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晚期神经内分泌肿瘤的治疗或迎新进展!和记黄埔已向EMA提交Surufatinib的营销授权申请

2020-08-10 Allan MedSci原创

和记黄埔中国医药科技有限公司(Chi-Med)今日宣布,它已从欧洲药品管理局(EMA)的人用药药品委员会(CHMP)获得了Surufatinib的科学建议,用于治疗晚期神经内分泌肿瘤(NET)。

和记黄埔中国医药科技有限公司(Chi-Med)今日宣布,它已从欧洲药品管理局(EMA)的人用药药品委员会(CHMP)获得了Surufatinib的科学建议,用于治疗晚期神经内分泌肿瘤(NET)。已完成的SANET-ep(非胰腺NET)和SANET-p(胰腺NET)研究,以及来自美国非胰腺和胰腺NET患者surufatinib的数据支持营销授权应用程序(MAA)。和记黄埔计划在2021年向美国食品药品管理局(FDA)提交新药申请(NDA)。

Surufatinib是一种新型的口服血管免疫激酶抑制剂,可选择性抑制与血管内皮生长因子受体(VEGFR)和成纤维细胞生长因子受体(FGFR)相关的酪氨酸激酶活性,Surufatinib可调节与肿瘤相关的巨噬细胞,促进人体对肿瘤细胞的免疫反应。

在美国,surufatinib在2020年4月被授予治疗NET的快速通道称号,并在2019年11月被授予治疗胰腺NET的孤儿药物称号。

在中国,中国国家药品监督管理局(NMPA)在2019年11月开始审查surufatinib治疗非胰腺NET晚期患者的NDA。该进展得到了SANET-ep研究数据的支持,该研究是Surufatinib在中国治疗非胰腺NET患者的III期研究,在2019年6月对198位患者的中期分析表明,Surufatinib显著延长了患者的无进展生存期(PFS)。

 

原始出处:

https://www.firstwordpharma.com/node/1747791?tsid=4

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    2020-08-12 fengyi812
  9. [GetPortalCommentsPageByObjectIdResponse(id=976699, encodeId=27ff9e66994f, content=有帮助, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201128/48ac6dadc2e54983b1a930ba25a9b4c0/9026c9863b1348c5bf5067bf6514de10.jpg, createdBy=e5725241065, createdName=147bed79m67暂无昵称, createdTime=Fri Jun 25 06:50:48 CST 2021, time=2021-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1763515, encodeId=c4991e63515c2, content=<a href='/topic/show?id=3fc83035361' target=_blank style='color:#2F92EE;'>#内分泌肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30353, encryptionId=3fc83035361, topicName=内分泌肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=763a37536718, createdName=1249898am27暂无昵称, createdTime=Wed Aug 19 19:55:54 CST 2020, time=2020-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029962, encodeId=f5c820299628b, content=<a href='/topic/show?id=d493e259c9' target=_blank style='color:#2F92EE;'>#fat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7259, encryptionId=d493e259c9, topicName=fat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=198d2500149, createdName=12498bd5m16暂无昵称, createdTime=Sun Feb 28 10:55:54 CST 2021, time=2021-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1682626, encodeId=d30c168262617, content=<a href='/topic/show?id=d4d031e8074' target=_blank style='color:#2F92EE;'>#分泌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=31780, encryptionId=d4d031e8074, topicName=分泌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Sun Nov 01 11:55:54 CST 2020, time=2020-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1953773, encodeId=e8281953e73b2, content=<a href='/topic/show?id=9bdbe41946e' target=_blank style='color:#2F92EE;'>#神经内分泌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74194, encryptionId=9bdbe41946e, topicName=神经内分泌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8143398, createdName=lily1616, createdTime=Sat Apr 10 19:55:54 CST 2021, time=2021-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1952263, encodeId=c163195226353, content=<a href='/topic/show?id=d3511692641' target=_blank style='color:#2F92EE;'>#surufatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16926, encryptionId=d3511692641, topicName=surufatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Fri Mar 26 04:55:54 CST 2021, time=2021-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1632074, encodeId=01df16320e439, content=<a href='/topic/show?id=caeb39e68f0' target=_blank style='color:#2F92EE;'>#和记黄埔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=39768, encryptionId=caeb39e68f0, topicName=和记黄埔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=534321850921, createdName=canlab, createdTime=Mon Jan 25 17:55:54 CST 2021, time=2021-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317584, encodeId=69ed131e5843e, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Wed Aug 12 12:55:54 CST 2020, time=2020-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=807439, encodeId=461b80e4398d, content=谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c4bd5125128, createdName=14643f34m67暂无昵称, createdTime=Tue Aug 11 09:29:34 CST 2020, time=2020-08-11, status=1, ipAttribution=)]
    2020-08-11 14643f34m67暂无昵称

    谢谢

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European Radiology:小于 2cm胰腺导管腺癌与神经内分泌肿瘤的多参数MRI放射组学特征鉴别

最近,放射组学作为一种新的图像分析方法出现,可对图像进行定量检查,产生比肉眼可见的更多信息。

反复腹痛并不是胃肠炎,而是这种除了指甲、头发上不长哪都长的肿瘤?很多人对它感到陌生,但赫本却被它夺取了生命!

48 岁赵先生因腹痛确诊直肠神经内分泌肿瘤(NET,G1)。介绍神经内分泌肿瘤,包括发病率上升、遍布全身、临床表现多样及诊断、治疗方法。

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