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重磅：肝癌在研新药FGFR4抑制剂获FDA孤儿药资格

2017-10-12 佚名 “药明康德”微信号

FGFR4抑制剂肝癌孤儿药
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日前，H3 Biomedicine公司宣布，该公司治疗肝细胞癌(hepatocellular carcinoma， HCC)的在研新药H3B-6527获得美国FDA授予的孤儿药资格。H3 Biomedicine公司是一家专精于研发癌症精准疗法的临床期生物制药公司。H3B-6527是该公司开发的第一个进入临床期的实体瘤在研药物。它是一种可口服的，有选择性的强力成纤维细胞生长因子受体4(fibrobl

日前，H3 Biomedicine公司宣布，该公司治疗肝细胞癌(hepatocellular carcinoma， HCC)的在研新药H3B-6527获得美国FDA授予的孤儿药资格。H3 Biomedicine公司是一家专精于研发癌症精准疗法的临床期生物制药公司。H3B-6527是该公司开发的第一个进入临床期的实体瘤在研药物。它是一种可口服的，有选择性的强力成纤维细胞生长因子受体4(fibroblast growth factor receptor 4， FGFR4)抑制剂。目前该药物正在临床1期试验中接受检验。孤儿药资格将给H3 Biomedicine公司的药物研发过程带来一系列便利。


HCC是一种复杂性和异质性很强的肿瘤类型。FGF19-FGFR4的信号通路异常是导致癌症发生的一个重要原因。FGF19通过与它的受体FGFR4结合，能够调节胆酸合成和肝细胞增殖。一部分HCC患者中FGF19基因出现扩增，导致FGF19-FGFR4信号通路被异常激活。在小鼠模型中，过度表达FGF19会导致肝癌的产生。因此，FGF19-FGFR4信号通路被认为是一个治疗HCC的潜在靶点。


FGF19/FGFR4信号通路

H3B-6527是H3 Biomedicine公司开发的一种可口服的，有选择性的FGFR4强力抑制剂。在多种临床前模型的研究中，H3B-6527能够导致FGF19-FGFR4信号通路异常激活的肿瘤出现持续性萎缩。在临床试验中，研究人员将使用一个伴随诊断检测来找出那些FGF19-FGFR4通路活性异常的HCC患者，并且在这一患者群中检测H3B-6527的安全性和疗效。

“H3B-6527获得孤儿药资格让H3公司向将这一创新疗法带给HCC患者的目标迈进了一大步，”H3 Biomedicine公司的总裁兼CEO Markus Warmuth博士说：“我们在靶向FGFR4方面的研究进展为未来的临床研究打下了一个坚实的基础。我们期待在肝癌患者中进一步研究H3B-6527对他们的影响。我们承诺将继续推进这一临床项目，为患者带来临床方面的裨益。”

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    2017-10-13 jklm09

    #抑制剂#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1851541, encodeId=b6a0185154157, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Oct 13 19:39:00 CST 2017, time=2017-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483062, encodeId=d61b148306256, content=<a href='/topic/show?id=5dcbe397d2' target=_blank style='color:#2F92EE;'>#FGFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7397, encryptionId=5dcbe397d2, topicName=FGFR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=31fb7872570, createdName=12498c24m71暂无昵称, createdTime=Sat Oct 14 04:39:00 CST 2017, time=2017-10-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534340, encodeId=f9751534340fa, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Sat Oct 14 04:39:00 CST 2017, time=2017-10-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549200, encodeId=8cff1549200ab, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Oct 14 04:39:00 CST 2017, time=2017-10-14, status=1, ipAttribution=)]
    2017-10-14 12498c24m71暂无昵称

    #FGFR#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1851541, encodeId=b6a0185154157, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Oct 13 19:39:00 CST 2017, time=2017-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483062, encodeId=d61b148306256, content=<a href='/topic/show?id=5dcbe397d2' target=_blank style='color:#2F92EE;'>#FGFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7397, encryptionId=5dcbe397d2, topicName=FGFR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=31fb7872570, createdName=12498c24m71暂无昵称, createdTime=Sat Oct 14 04:39:00 CST 2017, time=2017-10-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534340, encodeId=f9751534340fa, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Sat Oct 14 04:39:00 CST 2017, time=2017-10-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549200, encodeId=8cff1549200ab, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Oct 14 04:39:00 CST 2017, time=2017-10-14, status=1, ipAttribution=)]
    2017-10-14 liuyiping

    #GFR#

    0

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    2017-10-14 xxxx1054

    #重磅#

    0