麗珠醫藥(01513.HK):注射用奧美拉唑鈉通過仿製藥質量和療效一致性評價
格隆匯6月14日丨麗珠醫藥(01513.HK)公佈,近日,公司全資子公司麗珠集團麗珠製藥廠(“麗珠製藥廠”)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》,麗珠制藥廠生產的注射用奧美拉唑鈉通過仿製藥質量和療效一致性評價。
審批結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發〔2015〕44號)、《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號)和《國家藥監局關於開展化學藥品注射劑仿製藥質量和療效一致性評價工作的公吿》(2020年第62號)的規定,經審查,本品通過仿製藥質量和療效一致性評價,同意麗珠集團麗珠製藥廠為本品的藥品上市許可持有人。
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,適應症為:①消化性潰瘍出血、吻合口潰瘍出血;②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;③預防重症疾病(如腦出血、嚴重創傷等)應激狀態及胃手術後引起的上消化道出血等;④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綜合症。
截至公吿披露日,注射用奧美拉唑鈉一致性評價已累計投入的直接研發費用約人民幣547.1萬元。
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家通過本品的一致性評價(包括麗珠製藥廠)。根據IQVIA抽樣統計估測數據,奧美拉唑注射劑產品2020年國內樣本醫院銷售金額約為人民幣32.05億元。公司注射用奧美拉唑鈉2020年度的銷售收入為人民幣198.30萬元。
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