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九典制藥(300705.SZ):奧硝唑片通過一致性評價
格隆匯 05-31 09:06

格隆匯5月31日丨九典制藥(300705.SZ)宣佈,公司於近日收到國家藥品監督管理局核准下發的《藥品補充申請批准通知書》,公司產品“奧硝唑片”通過仿製藥質量與療效一致性評價。

奧硝唑為第三代硝基咪唑類抗生素,用於治療由厭氧菌感染引起的多種疾病;男女泌尿生殖道毛滴蟲、賈第氏鞭毛蟲感染引起的疾病;腸、肝阿米巴蟲病,腸、肝變形蟲感染引起的疾病;用於預防和治療各科手術後厭氧菌感染。

奧硝唑最早由美國Hoffer.M等開發研製,瑞士Roche公司於1977年首次在歐洲以商品名“Tiberal®”上市。奧硝唑上市劑型有片劑、膠囊劑和注射液等,其中奧硝唑片在國內有7家生產上市。

目前抗厭氧菌為主的口服藥物主要包括甲硝唑、替硝唑、奧硝唑。奧硝唑抗菌作用明確,安全性良好,被廣泛應用,為同類抗厭氧菌藥物的主流品種。據米內網數據庫統計分析,此類口服藥物2018-2020年市場規模約16.7億元,其中口服奧硝唑整體市場約9.66億元,全國零售和醫療終端奧硝唑片銷量約1.24億元。

截至該公吿日,公司為國內3家通過奧硝唑片一致性評價的企業之一。

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