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科倫藥業(002422.SZ):子公司釓布醇注射液獲得藥品註冊批准
格隆匯 07-12 17:23

格隆匯7月12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“釓布醇注射液”於近日獲得國家藥品監督管理局的藥品註冊批准。

釓布醇注射液是由拜耳開發的磁共振造影劑,目前已在美國、日本、歐洲等多國獲批上市,2009年中國獲批進口,用於成人及全年齡段兒童全身各部位病變的磁共振成像檢查及全身各部位的磁共振血管造影檢查。

磁共振造影劑根據化學結構分為線型和環型兩類,線性造影劑更易發生腎源性系統性纖維化及腦部釓沉積導致安全性風險,因此,國際上更傾向於優先使用環型造影劑。釓布醇注射液為環型造影劑,具有高濃度、高馳豫、高穩定性的特點,可明顯提升病灶細節的顯影水平,為目前適用人羣最廣泛的磁共振造影劑,已被《釓布醇對比增強MRI臨牀掃描方案專家共識(2022)》、《釓對比劑臨牀安全性應用中國專家建議(2019)》、《腎臟病患者應用靜脈釓造影劑(2020)》等國內外權威指南或專家共識推薦使用。釓布醇注射液為國家醫保乙類品種,2022年中國銷售1.4億元。

目前公司已有系列X射線和磁共振造影劑獲批,本次釓布醇注射液國產第3家獲批,將進一步豐富公司在診斷造影領域的產品管線。

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