山东新华制药股份现涨超3% 近日二十碳五烯酸乙酯软胶囊药品注册获批

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09 Jun
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  山东新华制药股份(00719)早盘股价上涨3.27%,现报6.31港元,成交额3170.07万港元。

  山东新华制药股份发布公告,近日,山东新华制药股份有限公司(“新华制药”或“本公司”)收到国家药品监督管理局核准签发的二十碳五烯酸乙酯软胶囊(以下简称“本品”)《药品注册证书》。2023年11月,新华制药向国家药品监督管理局药品审评中心(CDE)递交二十碳五烯酸乙酯软胶囊上市许可注册申报资料并获受理,2025年6月获得《药品注册证书》,审评结论为批准注册。

  据行业数据显示,2023年二十碳五烯酸乙酯制剂的全球销售额已突破18.38亿美元。新华制药此次产品获批将有效补充公司在心脑血管药物领域的管线布局。

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