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再鼎1.9亿美元引进再生元CD20xCD3双抗进展,已获批临床

2020-09-08 高雨杉 亿欧

亿欧大健康9月8日消息,今日CDE官网公示,再鼎医药申报的REGN1979注射液获批5项临床默示许可,适应症为“既往全身治疗后复发或难治的B细胞非霍奇金淋巴瘤(B-NHL)患者&rdquo

亿欧大健康9月8日消息,今日CDE官网公示,再鼎医药申报的REGN1979注射液获批5项临床默示许可,适应症为“既往全身治疗后复发或难治的B细胞非霍奇金淋巴瘤(B-NHL)患者”。这是该产品首次在中国获批临床。

REGN1979是再生元(Regeneron)开发的一款CD20xCD3双特异性抗体,通过再生元独有的Veloci-Bi双特异性抗体平台生成,这一技术平台能够生成与天然抗体类似的全长双特异性抗体,不但可以使用标准抗体生产技术进行制造,且具有与抗体类似的药代动力学特性。

REGN1979旨在通过与B细胞肿瘤蛋白(CD20)和免疫系统T细胞受体(CD3)结合来杀伤癌细胞。该在研产品已被美国FDA授予孤儿药资格,用于治疗弥漫性大B细胞淋巴瘤和滤泡性淋巴瘤。

据悉,今年4月,再鼎医药与再生元达成区域性战略合作,获得了REGN1979在大中华区(中国大陆、香港、澳门和台湾地区)肿瘤相关适应症的开发和独家商业化权利。此笔交易首付款和里程碑付款高达1.9亿美元。

若REGN1979在中国获批上市,再鼎医药将利用自身商业化团队推进其在协议区域内的商业化工作。除此之外,再生元还将获得未来REGN1979商业化后的部分收益。同时,再生元将负责为REGN1979在协议区域内的开发和商业化进行生产和供应。

与此同时,此项合作也将支持REGN1979的全球临床研发工作,包括目前正在进行的针对B细胞非霍奇金淋巴瘤的II期临床研究。

根据再生元在2019年第61届美国血液学会(ASH)年会上公布的数据,REGN1979在治疗多种B细胞非霍奇金淋巴瘤患者中表现出良好的效果。除REGN1979外,还有多款双特异性抗体在研药物的临床试验数据表明,它们可以在治疗难治性血液疾病,甚至是对CAR-T疗法产生耐药性的患者中产生良好的效果。 双特异性抗体或将成为CAR-T之外,血液疾病治疗领域的新突破。

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    2021-07-10 仁心济世
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    2020-09-14 刘煜

    阅读谢谢分享谢谢分享

    0

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  4. [GetPortalCommentsPageByObjectIdResponse(id=1943812, encodeId=138e194381255, content=<a href='/topic/show?id=44ca428e60' target=_blank style='color:#2F92EE;'>#CD20#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4287, encryptionId=44ca428e60, topicName=CD20)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sat Jul 10 06:16:25 CST 2021, time=2021-07-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885071, encodeId=41d98850e14b, content=阅读谢谢分享谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Mon Sep 14 06:39:34 CST 2020, time=2020-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1487257, encodeId=4be1148e25710, content=<a href='/topic/show?id=334b3e46139' target=_blank style='color:#2F92EE;'>#双抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37461, encryptionId=334b3e46139, topicName=双抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bbaa8296156, createdName=yeye5224615, createdTime=Thu Sep 10 14:16:25 CST 2020, time=2020-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883745, encodeId=40cf883e45ed, content=新突破,利好, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200923/8af58a8d80fa4d3e83e7cc9686930f6e/4638f64094bd40a4bb51a09cacaee275.jpg, createdBy=33335378595, createdName=ms9000001531324985, createdTime=Tue Sep 08 23:46:23 CST 2020, time=2020-09-08, status=1, ipAttribution=)]
    2020-09-08 ms9000001531324985

    新突破,利好

    0

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