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科倫藥業(002422.SZ):鹽酸莫西沙星滴眼液獲得藥品註冊證書
格隆匯 04-15 16:27

格隆匯 4 月 15日丨科倫藥業(002422.SZ)公佈,公司子公司江西科倫藥業有限公司的化學藥品鹽酸莫西沙星滴眼液於近日獲得國家藥品監督管理局的藥品註冊批准

鹽酸莫西沙星滴眼液諾華開發,2003在美國首獲批,後相繼在日本國等全球50國家上市,2018年國內獲批進口,用於治療敏感微生物引起的菌性結膜炎

細菌性結膜炎是眼科常見疾病,常導致眼部組織損傷,從而影響視力,甚至致盲。莫西沙星為最新一代(第四代)喹諾酮類藥物,在保留喹諾酮廣譜抗菌活性、抗菌效能和安全性優勢的基礎上,較臨牀使用最廣泛的左氧氟沙星滴眼液(第三代喹諾酮)顯著增強了抗革蘭氏陽性厭氧菌和耐藥菌的活性,且起效迅速療效持久、不含防腐劑、安全性高,可用於包括新生兒在內的所有年齡人羣,被美國《結膜炎臨牀指南(2018)》、《細菌性角膜炎臨牀指南(2018)》、英國《細菌性結膜炎臨牀管理指南(2016)》等多個國外權威指南推薦使用。鹽酸莫西沙星滴眼液為2020年國家醫保乙類品種,同類藥物左氧氟沙星滴眼液2019年中國銷售13.23億元

目前公司已有19感染產品獲批或通過一致性評價,且劑型和包裝形式多樣,已在感染性疾病領域形成優勢產品集羣,可為臨牀提供針對各種細菌、真菌、病毒感染的系統解決方案。此次公司鹽酸莫西沙星滴眼液的獲批,將進一步豐富公司感染性疾病領域的產品管線

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。公司此次獲批的鹽酸莫西沙星滴眼液即是按照這一要求研發藥監局公佈的原研產品信息如下:藥品通用名:鹽酸莫西沙星滴眼液,持證商:Novartis pharmaceuticals Corporation

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