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中国NMPA接受PD-1 /TGF-β双功能融合蛋白临床试验的申请

2021-03-08 Allan MedSci原创

NMPAPD-1 /TGF-β双功能融合蛋白JS201
关注

JS201是君实生物使用其专有技术开发的一种双功能融合蛋白，可以同时靶向PD-1和TGF-β（转化生长因子-β）。

最近，上海君实生物科技有限公司（Junshi Biosciences）宣布其PD-1 /TGF-β双功能融合蛋白JS201注射液（JS201）的临床试验申请已被中国国家药品管理局（NMPA）接受。

JS201是君实生物使用其专有技术开发的一种双功能融合蛋白，可以同时靶向PD-1和TGF-β（转化生长因子-β）。JS201是首个获准在中国进行临床试验的靶向PD-1/TGF-β的产品。JS201可有效阻断PD-1和TGF-β的免疫抑制途径，提高肿瘤微环境中的免疫调节作用，从而增强患者免疫系统对肿瘤细胞的杀伤作用、减少免疫逃逸和耐药性的发生。

Junshi Biosciences是中国第一家获得抗PD-1单克隆抗体销售许可的中国制药公司。其针对实体瘤的人类首创抗BTLA抗体是世界上第一个被FDA和NMPA批准用于临床试验的抗体。其抗PCSK9单克隆抗体是NMPA在中国批准的第一项临床试验。2020年初，Junshi Biosciences与中国科学院微生物研究所和礼来公司共同开发了JS016，这是中国首个针对SARS-CoV-2的完全人源单克隆抗体，现已进入临床试验。

目前，Junshi Biosciences在美国（旧金山和马里兰州）和中国（上海、苏州、北京和广州）拥有2,000多名员工。

 

原始出处：

https://www.firstwordpharma.com/node/1807148?tsid=4

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1987956, encodeId=7153198e95649, content=<a href='/topic/show?id=00d88886e5e' target=_blank style='color:#2F92EE;'>#融合蛋白#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88867, encryptionId=00d88886e5e, topicName=融合蛋白)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e4137, createdName=meichuangyi, createdTime=Wed Jun 02 05:43:06 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1003407, encodeId=0c8f100340eb8, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKFGucAbiblxRaM4pguwtZW1b9ht4VM4eOCaMop2XgRhYA3YnCbDvkYqNKBrQMqfuicPfIjWq70C74w/132, createdBy=7e5a2499123, createdName=lily81713, createdTime=Wed Jul 28 19:24:08 CST 2021, time=2021-07-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1003404, encodeId=45fb1003404ca, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKFGucAbiblxRaM4pguwtZW1b9ht4VM4eOCaMop2XgRhYA3YnCbDvkYqNKBrQMqfuicPfIjWq70C74w/132, createdBy=7e5a2499123, createdName=lily81713, createdTime=Wed Jul 28 19:22:46 CST 2021, time=2021-07-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2035912, encodeId=7d47203591217, content=<a href='/topic/show?id=575c1e341a8' target=_blank style='color:#2F92EE;'>#TGF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17341, encryptionId=575c1e341a8, topicName=TGF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=56ea361, createdName=changhe713, createdTime=Tue Dec 07 15:43:06 CST 2021, time=2021-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=947131, encodeId=7d6694e1310f, content=临床试验申请的接受, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210110/e6124a4b19bc40ce8afaae096d21126b/dd778ac260c9416eb87e7d08139507f5.jpg, createdBy=4d2f5079605, createdName=科研科研科研, createdTime=Wed Mar 10 14:59:04 CST 2021, time=2021-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1441391, encodeId=049e1441391b6, content=<a href='/topic/show?id=58dd1e34591' target=_blank style='color:#2F92EE;'>#TGF-β#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17345, encryptionId=58dd1e34591, topicName=TGF-β)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=496f4824495, createdName=ms6980045490879608, createdTime=Wed Mar 10 12:43:06 CST 2021, time=2021-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525568, encodeId=49cc15255685c, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Wed Mar 10 12:43:06 CST 2021, time=2021-03-10, status=1, ipAttribution=)]
    2021-06-02 meichuangyi

