Toripalimab联合化学疗法一线治疗鼻咽癌,中国国家药品监督管理局已批准其补充性新药申请

2021-02-20 Allan MedSci原创

中国国家药品监督管理局(NMPA)已接受Toripalimab联合化疗一线治疗复发性或转移性鼻咽癌的补充性新药申请。

鼻咽癌是一种发生于鼻咽腔或上咽喉部的癌症。在世界的某些地区,例如东南亚和非洲,患此病的人比其他地方多,过去认为是主要是膳食的影响,目前倾向为遗传基因为主要的影响因素。

中国制药公司君实生物近日宣布,中国国家药品监督管理局(NMPA)已接受Toripalimab联合化疗一线治疗复发性或转移性鼻咽癌的补充性新药申请。

这项批准是基于JUPITER-02研究(NCT03581786)的最新结果,该研究是一项随机、双盲、安慰剂对照的III期研究。研究结果表明,与标准的吉西他滨/顺铂一线疗法相比,Toripalimab单抗联合吉西他滨/顺铂一线治疗复发或转移性鼻咽癌患者时,显著延长了患者的无进展生存期(PFS)。

先前,Toripalimab已从美国FDA获得了治疗鼻咽癌的“突破性疗法称号”和“孤儿药称号”,君实生物也将在美国提交生物制剂许可申请(BLA)。Toripalimab可能会成为首个在海外市场实现商业化的中国抗PD-1单克隆抗体。

 

原始出处:

https://www.firstwordpharma.com/node/1802285?tsid=4

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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926102, encodeId=9ef392610257, content=已读,受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f03a5433387, createdName=ms5000000518166734, createdTime=Sun Feb 21 13:15:46 CST 2021, time=2021-02-21, status=1, ipAttribution=)]
    2021-07-23 吴牡丽

    学习了

    0

  5. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926102, encodeId=9ef392610257, content=已读,受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f03a5433387, createdName=ms5000000518166734, createdTime=Sun Feb 21 13:15:46 CST 2021, time=2021-02-21, status=1, ipAttribution=)]
    2021-04-26 小小医者
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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926102, encodeId=9ef392610257, content=已读,受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f03a5433387, createdName=ms5000000518166734, createdTime=Sun Feb 21 13:15:46 CST 2021, time=2021-02-21, status=1, ipAttribution=)]
    2021-09-19 snf701207
  8. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926102, encodeId=9ef392610257, content=已读,受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f03a5433387, createdName=ms5000000518166734, createdTime=Sun Feb 21 13:15:46 CST 2021, time=2021-02-21, status=1, ipAttribution=)]
    2021-02-22 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

  9. 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  10. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=926102, encodeId=9ef392610257, content=已读,受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f03a5433387, createdName=ms5000000518166734, createdTime=Sun Feb 21 13:15:46 CST 2021, time=2021-02-21, status=1, ipAttribution=)]
    2021-02-21 ms5000000518166734

    已读,受益匪浅

    0

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