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葫蘆娃(605199.SH):注射用奧美拉唑鈉通過仿製藥一致性評價
格隆匯 12-03 15:47

格隆匯12月3日丨葫蘆娃(605199.SH)公佈,公司近日收到藥品監督管理局核准簽發的關於“注射用奧美拉唑鈉的《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。

審批結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)、《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號)和《國家藥監局關於開展化學藥品注射劑仿製藥質量和療效一致性評價工作的公吿》(2020年第62號)的規定,經審查,本品通過仿製藥質量和療效一致性評價。同時同意以下變更:1、變更藥品處方及生產工藝;2、變更藥品質量標準;3、變更直接接觸藥品的包裝材料和容器;4、修訂藥品説明書。

奧美拉唑鈉為質子泵抑制劑,主要用於:消化性潰瘍出血、吻合口潰瘍出血;應激狀態時併發的急性胃粘膜損害、非甾體類抗炎藥引起的急性胃粘膜損傷;預防重症疾病(如腦出血、嚴重創傷等)應激狀態及胃手術後引起的上消化道出血等;作為當口服療法不適用時下列病症的替代療法:十二指腸潰瘍、胃潰瘍、反流性食管炎及Zollinger-Ellison 綜合徵。

公司注射用奧美拉唑鈉一致性評價項目於2019年立項,201912月提交注射用奧美拉唑鈉一致性評價的補充申請,20211 4日受理,並於近日獲得藥品充申請批件。

國內已有多家企業相關產品獲批上市,除公司外,江蘇奧賽康藥業有限公司、廣州一品紅製藥有限公司等企業已通過(或視同通過)一致性評價。 根據米內網數據顯示,2020注射用奧美拉唑鈉在全國公立醫療機構終端的銷售額為50億元。

截至公吿日,公司針對該藥品研發投入約418萬元人民幣(未經審計)。

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