中國生物製藥(01177.HK):抗病毒新產品“索磷布韋片”獲藥品註冊證書
格隆匯9月1日丨中國生物製藥(01177.HK)發佈公吿,集團開發的抗病毒新產品“索磷布韋片”(商品名稱:索衞迪)已獲中國國家藥品監督管理局頒發藥品註冊證書,同品種仿製藥國內第二家獲批,且視同通過仿製藥質量和療效一致性評價。
根據披露,索磷布韋用於治療慢性丙型肝炎病毒(HCV)感染,具有泛基因型療效、臨牀治癒率高、給藥方便、無明顯副作用、病毒耐藥發生率低、重度肝病患者安全有效性高等特點。索磷布韋的出現,使丙肝徹底成為一種臨牀可治癒的疾病,目前國內外多部最新指南均推薦索磷布韋作為丙肝的一線治療藥物。
世界衞生組織提出“2030年消除病毒性肝炎作為公共衞生威脅”的目標。作為丙肝治療方案的核心藥物,索磷布韋是實現這一目標的關鍵元素之一。索衞迪的獲批,將有助於進一步減輕國內丙肝患者治療負擔,為儘早實現清除丙肝做出貢獻。
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