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國內首家! 科倫藥業(002422.SZ)注射用頭孢他啶/5%葡萄糖注射液獲批上市
格隆匯 09-28 11:51

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“注射用頭孢他啶/5%葡萄糖注射液”於近日獲得國家藥品監督管理局的藥品註冊批准。

注射用頭孢他啶/5%葡萄糖注射液為公司粉液雙室袋平台首個獲批的產品。粉液雙室袋是國際上先進的輸液產品,其中粉體和液體分別位於兩個獨立的腔室,保證混合前各腔室藥液的穩定性,臨牀使用時即開、即混、即用,操作便捷,可有效避免配置過程中的錯配和污染風險,同時節約配置時間,尤其適用於緊急狀態下的快速救治。公司粉液雙室袋平台後續還有多個品種在研。

頭孢他啶為葛蘭素史克開發的第三代強效、廣譜頭孢菌素,較第一、二代頭孢菌素對革蘭氏陰性菌活性與β-內酰胺酶穩定性增強;與其他第三代頭孢菌素相比,對銅綠假單胞菌作用最強,常作為敏感菌的首選用藥之一,目前已在臨牀廣泛應用於神經內科、呼吸科、外科等科室。注射用頭孢他啶為2020版國家醫保乙類品種,及2018版國家基藥目錄品種,2020年中國銷售53.9億元。

目前公司已有系列抗感染、腸外營養、麻醉鎮痛、體液平衡類產品獲批或通過一致性評價,且劑型和包裝形式多樣,已在相關疾病領域形成優勢產品集羣,可為臨牀提供針對圍手術期用藥的系統解決方案。該次公司注射用頭孢他啶/5%葡萄糖注射液在國內首家獲批,將進一步豐富公司圍手術期用藥的產品管線。

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