诺华的长效化重组人粒细胞集落刺激因子生物仿制药Ziextenzo获得FDA批准上市

2019-11-06 不详 MedSci原创

诺华的Sandoz部门星期二宣布,FDA已经批准了Amgen的聚乙二醇化重组人粒细胞集落刺激因子Neulasta(pegfilgrastim)的生物仿制药Ziextenzo(pegfilgrastim-bmez),并计划"在今年尽快"在美国推出该药物。Ziextenzo在欧洲于2018年获批,用于减少接受骨髓抑制抗癌药物的非骨髓恶性肿瘤患者的发热性中性粒细胞减少症。

诺华的Sandoz部门星期二宣布,FDA已经批准了Amgen的聚乙二醇化重组人粒细胞集落刺激因子Neulasta(pegfilgrastim)生物仿制药Ziextenzo(pegfilgrastim-bmez),并计划"在今年尽快"在美国推出该药物。Ziextenzo在欧洲于2018年获批,用于减少接受骨髓抑制抗癌药物的非骨髓恶性肿瘤患者的发热性中性粒细胞减少症。

诺华指出,随着Ziextenzo的这一最新批准,Sandoz将成为唯一一个在美国同时提供长效和短效filgrastim生物仿制药的公司。

Sandoz总裁卡罗尔·林奇(Carol Lynch)表示,该批准"扩大了我们的肿瘤学产品组合,为医师提供了长期有效的肿瘤生物仿制药选择。"

同时,Amgen最近报告称,Neulasta在第三季度的销售额为7.11亿美元,较去年同期下降32%,部分原因是生物仿制药的竞争。

原始出处:


本文系梅斯医学(MedSci)原创编译整理,转载需授权!

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1815095, encodeId=5af61815095dc, content=<a href='/topic/show?id=417c9693209' target=_blank style='color:#2F92EE;'>#长效化重组人粒细胞集落刺激因子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96932, encryptionId=417c9693209, topicName=长效化重组人粒细胞集落刺激因子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e452500029, createdName=12498568m50暂无昵称, createdTime=Sat Dec 21 03:42:00 CST 2019, time=2019-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839740, encodeId=e4f51839e40d9, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Apr 21 13:42:00 CST 2020, time=2020-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261514, encodeId=f66d1261514f3, 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=42, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282777, encodeId=fbbb1282e77bb, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412938, encodeId=b36014129382c, 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=40, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1815095, encodeId=5af61815095dc, content=<a href='/topic/show?id=417c9693209' target=_blank style='color:#2F92EE;'>#长效化重组人粒细胞集落刺激因子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96932, encryptionId=417c9693209, topicName=长效化重组人粒细胞集落刺激因子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e452500029, createdName=12498568m50暂无昵称, createdTime=Sat Dec 21 03:42:00 CST 2019, time=2019-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839740, encodeId=e4f51839e40d9, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Apr 21 13:42:00 CST 2020, time=2020-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261514, encodeId=f66d1261514f3, 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=42, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282777, encodeId=fbbb1282e77bb, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412938, encodeId=b36014129382c, 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=40, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
    2020-04-21 bugit
  3. [GetPortalCommentsPageByObjectIdResponse(id=1815095, encodeId=5af61815095dc, content=<a href='/topic/show?id=417c9693209' target=_blank style='color:#2F92EE;'>#长效化重组人粒细胞集落刺激因子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96932, encryptionId=417c9693209, topicName=长效化重组人粒细胞集落刺激因子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e452500029, createdName=12498568m50暂无昵称, createdTime=Sat Dec 21 03:42:00 CST 2019, time=2019-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839740, encodeId=e4f51839e40d9, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Apr 21 13:42:00 CST 2020, time=2020-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261514, encodeId=f66d1261514f3, 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=42, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282777, encodeId=fbbb1282e77bb, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412938, encodeId=b36014129382c, 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=40, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
    2019-11-08 drwjr
  4. [GetPortalCommentsPageByObjectIdResponse(id=1815095, encodeId=5af61815095dc, content=<a href='/topic/show?id=417c9693209' target=_blank style='color:#2F92EE;'>#长效化重组人粒细胞集落刺激因子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96932, encryptionId=417c9693209, topicName=长效化重组人粒细胞集落刺激因子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e452500029, createdName=12498568m50暂无昵称, createdTime=Sat Dec 21 03:42:00 CST 2019, time=2019-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839740, encodeId=e4f51839e40d9, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Apr 21 13:42:00 CST 2020, time=2020-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261514, encodeId=f66d1261514f3, 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=42, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282777, encodeId=fbbb1282e77bb, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412938, encodeId=b36014129382c, 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=40, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1815095, encodeId=5af61815095dc, content=<a href='/topic/show?id=417c9693209' target=_blank style='color:#2F92EE;'>#长效化重组人粒细胞集落刺激因子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96932, encryptionId=417c9693209, topicName=长效化重组人粒细胞集落刺激因子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e452500029, createdName=12498568m50暂无昵称, createdTime=Sat Dec 21 03:42:00 CST 2019, time=2019-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839740, encodeId=e4f51839e40d9, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Apr 21 13:42:00 CST 2020, time=2020-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261514, encodeId=f66d1261514f3, 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=42, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282777, encodeId=fbbb1282e77bb, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412938, encodeId=b36014129382c, 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=40, 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=Fri Nov 08 04:42:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]

相关资讯

2019年全球OTC市场全解析

2018年,非处方药(OTC)行业见证了不少大型并购交易的进行,包括葛兰素史克(GSK)以130亿美元,收购了诺华在双方的消费者医疗合资公司中36.5%的股份;辉瑞和GSK合资,成立全球最大的OTC企业;宝洁斥资约34亿欧元(42亿美元)收购默克集团的消费者健康业务。这些并购活动为交易双方注入新的活力,也给予行业发展新的想象空间。

诺华的新型IgE单抗Ligelizumab在自发性荨麻疹试验中胜过奥马珠单抗

诺华(Novartis)宣布了IIb期剂量研究的结果,该研究发现与300 mg的Xolair(奥马珠单抗)相比,使用Ligelizumab(QGE031)治疗的慢性自发性荨麻疹患者症状效果更加显着。

诺华的IL-17A单抗Cosentyx治疗非放射线轴性脊柱关节炎的III期临床成功

​诺华公司公布了其IL-17A单抗Cosentyx(secukinumab)更多的阳性3期数据,这次是用于治疗非放射线轴性脊柱关节炎(nr-axSpA)患者。

诺华宣布其联合疗法QVM149和QMF149针对不受控的哮喘病患者III期阳性结果

​诺华宣布,在不受控制的哮喘中,其联合疗法QVM149(醋酸茚达特罗/溴化吡格隆溴铵/糠酸莫米松)和QMF149(醋酸茚达特罗/糠酸莫米松)联合疗法在III期均喜获阳性结果。

诺华与微软达成协议,使用人工智能加速药物开发

诺华制药近日宣布,与微软达成了一项为期多年的协议,以利用人工智能(AI)增强其研究工作并加快发现和开发新型治疗手段。

银屑病关节炎头对头实验中,诺华的IL-17单抗Cosentyx与Humira相比未能实现统计学意义的改善

在银屑病关节炎(PsA)的头对头试验中,诺华的白细胞介素-17单抗Cosentyx(secukinumab)未能显示出超过AbbVie的Humira(adalimumab)的显着优势。尽管Cosentyx与Humira相比显示出更高的结果,但勉强错过了EXCEED试验主要终点,即ACR 20具有统计学意义的优越性。