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太極集團(600129.SH):氫溴酸西酞普蘭片獲得仿製藥一致性評價
格隆匯 04-21 22:14

格隆匯4月21日丨太極集團(600129.SH)公佈,公司獲悉,近日公司控股子公司西南藥業股份有限公司(以下簡稱:西南藥業)收到國家藥品監督管理局關於氫溴酸西酞普蘭片的《補充申請批件》,批件號為2020B02780。根據上海證券交易所《上市公司行業信息披露指引第七號—醫藥製造》的相關要求。

氫溴酸西酞普蘭片的適應症為治療抑鬱症。

2019年2月,西南藥業向國家藥監局提交了該產品的一致性評價申請,並獲得受理,現已獲得一致性評價批件。西南藥業對該產品累計投入研發費用610萬元(未經審計)。

氫溴酸西酞普蘭片為《國家基本醫療保險、工傷保險和生育保險目錄(2019版)》乙類藥品。

截至本公告日,經查詢國家藥品監督管理局數據庫,國內有8家公司有該產品生產批件。西南藥業是第二家獲得藥品一致性評價批件的公司。經《Menet》數據庫統計,2018年該藥品在中國城市公立醫院銷售總額約21668萬元。

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