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CASI宣布注射用盐酸美法仑(迈维宁® )在中国正式上市


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




关于CASI

英创远达制药(纳斯达克股票代码:CASI)一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国患者提供先进的疾病治疗方案。公司总部位于美国马里兰州罗克韦尔市,在北京和江苏省无锡市设有全资子公司及生产和研发中心。公司目前产品及研发管线覆盖了多发性骨髓瘤、B细胞非霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。我们与全球各大关注血液病的科研机构建立了联系,力求以最快的速度将突破性科研成果进行商业转化。未来CASI将持续加大研发和新药引进的投入,延长患者的生命,成为医生的合作伙伴。



Forward-Looking Statements

 

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals.  Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed.  Actual results could differ materially from those currently anticipated due to a number of factors, including: the difficulty of executing our business strategy in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the FDA, NMPA, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the volatility in the market price of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with CID-103, CNCT19, and our product candidates; risks associated with CID-103, CNCT19, and our other early-stage products under development; risks that results in preclinical and early clinical models are not necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; and our dependence on third parties.  Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition.  We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.