萬邦德(002082.SZ):獲得富馬酸丙酚替諾福韋請批准通知書
格隆匯3月1日丨萬邦德(002082.SZ)公佈,公司全資子公司萬邦德製藥集團有限公司於近日收到國家藥品監督管理局核准簽發的富馬酸丙酚替諾福韋《化學原料藥上市申請批准通知書》。
丙酚替諾福韋是替諾福韋的一種亞磷酰胺藥物前體,在原代肝細胞內丙酚替諾福韋主要通過羧酸酯酶1進行水解以形成替諾福韋,替諾福韋對乙型肝炎病毒和人類免疫缺陷病毒(HIV-1和HIV-2)有特異性活性,通過抑制乙肝病毒逆轉錄酶的活性,從而阻斷乙肝病毒的複製過程,減輕肝臟的驗證反應,為抗病毒藥。
富馬酸丙酚替諾福韋製劑主要用於治療成人和青少年(年齡12歲及以上,體重至少為35kg)慢性乙型肝炎(HBV)。根據美國AASLD《慢性乙型肝炎預防、診斷和治療(2018年)》、中華醫學會《慢性乙型肝炎基層診療指南(2020年)》、《慢性乙型肝炎防治指南(2019年版)》等國內外權威指南均推薦富馬酸丙酚替諾福韋製劑作為治療慢性乙型肝炎的首選藥物之一。
國家藥品監督管理局數據顯示,目前國內有32家生產單位取得了富馬酸丙酚替諾福韋製劑的批准文號。根據米內網數據,2022年富馬酸丙酚替諾福韋製劑在國內銷售收入約16.5億元。
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