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科倫藥業(002422.SZ):化藥奧硝唑注射液獲批上市
格隆匯 10-14 17:13

格隆匯10月14日丨科倫藥業(002422.SZ)公佈,公司的化學藥品“奧硝唑注射液”於近日獲得國家藥品監督管理局的藥品註冊批准。

奧硝唑注射液由羅氏製藥開發,1980年瑞士首上市,隨後在歐洲多國獲批上市,用於厭氧菌感染的術前預防和術後治療以及腸道和肝臟嚴重的阿米巴病。

硝基咪唑類是預防和治療厭氧菌感染的首選藥物之一,其中奧硝唑是繼甲硝唑、替硝唑之後上市的第三代硝基咪唑類藥物,與同類相比具有療效確切、適用人羣更廣、不良反應更小等優勢,目前已在臨牀廣泛用於普外科、婦產科、兒科等科室,已被《抗菌藥物臨牀應用指導原則(2015年版)》和《膽道外科抗菌藥物規範化應用專家共識(2019版)》等國內權威指南或專家共識推薦。奧硝唑注射劑為2021年國家醫保乙類品種,2021年中國公立醫院銷售18.5億元。

目前公司已有系列抗感染產品獲批或通過一致性評價,可為臨牀提供針對各種細菌、真菌、病毒感染的系統解決方案。該次奧硝唑注射液獲批,將進一步豐富公司在感染性疾病領域的產品管線。

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