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國藥現代(600420.SH):國藥致君注射用頭孢呋辛鈉(1.0g、1.5g)通過仿製藥一致性評價
格隆匯 04-11 15:40

格隆匯4月11日丨國藥現代(600420.SH)公佈,近日,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(1.0g、1.5g)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,主要用於治療敏感菌株引起的呼吸道感染、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。

根據PDB藥物綜合數據庫數據顯示,注射用頭孢呋辛鈉2021年全球銷售額為4.54億美元;2022年國內樣本醫院銷售額為人民幣3.07億元。2022年國藥致君注射用頭孢呋辛鈉(1.0g、1.5g)銷售收入約為人民幣10,300萬元。

CDE網站顯示,注射用頭孢呋辛鈉(1.0g、1.5g)除國藥致君外,國內還有山東潤澤製藥有限公司、齊魯安替製藥有限公司、南昌立健藥業有限公司、廣東金城金素製藥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(1.0g、1.5g)一致性評價累計研發投入約人民幣510萬元(未經審計)。

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