百濟神州(06160.HK)：NMPA批准百悦澤®(澤布替尼)用於治療復發或難治性華氏巨球蛋白血癥患者
格隆匯6月21日丨百濟神州(06160.HK)於2021年6月18日(美國東部時間)宣佈，中國國家藥品監督管理局(NMPA)已授予百悦澤®(澤布替尼)附條件批准，用於治療既往至少接受過一種治療的成人華氏巨球蛋白血癥(WM)患者。NMPA藥品審評中心(CDE)於2020年10月將這項新適應症上市許可申請納入優先審評。
百濟神州總裁、首席運營官兼中國區總經理吳曉濱博士表示：“WM是一種目前仍無法治癒的血液惡性腫瘤，可能對患者的生命和生活品質帶來嚴重威脅。國家藥監局批准我們的新型BTK抑制劑百悦澤®在該適應症中的上市許可，使得我們能夠為患者、他們的家人與廣大臨牀醫生帶來一項治療WM的新選擇，這讓我們倍感自豪。此次獲批也標誌着百悦澤®在中國取得第三項針對B細胞惡性腫瘤的批准，我們相信，它將在滿足全球血液腫瘤患者尚未被滿足的醫療需求中，發揮重要作用。”
中國醫學科學院血液病醫院淋巴瘤診療中心主任，同時也是百悦澤®在WM的關鍵性臨牀試驗BGB-3111-210研究的主要研究者邱錄貴教授表示：“罹患WM的多為老年患者，對於這類疾病，維持較長時間的治療可能有助於改善預後效果，但這同時也使得耐受性與安全性成為臨牀上需要格外重視的問題。此前公佈的研究結果表明，百悦澤®能夠降低患者發生心血管相關不良反應的風險，併產生深度和持久的疾病緩解，我很欣慰百悦澤®在WM中取得批准，將為更多中國患者帶來獲益。”
百濟神州血液學首席醫學官黃蔚娟醫學博士表示：“百悦澤®由百濟神州的科學家們進行了特殊設計，經過優化，減少了過去在第一代BTK抑制劑中觀察到的脱靶效應。公司已經開展了廣泛的臨牀開發專案來評估百悦澤®的臨牀獲益，包括ASPEN研究這項頭對頭臨牀試驗。我們衷心感謝所有參與試驗的患者和臨牀醫生，並希望隨着百悦澤®全球註冊的推進，能夠進一步提升這款藥物對於WM和其他血液系統惡性腫瘤患者的可及性。”
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