百濟神州(06160.HK)在EHA線上年會上公佈澤布替尼和替雷利珠單抗臨牀數據
格隆匯 6 月 16日丨百濟神州(06160.HK)發佈公告,公司於2020年6月12日宣佈在第25屆歐洲血液學協會(EHA)線上年會上公佈BTK抑制劑百悦澤®(澤布替尼)用於治療復發╱難治性(R/R)邊緣區淋巴瘤(MZL)和其他B細胞惡性腫瘤以及抗PD-1抗體百澤安®(替雷利珠單抗)用於治療R/RNK/T細胞淋巴瘤的數據。本次EHA線上年會於2020年6月11日至14日舉行。
百濟神州血液學首席醫學官黃蔚娟醫學博士表示:“我們很高興能在今年的EHA年會上和大家分享公司廣泛開發專案中多項臨牀試驗的結果。澤布替尼在包括R/RMZL在內的多項適應症中展示了令人欣慰的有效性和安全性。一項用於治療R/RMZL患者的潛在註冊性2期臨牀試驗目前已完成患者入組,我們也期待能儘快看到這項試驗的數據。”
據悉,百澤安®(替雷利珠單抗)是一款人源化lgG4抗程式性死亡受體1(PD-1)單克隆抗體,設計目的是為最大限度地減少與巨噬細胞中的FcγR受體結合。臨牀前數據表明,巨噬細胞中的FcγR受體結合之後會啟動抗體依賴細胞介導殺傷T細胞,從而降低了PD-1抗體的抗腫瘤活性。替雷利珠單抗是第一款由百濟神州的免疫腫瘤生物平台研發的候選藥物,目前正進行單藥及聯合療法臨牀試驗,開發一系列針對實體瘤和血液腫瘤的廣泛適應症。
百澤安®已獲得國家藥品監督管理局(NMPA)批准用於治療至少經過二線系統化療的復發或難治性經典型霍奇金淋巴瘤患者,以及獲批用於治療PD-L1高表達的含鉑化療失敗包括新輔助或輔助化療12個月內進展的局部晚期或轉移性尿路上皮癌患者。此外,國家藥品監督管理局藥品審評中心(CDE)已受理公司抗PD-1抗體藥物百澤安®(替雷利珠單抗注射液)聯合兩項化療方案用於治療一線晚期鱗狀非小細胞肺癌(NSCLC)患者的新適應症上市申請(sNDA)。
目前共有15項百澤安®的註冊性臨牀試驗在中國和全球範圍內開展,其中包括11項3期臨牀試驗,4項關鍵性2期臨牀試驗。
根據披露,百濟神州是一家全球性、商業階段的生物科技公司,專注於研究、開發、生產以及商業化創新性藥物以為全世界患者提高療效和藥品可及性。百濟神州目前在中國大陸、美國、澳大利亞和歐洲擁有3800多名員工,正在加速推動公司多元化的新型癌症療法藥物管線。目前,百濟神州兩款自主研發的藥物,BTK抑制劑百悦澤®(澤布替尼膠囊)正在美國和中國進行或計劃進行銷售、抗PD1抗體藥物百澤安®(替雷利珠單抗注射液)在中國進行銷售。此外,百濟神州在中國正在或計劃銷售多款由安進公司、新基物流有限公司(隸屬百時美施貴寶公司)以及EUSAPharma授權的腫瘤藥物。
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