FDA批准抗肿瘤药物PI3Kα抑制剂CYH33临床试验

2020-06-26 网络 网络

2018年1月,中国科学院上海药物研究所和上海海和药物研究开发有限公司共同研发的抗肿瘤1类新药CYH33,获得国家食品药品监督管理总局颁发的临床试验批件,获批开展临床试验。上海药物所研究人员历时3年多

2018年1月,中国科学院上海药物研究所和上海海和药物研究开发有限公司共同研发的抗肿瘤1类新药CYH33,获得国家食品药品监督管理总局颁发的临床试验批件,获批开展临床试验。上海药物所研究人员历时3年多,合理设计、合成与筛选了上千个化合物,最终确定候选药物CYH33;CYH33是结构独特的全新化学分子实体,为PI3Ka高选择性高活性抑制剂,已获得中国、美国、日本以及加拿大等国专利授权。

临床前研究显示,CYH33体内外抗肿瘤活性显著优于国际上进展前列的同类抑制剂,尤其对中国人种特色肿瘤表现出优异的抑制活性。

2018年,上海海和生物制药有限公司(以下简称“海和生物”)宣布,公司开发的1类创新药物CYH33近日完成首例肿瘤患者给药。海和生物CEO董瑞平博士表示:“我们非常高兴CYH33项目完成首例肿瘤患者给药,这是一个很好的开端。我们将尽全力推进独特生物标记物指导下的临床开发,争取该新药早日通过临床研究的各个阶段,获批上市,惠及中国及世界的肿瘤患者。”

上海药物研究所与海和生物联合研发的磷脂肌醇3-激酶(PI3K)α抑制剂CYH33已于近日获得美国食品药品监督管理局(FDA)的临床试验默示许可(IND),拟用于治疗晚期实体肿瘤。 

PI3K 信号通路失调涉及绝大多数人类癌症,PIK3CA(编码PI3K 催化亚单位α)是人类肿瘤中常见的突变致癌基因之一,约2-5%的人类实体肿瘤中存在癌基因 PIK3CA 的突变,涉及肿瘤类型如乳腺癌卵巢癌结肠癌、成胶质细胞瘤、肺癌和食管癌等。

CYH33是上海药物所与海和生物共同研究开发的一种新型、高效、特异性的PI3Kα抑制剂,通过抑制PI3K介导的信号通路,阻滞细胞于G1 期,从而抑制肿瘤细胞增殖。上海药物所杨春皓课题组利用自身发展的合成方法学,首次将药物化学优势结构吡咯并三嗪母核引入PI3K抑制剂的研究中,通过系统的构效关系研究,与丁健院士团队通力协作发现了候选药物CYH33。临床前研究表明,CYH33体内外活性优于同类已上市药物BYL719。  

