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國藥現代(600420.SH):硝苯地平控釋片(30mg)、奧美拉唑腸溶片(20mg)通過仿製藥一致性評價
格隆匯 02-22 17:16

格隆匯2月22日丨國藥現代(600420.SH)公佈,近日,公司及全資子公司國藥集團工業有限公司(簡稱“國工有限”)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》,批准硝苯地平控釋片(30mg)、奧美拉唑腸溶片(20mg)通過仿製藥質量和療效一致性評價。

硝苯地平主要用於高血壓和冠心病(慢性穩定性心絞痛)的治療。硝苯地平控釋片採用膜調控的推拉滲透泵原理,藥物以零級速率釋放,能夠有效改善血藥濃度的“峯谷”現象,相對於普通片和緩釋片降壓效果更平穩,有利於控制病患症狀,同時有效減少副作用。

根據米內網數據庫顯示,硝苯地平控釋片2020年全國公立醫院銷售額約為人民幣21.77億元。公司硝苯地平控釋片2020年銷售收入約為人民幣13.42億元。

CDE網站顯示,目前硝苯地平控釋片通過或視同通過一致性評價的企業還有北京紅林製藥有限公司、廣州一品紅製藥有限公司等。截止目前,公司用於硝苯地平控釋片(30mg)一致性評價累計研發投入約人民幣2843.58萬元(未經審計)。

奧美拉唑臨牀主要用於治療十二指腸潰瘍、卓-艾綜合徵(胃泌素瘤)以及胃潰瘍和反流性食管炎等;同時可與阿莫西林和克林黴素或與甲硝唑與克拉黴素合用,以殺滅幽門螺桿菌。

根據PDB藥物綜合數據庫數據顯示,奧美拉唑腸溶片近三年國內樣本醫院銷售額為人民幣6,294.99萬元。近三年國工有限奧美拉唑腸溶片銷售收入約人民幣432.38萬元。

CDE網站顯示,目前奧美拉唑腸溶片通過或視同通過一致性評價的企業還有湖南方盛製藥股份有限公司、山東新時代藥業有限公司等。截止目前,國工有限用於開展奧美拉唑腸溶片(20mg)一致性評價累計研發投入約人民幣1834.35萬元(未經審計)。

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