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江蘇吳中(600200.SH):子公司注射用奧美拉唑鈉通過仿製藥一致性評價
格隆匯 09-22 15:38

格隆匯9月22日丨江蘇吳中(600200.SH)公佈,近日,公司全資子公司江蘇吳中醫藥集團有限公司下屬分支機構江蘇吳中醫藥集團有限公司蘇州製藥廠(“蘇州製藥廠”)收到了國家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》(通知書編號:2021B03107),該藥品通過仿製藥質量和療效一致性評價。

奧美拉唑鈉為質子泵抑制劑,主要用於:①消化性潰瘍出血、吻合口潰瘍出血;②應激狀態時併發的急性胃黏膜損害、非甾體類抗炎藥引起的急性胃黏膜損傷;③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;④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。

經查詢,注射用奧美拉唑鈉 2020年國內樣本醫院銷售額約為7.77億元(PDB數據庫)。截至2021年8月末,公司注射用奧美拉唑鈉項目共計已投入研發費用約為636.48萬元人民幣。

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