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復旦復華(600624.SH):卡馬西平片首家通過一致性評價
格隆匯 04-20 15:50

格隆匯4月20日丨復旦復華(600624.SH)宣佈,2021年4月18日,公司控股子公司上海復旦復華藥業有限公司(簡稱“藥業公司”)收到國家藥品監督管理局頒發的關於卡馬西平片0.1g(統稱“該藥品”)的《藥品補充申請批准通知書》,該藥品通過仿製藥質量和療效一致性評價(簡稱“仿製藥一致性評價”或“一致性評價”)。

卡馬西平片為國家基本藥物,並進入《國家醫保目錄(2020年版)》(甲類藥品),適應症為癲癇及三叉神經痛。卡馬西平於1957年被J.R.Geigy公司首次合成,是一種二苯並氮雜類抗驚厥和抗癲癇藥,於1974年進入中國。PDB藥物綜合數據庫數據顯示,卡馬西平製劑屬於世界暢銷藥500強之一,在抗癲癇藥領域具有穩定的市場地位。

2019年4月,藥業公司就該藥品仿製藥質量和療效一致性評價向國家藥品監督管理局提交申請並獲得受理。2021年4月18日,藥業公司收到國家藥品監督管理局頒發的《藥品補充申請批准通知書》。根據米內網數據統計,2019年度卡馬西平在全國城市、縣級、鄉鎮樣本公立醫院及城市樣本零售藥店的銷售額約為人民幣1.64億元,主要生產廠商除藥業公司外,還包括北京諾華製藥有限公司、江蘇鵬鷂藥業有限公司、齊魯製藥有限公司等。藥業公司2020年的卡馬西平片銷售收入約為人民幣5616萬元(未經審計)。

截至該公吿披露日,藥業公司是首家通過卡馬西平片一致性評價的公司,藥業公司對該藥品一致性評價累計研發投入約人民幣1827.84萬元(未經審計)。

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