康恩貝(600572.SH):金華康恩貝10mg和20mg規格的奧美拉唑腸溶膠囊通過仿製藥一致性評價
格隆匯1月24日丨康恩貝(600572.SH)公佈,近日,浙江康恩貝製藥股份有限公司控股子公司浙江金華康恩貝生物製藥有限公司(金華康恩貝)收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,金華康恩貝10mg和20mg規格的奧美拉唑腸溶膠囊(統稱“該藥品”)通過仿製藥質量和療效一致性評價。
奧美拉唑腸溶膠囊適用於胃潰瘍、十二指腸潰瘍、應激性潰瘍、反流性食管炎和卓-艾綜合症(胃泌素瘤)的治療;用於胃酸過多引起的燒心和反酸症狀的短期緩解,是《國家基本醫療保險、工傷保險和生育保險藥品目錄》(2021版)甲類品種,並納入《國家基本藥物目錄》(2018年版)。
截至公吿披露日,通過國家藥監局一致性評價的10mg規格奧美拉唑腸溶膠囊的廠家有金華康恩貝等2家公司,20mg規格奧美拉唑腸溶膠囊的廠家有金華康恩貝等8家公司。
金華康恩貝奧美拉唑腸溶膠囊是公司大品牌大品種工程的主要品種之一。米內網終端數據顯示:2020年奧美拉唑口服制劑國內終端銷售規模為33.7億元,其中金華康恩貝奧美拉唑腸溶膠囊終端銷售為5.5億元,佔市場份額的16.3%。
截至公吿披露日,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1629萬元。
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