國藥現代(600420.SH):注射用鹽酸頭孢吡肟通過仿製藥一致性評價
格隆匯2月21日丨國藥現代(600420.SH)公佈,近日,公司控股子公司國藥集團致君(深圳)製藥有限公司(以下簡稱“國藥致君”)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》,批准注射用鹽酸頭孢吡肟(0.5g、1.0g)通過仿製藥質量和療效一致性評價(以下簡稱“一致性評價”)。
頭孢吡肟可用於治療包括下呼吸道感染、婦產科感染、敗血症、中性粒細胞減少症伴發熱患者的經驗治療以及腹腔手術患者的預防性用藥,也可用於兒童細菌性腦脊髓膜炎。該藥品最早由美國施貴寶公司開發,於1993年首次在瑞典上市,隨後在日本、美國、歐洲、中國等國上市。
根據PDB藥物綜合數據庫數據顯示,注射用鹽酸頭孢吡肟2020年全球銷售額為2.66億美元;國內樣本醫院銷售額為人民幣6600.00萬元。2020年國藥致君注射用鹽酸頭孢吡肟銷售收入約為人民幣1050.00萬元。
CDE網站顯示,注射用鹽酸頭孢吡肟除國藥致君外,國內還有江蘇恆瑞醫藥股份有限公司、深圳信立泰藥業股份有限公司、成都倍特藥業股份有限公司等已通過或視同通過一致性評價。截止目前,國藥致君用於開展注射用鹽酸頭孢吡肟一致性評價累計研發投入約人民幣650.00萬元(未經審計)。
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