    #融合蛋白#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1987956, encodeId=7153198e95649, content=<a href='/topic/show?id=00d88886e5e' target=_blank style='color:#2F92EE;'>#融合蛋白#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88867, encryptionId=00d88886e5e, topicName=融合蛋白)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e4137, createdName=meichuangyi, createdTime=Wed Jun 02 05:43:06 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1003407, encodeId=0c8f100340eb8, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKFGucAbiblxRaM4pguwtZW1b9ht4VM4eOCaMop2XgRhYA3YnCbDvkYqNKBrQMqfuicPfIjWq70C74w/132, createdBy=7e5a2499123, createdName=lily81713, createdTime=Wed Jul 28 19:24:08 CST 2021, time=2021-07-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1003404, encodeId=45fb1003404ca, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKFGucAbiblxRaM4pguwtZW1b9ht4VM4eOCaMop2XgRhYA3YnCbDvkYqNKBrQMqfuicPfIjWq70C74w/132, createdBy=7e5a2499123, createdName=lily81713, createdTime=Wed Jul 28 19:22:46 CST 2021, time=2021-07-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2035912, encodeId=7d47203591217, content=<a href='/topic/show?id=575c1e341a8' target=_blank style='color:#2F92EE;'>#TGF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17341, encryptionId=575c1e341a8, topicName=TGF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=56ea361, createdName=changhe713, createdTime=Tue Dec 07 15:43:06 CST 2021, time=2021-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=947131, encodeId=7d6694e1310f, content=临床试验申请的接受, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210110/e6124a4b19bc40ce8afaae096d21126b/dd778ac260c9416eb87e7d08139507f5.jpg, createdBy=4d2f5079605, createdName=科研科研科研, createdTime=Wed Mar 10 14:59:04 CST 2021, time=2021-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1441391, encodeId=049e1441391b6, content=<a href='/topic/show?id=58dd1e34591' target=_blank style='color:#2F92EE;'>#TGF-β#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17345, encryptionId=58dd1e34591, topicName=TGF-β)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=496f4824495, createdName=ms6980045490879608, createdTime=Wed Mar 10 12:43:06 CST 2021, time=2021-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525568, encodeId=49cc15255685c, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Wed Mar 10 12:43:06 CST 2021, time=2021-03-10, status=1, ipAttribution=)]
    2021-07-28 lily81713

    好

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1987956, encodeId=7153198e95649, content=<a href='/topic/show?id=00d88886e5e' target=_blank style='color:#2F92EE;'>#融合蛋白#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88867, encryptionId=00d88886e5e, topicName=融合蛋白)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e4137, createdName=meichuangyi, createdTime=Wed Jun 02 05:43:06 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1003407, encodeId=0c8f100340eb8, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKFGucAbiblxRaM4pguwtZW1b9ht4VM4eOCaMop2XgRhYA3YnCbDvkYqNKBrQMqfuicPfIjWq70C74w/132, createdBy=7e5a2499123, createdName=lily81713, createdTime=Wed Jul 28 19:24:08 CST 2021, time=2021-07-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1003404, encodeId=45fb1003404ca, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKFGucAbiblxRaM4pguwtZW1b9ht4VM4eOCaMop2XgRhYA3YnCbDvkYqNKBrQMqfuicPfIjWq70C74w/132, createdBy=7e5a2499123, createdName=lily81713, createdTime=Wed Jul 28 19:22:46 CST 2021, time=2021-07-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2035912, encodeId=7d47203591217, content=<a href='/topic/show?id=575c1e341a8' target=_blank style='color:#2F92EE;'>#TGF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17341, encryptionId=575c1e341a8, topicName=TGF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=56ea361, createdName=changhe713, createdTime=Tue Dec 07 15:43:06 CST 2021, time=2021-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=947131, encodeId=7d6694e1310f, content=临床试验申请的接受, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210110/e6124a4b19bc40ce8afaae096d21126b/dd778ac260c9416eb87e7d08139507f5.jpg, createdBy=4d2f5079605, createdName=科研科研科研, createdTime=Wed Mar 10 14:59:04 CST 2021, time=2021-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1441391, encodeId=049e1441391b6, content=<a href='/topic/show?id=58dd1e34591' target=_blank style='color:#2F92EE;'>#TGF-β#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17345, encryptionId=58dd1e34591, topicName=TGF-β)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=496f4824495, createdName=ms6980045490879608, createdTime=Wed Mar 10 12:43:06 CST 2021, time=2021-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525568, encodeId=49cc15255685c, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Wed Mar 10 12:43:06 CST 2021, time=2021-03-10, status=1, ipAttribution=)]
    2021-07-28 lily81713

    很好

    0

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    2021-12-07 changhe713

    #TGF#

    0

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    2021-03-10 科研科研科研

    临床试验申请的接受

    0

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    2021-03-10 ms6980045490879608

    #TGF-β#

    0

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    2021-03-10 licz0427

    #融合#

    0

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