李氏大藥廠(00950.HK)治療晚期霍奇金淋巴瘤藥物Natulan®新藥上市申請獲受理
格隆匯5月8日丨李氏大藥廠(00950.HK)宣佈，於2020年4月28日，公司全資附屬公司李氏香港的Natulan®新藥上市申請已獲國家藥監局受理，該藥物乃用於治療晚期霍奇金淋巴瘤("HL")。預期集團將於2020年5月底前提交新藥申請的優先審評申請。
驗證性研究(NCT02800447)為一項開放、隨機、受控及多中心研究，乃由中國13個以上試驗單位主導。該項研究旨在觀察及比較BEACOPP(包括博來黴素、依託泊苷、鹽酸阿黴素(阿黴素)、環磷酰胺、長春新礆、丙卡巴肼及潑尼鬆的聯合化療)基線方案組及ABVD(包括鹽酸阿黴素(阿黴素)、博來黴素、長春礆及達卡巴嗪的聯合化療)治療方案組對晚期HL患者的客觀緩解率，並評估將Natulan®用於治療中國晚期HL患者的安全性。合共93名晚期HL患者參與研究，而研究結果不僅與其主要最終目標匹配(即BEACOPP基線方案組的客觀緩解率並不遜色於ABVD方案組)，且於完成四個週期的治療後，BEACOPP基線方案組(每個週期21天)患者的完全緩解率亦顯著提高至16.22%(6/37)，而ABVD方案組(每個週期28天)則為2.17%(1/46)。
據悉，HL為淋巴系統的癌症，可影響淋巴結、脾臟、骨髓及其他內部器官。HL為兩種常見淋巴系統癌症之一。根據GLOBOCAN資料庫，中國於2018年新增約5,007宗HL病例。李氏香港已於2018年五月與Leadiant Biosciences Ltd簽署經銷協議，以使Natulan®於大中華地區獨家上市。
聯合化療中的Natulan(鹽酸丙卡巴肼膠囊)適用於治療HL及部分腦癌(例如多形性膠質母細胞瘤)。其屬於其中一種烷化劑藥物，最初由Hoffmann-La Roche研發並首先申請了專利，闡明其製備工藝及用途。該藥物(Matulane®)已於1969年7月獲得美國食品及藥物管理局的批准。
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