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金城醫藥(300233.SZ):子公司收到藥品GMP符合性檢查結果
格隆匯 10-26 23:15

格隆匯10月26日丨金城醫藥(300233.SZ)公佈,公司全資子公司山東金城崑崙藥業有限公司(以下簡稱"崑崙藥業")於近日收到山東省藥品監督管理局下發的《藥品GMP符合性檢查結果通知書》,其申報的原料藥枸櫞酸託法替布已通過《藥品生產質量管理規範》符合性檢查(即GMP符合性檢查)。

託法替布是一種酪氨酸激酶(JAKs)抑制劑,主要適用於治療對甲氨蝶呤反應不佳或不能耐受的中度至重度活動性類風濕性關節炎成年患者。可用於單藥治療或與甲氨蝶呤或其他非生物製品類改善症狀型抗風濕藥物(DMARDs)聯用。

枸櫞酸託法替布由美國輝瑞公司研發,製劑枸櫞酸託法替布片於2012年首次在美國獲得上市批准,此後在日本、歐盟等國家及地區上市。IMS數據顯示,2020年~2022年枸櫞酸託法替布製劑全球銷售額分別為38.3億美元、41億美元、37億美元。公司枸櫞酸託法替布原料藥於2021年1月申報註冊,2023年7月4日獲得了國家藥品監督管理局下發的《化學原料藥上市申請批准通知書》,該原料藥在CDE原輔包登記信息平台上顯示狀態為"A"。近日枸櫞酸託法替布順利通過GMP符合性檢查,並獲得了《藥品GMP符合性檢查結果通知書》。目前,國內擁有枸櫞酸託法替布原料藥的企業主要有四川科倫藥業股份有限公司、浙江海正藥業股份有限公司、南京正大天晴製藥有限公司等。

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