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我国自主研发上市的抗PD-1单抗特瑞普利单抗注射液纳入国家医保药品目录

2020-12-29 新闻稿 君实生物

君实生物宣布其研发的抗PD-1单抗药物特瑞普利单抗注射液纳入新版《国家基本医疗保险、工伤保险和生育保险药品目录(2020版)》

2020年12月28日,君实生物(1877.HK,688180.SH)宣布,由公司自主研发的抗PD-1单抗药物特瑞普利单抗注射液(拓益®)通过国家医保谈判,被纳入新版《国家基本医疗保险、工伤保险和生育保险药品目录(2020版)》乙类范围,主规格为80mg(2ml)/瓶,这也是此次新版目录中唯一用于黑色素瘤治疗的抗PD-1单抗药物。

黑色素瘤被称为“癌中之王”,是一种程度极高进展快易转移的难治性实体瘤严重威胁患者生命,长期以来缺乏有效的治疗手段。黑色素瘤对于既往标准治疗不敏感,但具有明显的肿瘤相关抗原,即肿瘤识别标志,使之成为了整个免疫治疗探索的“试金石”。2018年12月,特瑞普利单抗(拓益®)正式获得国家药品监督管理局(NMPA)的批准,用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗成为首个在我国成功上市的国产抗PD-1单抗药物,打破了我国黑色素瘤的治疗困境,并开启了中国肿瘤免疫治疗的新纪元。

特瑞普利单抗(拓益®)是由君实生物独立研发,具有全球范围内完全自主知识产权的生物制品创新药物,在“十二五”和“十三五”两次获得“重大新药创制”国家科技重大专项项目支持。目前,特瑞普利单抗(拓益®)已在中国、美国、新加坡等国开展了覆盖10多个瘤种的30多项临床试验,并在多项研究中显示出显著的疗效与良好的安全性。

 2020年,君实生物向国家药品监督管理局(NMPA)提交了特瑞普利单抗(拓益®)治疗鼻咽癌和尿路上皮癌两项新适应症上市申请并被纳入快速审评。此外,美国食品药品监督管理局(FDA)也授予特瑞普利单抗(拓益®)在黏膜黑色素瘤、鼻咽癌、软组织肉瘤治疗领域共计3项孤儿药资格认定,以及1项鼻咽癌领域的突破性疗法认定。特瑞普利单抗(拓益®)成为首个获得FDA突破性疗法认定的中国自主研发的抗PD-1单抗药物,这将有助于支持并加速其在海外的商业化开发计划。 

北京大学肿瘤医院副院长、中国临床肿瘤学会(CSCO)副理事长兼秘书长、CSCO黑色素瘤专家委员会主任委员郭军教授表示:“拓益®是我国首个自主研发的抗PD-1单抗药物,也是首个在黑色素瘤领域取得突破性进展的国产创新药物,其疗效与安全性均可媲美国际同类进口产品。当前,肿瘤免疫治疗抗PD-1单抗药物已成为针对黑色素瘤患者最基本的治疗。抗PD-1单抗药物的多种联合治疗方式在黑色素瘤领域,特别是我们亚洲常见的肢端和黏膜黑色素瘤亚型方面表现出了卓越的疗效。因此拓益®能够纳入国家医保目录,将大大减轻黑色素瘤患者的就医负担,并且使他们有更好的生存获益。”

君实生物首席执行官李宁博士表示:“非常感谢国家医保部门给予的认可。提升中国肿瘤治疗药物的可及性与可负担性是君实生物作为本土创新药企的责任。相信进入医保目录后在国家相关部门的支持下,能够进一步加速与提升肿瘤免疫治疗的可及性,同时在该治疗领域内,提高医保基金的使用效率未来君实生物继续秉持‘大人不华,君子务实’的企业精神,致力推动中国生物医药技术的进步让源源不断的本土创新成果惠及中国乃至全球患者

 

