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康恩貝(600572.SH):注射用奧美拉唑鈉通過一致性評價
格隆匯 06-17 17:29

格隆匯6月17日丨康恩貝(600572.SH)宣佈,近日,公司控股子公司浙江金華康恩貝生物製藥有限公司(簡稱“金華康恩貝”)收到國家藥監局核准簽發的《藥品補充申請通知書》,金華康恩貝生產的注射用奧美拉唑鈉(40mg)通過仿製藥質量和療效一致性評價。

注射用奧美拉唑鈉是《國家基本醫療保險、工傷保險和生育保險藥品目錄》(醫保發〔2020〕53號)乙類品種,作為當口服療法不適用時下列病症的替代療法:十二指腸潰瘍、胃潰瘍、反流性食管炎及Zollinger-Ellison綜合徵。適應症為:消化性潰瘍出血、吻合口潰瘍出血;應激狀態時併發的急性胃黏膜損害、非甾體類抗炎藥引起的急性胃黏膜損傷;亦常用於預防重症疾病(如腦出血、嚴重創傷等)胃手術後預防再出血,全身麻醉或大手術後以及衰弱昏迷患者防止胃酸反流合併吸入性肺炎等。

目前,國內共有103家企業持有注射用奧美拉唑鈉(40mg)生產批文,其中10家通過該藥品的一致性評價(包括金華康恩貝)。根據米內網數據顯示,2020年奧美拉唑鈉注射劑國內醫療市場銷售規模為52.10億元,其中金華康恩貝注射用奧美拉唑鈉終端銷售為1.53億元,佔市場份額的2.94%。

截至該公吿披露日,金華康恩貝對該藥品進行仿製藥質量和療效一致性評價已投入研發費用約人民幣366.22萬元。

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