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中关村(000931.SZ)盐酸羟考酮注射液化学药品4类注册申报收到国家药监局《受理通知书》
格隆汇 08-16 17:32

格隆汇8月16日丨中关村(000931.SZ)公布,近日,公司全资子公司北京中关村四环医药开发有限责任公司之控股子公司北京华素制药股份有限公司(华素制药)收到国家药品监督管理局(国家药监局)签发的《受理通知书》,华素制药研发的盐酸羟考酮注射液按照化学药品4类进行注册申报。

药品名称为盐酸羟考酮注射液;剂型为注射剂;制剂规格为1ml:10mg;2ml:20mg;注册分类为化学药品4类。

2019年07月26日,华素制药向国家药监局递交了盐酸羟考酮注射液化学药品4类注册申报。该品为强效镇痛药,用于治疗中度至重度急性疼痛,包括手术后引起的中度至重度疼痛,以及需要使用强阿片类药物治疗的重度疼痛。

盐酸羟考酮注射液由萌蒂制药研发,最早于2004年在荷兰上市,同年在瑞典上市;2012在日本上市,2013年在中国上市销售。2018年国内销售额为3.8亿元,且目前尚未有国内生产厂家获批上市。

华素制药研发的盐酸羟考酮注射液按照化学药品4类(仿制境内已上市原研药品的药品)进行注册申报,并于2019年8月13日获得国家药监局签发的《受理通知书》。

截止公告日,盐酸羟考酮注射液项目已累计投入研发费用逾139万元。

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