魯抗醫藥(600789.SH):阿卡波糖片獲得藥品註冊證書
格隆匯11月29日丨魯抗醫藥(600789.SH)公佈,近日,公司收到國家藥品監督管理局頒發的關於阿卡波糖片的《藥品註冊證書》(證書編號:2021S01164)。
阿卡波糖是一種α-糖苷酶抑制劑,用於治療2型糖尿病。原研廠家為德國拜耳醫藥,1990年在德國上市,1994年在中國批准註冊上市,1995年獲得美國FDA批准並上市。國內上市規格為50mg、0.1g。阿卡波糖製劑國內共10家獲批,其中片劑9家,膠囊劑1家,咀嚼片1家,根據《國家藥監局關於發佈化學藥品註冊分類及申報資料要求的通吿(2020年第44號)》,該項目屬於化學藥物4類—境內申請人仿製已在境內上市原研藥品的註冊申請。
根據米內網數據顯示,2020年中國城市實體藥店終端阿卡波糖片銷售額為8.6億元。
截至公吿披露日,公司在該藥品的研發投入約為2322.30萬元人民幣(未經審計)。
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