四環醫藥(00460.HK):富馬酸丙酚替諾福韋片獲頒發藥品註冊批件
格隆匯2月24日丨四環醫藥(00460.HK)發佈公吿,集團附屬公司吉林四環製藥有限公司開發的抗乙型肝炎病毒藥富馬酸丙酚替諾福韋片(25毫克),獲得國家藥監局頒發的藥品註冊批件,視同通過仿製藥質量和療效一致性評價。
根據披露,富馬酸丙酚替諾福韋片是一種高效的抗乙肝藥物,用於治療成人和青少年慢性乙型肝炎,該產品在血漿中穩定性更高、靶向性更強,能更有效地傳遞到肝細胞,且因單日服用劑量小,顯著降低其副作用風險,具有抗毒作用強、耐藥率低和妊娠安全級別高的特點,具有更好的骨骼安全性和腎臟安全性。該產品屬於中國國家醫保乙類(2021年版)。
抗感染領域為集團重點佈局領域,本次富馬酸丙酚替諾福韋片(25毫克)獲頒發藥品註冊批件批准上市,將進一步惠及廣大患者,同時為集團的抗感染藥物管線再添一重磅品種,利於該產品未來的市場銷售和市場競爭,對集團的經營業績產生積極影響。
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