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李氏大藥廠(00950.HK):INOMAX取得藥品註冊許可證
格隆匯 04-21 20:49

格隆匯4月21日丨李氏大藥廠(00950.HK)公吿,於2022年3月8日,INOmax(吸入用一氧化氮)取得中國國家藥品監督管理局的藥品註冊許可證。

INOmax是一種獲認可用於治療患有低氧性呼吸衰竭(HRF)並伴隨肺動脈高壓(PPHN)的足月及早產新生兒(34周以上)的吸入用一氧化氮藥物。

於2021年,中國的新生兒數約為1,062萬名。按Liu等於Respiratory Research (2019) 20:174所報導,HRF於中國的發病率為每1,000名新生兒有2至6名,死亡率約為10至20%。INOmax將提供治療方法,填補患有該病而得不到治療服務的患者的醫療需求缺口。

據悉,INOmax是一種從Mallinckrodt Pharmaceuticals引進至中國內地、香港、澳門及台灣的產品。

INOmax是一種獲美國食品藥品監督管理局(FDA)認可用於治療患有HRF並伴隨PPHN的足月兒及34周以上的早產兒的治療藥物。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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