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復星醫藥(600196.SH):雙氫青蒿素磷酸哌喹分散片及雙氫青蒿素磷酸哌喹片通過WHO PQ認證
格隆匯 11-21 16:56

格隆匯11月21日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司桂林南藥股份有限公司(“桂林南藥”)研製的雙氫青蒿素磷酸哌喹分散片、雙氫青蒿素磷酸哌喹片(“該等產品”)通過WHO Prequalification(即世界衞生組織藥品預認證,“WHO PQ認證”)。

1、產品名稱:雙氫青蒿素磷酸哌喹分散片

規格:20mg/160mg、40mg/320mg

申請人:桂林南藥

2、產品名稱:雙氫青蒿素磷酸哌喹片

規格:40mg/320mg、80mg/640mg

申請人:桂林南藥

該等產品為集團(即公司及控股子公司/單位,下同)自主研發的雙氫青蒿素磷酸哌喹產品,為抗瘧藥品。2018年度,桂林南藥該等產品於全球的銷售額摺合人民幣約1,635萬元(未經審計)。此次通過認證的品種之一“雙氫青蒿素磷酸哌喹分散片”為首個適用於兒童的雙氫青蒿素磷酸哌喹類劑型。

瘧疾高發於非洲等地區,目前青蒿素類抗瘧藥品主要由WHO(即世界衞生組織,下同)全球基金、政府基金等採購。於全球上市的青蒿素類抗瘧藥品主要包括用於一般瘧疾治療的青蒿素類複方口服藥物(如蒿甲醚苯芴醇、青蒿琥酯阿莫地喹、青蒿琥酯甲氟喹、青蒿琥酯、磺胺多辛乙胺嘧啶和雙氫青蒿素磷酸哌喹)和用於重症瘧疾治療的青蒿素類注射劑(如注射用青蒿琥酯和蒿甲醚)。根據WHO2018年《世界瘧疾報告》,據估計,2010年至2017年,各國共採購27.4億人份青蒿素類複方藥物。

截至2019年10月,集團現階段針對該等產品累計研發投入人民幣約2396萬元(未經審計)。

WHO全球基金旨在為發展中國家和地區提供藥品援助(其中包括抗瘧藥品)。此次通過WHO PQ認證,標誌着桂林南藥該等產品已符合WHO全球基金的採購標準,並被納入WHO推薦採購清單。

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