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  4. 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  5. 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  6. 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createdAvatar=https://img.medsci.cn/20220301/6252e946e5ef413b86dc0f7d1f73b6db/9a7e8c88a38e487b8da4968a67bbd261.png, createdBy=b9f692910, createdName=rayms, createdTime=Wed Dec 30 13:55:39 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=911961, encodeId=f617911961c0, content=人民的福利,造福人类。, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210104/9530cd0e9d7541e38b8f9ffee4777f85/c71bc9ddd68c4654b20bcb2ccb4eced3.jpg, createdBy=e6e32052510, createdName=ms2210656164410203, createdTime=Tue Dec 29 20:27:03 CST 2020, time=2020-12-29, status=1, ipAttribution=)]
    2020-12-31 lqvr
  7. [GetPortalCommentsPageByObjectIdResponse(id=1700586, encodeId=a4831e00586ab, content=<a href='/topic/show?id=57ef3389402' target=_blank style='color:#2F92EE;'>#医保药品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=33894, encryptionId=57ef3389402, topicName=医保药品)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=158530178542, createdName=yangjxjc, createdTime=Sun Oct 17 10:34:02 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2027425, encodeId=e355202e4252d, content=<a href='/topic/show?id=48b368e28ea' target=_blank style='color:#2F92EE;'>#瑞普利单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68728, encryptionId=48b368e28ea, topicName=瑞普利单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da20314, createdName=lfcmxl, createdTime=Fri Jul 23 13:34:02 CST 2021, time=2021-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2028920, encodeId=34bc2028920c1, content=<a href='/topic/show?id=76463619101' target=_blank style='color:#2F92EE;'>#单抗注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36191, encryptionId=76463619101, topicName=单抗注射液)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erCiat0j36p5MejdM9yCLtcVcY8WS5VIKuCMqXFNs56U6iacZib5CJvh6mVxGERicM6ZAkl91jMgpcDrw/132, createdBy=37622500012, createdName=ms2999106592497887, createdTime=Mon Jan 11 15:34:02 CST 2021, time=2021-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1672188, encodeId=a5f916e2188a4, content=<a href='/topic/show?id=177c85966dc' target=_blank style='color:#2F92EE;'>#自主研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85966, encryptionId=177c85966dc, topicName=自主研发)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d2c26890289, createdName=xlwang2700, createdTime=Sat May 15 01:34:02 CST 2021, time=2021-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1759072, encodeId=66b41e590720e, content=<a href='/topic/show?id=b0d21391250' target=_blank style='color:#2F92EE;'>#PD-1单抗特瑞普利#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13912, encryptionId=b0d21391250, topicName=PD-1单抗特瑞普利)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=238a37405712, createdName=124987e8m19暂无昵称, createdTime=Wed Sep 29 11:34:02 CST 2021, time=2021-09-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300443, encodeId=62d9130044304, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Thu Dec 31 04:34:02 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1364907, encodeId=084d136490eb5, content=<a href='/topic/show?id=da511390508' target=_blank style='color:#2F92EE;'>#PD-1单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13905, encryptionId=da511390508, topicName=PD-1单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8fc0211, createdName=doctor-chen9582, createdTime=Thu Dec 31 04:34:02 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1586598, encodeId=5268158659826, content=<a href='/topic/show?id=f87c6499085' target=_blank style='color:#2F92EE;'>#注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64990, encryptionId=f87c6499085, topicName=注射液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c93417353045, createdName=shijzhiewnjhch, createdTime=Thu Dec 31 04:34:02 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=912154, encodeId=cfa4912154b8, content=带来启发 , beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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  8. [GetPortalCommentsPageByObjectIdResponse(id=1700586, encodeId=a4831e00586ab, content=<a href='/topic/show?id=57ef3389402' target=_blank style='color:#2F92EE;'>#医保药品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=33894, encryptionId=57ef3389402, topicName=医保药品)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=158530178542, createdName=yangjxjc, createdTime=Sun Oct 17 10:34:02 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2027425, encodeId=e355202e4252d, content=<a href='/topic/show?id=48b368e28ea' target=_blank style='color:#2F92EE;'>#瑞普利单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68728, encryptionId=48b368e28ea, topicName=瑞普利单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da20314, createdName=lfcmxl, createdTime=Fri Jul 23 13:34:02 CST 2021, time=2021-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2028920, encodeId=34bc2028920c1, content=<a href='/topic/show?id=76463619101' target=_blank style='color:#2F92EE;'>#单抗注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36191, encryptionId=76463619101, topicName=单抗注射液)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erCiat0j36p5MejdM9yCLtcVcY8WS5VIKuCMqXFNs56U6iacZib5CJvh6mVxGERicM6ZAkl91jMgpcDrw/132, createdBy=37622500012, createdName=ms2999106592497887, createdTime=Mon Jan 11 15:34:02 CST 2021, time=2021-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1672188, encodeId=a5f916e2188a4, content=<a href='/topic/show?id=177c85966dc' target=_blank style='color:#2F92EE;'>#自主研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85966, encryptionId=177c85966dc, topicName=自主研发)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d2c26890289, createdName=xlwang2700, createdTime=Sat