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步長製藥(603858.SH):流感病毒裂解疫苗獲藥品再註冊批件
格隆匯 05-18 16:54

格隆匯5月18日丨步長製藥(603858.SH)公佈,公司於近日獲悉,公司控股子公司浙江天元生物藥業有限公司(以下簡稱“浙江天元”)收到浙江省藥品監督管理局核准簽發的藥品再註冊批件。

流感病毒裂解疫苗注射劑每支0.5ml。每1次人用劑量為0.5ml(成人及3歲以上兒童)。含各型流感病毒株血凝素為15μg;及注射劑每支0.25ml。每1次人用劑量為0.25ml(6個月至3週歲兒童)。含各型流感病毒株血凝素為7.5μg。

本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。本次為公司原有產品再次註冊,產品再註冊費用為2.49萬元。

浙江天元生產的流感疫苗為三價流感疫苗。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4.82億元,2019年中國流感病毒裂解疫苗折算批簽發額為9.67億元,較2018年增長101%。

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