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丽珠用于治疗女性不孕症的药物获批临床

2017-06-23 佚名 新浪医药新闻

丽珠女性不孕
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近日，健康元药业集团股份有限公司控股子公司丽珠医药集团股份有限公司下属全资子公司丽珠集团丽珠制药厂、丽珠集团丽珠医药研究所，以及控股子公司上海丽珠制药有限公司收到国家食品药品监督管理总局核准签发的《药物临床试验批件》(批件号：2017L02424)和《审批意见通知件》(批件号：2017L01719)。


近日，健康元药业集团股份有限公司控股子公司丽珠医药集团股份有限公司下属全资子公司丽珠集团丽珠制药厂、丽珠集团丽珠医药研究所，以及控股子公司上海丽珠制药有限公司收到国家食品药品监督管理总局核准签发的《药物临床试验批件》(批件号：2017L02424)和《审批意见通知件》(批件号：2017L01719)。

一、药品批件主要内容

药物名称：注射用高纯度尿促性素

剂型：注射剂

规格：75 IU FSH + 75 IU LH

申请事项：已有国家标准药品申请

注册分类：原化学药品第6类

申请人：丽珠集团丽珠制药厂

审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求，同意本品进行临床试验。

药物名称：高纯度尿促性素

剂型：原料药

申请事项：国产药品注册

注册分类：化学药品

申请人：上海丽珠制药有限公司、丽珠集团丽珠医药研究所

审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求，批准本品制剂进行临床试验。

二、药品研发及相关情况

注射用高纯度尿促性素及原料历经6年研发，是丽珠集团自主开发的原化学药3.1类(原料)+6类(制剂)。丽珠集团首次提交高纯度尿促性素原料临床试验申请获得受理的时间为2015年01月06日(受理号：CXHL1500048粤)，首次提交注射用高纯度尿促性素生产申请获得受理的时间为2015年01月04日(受理号：CYHS1500015粤)。

本产品适应症为用于治疗低促性腺激素性或正常促性腺激素性的卵巢功能不足所导致的女性不孕症。高纯度尿促性素是从天然提取的促性腺激素制剂，纯度可达到重组单组分制剂的水平，是一种高耐受性和方便使用(主要是可以皮下注射给药)的高纯度产品。

截至本日，注射用高纯尿促性素及原料累计研发投入约为人民币221.36万元。

三、同类药品市场状况

目前，辅助生殖类产品主要包括尿促性素、尿促卵泡素和绒促性素。根据IMS统计数据，以上三种产品2015年国际销售总额约为7.79亿美元，其中尿促性素市场占有率约58.15%；2016年国内销售总额约为8.86亿元，其中尿促性素市场占有率约31.96%。

根据CDE审评中心网站及咸达数据库显示，截止本公告日，国内有1家进口产品上市，没有国产厂家取得生产批件。获批临床2家(包括丽珠)，在审1家(申报进口)。

评论区 (4)
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    2017-06-30 133****4869

    学了，谢。

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=216989, encodeId=f4a521698914, content=学了，谢。, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/05/30/99bec6cc787188da3751f87718b3f54e.jpg, createdBy=86442053325, createdName=133****4869, createdTime=Fri Jun 30 07:32:42 CST 2017, time=2017-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2009646, encodeId=957a2009646d0, content=<a href='/topic/show?id=555644615f4' target=_blank style='color:#2F92EE;'>#女性不孕症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44615, encryptionId=555644615f4, topicName=女性不孕症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c77e138, createdName=kalseyzl, createdTime=Wed Aug 09 18:43:00 CST 2017, time=2017-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=214599, encodeId=faf0214599ac, content=健康元，在优秀的企业道路上。, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLCxzIqGgHGpnv0v7a7MZQHVVjxvBfHWenpTPmFhDxa6vn3qno88vft2DRqYcyUBQFCRouANp2WgxQ/0, createdBy=b35a44222, createdName=kane35, createdTime=Sat Jun 24 05:54:35 CST 2017, time=2017-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=214328, encodeId=fe1721432874, content=学习，谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyhb9xDeHojCicsdRdyC3XXdGk2ib9yLypZuHN06WeW4HO8WN0GGrgEfvnTX8gsckof05GHOU5OM4Mvx/0, createdBy=9cee1982656, createdName=执着追梦, createdTime=Fri Jun 23 09:53:32 CST 2017, time=2017-06-23, status=1, ipAttribution=)]
    2017-08-09 kalseyzl

    #女性不孕症#

    0

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    2017-06-24 kane35

    健康元，在优秀的企业道路上。

    0

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    2017-06-23 执着追梦

    学习，谢谢分享

    0