百濟神州(06160.HK)和NewBridge宣佈百悦澤®在沙特獲批用於治療復發或難治性套細胞淋巴瘤患者
格隆匯11月15日丨百濟神州(06160.HK)和NewBridge Pharmaceuticals(一家專業性公司，致力於在中東與北非地區(MENA)通過與全球性製藥和生物科技企業合作，為藥品准入建立紐帶)於2021年11月15日共同宣佈，百悦澤®(澤布替尼)已獲得沙特食品藥品監督管理局(SFDA)批准，用於治療既往接受過至少一種治療的套細胞淋巴瘤(MCL)成人患者。此次獲批後，百濟神州將繼續與NewBridge Pharmaceuticals共同努力，為沙特阿拉伯及其他MENA地區的臨牀醫生與MCL患者帶來百悦澤®。
沙特阿拉伯王國國民衞隊衞生事務部門血液學負責人Ahmad Absi博士表示："非霍奇金淋巴瘤是沙特阿拉伯癌症發病和致死的主要原因之一，罹患MCL等淋巴瘤的患者醫療需求遠未得到滿足。百悦澤®是新一代BTK抑制劑，能夠改善在同類藥物中普遍存在的耐受性問題，同時其有效性已在用於復發或難治性MCL患者的臨牀試驗中得到證實。"
百濟神州MENA新市場高級總監Mohammed Al-Kapany表示："我們很高興沙特阿拉伯的MCL患者馬上就可以用得上百悦澤®-這樣一款具備'同類最佳'潛力的BTK抑制劑。在百濟神州的理念-百創新藥，濟世惠民-的驅動下，我們致力於為所有存在需求的患者提供切實有效的創新藥物。隨着百悦澤®在沙特阿拉伯以及今年早些時候在阿聯酋的獲批，我們正在與NewBridge Pharmaceuticals繼續合作，將百悦澤®帶給MENA地區的更多患者。這也印證了百濟神州鋭意創新的價值觀，我們為全球患者許下承諾，並正在將其逐一兑現。"
NewBridge Pharmaceuticals總裁兼首席執行官Joe Henein評論道："百悦澤®在沙特阿拉伯的獲批是我們與百濟神州持續合作的一項重要里程碑。目前，隨着這款具有差異化的BTK抑制劑在MENA地區的兩個市場相繼獲批，我們能夠為更多的MCL患者提供新的治療方案。"
百悦澤®的推薦劑量為160mg每日兩次或320mg每日一次，空腹或餐後口服均可。用藥劑量可根據不良反應調整，重度肝損害和正在服用與百悦澤®存在潛在藥物相互作用的患者可降低劑量。
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