國藥現代(600420.SH):馬來酸依那普利片(10mg)、注射用米卡芬淨鈉(50mg)通過仿製藥質量和療效一致性評價
格隆匯1月26日丨國藥現代(600420.SH)公佈,近日,上海現代製藥股份有限公司及控股子公司上海天偉生物製藥有限公司(“天偉生物”)分別收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,批准馬來酸依那普利片(10mg)、注射用米卡芬淨鈉(50mg)通過仿製藥質量和療效一致性評價。
馬來酸依那普利片為一種血管緊張素轉移酶抑制藥,主要用於治療原發性高血壓、腎血管性高血壓及症狀性心力衰竭等病症,是繼β-阻斷劑治療高血壓後,又一類毒副作用小,療效好的抗高血壓藥物。馬來酸依那普利片由Merck Sharp & Dohme (Australia) Pty. Ltd 及 Valeant Pharmaceuticals International公司共同開發,自1984年開始,先後在西德、英國等國家上市。根據醫藥魔方數據庫顯示,馬來酸依那普利片2020年全國公立醫院銷售額約為人民幣4.72億元。公司馬來酸依那普利片(10mg)2020年的銷售收入約為人民幣7820.52萬元。
公司用於開展馬來酸依那普利片(10mg)一致性評價累計研發投入約人民幣1696.45萬元(未經審計)。
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