CYH33已开展的临床研究表明,化合物具有良好的安全性和初步临床疗效。目前国内未有选择性PI3Kα抑制剂获批上市。

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    2020-12-17 bugit
  3. 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    2021-01-18 jklm09
  4. [GetPortalCommentsPageByObjectIdResponse(id=1751720, encodeId=cebf1e517201d, content=<a href='/topic/show?id=4fb514244f6' target=_blank style='color:#2F92EE;'>#PI3Kα抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14244, encryptionId=4fb514244f6, topicName=PI3Kα抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b0136383864, createdName=zhangyxzsh, createdTime=Sat Dec 19 08:55:36 CST 2020, time=2020-12-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839837, encodeId=ed2e183983e3d, 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=44, 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=Thu Dec 17 12:55:36 CST 2020, time=2020-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852419, encodeId=6be9185241977, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Mon Jan 18 01:55:36 CST 2021, time=2021-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=801862, encodeId=3b4380186252, content=了解一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Thu Jul 09 17:03:50 CST 2020, time=2020-07-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1333235, encodeId=e34813332358f, content=<a href='/topic/show?id=ecfa1423117' target=_blank style='color:#2F92EE;'>#PI3K#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14231, encryptionId=ecfa1423117, topicName=PI3K)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/BF4BC9769C2FF12AC93CAA0069C0696C/100, createdBy=7bb22500091, createdName=ms1292405679162969, createdTime=Sun Jun 28 05:55:36 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1446804, encodeId=7ad0144680480, content=<a href='/topic/show?id=94bd830865e' target=_blank style='color:#2F92EE;'>#肿瘤药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83086, encryptionId=94bd830865e, topicName=肿瘤药物)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKneTxOtx0KRAPibib3sfmib4P2269UG6op6ZN5ZKddPvUibR7RfFob8X6FicRugoeY8Dicy4cibArjj168Q/132, createdBy=c17d5287383, createdName=smartjoy, createdTime=Sun Jun 28 05:55:36 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1537744, encodeId=e23e153e74456, content=<a href='/topic/show?id=1f9983082fa' target=_blank style='color:#2F92EE;'>#肿瘤药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83082, encryptionId=1f9983082fa, topicName=肿瘤药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ed1012894470, createdName=30397608, createdTime=Sun Jun 28 05:55:36 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1593720, encodeId=c3991593e200c, content=<a href='/topic/show?id=ff895565586' target=_blank style='color:#2F92EE;'>#抗肿瘤药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55655, encryptionId=ff895565586, topicName=抗肿瘤药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=aa5e18156549, createdName=zhu_jun9843, createdTime=Sun Jun 28 05:55:36 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=800038, encodeId=fc6a800038a1, content=了解一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Jun 27 19:44:17 CST 2020, time=2020-06-27, status=1, ipAttribution=)]
    2020-07-09 wxl882001

    了解一下

    0

  5. 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createdBy=30bd35, createdName=bugit, createdTime=Thu Dec 17 12:55:36 CST 2020, time=2020-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852419, encodeId=6be9185241977, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Mon Jan 18 01:55:36 CST 2021, time=2021-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=801862, encodeId=3b4380186252, content=了解一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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content=<a href='/topic/show?id=94bd830865e' target=_blank style='color:#2F92EE;'>#肿瘤药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83086, encryptionId=94bd830865e, topicName=肿瘤药物)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKneTxOtx0KRAPibib3sfmib4P2269UG6op6ZN5ZKddPvUibR7RfFob8X6FicRugoeY8Dicy4cibArjj168Q/132, createdBy=c17d5287383, createdName=smartjoy, createdTime=Sun Jun 28 05:55:36 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1537744, encodeId=e23e153e74456, content=<a href='/topic/show?id=1f9983082fa' target=_blank style='color:#2F92EE;'>#肿瘤药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83082, encryptionId=1f9983082fa, topicName=肿瘤药)], attachment=null, 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authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Jun 27 19:44:17 CST 2020, time=2020-06-27, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1751720, encodeId=cebf1e517201d, content=<a href='/topic/show?id=4fb514244f6' target=_blank style='color:#2F92EE;'>#PI3Kα抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14244, encryptionId=4fb514244f6, topicName=PI3Kα抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b0136383864, createdName=zhangyxzsh, createdTime=Sat Dec 19 08:55:36 CST 2020, time=2020-12-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839837, encodeId=ed2e183983e3d, 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=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, 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content=<a href='/topic/show?id=94bd830865e' target=_blank style='color:#2F92EE;'>#肿瘤药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83086, encryptionId=94bd830865e, topicName=肿瘤药物)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKneTxOtx0KRAPibib3sfmib4P2269UG6op6ZN5ZKddPvUibR7RfFob8X6FicRugoeY8Dicy4cibArjj168Q/132, createdBy=c17d5287383, createdName=smartjoy, createdTime=Sun Jun 28 05:55:36 CST 2020, time=2020-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1537744, encodeId=e23e153e74456, content=<a href='/topic/show?id=1f9983082fa' target=_blank style='color:#2F92EE;'>#肿瘤药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83082, encryptionId=1f9983082fa, topicName=肿瘤药)], attachment=null, 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authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Jun 27 19:44:17 CST 2020, time=2020-06-27, status=1, ipAttribution=)]
  7. 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  8. 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    2020-06-27 wxl882001

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