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復星醫藥(02196.HK):丙硫氧嘧啶片通過仿製藥質量與療效一致性評價
格隆匯 11-03 18:49

格隆匯 11 月 3日丨復星醫藥(02196.HK)公告,近日,上海復星醫藥(集團)股份有限公司控股子公司上海朝暉藥業有限公司(以下簡稱“朝暉藥業”)收到國家藥品監督管理局頒發的關於丙硫氧嘧啶片(以下簡稱“該藥品”)的《藥品補充申請批准通知書》(通知書編號:2020B04817),該藥品通過仿製藥質量與療效一致性評價。

該藥品主要用於各種類型的甲狀腺功能亢進症。2019年度,朝暉藥業該藥品於中國境內(不包括港澳台地區,下同)的銷售額約為人民幣1022萬元。截至本公告日,其他於中國境內已上市的丙硫氧嘧啶片主要包括Hemony Pharmaceutical Germany GmbH、精華製藥集團股份有限公司、廣州康和藥業有限公司的丙硫氧嘧啶片。

根據IQVIACHPA最新數據(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商;IQVIACHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場,不同的藥品因其各自銷售渠道佈局的不同,實際銷售情況可能與IQVIACHPA數據存在不同程度的差異),2019年度,丙硫氧嘧啶片於中國境內銷售額約為人民幣3018萬元。

截至2020年9月,朝暉藥業現階段針對該藥品一致性評價累計研發投入約為人民幣881萬元(未經審計)。

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