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科倫藥業(002422.SZ):左氧氟沙星氯化鈉注射液獲得藥品註冊證書
格隆匯 12-28 18:47

格隆匯 12 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於近日獲得國家藥品監督管理局核准簽發的化學藥品氧氟沙星氯化鈉注射液的《藥品註冊證書》。

左氧氟沙星氯化鈉注射液由日本第一三共株式會社開發,1996年在美國首獲批,後相繼在日本、英國等全球40多個國家獲批上市,2002年國內獲批進口,主要用於治療成人由敏感菌引起的輕、中、重度感染,包括醫院或社區獲得性肺炎、急性細菌性鼻竇炎、慢性支氣管炎、複雜性皮膚及結構感染、尿路感染等。

左氧氟沙星為氧氟沙星的左旋異構體,具有抗菌譜廣、抗菌作用強、肺組織濃度高等優勢,臨牀廣泛用於呼吸科、泌尿科、婦產科等科室,已被《抗菌藥物臨牀應用指導原則(2015)》、《成人社區獲得性肺炎基層診療指南(2018)》、《喹諾酮類抗菌藥物急診臨牀應用指導意見(2020)》等國內權威指南和專家共識推薦。左氧氟沙星氯化鈉注射液為2019版國家醫保目錄品種,2019年左氧氟沙星輸液中國銷售52.3億元。

目前公司已有11個細菌感染新產品獲批或通過一致性評價,且劑型與包裝形式多樣,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。本次公司左氧氟沙星氯化鈉注射液獲批,以及後續系列品種的續貫獲批,將進一步豐富公司細菌感染領域的產品管線。

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。公司本次獲批的左氧氟沙星氯化鈉注射液即是按照這一要求研發,並以國產第3家獲批上市。藥監局公佈的原研產品信息如下:商品名:CRAVIT,持證商:第一三共株式會社。

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