科倫藥業(002422.SZ):子公司釓塞酸二鈉注射液獲批上市
格隆匯9月28日丨科倫藥業(002422.SZ)公佈,公司子公司湖南科倫製藥有限公司的化學藥品“釓塞酸二鈉注射液”於近日獲得國家藥品監督管理局的藥品註冊批准。
釓塞酸二鈉注射液為拜耳開發的磁共振造影劑,2004年在歐洲首獲批,後相繼在美國、日本等多個國家獲批上市,2010年國內批准進口,用於檢測肝臟局灶性病變。
釓塞酸二鈉是一種肝臟高特異性的磁共振造影劑,與其他磁共振造影劑相比,可提高肝臟局灶性病變的檢出率及定性診斷的準確率,尤其對微小病灶的檢出和鑑別診斷更具優勢,已被《肝細胞癌癌前病變的診斷和治療多學科專家共識(2020)》、《肝臟局灶性病變CT和MRI標註專家共識(2020)》、《美國ACG臨牀指南:肝臟局灶性病變的診斷和管理(2014)》等國內外權威指南或專家共識推薦用於肝臟病變的診斷。釓塞酸二鈉注射液2020年中國銷售2.2億元。
釓塞酸二鈉注射液為公司繼碘帕醇注射液後在診斷造影領域第二個獲批的產品,未來將與公司已申報的釓特醇注射液及在研的系列X射線、磁共振和超聲造影劑,共同形成診斷造影領域的優勢產品集羣。
2015年國家藥監政策改革,要求新申報的仿製藥必須與原研質量和療效一致。公司該次獲批的釓塞酸二鈉注射液即是按照這一要求研發,併為該品種國內首家通過一致性評價的仿製藥。藥監局公佈的參比製劑信息如下:商品名:Primovist(普美顯),持證商:Bayer Vital GmbH。
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