華納藥廠(688799.SH):化學原料藥溴夫定的上市申請獲批
格隆匯5月7日丨華納藥廠(688799.SH)公佈,近日,公司全資子公司湖南華納大藥廠手性藥物有限公司收到國家藥品監督管理局簽發的溴夫定(受理號:CYHS2160503)《化學原料藥上市申請批准通知書》,並在國家藥品監督管理局藥品審評中心(CDE)“原料藥、藥用輔料和藥包材登記信息公示”平台公示。
溴夫定是一種與核苷極為相似的物質,可以抑制水痘-帶狀皰疹(VZV)的複製。在病毒感染的細胞中,溴夫定進行一系列的磷酸化,在細胞內的磷酸轉化過程由病毒胸苷激酶催化,最終形成溴夫定三磷酸鹽,其可以抑制病毒的複製。這個過程只有在病毒感染的細胞中進行,因此溴夫定的抗病毒作用具有高度的選擇性。
手性藥物公司化學原料藥溴夫定獲得《化學原料藥上市申請批准通知書》,表明該原料藥已符合國家相關藥品審評技術標準,已批准在國內製劑中使用,可以在國內市場進行銷售,將進一步豐富公司產品線,提升公司核心競爭力。
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