再鼎医药的PARP抑制剂Niraparib用于卵巢癌维持治疗,获得NMPA授予优先审查

2020-04-18 MedSci原创 MedSci原创

再鼎医药宣布,国家药品监督管理局(NMPA)为其PARP抑制剂Niraparib的补充新药申请(sNDA)授予优先审查地位。

再鼎医药(Zai Lab)宣布,国家药品监督管理局(NMPA)已为其PARP抑制剂ZEJULA(Niraparib,尼拉帕利)的补充新药申请(sNDA)授予优先审查地位,用作对铂类一线化疗后部分或完全应答的晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者的维持治疗。

卵巢癌是中国最常见的妇科癌症之一,每年新诊断病例超过52000例,死亡23000例。尽管铂类化疗可有效诱导卵巢癌的初始反应,但大多数女性患者仍然会复发。Niraparib可延长铂类药物治疗后的反应持续时间并延缓卵巢癌的复发,从而使卵巢癌患者受益。

再鼎医药正在中国卵巢癌患者中进行一线和二线维持疗法的关键研究。还完成了尼拉帕利在中国卵巢癌患者中的1期药代动力学(PK)研究,结果于2019年8月发表在The Oncologist杂志上。

再鼎医药是从葛兰素史克公司获取了Niraparib在中国大陆、香港和澳门的许可权。针对复发性卵巢癌的NDA于2018年12月被NMPA接受,于2019年1月获得优先审查,并于2019年12月获得批准。

原始出处:

