2019年8月12日—CASI制药(纳斯达克股票代码:CASI)宣布旗下第一款商业化产品迈维宁® (注射用盐酸美法仑)正式在华上市。
国家药品监督管理局于2018年11月批准迈维宁® (注射用盐酸美法仑) 上市,用于多发性骨髓瘤患者造血干细胞移植前的高剂量预处理治疗,和不适合口服剂型治疗的多发性骨髓瘤患者的姑息治疗。迈维宁®是中国市场上唯一的注射用美法仑产品。
CASI董事长兼首席执行官何为无博士表示:“这对CASI而言是值得骄傲的时刻!我们将与医院和医生共同努力,来面对患者的切实治疗需求,尽我们所能满足患者的药物可及性。迈维宁®的上市也标志着CASI公司正式进入全面商业运营阶段。我们十分期待未来在血液肿瘤领域上市一个个新产品,满足未被满足的医疗需求。”
关于多发性骨髓瘤
多发性骨髓瘤是一种恶性血液病,其特征在于骨髓中克隆浆细胞的异常增殖,和在血清或尿液中可检测到的单克隆免疫球蛋白的分泌。多发性骨髓瘤占血液系统恶性肿瘤的10-13%1,2,在西方国家,估计发病率为每10万人5.6例2。中国多发性骨髓瘤的估计发病率为每100,000人约2.0例3,估计年发病人数约为27,800人3。中国多发性骨髓瘤患者适合大剂量化疗联合自体造血干细胞移植的候选人数约为16,900 /年。 目前在中国接受造血干细胞移植的多发性骨髓瘤患者人数估计约为800 /年。大剂量化疗联合自体干细胞移植(ASCT)已被证明可提高多发性骨髓瘤患者的完全缓解率并延长中位总生存期,并被认为是符合移植要求患者的标准治疗方案1,3。ASCT的优选预处理方案是美法仑1。
1. S. Rajkumar, Mayo Clin Proc. 2016 January; 91(1): 101–119
2. A. Palumbo, N Engl J Med, 2011; 364: 1046-60
3. J. Lu, Blood Cancer Journal (2014) 4, e239; doi:10.1038/bcj.2014.55
Forward-Looking Statements
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