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科倫藥業(002422.SZ):碘帕醇注射液為科倫首個獲批進入診斷造影領域的藥物
格隆匯 06-21 16:20

格隆匯6月21日丨科倫藥業(002422.SZ)公佈,公司子公司山東科倫藥業有限公司的化學藥品“碘帕醇注射液”於近日獲得國家藥品監督管理局的藥品註冊批准。

碘帕醇為意大利Bracco公司開發的非離子型單體造影劑,1981年在意大利首獲批,後相繼在美國、日本等多個國家獲批上市,2002年國內批准進口,用於神經放射學相關造影、血管造影、數字減影血管造影、尿路造影、CT檢查中增強掃描等。

碘帕醇為X射線非離子型碘造影劑,與其他離子型碘造影劑相比,具有顯影質量更高、血管及神經毒性更小、耐受性更好等優勢,已被《碘對比劑使用指南第二版(2013)》、《腦血管造影術操作規範中國專家共識(2018)》、《美國ACRNKF:靜脈注射碘造影劑在腎病患者中的應用共識(2020)》等國內外權威指南或專家共識推薦用於腫瘤、心腦血管等多種疾病的診斷。碘帕醇注射液為2020年國家醫保甲類品種,2020年中國銷售9.0億元。

碘帕醇注射液為科倫首個獲批進入診斷造影領域的藥物,未來將與公司已申報的釓塞酸二鈉注射液、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。公司此次獲批的碘帕醇注射液即是按照這一要求研發,併為國產第3家通過一致性評價的企業。藥監局公佈的參比製劑信息如下:商品名:Iopamidol Injection/Iopamiro(典比樂),持證商:Bracco Imaging Italia S.r.L.

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