海正藥業(600267.SH):比卡魯胺片已通過仿製藥質量和療效一致性評價
格隆匯 3 月 9日丨海正藥業(600267.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的比卡魯胺片的《藥品補充申請批准通知書》,公司的比卡魯胺片已通過仿製藥質量和療效一致性評價。
比卡魯胺片主要適用於晚期前列腺癌的治療。比卡魯胺片原研產品康士得由阿斯利康公司研發,目前為國家醫保目錄乙類品種。
目前,國內主要生產廠商有上海朝暉藥業有限公司、上海復旦復華藥業有限公司等。據統計,比卡魯胺片2020年全球銷售額約39494.92萬美元,其中中國銷售額約11244.81萬美元(數據來源於IMS數據庫)。
2020年5月7日,國家藥監局受理了公司遞交的比卡魯胺片一致性評價申請。截至目前,公司針對該藥品仿製藥質量和療效一致性評價已投入約1000.76萬元人民幣。
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