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FDA授予基石藥業(02616.HK)CS1003治療肝細胞癌的孤兒藥資格
格隆匯 07-24 08:52

格隆匯7月24日丨基石藥業-B(02616.HK)宣佈,美國食品和藥物管理局(“FDA”)已授予CS1003(一種靶向人程式性細胞死亡蛋白1(“PD-1”)抗體)孤兒藥資格,用於治療肝細胞癌。

孤兒藥資格認定源自孤兒藥法案,是FDA鼓勵開發用於治療罕見病創新藥的措施。凡獲得孤兒藥資格認定的新藥,有機會獲得七年市場獨佔權。除此之外,FDA對孤兒藥有税費優惠、減免處方藥使用者費用、研發資助和方案協助、快速審批通道等一系列的配套措施。

CS1003是一種PD-1的人源化重組IgG4單克隆抗體,公司正在開發以用於多種腫瘤的免疫治療。與已經獲批、或者正在臨牀試驗的大多數結合人源及猴PD-1的單克隆抗體相比,CS1003不僅能夠結合人源及鼠源PD-1,而且在同源小鼠腫瘤模型的藥效測試中,表現出獨特的競爭優勢。CS1003的I期臨牀試驗目前正在澳洲,紐西蘭和中國同步進行。同時,CS1003聯合lenvatinib一線治療治療晚期肝癌患者的全球多中心III期註冊臨牀研究也正在入組。

基石藥業董事長兼首席執行官江寧軍博士表示:“肝細胞癌是一種侵襲性極強的疾病,中國又是肝癌大國,加上缺乏有效治療藥物,導致患者整體預後較差。CS1003是基石藥業腫瘤免疫核心產品之一,目前對其已開展了多項聯合治療的臨牀研究。美國FDA授予CS1003孤兒藥資格,是對缺乏有效治療手段的肝細胞癌患者的一大福音。

基石藥業政府與註冊事務高級副總裁王三虎先生進一步表示:“CS1003是基石藥業自主研發的PD-1單克隆抗體,與已經上市和在研的PD-1抗體相比有明顯的差異化優勢。此次美國FDA孤兒藥資格認定是CS1003全球戰略佈局的一個重要進展,我們將繼續致力於在肝細胞癌這樣的複雜癌種中,探索聯合療法的有效性與安全性,以解決患者的臨牀治療之需。

據悉,PD-1全稱為細胞程式性死亡受體1,是一種主要表達在T細胞上的抑制性受體,在正常生理情形下,PD-1會通過與程式性死亡配體1(“PD-L1”)或配體2(“PD-L2”)結合來抑制T細胞的活化及細胞因子的產生,進而起到保護機體免受自身免疫系統攻擊的作用。然而,研究發現,在人類的多種實體瘤以及一些血液惡性腫瘤細胞表面上也有大量表達的PD-L1分子,腫瘤細胞可以通過這些PDL1分子與T細胞上的PD-1的結合,成功逃避機體免疫系統的識別和攻擊。PD-1或PD-L1免疫檢查點抑制劑類的抗癌藥物可以阻斷腫瘤免疫逃逸機制,恢復患者自身的免疫系統,以達到抗癌功能。

CS1003是一種PD-1的人源化重組IgG4單克隆抗體,正在開發用於多種腫瘤的免疫治療。與已經獲批或正在臨牀試驗的大多數結合人源及猴PD-1的單克隆抗體相比,CS1003不僅能夠結合人源及鼠源PD-1,而且在同源小鼠腫瘤模型的藥效測試中,表現出獨特的競爭優勢。

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