大学医院等。


▲成都康弘药业集团副总裁陈粟先生致欢迎词

成都康弘药业集团副总裁陈粟先生出席会议并致欢迎词，对各位专家莅临表示了热烈的欢迎。会议期间，美国波士顿眼科咨询中心副主席Jeff Heier教授对康柏西普的产品及研究背景进行了阐述，克利夫兰COLE眼科研究院的讲习教授Peter Kaiser教授对研究方案及实验设计进行了概述。


与会专家围绕试验设计、试验管理和试验操作等多个议题进行了充分深入的讨论。通过对于既往研究数据的回顾， Heier教授和Kaiser教授及与会的各位专家对康柏西普的疗效和安全性给予了充分的肯定。随后，参会专家分别就该临床试验GCP、中心实验室、临床运营的交互网络应答系统（IxRS）、数据采集（EDC）及管理（Data management）、试验主要终点-视力检测（BCVA）等进行了专题的讨论，并进行了研究者问答和读片中心问答等专项讨论。最后，成都康弘药业集团总裁助理程焰博士致闭幕词祝贺会议圆满结束。


康柏西普是新一代抗VEGF融合蛋白，中国首个获得世界卫生组织国际通用名的拥有全自主知识产权的生物I类新药。康柏西普（Conbercept）是利用中国仓鼠卵巢（CHO）细胞表达系统生产的重组融合蛋白（由人血管内皮生长因子VEGF受体1中的免疫球蛋白样区域2和VEGF受体2中的免疫球蛋白样区域3和4，与人免疫球蛋白Fc片段经过融合而成）。于2016年10月获得美国FDA准许直接在美国开展III期临床试验，目前已经完成了北美区及亚太区的研究启动及研究者会议。


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    2019-02-22 医生2402

    #I期临床#

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    2019-04-16 839640778

    #I期临床试验#

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    2019-10-25 智者为医08

    #多中心#

    0

  4. 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    2019-07-22 kksonne

    #II期临床试验#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1652846, encodeId=6408165284669, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri Feb 22 23:30:00 CST 2019, time=2019-02-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088713, encodeId=e0112088e1329, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Tue Apr 16 19:30:00 CST 2019, time=2019-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1903967, encodeId=e1b0190396e1e, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Fri Oct 25 10:30:00 CST 2019, time=2019-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931443, encodeId=f95b19314437b, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Mon Jul 22 16:30:00 CST 2019, time=2019-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916056, encodeId=8ebd1916056a2, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Thu Jul 25 15:30:00 CST 2019, time=2019-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524665, encodeId=9635152466546, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581058, encodeId=8e45158105874, content=<a href='/topic/show?id=3beb12600e5' target=_blank style='color:#2F92EE;'>#NDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12600, encryptionId=3beb12600e5, topicName=NDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a9e16702381, createdName=12498a49m65暂无昵称, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588012, encodeId=131415880128c, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594546, encodeId=5bde1594546f0, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=15, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=)]
    2019-07-25 juliusluan78

    #III#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1652846, encodeId=6408165284669, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri Feb 22 23:30:00 CST 2019, time=2019-02-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088713, encodeId=e0112088e1329, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Tue Apr 16 19:30:00 CST 2019, time=2019-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1903967, encodeId=e1b0190396e1e, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Fri Oct 25 10:30:00 CST 2019, time=2019-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931443, encodeId=f95b19314437b, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Mon Jul 22 16:30:00 CST 2019, time=2019-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916056, encodeId=8ebd1916056a2, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Thu Jul 25 15:30:00 CST 2019, time=2019-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524665, encodeId=9635152466546, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581058, encodeId=8e45158105874, content=<a href='/topic/show?id=3beb12600e5' target=_blank style='color:#2F92EE;'>#NDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12600, encryptionId=3beb12600e5, topicName=NDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a9e16702381, createdName=12498a49m65暂无昵称, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588012, encodeId=131415880128c, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594546, encodeId=5bde1594546f0, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=15, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=)]
    2018-12-24 guihongzh

    #II期临床#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1652846, encodeId=6408165284669, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri Feb 22 23:30:00 CST 2019, time=2019-02-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088713, encodeId=e0112088e1329, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Tue Apr 16 19:30:00 CST 2019, time=2019-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1903967, encodeId=e1b0190396e1e, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Fri Oct 25 10:30:00 CST 2019, time=2019-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931443, encodeId=f95b19314437b, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Mon Jul 22 16:30:00 CST 2019, time=2019-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916056, encodeId=8ebd1916056a2, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Thu Jul 25 15:30:00 CST 2019, time=2019-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524665, encodeId=9635152466546, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581058, encodeId=8e45158105874, content=<a href='/topic/show?id=3beb12600e5' target=_blank style='color:#2F92EE;'>#NDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12600, encryptionId=3beb12600e5, topicName=NDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a9e16702381, createdName=12498a49m65暂无昵称, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588012, encodeId=131415880128c, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594546, encodeId=5bde1594546f0, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=15, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Mon Dec 24 03:30:00 CST 2018, time=2018-12-24, status=1, ipAttribution=)]
    2018-12-24 12498a49m65暂无昵称

    #NDA#

    0

  8. 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    2018-12-24 guihongzh

    #III期临床试验#

    0

  9. 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    2018-12-24 智智灵药

    #III期#

    0