百濟神州(06160.HK):倍利妥®在中國獲批用於治療成人復發或難治性前體B細胞急性淋巴細胞白血病
格隆匯 12 月 9日丨百濟神州(06160.HK)發佈公告,百濟神州於2020年12月7日(美國東部時間)宣佈中國國家藥品監督管理局(NMPA)已批准倍利妥®(BLINCYTO®,注射用貝林妥歐單抗)用於治療成人復發或難治性(R/R)前體B細胞急性淋巴細胞白血病(ALL)。此項生物製品上市許可申請(BLA)由安進公司遞交,並被NMPA藥品審評中心(CDE)納入優先審評。倍利妥®由安進公司開發,百濟神州根據今年早先達成的全球腫瘤戰略合作獲得其在中國的授權。該上市申請獲批是倍利妥®在中國的首項獲批,也是百濟神州從安進公司授權引進產品中首款全新獲批的產品。倍利妥®也就該項獲批成為中國首款獲批的雙特異性免疫藥物。
百濟神州中國區總經理兼公司總裁吳曉濱博士評論道:“倍利妥®是首款獲批針對成人復發或難治性前體B細胞ALL的免疫療法,我們很高興有機會將這款產品帶給廣大中國患者。同時,倍利妥®是首款與化療相比在總存留期中達到優效性的免疫療法,在中國以外國家和地區開展的臨牀試驗中作為復發或難治性ALL患者的首次挽救治療,更是成功將患者的存活概率翻倍。”
吳曉濱博士補充道:“我們將繼續努力,確保可以儘快將倍利妥®帶給中國患者。公司在中國的商業團隊規模現已發展至1,500多位員工,我們很激動能夠將倍利妥®納入目前共有六款獲批癌症療法的產品羣組中。”
倍利妥®此項獲批是基於一項在中國開展的3期臨牀試驗(NCT03476239)結果,該試驗旨在評估倍利妥®在成人費城染色體陰性R/R前體B細胞ALL患者中的有效性和安全性。基於67例患者的中期分析結果表明在中國受試者中的有效性數據與在全球其他國家以及日本費城染色體陰性R/R ALL受試者中的數據相符。試驗主要終點,即接受倍利妥®兩個治療週期後的完全緩解以及血細胞部分恢復的完全緩解(CR/CRh)率為47.8%(67例患者中共有32例達到;95%CI:35.4,60.3)。中位總存留期為9.6個月(95%CI:6.4,不可估)。在中國受試者中觀察到的安全性數據與倍利妥®針對R/RALL的全球試驗數據相符。基於對中國受試者中產生的不良事件的中期分析,未出現新的安全警示。
安進公司副總裁兼安進日本亞太地區總經理柯美玲女士表示:“我們與百濟神州的合作正在不斷推動安進腫瘤管線開發,覆蓋多個仍有嚴重未被滿足醫療需求的領域。我們有信心今天在中國的獲批能有望為成人R/R前體B細胞ALL患者帶來有意義的改善。我們承諾將繼續為身患衰竭性癌症的中國患者帶來治療選擇,並通過創新型產品以及預防例如心血管疾病和脆性骨折等慢性疾病的項目,積極支持中國政府推進健康老齡化建設。”
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