https://www.firstwordpharma.com/node/1716395?tsid=4

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    2020-12-09 jklm09
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topicList=[TopicDto(id=30710, encryptionId=226d30e1046, topicName=再鼎医药)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTI5PdY90y5Jib8FnPhCXTR2d9v3K17epNSwB2eb0vmXUldNJl2e72S4unZTAHLAojicdVSialTDFHAxA/132, createdBy=78d82500042, createdName=ms7514935887898259, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400158, encodeId=5ac814001588f, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410013, encodeId=a4b61410013b4, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1488603, encodeId=589c14886032f, content=<a href='/topic/show?id=1f611289363' target=_blank style='color:#2F92EE;'>#NMPA授予优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12893, encryptionId=1f611289363, topicName=NMPA授予优先审查)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3a698448997, createdName=lmm400, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581381, encodeId=6486158138123, content=<a href='/topic/show?id=8d991281805' target=_blank style='color:#2F92EE;'>#Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12818, encryptionId=8d991281805, topicName=Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=855416780985, createdName=12498bb3m95(暂无昵称), createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621361, encodeId=60f01621361e6, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fd4d20248280, createdName=lishiwen, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1715628, encodeId=5e311e15628f4, content=<a href='/topic/show?id=d4c513e6337' target=_blank style='color:#2F92EE;'>#PARP抑制剂Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13763, encryptionId=d4c513e6337, topicName=PARP抑制剂Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d54031982059, createdName=ms1260584454294838, createdTime=Sun Jun 28 20:32:46 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852335, encodeId=323b18523355e, 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=27, 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=Wed Dec 09 07:32:46 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338213, encodeId=191a13382134a, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1389626, encodeId=e1a313896266e, content=<a href='/topic/show?id=226d30e1046' target=_blank style='color:#2F92EE;'>#再鼎医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30710, encryptionId=226d30e1046, topicName=再鼎医药)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTI5PdY90y5Jib8FnPhCXTR2d9v3K17epNSwB2eb0vmXUldNJl2e72S4unZTAHLAojicdVSialTDFHAxA/132, createdBy=78d82500042, createdName=ms7514935887898259, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400158, encodeId=5ac814001588f, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410013, encodeId=a4b61410013b4, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1488603, encodeId=589c14886032f, content=<a href='/topic/show?id=1f611289363' target=_blank style='color:#2F92EE;'>#NMPA授予优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12893, encryptionId=1f611289363, topicName=NMPA授予优先审查)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3a698448997, createdName=lmm400, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581381, encodeId=6486158138123, content=<a href='/topic/show?id=8d991281805' target=_blank style='color:#2F92EE;'>#Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12818, encryptionId=8d991281805, topicName=Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=855416780985, createdName=12498bb3m95(暂无昵称), createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621361, encodeId=60f01621361e6, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fd4d20248280, createdName=lishiwen, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1715628, encodeId=5e311e15628f4, content=<a href='/topic/show?id=d4c513e6337' target=_blank style='color:#2F92EE;'>#PARP抑制剂Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13763, encryptionId=d4c513e6337, topicName=PARP抑制剂Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d54031982059, createdName=ms1260584454294838, createdTime=Sun Jun 28 20:32:46 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852335, encodeId=323b18523355e, 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=27, 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=Wed Dec 09 07:32:46 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338213, encodeId=191a13382134a, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1389626, encodeId=e1a313896266e, content=<a href='/topic/show?id=226d30e1046' target=_blank style='color:#2F92EE;'>#再鼎医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30710, encryptionId=226d30e1046, topicName=再鼎医药)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTI5PdY90y5Jib8FnPhCXTR2d9v3K17epNSwB2eb0vmXUldNJl2e72S4unZTAHLAojicdVSialTDFHAxA/132, createdBy=78d82500042, createdName=ms7514935887898259, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400158, encodeId=5ac814001588f, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410013, encodeId=a4b61410013b4, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1488603, encodeId=589c14886032f, content=<a href='/topic/show?id=1f611289363' target=_blank style='color:#2F92EE;'>#NMPA授予优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12893, encryptionId=1f611289363, topicName=NMPA授予优先审查)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3a698448997, createdName=lmm400, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581381, encodeId=6486158138123, content=<a href='/topic/show?id=8d991281805' target=_blank style='color:#2F92EE;'>#Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12818, encryptionId=8d991281805, topicName=Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=855416780985, createdName=12498bb3m95(暂无昵称), createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621361, encodeId=60f01621361e6, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fd4d20248280, createdName=lishiwen, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=)]
    2020-04-20 cathymary
  7. [GetPortalCommentsPageByObjectIdResponse(id=1715628, encodeId=5e311e15628f4, content=<a href='/topic/show?id=d4c513e6337' target=_blank style='color:#2F92EE;'>#PARP抑制剂Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13763, encryptionId=d4c513e6337, topicName=PARP抑制剂Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d54031982059, createdName=ms1260584454294838, createdTime=Sun Jun 28 20:32:46 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852335, encodeId=323b18523355e, 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=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, 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GetPortalCommentsPageByObjectIdResponse(id=1410013, encodeId=a4b61410013b4, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1488603, encodeId=589c14886032f, content=<a href='/topic/show?id=1f611289363' target=_blank style='color:#2F92EE;'>#NMPA授予优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12893, encryptionId=1f611289363, topicName=NMPA授予优先审查)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3a698448997, createdName=lmm400, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581381, encodeId=6486158138123, content=<a href='/topic/show?id=8d991281805' target=_blank style='color:#2F92EE;'>#Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12818, encryptionId=8d991281805, topicName=Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=855416780985, createdName=12498bb3m95(暂无昵称), createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621361, encodeId=60f01621361e6, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fd4d20248280, createdName=lishiwen, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=)]
  8. 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  9. 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createdBy=3a698448997, createdName=lmm400, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581381, encodeId=6486158138123, content=<a href='/topic/show?id=8d991281805' target=_blank style='color:#2F92EE;'>#Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12818, encryptionId=8d991281805, topicName=Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=855416780985, createdName=12498bb3m95(暂无昵称), createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621361, encodeId=60f01621361e6, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fd4d20248280, createdName=lishiwen, createdTime=Mon Apr 20 01:32:46 CST 2020, time=2020-04-20, status=1, ipAttribution=)]
    2020-04-20 lishiwen

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