廣生堂(300436.SZ):乙肝治療一線用藥富馬酸丙酚替諾福韋片(TAF)生產註冊獲受理
格隆匯11月4日丨廣生堂(300436.SZ)宣佈,公司已完成富馬酸丙酚替諾福韋片(TAF)與原研藥品的體外質量與體內療效的一致性評價,即與原研藥體外藥學質量一致且人體生物等效。公司已向國家藥品監督管理局藥品審評中心遞交了生產註冊申請,並於2019年11月4日收到國家藥品監督管理局下發的《受理通知書》。
有着“史上最強乙肝藥物”之稱的富馬酸丙酚替諾福韋(TAF)是治療成人和青少年慢性乙型肝炎的抗病毒強效藥,25mg劑量的TAF治療慢性乙型肝炎的療效即與300mg劑量的富馬酸替諾福韋二吡呋酯(TDF)相當,且具有更好的骨骼安全性和腎臟安全性。富馬酸丙酚替諾福韋片是美國FDA十年來批准的唯一一款乙肝新藥。富馬酸丙酚替諾福韋片(TAF)、富馬酸替諾福韋二吡呋酯(TDF)、恩替卡韋(ETV)同屬核苷(酸)類藥物,並列全球乙肝治療指南三大一線用藥,但仍未能實現以停藥為目的的功能性治癒乙肝,要實現功能性治癒乙肝必須另闢蹊徑,這也是廣生堂開發非核苷(酸)類的新靶點全球乙肝創新藥GST-HG141、GST-HG131和GST-HG121的意義所在。
公司富馬酸丙酚替諾福韋(TAF)若成功獲批上市,將為中國乙肝患者提供更多更好的用藥選擇,造福廣大乙肝患者,同時將進一步完善公司抗乙肝病毒藥物產品線,為乙肝功能性治癒提供更多的組合方案,有力提升公司市場競爭力。
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