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科倫藥業(002422.SZ):獲得“注射用頭孢曲松鈉”的藥品補充申請批准通知書
格隆匯 12-29 21:27

格隆匯 12 月 29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於近日獲得國家藥品監督管理局核准簽發的化學藥品射用頭孢曲松鈉的《藥品補充申請批准通知書》。

近日公司的注射用頭孢曲松鈉通過一致性評價並獲得藥品補充申請批准通知書,主要用於治療對本品敏感的致病菌引起的感染,腹部感染呼吸道感染生殖系統感染

頭孢曲松為長效、廣譜的第三代頭孢菌素類抗生素,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;其他第三代頭孢菌素相比,具有半衰期長、組織穿透力強、毒副作用小等優勢,目前已在臨牀廣泛應用於吸科、外科、婦科等科室,已被《抗菌藥物臨牀應用指導原則(2015)、《中國腹腔感染診治指南(2019)》、《兒童社區獲得性肺炎診療規範(2019)》、《成人社區獲得性肺炎基層合理用藥指南(2020)》等國內權威指南推薦。注射用頭孢曲松鈉為2019版國家醫保甲類目錄品種2018年版國家基藥目錄品種2019年中國銷售額38.4億元。

目前公司已有12個細菌感染新產品獲批或通過一致性評價,劑型包裝形式多樣,已在細菌感染領域形成優勢產品集羣,可為臨牀提供針對革蘭氏陽性菌、革蘭氏陰性菌、耐藥菌、厭氧菌等不同感染的系統解決方案。本次公司注射用頭孢曲松鈉國內首家通過一致性評價,也將進一步提升該品種的市場競爭力。

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