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國藥現代(600420.SH):國藥致君注射用頭孢呋辛鈉(0.75g)通過仿製藥一致性評價
格隆匯 06-27 20:25

格隆匯6月27日丨國藥現代(600420.SH)公佈,近日,上海現代製藥股份有限公司控股子公司國藥集團致君(深圳)製藥有限公司(簡稱“國藥致君”)收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,批准注射用頭孢呋辛鈉(0.75g)通過仿製藥質量和療效一致性評價。

頭孢呋辛鈉為第二代頭孢菌素類抗生素,具有抗菌譜廣,殺菌活性強、毒性低、臨牀療效肯定、適應症廣等優勢,可用於治療呼吸道感染、耳鼻喉感染、泌尿道感染、皮膚和軟組織感染、敗血症、腦膜炎、淋病、骨和關節感染、產褥期和婦科感染等疾病,還可用於術前預防性使用,防止敏感致病細菌生長。

頭孢呋辛由葛蘭素史克公司(GSK)研製成功,於1978年在英國、愛爾蘭、德國和意大利上市,1983年在美國獲批准上市,1998年在中國獲批准上市。

根據PDB藥物綜合數據庫數據顯示,注射用頭孢呋辛鈉2021年國內樣本醫院銷售額為人民幣4.31億元。2021年國藥致君注射用頭孢呋辛鈉(0.75g)銷售收入約為人民幣3600.00萬元。

CDE網站顯示,注射用頭孢呋辛鈉(0.75g)除國藥致君外,國內還有浙江惠迪森藥業有限公司、山東潤澤製藥有限公司、深圳信立泰藥業股份有限公司等已通過或視同通過一致性評價。截止目前,國藥致君用於開展注射用頭孢呋辛鈉(0.75g)一致性評價累計研發投入約人民幣360.00萬元(未經審計)。

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