復星醫藥(02196.HK)非布司他片通過仿製藥一致性評價
格隆匯4月16日丨復星醫藥(02196.HK)公告,近日,公司控股子公司江蘇萬邦生化醫藥集團有限責任公司(以下簡稱“江蘇萬邦”)收到國家藥品監督管理局頒發的關於非布司他片(商品名稱:優立通)的《藥品補充申請批件》,該藥品通過仿製藥一致性評價。
非布司他片主要用於痛風患者高尿酸血癥的長期治療。2019年度,江蘇萬邦非布司他片於中國境內(不包括港澳台地區,下同)的銷售額約為人民幣11.26億元。截至本公告日,於中國境內已上市的非布司他片主要包括江蘇恆瑞醫藥股份有限公司的瑞揚、江蘇萬邦的優立通、杭州朱養心藥業有限公司的風定寧、安斯泰來製藥(中國)有限公司的菲布力等。根據IQVIACHPA最新數據,2019年度,非布司他片於中國境內銷售額約為人民幣12.75億元。
截至2020年3月,江蘇萬邦現階段針對該藥品一致性評價累計研發投入人民幣約2,142萬元(未經審計)。
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