華東醫藥(000963.SZ):奧硝唑片通過仿製藥質量和療效一致性評價
格隆匯9月29日丨華東醫藥(000963.SZ)公佈,近日,公司全資子公司華東醫藥(西安)博華製藥有限公司(“西安博華”)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》(通知書編號:2021B03181),西安博華生產的奧硝唑片通過仿製藥質量和療效一致性評價。
奧硝唑(Ornidazole),是繼甲硝唑、替硝唑之後的第三代新型硝基咪唑類衍生物,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,以及用於預防和治療各科手術後厭氧菌感染。奧硝唑的原藥和中間代謝物均有活性,作用於厭氧菌、阿米巴蟲、賈第蟲和毛滴蟲細胞的 DNA,使其螺旋結構斷裂或阻斷其轉錄複製而致死亡。
奧硝唑最早由美國Hoffer.M等研製,瑞士Roche公司於1977年首次在歐洲以商品名“Tiberal®”上市。經查詢,原研奧硝唑片未在國內批准上市。
奧硝唑口服常釋劑型先後被納入《國家基本醫療保險、工傷保險和生育保險藥品目錄》2019年版、2020年版,醫保類別均為乙類。
西安博華是國內最早取得奧硝唑原料藥及片劑生產批件的藥品生產企業。截至目前,國內共有7家企業持有奧硝唑片生產批件,其中4家通過仿製藥一致性評價(包括西安博華)。根據米內網數據庫,2020年口服片劑奧硝唑的銷售額約1.96億元,其中西安博華的奧硝唑片銷售收入約1325萬元,市場佔有率約為6.76%。
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