NMPA批准中国曲妥珠单抗生物仿制药

2020-08-20 MedSci原创 MedSci原创

曲妥珠单抗生物仿制药HLX02成为首个在欧洲获批的“中国籍”单抗生物仿制药。

复宏汉霖宣布其自主研发的曲妥珠单抗生物仿制药HLX02已获国家药品监督管理局(NMPA)的批准上市。7月27 日,HLX02(Zercepac)还获得了欧盟委员会(EC)的批准,使HLX02成为首个在欧洲获批的“中国籍”单抗生物仿制药。

HLX02的通用名称是曲妥珠单抗注射剂(150mg/瓶,不含防腐剂),可用于治疗HER2阳性早期乳腺癌、HER2阳性转移性乳腺癌和HER2阳性转移性胃癌

在HLX02的开发过程中,复宏汉霖严格遵循了NMPA和欧洲药品管理局(EMA)的生物仿制药指南,并在HLX02与赫赛汀之间进行了多次头对头比较。临床前研究、1期临床研究和全球多中心3期临床研究的结果显示,HLX02在质量、安全性和功效方面与赫赛汀高度相似。

See the source image

图片来源:复宏汉霖官网

复宏汉霖总裁张文杰先生表示:“ HLX02是复宏汉霖在利妥昔单抗仿制药后国内获批的第二个产品,也是第一个获得国际药物监管机构认可的产品。希望HLX02将使中国HER2阳性乳腺癌和胃癌患者受益。”

原始出处:

https://www.firstwordpharma.com/node/1749870?tsid=4

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1648169, encodeId=9b8f1648169af, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Thu Mar 18 21:13:51 CST 2021, time=2021-03-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=814238, encodeId=292c81423855, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Thu Aug 27 18:49:15 CST 2020, time=2020-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813270, encodeId=a5ac8132e020, content=<a href='/topic/show?id=cbef6022e4c' target=_blank style='color:#2F92EE;'>#曲妥珠单抗#</a><a href='/topic/show?id=df1269423df' target=_blank style='color:#2F92EE;'>#生物类似物#</a>,这是必然的过程, beContent=null, objectType=article, channel=null, level=null, likeNumber=202, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60227, encryptionId=cbef6022e4c, topicName=曲妥珠单抗), TopicDto(id=69423, encryptionId=df1269423df, topicName=生物类似物)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Wed Aug 26 07:44:37 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261535, encodeId=654a12615357f, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Sat Aug 22 11:13:51 CST 2020, time=2020-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412943, encodeId=c1b91412943db, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Sat Aug 22 11:13:51 CST 2020, time=2020-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585657, encodeId=b672158565e02, content=<a href='/topic/show?id=234560231be' target=_blank style='color:#2F92EE;'>#曲妥珠单抗生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60231, encryptionId=234560231be, topicName=曲妥珠单抗生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0dfb17256974, createdName=李研东, createdTime=Sat Aug 22 11:13:51 CST 2020, time=2020-08-22, status=1, ipAttribution=)]
    2020-08-27 14818eb4m67暂无昵称

    学习了

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1648169, encodeId=9b8f1648169af, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Thu Mar 18 21:13:51 CST 2021, time=2021-03-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=814238, encodeId=292c81423855, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Thu Aug 27 18:49:15 CST 2020, time=2020-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=813270, encodeId=a5ac8132e020, content=<a href='/topic/show?id=cbef6022e4c' target=_blank style='color:#2F92EE;'>#曲妥珠单抗#</a><a href='/topic/show?id=df1269423df' target=_blank style='color:#2F92EE;'>#生物类似物#</a>,这是必然的过程, beContent=null, objectType=article, channel=null, level=null, likeNumber=202, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60227, encryptionId=cbef6022e4c, topicName=曲妥珠单抗), TopicDto(id=69423, encryptionId=df1269423df, topicName=生物类似物)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Wed Aug 26 07:44:37 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261535, encodeId=654a12615357f, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Sat Aug 22 11:13:51 CST 2020, time=2020-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412943, encodeId=c1b91412943db, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Sat Aug 22 11:13:51 CST 2020, time=2020-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585657, encodeId=b672158565e02, content=<a href='/topic/show?id=234560231be' target=_blank style='color:#2F92EE;'>#曲妥珠单抗生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60231, encryptionId=234560231be, topicName=曲妥珠单抗生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0dfb17256974, createdName=李研东, createdTime=Sat Aug 22 11:13:51 CST 2020, time=2020-08-22, status=1, ipAttribution=)]
    2020-08-26 lovetcm

    #曲妥珠单抗##生物类似物#,这是必然的过程

    0

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    2020-08-22 drwjr
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