May 15 01:34:02 CST 2021, time=2021-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1759072, encodeId=66b41e590720e, content=<a href='/topic/show?id=b0d21391250' target=_blank style='color:#2F92EE;'>#PD-1单抗特瑞普利#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13912, encryptionId=b0d21391250, topicName=PD-1单抗特瑞普利)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=238a37405712, createdName=124987e8m19暂无昵称, createdTime=Wed Sep 29 11:34:02 CST 2021, time=2021-09-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300443, encodeId=62d9130044304, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Thu Dec 31 04:34:02 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1364907, encodeId=084d136490eb5, content=<a href='/topic/show?id=da511390508' target=_blank style='color:#2F92EE;'>#PD-1单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13905, encryptionId=da511390508, topicName=PD-1单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8fc0211, createdName=doctor-chen9582, createdTime=Thu Dec 31 04:34:02 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1586598, encodeId=5268158659826, content=<a href='/topic/show?id=f87c6499085' target=_blank style='color:#2F92EE;'>#注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64990, encryptionId=f87c6499085, topicName=注射液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c93417353045, createdName=shijzhiewnjhch, createdTime=Thu Dec 31 04:34:02 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=912154, encodeId=cfa4912154b8, content=带来启发 , beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220301/6252e946e5ef413b86dc0f7d1f73b6db/9a7e8c88a38e487b8da4968a67bbd261.png, createdBy=b9f692910, createdName=rayms, createdTime=Wed Dec 30 13:55:39 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=911961, encodeId=f617911961c0, content=人民的福利,造福人类。, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210104/9530cd0e9d7541e38b8f9ffee4777f85/c71bc9ddd68c4654b20bcb2ccb4eced3.jpg, createdBy=e6e32052510, createdName=ms2210656164410203, createdTime=Tue Dec 29 20:27:03 CST 2020, time=2020-12-29, status=1, ipAttribution=)]
  9. [GetPortalCommentsPageByObjectIdResponse(id=1700586, encodeId=a4831e00586ab, content=<a href='/topic/show?id=57ef3389402' target=_blank style='color:#2F92EE;'>#医保药品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=33894, encryptionId=57ef3389402, topicName=医保药品)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=158530178542, createdName=yangjxjc, createdTime=Sun Oct 17 10:34:02 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2027425, encodeId=e355202e4252d, content=<a href='/topic/show?id=48b368e28ea' target=_blank style='color:#2F92EE;'>#瑞普利单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68728, encryptionId=48b368e28ea, topicName=瑞普利单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da20314, createdName=lfcmxl, createdTime=Fri Jul 23 13:34:02 CST 2021, time=2021-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2028920, encodeId=34bc2028920c1, content=<a href='/topic/show?id=76463619101' target=_blank style='color:#2F92EE;'>#单抗注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36191, encryptionId=76463619101, topicName=单抗注射液)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erCiat0j36p5MejdM9yCLtcVcY8WS5VIKuCMqXFNs56U6iacZib5CJvh6mVxGERicM6ZAkl91jMgpcDrw/132, createdBy=37622500012, createdName=ms2999106592497887, createdTime=Mon Jan 11 15:34:02 CST 2021, time=2021-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1672188, encodeId=a5f916e2188a4, content=<a href='/topic/show?id=177c85966dc' target=_blank style='color:#2F92EE;'>#自主研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85966, encryptionId=177c85966dc, topicName=自主研发)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d2c26890289, createdName=xlwang2700, createdTime=Sat May 15 01:34:02 CST 2021, time=2021-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1759072, encodeId=66b41e590720e, content=<a href='/topic/show?id=b0d21391250' target=_blank style='color:#2F92EE;'>#PD-1单抗特瑞普利#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13912, encryptionId=b0d21391250, topicName=PD-1单抗特瑞普利)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=238a37405712, createdName=124987e8m19暂无昵称, createdTime=Wed Sep 29 11:34:02 CST 2021, time=2021-09-29, status=1, ipAttribution=), 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createdName=doctor-chen9582, createdTime=Thu Dec 31 04:34:02 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1586598, encodeId=5268158659826, content=<a href='/topic/show?id=f87c6499085' target=_blank style='color:#2F92EE;'>#注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64990, encryptionId=f87c6499085, topicName=注射液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c93417353045, createdName=shijzhiewnjhch, createdTime=Thu Dec 31 04:34:02 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=912154, encodeId=cfa4912154b8, content=带来启发 , beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220301/6252e946e5ef413b86dc0f7d1f73b6db/9a7e8c88a38e487b8da4968a67bbd261.png, createdBy=b9f692910, createdName=rayms, createdTime=Wed Dec 30 13:55:39 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=911961, encodeId=f617911961c0, content=人民的福利,造福人类。, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210104/9530cd0e9d7541e38b8f9ffee4777f85/c71bc9ddd68c4654b20bcb2ccb4eced3.jpg, createdBy=e6e32052510, createdName=ms2210656164410203, createdTime=Tue Dec 29 20:27:03 CST 2020, time=2020-12-29, status=1, ipAttribution=)]
    2020-12-30 rayms

    带来启发

    0

  10. 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    2020-12-29 ms2210656164410203

    人民的福利,造福人类。

    0

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