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魯抗醫藥(600789.SH):賽特公司替硝唑片(0.5g)通過仿製藥一致性評價
格隆匯 02-08 17:37

格隆匯2月8日丨魯抗醫藥(600789.SH)發佈,近日,山東魯抗醫藥股份有限公司控股子公司山東魯抗醫藥集團賽特有限責任公司(“賽特公司”)收到國家藥品監督管理局頒發的關於替硝唑片(“該藥品”)的《藥品補充申請批件》(批件號:2022B00358),該藥品通過仿製藥質量和療效一致性評價。

替硝唑(tinidazole)是抗原蟲藥和抗菌藥,也是繼甲硝唑後療效更高、療程更短、耐受性更好、體內分佈更廣的硝基咪唑類衍生物。由美國輝瑞(Pfizer)公司研究開發,1971年首次在德國上市。替硝唑片用於各種厭氧菌感染,如敗血症、骨髓炎、腹腔感染、盆腔感染、肺支氣管感染、肺炎、鼻竇炎、皮膚蜂窩組織炎、牙周感染及術後傷口感染:用於結腸直腸手術、婦產科手術及口腔手術等的術前預防用藥;用於腸道及腸道外阿米巴病、陰道滴蟲病、賈第蟲病、加得納菌陰道炎等的治療;也可作為甲硝唑的替代藥用於幽門螺桿菌所致的胃竇炎及消化性潰瘍的治療。

該品已相繼進入2018版國家基藥、2021版國家醫保乙類藥目錄,第五批國家帶量採購名單等。根據工信部PDB數據庫數據顯示,2021年前三季度替硝唑國內樣本醫院製劑用藥金額約為3814萬元。賽特公司2021年前三季度該產品的銷售額約為606.78萬元。

截至公吿披露日,賽特公司在該藥品的研發投入約為493.48萬元人民幣(未經審計)。

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