中國醫藥(600056.SH):“非那雄胺片”通過仿製藥一致性評價
格隆匯4月1日丨中國醫藥(600056.SH)公佈,近日,公司下屬全資子公司天方藥業有限公司(“天方有限”)獲得國家藥品監督管理局(“國家藥監局”)核准簽發的化學藥品“非那雄胺片”兩份《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價。
非那雄胺是5α-還原酶抑制劑,由美國默克公司研發,上市規格為5mg和1mg,其中5mg規格商品適用於前列腺肥大男性患者治療已有症狀的良性前列腺增生症,可以改善症狀,降低發生急性尿瀦留的危險性,以及減少手術風險。1mg規格商品用於治療男性禿髮(雄激素性禿髮),能促進頭髮生長並防止繼續脱髮。
國家藥監局於2019年1月受理天方有限該藥品的一致性評價申請。
截至公告披露日,該藥品研發投入約879萬元人民幣(未經審計)。
截至目前,天方有限為首家通過非那雄胺片1mg規格一致性評價的企業,該藥品5mg規格通過一致性評價的有華潤賽科藥業有限責任公司、揚子江藥業集團四川海蓉藥業、南京聖和藥業股份有限公司、成都倍特藥業有限公司、湖北舒邦藥業有限公司等五家企業。該藥品5mg規格已進入《2019版國家醫保藥品目錄》及《國家基本藥物目錄(2018年版)》。
根據第三方數據庫PDB最新查詢數據顯示,非那雄胺片2018年國內樣本醫院銷售額約為2.33億元。2019年天方有限累計實現非那雄胺片銷售收入約為6024萬元人民幣(未經審計)。
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