步長製藥(603858.SH):四價流感病毒裂解疫苗獲批臨牀試驗
格隆匯 12 月 31日丨步長製藥(603858.SH)公佈,公司控股子公司浙江天元生物藥業有限公司近日收到國家藥品監督管理局核准簽發的關於四價流感病毒裂解疫苗的《藥物臨牀試驗批准通知書》。
根據《中華人民共和國藥品管理法》、《中華人民共和國疫苗管理法》及有關規定,經審查,2020年9月30日受理的四價流感病毒裂解疫苗符合藥品註冊的有關要求,同意開展預防當年度流行的四型流感病毒引起的流行性感冒的臨牀試驗。
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48172萬元,2019年中國流感病毒裂解疫苗折算批簽發額為96720萬元,較2018年增長101%。
截至目前,該產品累計已投入研發費用約為3381.37萬元。
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