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又有3款创新药或加速上市，这个1类新药厉害了

2019-01-22 佚名 米内网

创新药优微芯生物
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日前，CDE发布新一批拟优先审评产品信息，有6个受理号(涉及3个品种，3家企业)拟纳入优先审评，有望加速上市。

据悉，3个品种均以“具有明显治疗优势”为由拟纳入优先审评。



表1：拟纳入优先审评品种

(来源：CDE官网)

深圳微芯生物科技的西达本胺片，以新药2.4的注册类型申报上市，受理号为CXHS1800033，推测适应症为乳腺癌。2014年12月，深圳微芯生物科技的西达本胺片以新药1.1申报上市并获得国家药监局批准，获批的适应症是T细胞淋巴瘤。



图1：2015-2017年中国公立医疗机构终端西达本胺片销售情况(单位：万元)

（来源：米内网中国公立医疗机构终端竞争格局）

据米内网数据，目前国内市场上市销售西达本胺片的企业仅深圳微芯生物科技一家，该公司产品自上市销售以来，销售额呈现逐年递增的态势，2018年有望突破1亿元大关。

再鼎医药的对甲苯磺酸尼拉帕利及对甲苯磺酸尼拉帕利胶囊，以新药1类申报上市并获得CDE受理承办，受理号为CXHS1800042、CXHS1800043，该产品于2017年3月在国内提交临床申请，同年7月获批临床。

对甲苯磺酸尼拉帕利是一种高效、选择性的每日一次口服小分子聚(ADP-核糖)PARP 1/2抑制剂，基于在美国和欧洲的获批，再鼎医药在香港提交Niraparib的市场注册申请，2018年10月22日，再鼎医药宣布，公司研发的1类新药对甲苯磺酸尼拉帕利胶囊(英文名Niraparib，代号ZL-2306)在香港获批上市，用于对含铂化疗完全缓解(CR)或部分缓解(PR)的铂敏感复发性高级别浆液性的上皮卵巢癌患者的治疗。

Niraparib已于2017年3月在美国获批，成为FDA批准上市的第三个PARP抑制剂，此前阿斯利康的Olaparib和Clovis的Rucaparib已经上市，用于BRCA变异复发卵巢癌的治疗。Niraparib是第一个用于维持治疗的PARP抑制剂，即用于维持处于缓解阶段的患者，且Niraparib没有BRCA变异限制，所以适用人群大于前两个PARP抑制剂；同年11月，Niraparib在欧洲获批，用于维持治疗对含铂化疗完全或部分缓解的复发性上皮卵巢癌、输卵管癌或原发性腹膜癌患者。

阿斯利康的布地奈德格隆溴铵福莫特罗吸入气雾剂，以进口2.3的注册类型提交上市申请，已获得CDE受理承办，受理号为JXHS1800033、JXHS1800034、JXHS1800035。布地奈德格隆溴铵福莫特罗吸入气雾剂由一个吸入性糖皮质激素、一个长效M受体拮抗剂以及一个长效β2受体激动剂组成，支气管扩张作用会更强。目前该三方制剂尚未在全球上市，中国有望首次批准。

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1285706, encodeId=26431285e06b3, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Thu Jan 24 13:16:00 CST 2019, time=2019-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358994, encodeId=db8a35899487, content=谢谢分享，学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Jan 23 09:03:48 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358983, encodeId=8d8635898357, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2019/01/02/f667a67c6692f1e356c51a346d5b382f.jpg, createdBy=7b7a2515105, createdName=Janeinair, createdTime=Wed Jan 23 07:29:47 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358981, encodeId=daea35898159, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Wed Jan 23 07:19:16 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358978, encodeId=ce8a3589e82c, content=谢谢了，学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=30331616752, createdName=txqjm, createdTime=Wed Jan 23 07:05:33 CST 2019, time=2019-01-23, status=1, ipAttribution=)]
    2019-01-24 lilianxiang

    #创新#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1285706, encodeId=26431285e06b3, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Thu Jan 24 13:16:00 CST 2019, time=2019-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358994, encodeId=db8a35899487, content=谢谢分享，学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Jan 23 09:03:48 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358983, encodeId=8d8635898357, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2019/01/02/f667a67c6692f1e356c51a346d5b382f.jpg, createdBy=7b7a2515105, createdName=Janeinair, createdTime=Wed Jan 23 07:29:47 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358981, encodeId=daea35898159, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Wed Jan 23 07:19:16 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358978, encodeId=ce8a3589e82c, content=谢谢了，学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=30331616752, createdName=txqjm, createdTime=Wed Jan 23 07:05:33 CST 2019, time=2019-01-23, status=1, ipAttribution=)]
    2019-01-23 明月清辉

    谢谢分享，学习了

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1285706, encodeId=26431285e06b3, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Thu Jan 24 13:16:00 CST 2019, time=2019-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358994, encodeId=db8a35899487, content=谢谢分享，学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Jan 23 09:03:48 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358983, encodeId=8d8635898357, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2019/01/02/f667a67c6692f1e356c51a346d5b382f.jpg, createdBy=7b7a2515105, createdName=Janeinair, createdTime=Wed Jan 23 07:29:47 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358981, encodeId=daea35898159, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Wed Jan 23 07:19:16 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358978, encodeId=ce8a3589e82c, content=谢谢了，学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=30331616752, createdName=txqjm, createdTime=Wed Jan 23 07:05:33 CST 2019, time=2019-01-23, status=1, ipAttribution=)]
    2019-01-23 Janeinair

    学习了

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1285706, encodeId=26431285e06b3, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Thu Jan 24 13:16:00 CST 2019, time=2019-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358994, encodeId=db8a35899487, content=谢谢分享，学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Jan 23 09:03:48 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358983, encodeId=8d8635898357, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2019/01/02/f667a67c6692f1e356c51a346d5b382f.jpg, createdBy=7b7a2515105, createdName=Janeinair, createdTime=Wed Jan 23 07:29:47 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358981, encodeId=daea35898159, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Wed Jan 23 07:19:16 CST 2019, time=2019-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=358978, encodeId=ce8a3589e82c, content=谢谢了，学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=30331616752, createdName=txqjm, createdTime=Wed Jan 23 07:05:33 CST 2019, time=2019-01-23, status=1, ipAttribution=)]
    2019-01-23 飛歌

    学习了很有用不错

    0

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    2019-01-23 txqjm

    谢谢了，学习

    0