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中國生物製藥(01177.HK)治療乙型肝炎藥物“阿德福韋酯膠囊”獲通過一致性評價
格隆匯 08-04 17:02

格隆匯 8 月 4日丨中國生物製藥(01177.HK)發佈公告,集團的治療乙型肝炎藥物“阿德福韋酯膠囊”(商標名:名正)已獲得國家藥品監督管理局頒發藥品補充申請批准通知書,成為同品種首個通過仿製藥質量和療效一致性評價的產品。名正的適應症為用於治療有乙型肝炎病毒活動複製證據,並伴有血清氨基酸轉移酶持續升高或肝臟組織學活動性病變的肝功能代償的成年慢性乙型肝炎患者。

阿德福韋酯是阿德福韋的前體,在體內水解為阿德福韋發揮抗病毒作用。阿德福韋酯是目前國內乙肝抗病毒藥物中交叉耐藥較少的藥物,因此也被用於與其他藥物的聯合治療。隨着拉米夫定耐藥率的逐漸遞增,阿德福韋酯已逐漸替代拉米夫定成為治療乙肝的一線藥物。

名正於2006年獲批上市,近年銷售一直保持穩定。通過了仿製藥一致性評價,名正作為本地生產的阿德福韋酯膠囊被正式認可可作為原研藥的替代,為患者提供更多優質低價的用藥選擇。

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