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李氏大藥廠(00950.HK)吸入劑產品新藥上市申請獲優先審評資格
格隆匯 03-16 22:08

格隆匯3月16日丨李氏大藥廠(00950.HK)發佈公告,2020年2月20日,公司全資附屬公司李氏大藥廠(香港)有限公司的INOmax®(一氧化氮)吸入劑(“INOmax®”)新藥上市申請已獲得國家藥品監督管理局就治療兒科罕見病授予的優先審評資格。INOmax®是一種用於治療患有低氧性呼吸衰竭(“HRF”)並伴隨肺動脈高壓的足月兒及34周以上的早產兒的吸入一氧化氮藥物。

根據披露,INOmax®為獲美國食品藥品監督管理局批准用於治療HRF並伴隨肺動脈高壓(“PPHN”)的足月兒及胎齡34周以上的早產兒的藥物。PPHN是一種肺血管收縮導致血液難以供氧的嚴重疾病,經常導致HRF。INOmax®是一種血管擴張劑,其可選擇性地讓肺血管放鬆,並通過配合換氣裝置及其他適當藥物,改善脆弱新生兒羣體的氧合。

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