恆瑞醫藥(600276.SH):釓布醇注射液獲批上市
格隆匯3月27日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥品註冊證書》,藥品名稱為釓布醇注射液。
公吿顯示,釓布醇注射液是一種用於磁共振成像(MRI)的順磁性對比劑,最早由BayerSchering公司開發,商品名為Gadovist,1999年在瑞士獲批上市,後在包括中國在內的多個國家陸續獲批上市。釓布醇注射液適用於成人及全年齡段兒童(包括足月新生兒),僅供靜脈內給藥,用於診斷:全身各部位(包括顱腦和脊髓)病變的對比增強磁共振成像(CE-MRI)檢查;全身各部位的對比增強磁共振血管造影(CE-MRA)檢查。截至目前,除原研外,國內僅有公司的釓布醇注射液獲批上市,視同通過仿製藥質量和療效一致性評價。
經查詢,2020年釓布醇注射液全球銷售額約3.07億美元。截至目前,釓布醇注射液相關項目累計已投入研發費用約2738萬元。
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