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中國醫藥(600056.SH):子公司藥品那格列奈片通過仿製藥一致性評價
格隆匯 01-28 18:10

格隆匯1月28日丨中國醫藥(600056.SH)公佈,近日,中國醫藥健康產業股份有限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核准簽發的一份那格列奈片(簡稱“該藥品”)《藥品補充申請批准通知書》,該藥品通過仿製藥質量和療效一致性評價。

那格列奈屬於D-苯丙氨酸衍生物,是繼瑞格列奈後的第2個新型非磺脲類口服降糖藥,通過刺激胰島β細胞分泌胰島素而發揮作用。那格列奈片可以單獨用於經飲食和運動不能有效控制高血糖的2型糖尿病病人。也可用於使用二甲雙胍不能有效控制高血糖的2型糖尿病病人,採用與二甲雙胍聯合應用,但不能替代二甲雙胍。

截至公吿披露日,該藥品一致性評價研發投入約為1665萬元(未經審計,並含2021年3月已通過一致性評價的該藥品60mg、120mg規格的研發投入)。

該藥品為《國家基本醫療保險、工傷保險和生育保險藥品目錄(2021年)》乙類藥品。根據第三方數據庫PDB查詢顯示,該藥品2021年前三季度國內樣本醫院銷售額約為1060萬元。公司該藥品2021年銷售收入約為137萬元(未經審計)。

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