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東誠藥業(002675.SZ):氟[18F]化鈉注射液獲得國家藥品監督管理局上市許可

格隆匯5月27日丨東誠藥業(002675.SZ)公佈,近日,煙臺東誠藥業集團股份有限公司全資子公司南京江原安迪科正電子研究發展有限公司(簡稱“安迪科”)收到國家藥品監督管理局覈準簽發的氟[18F]化鈉注射液《藥品註冊證書》,氟[18F]化鈉注射液通過藥品上市許可申請,可生產銷售。

[18F]化鈉注射液是正電子發射斷層掃描(PET)放射性顯像劑,在骨顯像中確定成骨活性改變的區域。氟[18F]化鈉注射液中的氟[18F]離子可與骨骼的羥基磷灰石晶體中的羥基發生變換,生成氟代磷灰石,化學吸附於骨組織。骨對氟[18F]離子的攝取依賴於骨的局部血流和成骨活性,因此優先在骨轉換率高和重塑活躍的骨組織中發生沉積,表現爲在成骨與溶骨性骨轉移瘤中均有很高的濃聚。在已完成的臨牀試驗中,氟[18F]化鈉注射液被證明具有優秀的診斷效能與良好安全性,可以更早、更敏感地發現骨轉移病竈,爲臨牀患者提供更多治療策略。

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