普利製藥(300630.SZ):注射用艾司奧美拉唑鈉通過荷蘭藥物評價委員會(CBG)技術審評
格隆匯2月10日丨普利製藥(300630.SZ)公佈,公司於近日收到荷蘭藥物評價委員會(簡稱“CBG”)批准注射用艾司奧美拉唑鈉的技術審評報吿的通知。
注射用艾司奧美拉唑鈉適應症:1、作為當口服療法不適用時,胃食管反流病的替代療法。2、用於口服療法不適用的急性胃或十二指腸潰瘍出血的低危患者(胃鏡下Forrest分級IIc-III)。3、用於降低成人胃和十二指腸潰瘍出血內鏡治療後再出血風險。
艾司奧美拉唑,又名埃索美拉唑,是奧美拉唑的單一左旋異構體,兩者均屬於質子泵抑制劑,能有效抑制胃酸分泌,臨牀上用於治療胃食管反流性疾病、糜爛性反流性食管炎等。該藥是最成功的異構體開發範例之一,較第一代的奧美拉唑而言,其抑制胃酸的效果更強,不良反應也更小。該藥最早由阿斯利康研發,2000年其口服制劑在瑞典上市,商品名為Nexium,注射劑於2003年推出。
普利製藥的注射用艾司奧美拉唑鈉成功研發後,分別遞交歐洲、美國和中國的仿製藥註冊申請。於近日,公司收到了荷蘭藥物評價委員會的批准通知,審評結論為批准。目前進入荷蘭和德國的國家階段的產品特性概要、説明書和標籤的審核和批件發放階段,之後該產品即可在荷蘭、德國市場進行上市銷售。
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