國藥現代(600420.SH):國藥江蘇威奇達硫酸阿巴卡韋原料藥獲得CPQ證書
格隆匯12月13日丨國藥現代(600420.SH)公佈,近日,公司全資孫公司江蘇威奇達藥業有限公司(簡稱“國藥江蘇威奇達”)收到世界衞生組織(簡稱“WHO”)出具的PQ(預認證)確認函(Confirmation of WHO Active Pharmaceutical Ingredient Prequalification[CPQ])(簡稱“CPQ證書”)。藥品名稱:Abacavir Sulfate/硫酸阿巴卡韋;藥品劑型:原料藥;證書編號:WHOAPI-377。
硫酸阿巴卡韋主要適用於人類免疫缺陷病毒(HIV)感染的成人,進行抗逆轉錄病毒的聯合治療。
目前,硫酸阿巴卡韋原料藥國內主要生產廠商有國藥江蘇威奇達、湖北恆景瑞化工有限公司、陝西林奈生物化工有限公司等。根據PDB數據,2021年阿巴卡韋原料全球消耗量約為9.86萬kg。
國藥江蘇威奇達於2019年1月向WHO提交硫酸阿巴卡韋原料藥的PQ認證申請,於2022年12月獲得CPQ證書。國藥江蘇威奇達用於該產品研發投入累計約1424萬元人民幣(未經審計)。
該次國藥江蘇威奇達硫酸阿巴卡韋原料藥獲得CPQ證書,表明該產品符合WHO對該品種的質量要求,顯示規範市場對國藥江蘇威奇達該產品質量的認可和肯定,標誌着國藥江蘇威奇達該原料藥產品可以在規範市場及註冊優先CPQ證書的市場進行銷售。也為公司各項產品不斷走入國際市場帶來積極影響。
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