百濟神州(06160.HK)：百悦澤®在俄羅斯獲批用於治療復發或難治性套細胞淋巴瘤患者
格隆匯10月21日丨百濟神州(06160.HK)發佈公吿稱，百濟神州於2021年10月20日(美國東部時間)與Nanolek，俄羅斯的一家專營進口替代藥品與創新藥生產的生物製藥公司宣佈，百悦澤®(澤布替尼)已獲得俄羅斯衞生部批准，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。百濟神州和Nanolek已簽署獨家分銷協定，Nanolek有權在俄羅斯聯邦商業化百悦澤®。
“百悦澤®是一款新一代BTK抑制劑，它能夠改善患者的臨牀獲益，並減少脱靶副作用。百悦澤®的獲批，將為臨牀醫生與患者帶來新的選擇，有望幫助俄羅斯MCL患者得到預後更佳、耐受性更好的治療方案。”俄羅斯科學院院士，俄羅斯醫學研究生學院腫瘤學主任Irina Vladimirovna Poddubnaya教授表示。
百濟神州血液學首席醫學官黃蔚娟醫學博士表示：“此次批准再次印證了，百悦澤®作為一項潛在的「同類最優」BTK抑制劑，用於治療血液惡性腫瘤的潛力。我們很高興能為俄羅斯MCL患者帶去這一藥物。百濟神州一直致力於為全球各地的患者改善臨牀獲益，而今年截至目前為止，百悦澤®已經在包括美國、加拿大、拉丁美洲以及APAC和EMEA地區獲得了12項藥政批准。”
百濟神州俄羅斯新市場開發團隊高級總監Vitaly Sokolinsky表示：“我們期待與Nanolek一道，將這一臨牀急需的新療法帶給俄羅斯的MCL患者。百濟神州正在俄羅斯、歐洲等地區積極拓展，將我們的專業經驗和成果帶向全球更多的新市場，此次百悦澤®在俄羅斯取得MCL的獲批，正是這些工作成果的有力體現。”
Nanolek公司總裁Vladimir Khristenko表示：“此次的獲批是為患者謀求福祉的重要里程碑，我們為此感到自豪。我們期待通過與百濟神州的強強聯手，推動百悦澤®惠及全球患者。我們雙方將通力協作，為俄羅斯的癌症患者提供創新療法。”
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