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中國生物製藥(01177.HK)"富馬酸丙酚替諾福韋片"獲藥品註冊證書
格隆匯 06-28 20:51

格隆匯6月28日丨中國生物製藥(01177.HK)公吿,集團開發的新型治療乙型肝炎藥物"富馬酸丙酚替諾福韋片"(商品名:晴力得)已獲中華人民共和國國家藥品監督管理局頒發藥品註冊證書。該品種按化學藥品3類申報,且視同通過仿製藥質量和療效一致性評價;獲批准的適應症為:用於成人代償性慢性乙型肝炎病毒感染的治療。

富馬酸丙酚替諾福韋是一種新型核苷類逆轉錄酶抑制劑,是富馬酸替諾福韋二吡呋酯("TDF")的升級版;用藥量只需要TDF的十分之一就能達到同樣的效果,而且較TDF具有更好的骨骼安全性和腎臟安全性。憑藉其療效確切、穩定的特性,富馬酸丙酚替諾福韋被美國肝病研究學會(AASLD)、歐洲肝病研究學會(EASL)、國內《慢性乙型肝炎防治指南(2019年版)》推薦為慢乙肝抗病毒治療的一線用藥。

乙型肝炎是全球公共衞生健康問題。它是由B型肝炎病毒("HBV")感染而引起的肝細胞壞死和炎症,能引起一系列的併發症如肝衰竭、肝硬化和肝細胞癌。中國是慢性乙型肝炎高發區,乙肝市場規模及用藥需求巨大。晴力得獲批上市,將進一步完善集團抗HBV產品線佈局,同時有利於減輕患者經濟負擔。

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