中國生物製藥(01177.HK)治療愛滋病藥物“恩曲他濱替諾福韋片”獲藥品註冊批件
格隆匯6月9日丨中國生物製藥(01177.HK)發佈公告,集團開發的治療愛滋病藥物“恩曲他濱替諾福韋片”(商品名稱:克艾可)已獲得國家藥品監督管理局頒發藥品註冊批件,為該品種仿製藥國內首家獲批,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:與其他抗逆轉錄病毒藥物聯用,治療成人和12歲(含)以上兒童的HIV-1(人類免疫缺陷病毒-1型)感染。
恩曲他濱替諾福韋片含兩種活性成份-恩曲他濱和富馬酸替諾福韋二吡夫酯,均為高效抗逆轉錄病毒藥物。恩曲他濱替諾福韋片為單一片劑,具有治療簡化、療效顯著、患者給藥順應性高、耐藥性低等特點,已被納入二零一七年版國家醫保目錄。
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