抗PD-1单抗药物“派安普利”III期临床试验中期显示优异结果

2021-03-07 中国新闻网中国新闻网

中国生物制药有限公司近日宣布，该集团与康方生物科技(开曼)有限公司共同开发的抗PD-1单抗药物“派安普利”联合化疗一线治疗鳞状非小细胞肺癌患者的III期临床试验的中期分析显示出

中国生物制药有限公司近日宣布，该集团与康方生物科技(开曼)有限公司共同开发的抗PD-1单抗药物“派安普利”联合化疗一线治疗鳞状非小细胞肺癌患者的III期临床试验的中期分析显示出优异结果，达到预期的客观缓解率主要研究终点。该项临床试验的安全性数据与已知风险相符，未出现新的安全性问题。

当前，肺癌是中国发病率和死亡率均排名第一的恶性肿瘤，在所有肺癌中，非小细胞肺腺癌约占总数的80%。本次研究中期分析结果经独立数据审核委员会(IDMC)审核，其结果显示，派安普利单抗联合紫杉醇和卡铂对比安慰剂联合紫杉醇和卡铂，可显着降低疾病进展或死亡风险，主要研究终点达到方案预设的优效界值，安全性特征与既往报道的派安普利单抗研究结果一致，无新的安全性问题。详细研究结果将在后续的学术会议上予以公布。

派安普利的Fc受体和补体介导效用功能通过Fc区突变而完全去除，与国外已上市的PD-1抗体相比，抗原结合解离速率较慢。这些特点使得派安普利能够更有效地阻断PD-1通路活性，并维持更强的T细胞抗肿瘤活性，有望成为临床获益更好的抗PD-1药物。

派安普利单抗由康方生物与中国生物制药有限公司(1177.HK)旗下正大天晴药业集团股份有限公司所设立的合营企业共同开发及商业化。目前派安普利布局的主要适应症包括肝癌、胃癌、肺癌等疾病，同时开展多项联合正大天晴现有的拳头产品安罗替尼在多个瘤种的临床试验。

国家药品监督管理局已于2020年5月受理派安普利单抗用于治疗至少经过二线系统化疗复发或难治性经典型霍奇金淋巴瘤(r/rcHL)的新药上市申请。派安普利三线治疗转移性鼻咽癌注册性临床试验亦达到主要终点。

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2022-02-11 839640778

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2021-07-18 12498636m59(暂无昵称)

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2021-12-26 医生2402

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encodeId=5b3315880e53d, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Mon Mar 08 14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594868, encodeId=e42c1594868b4, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Mon Mar 08 14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=)]
2021-06-23 juliusluan78

#III#

73 0
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encodeId=5b3315880e53d, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Mon Mar 08 14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594868, encodeId=e42c1594868b4, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Mon Mar 08 14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=)]
2022-01-10 kksonne

#II期临床试验#

86 0
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encodeId=5b3315880e53d, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Mon Mar 08 14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594868, encodeId=e42c1594868b4, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Mon Mar 08 14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=)]
2021-03-08 doctor-chen9582

#PD-1单抗#

122 0
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encodeId=5b3315880e53d, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Mon Mar 08 14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594868, encodeId=e42c1594868b4, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Mon Mar 08 14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=)]
2021-03-08 guihongzh

#II期临床#

70 0
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14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=)]
2021-03-08 guihongzh

#III期临床试验#

81 0
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14:33:27 CST 2021, time=2021-03-08, status=1, ipAttribution=)]
2021-03-08 智智灵药

#III期#

68 0

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抗PD-1单抗药物“派安普利”III期临床试验中期显示优异结果

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