國藥現代(600420.SH):鹽酸米那普侖片通過一致性評價
格隆匯5月23日丨國藥現代(600420.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的鹽酸米那普侖片《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價(簡稱“一致性評價”)。經審查,本品通過仿製藥質量和療效一致性評價,同時同意處方、工藝及質量標準變更等。
鹽酸米那普侖最初由法國Pierre Fabre Medicament公司研製開發,是一種新型的特異性5-HT和NE再攝取抑制劑(SNRI),用於治療抑鬱症。CDE網站顯示,目前公司生產的鹽酸米那普侖片為國內獨家上市產品。
根據米內網數據庫顯示,鹽酸米那普侖片2021年全國城市公立醫院銷售額總計約2461萬元。截止目前,公司用於開展該產品一致性評價累計研發投入約為人民幣1642.34萬元(未經審計)。
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