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步長製藥(603858.SH):四價流感病毒裂解疫苗獲審批臨牀試驗
格隆匯 06-18 17:03

格隆匯6月18日丨步長製藥(603858.SH)公佈,近日,公司控股子公司浙江天元生物藥業有限公司(“浙江天元”)的產品“四價流感病毒裂解疫苗”獲得了雲南省疾病預防控制中心疫苗臨牀試驗倫理委員會倫理審查批件,啟動Ⅰ/Ⅱ期臨牀試驗。

根據我國藥品註冊相關的法律法規要求,藥物在完成臨牀試驗後,尚需經國家藥品監督管理局審評、審批通過後方可生產上市。

四價流感病毒裂解疫苗主要用於刺激機體產生抗流行性感冒病毒的免疫力,預防本毒株引起的流行性感冒。根據米內網數據統計顯示,2018年中國流感病毒裂解疫苗折算批簽發額為4.8172億元,2019年中國流感病毒裂解疫苗折算批簽發額為9.672億元。

截至該公吿日,該項目上已投入的研發費用約為3690.95萬元。

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