百时美施贵宝血液病创新药Luspatercept上市申请获CDE优先审评

2021-02-04 MedSci MedSci

2021年2月4日,百时美施贵宝中国宣布,其红细胞成熟剂Luspatercept(英文商品名Reblozyl;自拟中文通用名:注射用罗特西普;自拟中文商品名:利布洛泽)的上市申请已获CDE正式受理。

2021年2月4日,百时美施贵宝中国宣布,其红细胞成熟剂Luspatercept(英文商品名Reblozyl;自拟中文通用名:注射用罗特西普;自拟中文商品名:利布洛泽)的上市申请已获国家药品监督管理局药品审评中心(CDE)正式受理并被授予优先审评资格,用于需要定期输注红细胞(RBC)的成人β-地中海贫血患者。
 
“自2018年以来,我们有幸见证‘中国新药速度’被不断刷新。我们由衷感谢中国政府对优化药品审评审批、加速临床亟需药物研发的创新政策支持。” 百时美施贵宝全球研发副总裁、中国区研发负责人蔡学钧博士表示,“Luspatercept是百时美施贵宝中国首个向CDE提交境外临床试验数据后被纳入优先审评的血液病创新药。我们相信该创新药将填补中国地中海贫血药物治疗的空白,改变患者生命。”
 
终身输血难以保障,地贫治疗困局待解

 
β-地中海贫血是一类由于β珠蛋白肽链合成减少或缺乏而引起的以贫血为特征的遗传性血液病。重度β-地中海贫血是一种呈慢性进行性溶血性贫血的罕见疾病。患者目前依赖于终身输血、祛铁治疗或造血干细胞移植来维持生命。
 
但现实中,中国重型β-地中海贫血治疗正面临多重困境。血源紧张、血制品供应不稳定,且长期输血可导致患者铁超负荷、经济负担加重和潜在感染风险,这些都使得终身输血难以保障。广大患者对于创新药的需求迫在眉睫。
 
全球首创作用机制,“手”护中国患者生命
 
Luspatercept的出现将有望打破中国β-地中海贫血的治疗困局。作为一种全球首个的重组融合蛋白类药物,Luspatercept通过促进晚期红细胞的成熟,提高血红蛋白水平。
 
它的全新机制将有望降低患者对输血及祛铁治疗的依赖,提高治疗依从性,同时还能规避反复输血引起的潜在风险,比如长期铁过载导致铁元素沉积于心脏、肝脏等,继而引发心功能衰竭、肝硬化等,甚至死亡。
 
根据本次Luspatercept纳入优先审评所基于的一项名为BELIEVE的全球III期临床研究,经Luspatercept治疗后,有21.4%的患者的输血负担与基线相比降低超过33%,显著优于安慰剂组(4.5%),且患者铁过载显著降低,由此可能改善患者生活质量。
 
“此次Luspatercept被纳入优先审评也标志着百时美施贵宝‘中国战略2030’的顺利推进。” 百时美施贵宝全球研发副总裁、中国区研发负责人蔡学钧博士表示,“随着‘中国战略2030’于近期正式落地,我们致力于成为肿瘤、血液学、免疫学等核心治疗领域的领导者。未来5年,我们将加速引进近30个创新药或适应症。它们多数具有潜力成为相关领域的首个(first-in-class)或最佳(best-in-class)产品。我们将以实际行动‘引领科学,改变患者生命’,助推‘健康中国2030’国家战略的实施。”

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    2021-08-09 gostraight
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    2021-04-29 jktdtl
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