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華東醫藥(000963.SZ):中美華東奧美拉唑碳酸氫鈉膠囊獲批上市
格隆匯 06-22 18:12

格隆匯6月22日丨華東醫藥(000963.SZ)宣佈,近日,公司全資子公司杭州中美華東製藥有限公司(簡稱“中美華東”)收到國家藥監局核准簽發的關於奧美拉唑碳酸氫鈉膠囊的《藥品註冊證書》。

奧美拉唑碳酸氫鈉膠囊劑是首個獲批上市的非腸溶質子泵抑制劑,起效更快,作用更持久,其中的碳酸氫鈉不但可以保護奧美拉唑不受胃酸破壞,還可快速中和胃酸,激活質子泵通道而無需食物刺激,患者可以按需服用,臨牀用藥順應性好。

奧美拉唑碳酸氫鈉膠囊原研廠家為美國SANTARUS INC公司(2014年1月被Salix Pharmaceuticals Ltd收購),於2006年2月在美國首次獲批,商品名為Zegerid,尚未進口國內。經查詢,截止目前,國內共有3家企業(含中美華東)取得了奧美拉唑碳酸氫鈉膠囊的藥品註冊證書。經IQVIA數據庫查詢,該產品2020年全球銷售額為1.07億美元。

截至該公吿日,公司奧美拉唑碳酸氫鈉膠囊累計直接的研發投入約為人民幣2600萬元。

公司在消化領域構築了良好的品牌效應,積累了一定的市場基礎,現有產品包括注射用泮托拉唑鈉、泮托拉唑鈉腸溶膠囊、多潘立酮片、奧美拉唑腸溶膠囊等,其中泮托拉唑注射劑2019年獲得該產品國內首個美國FDA的暫時批准文號,2020年11月通過一致性評價,2021年2月中標國家第四批藥品集中帶量採購。

該次公司奧美拉唑碳酸氫鈉膠囊獲批上市,將進一步完善公司在消化領域的產品結構,與公司現有該領域上市品種形成協同效應,有利於提升公司在該領域的市場競爭力,對公司未來業績提升有一定積極作用。

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