科倫藥業(002422.SZ):甲硝唑氯化鈉注射液國內首家通過一致性評價
格隆匯3月1日丨科倫藥業(002422.SZ)宣佈,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“甲硝唑氯化鈉注射液”的《藥品補充申請批准通知書》。經審查,該藥品通過仿製藥質量和療效一致性評價。
近日公司的甲硝唑氯化鈉注射液通過一致性評價並獲得藥品補充申請批准通知書,主要用於治療敏感厭氧菌引起的腹腔內感染、皮膚和軟組織感染、婦科感染、下呼吸道感染等嚴重感染以及預防擇期結直腸手術的術後厭氧菌感染。
甲硝唑是全球首個上市的硝基咪唑類抗生素,為厭氧菌感染的首選藥物之一,療效確切,安全性好,臨牀廣泛應用於呼吸科、外科、婦產科等科室,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)》、《新生兒敗血症診斷及治療專家共識(2019)》、《盆腔炎症性疾病診治規範(2019)》等國內權威指南推薦。甲硝唑氯化鈉注射液為2020年國家醫保目錄品種,及2018年國家基藥目錄品種,2019年中國銷售額約3.6億元。
目前公司已有16個抗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。該次公司甲硝唑氯化鈉注射液國內首家通過一致性評價,將進一步豐富公司在感染性疾病領域的產品管線。
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