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CASI宣布注射用鹽酸美法侖(邁維寧? )在中國正式上市

2019年8月12日—CASI制藥(納斯達克股票代碼:CASI)宣布旗下第一款商業化產品邁維寧? (注射用鹽酸美法侖)正式在華上市。


國家藥品監督管理局于2018年11月批準邁維寧? (注射用鹽酸美法侖) 上市,用于多發性骨髓瘤患者造血干細胞移植前的高劑量預處理治療,和不適合口服劑型治療的多發性骨髓瘤患者的姑息治療。邁維寧?是中國市場上唯一的注射用美法侖產品。


CASI董事長兼首席執行官何為無博士表示:“這對CASI而言是值得驕傲的時刻!我們將與醫院和醫生共同努力,來面對患者的切實治療需求,盡我們所能滿足患者的藥物可及性。邁維寧?的上市也標志著CASI公司正式進入全面商業運營階段。我們十分期待未來在血液腫瘤領域上市一個個新產品,滿足未被滿足的醫療需求?!?/span>



關于多發性骨髓瘤


多發性骨髓瘤是一種惡性血液病,其特征在于骨髓中克隆漿細胞的異常增殖,和在血清或尿液中可檢測到的單克隆免疫球蛋白的分泌。多發性骨髓瘤占血液系統惡性腫瘤的10-13%1,2,在西方國家,估計發病率為每10萬人5.6例2。中國多發性骨髓瘤的估計發病率為每100,000人約2.0例3,估計年發病人數約為27,800人3。中國多發性骨髓瘤患者適合大劑量化療聯合自體造血干細胞移植的候選人數約為16,900 /年。 目前在中國接受造血干細胞移植的多發性骨髓瘤患者人數估計約為800 /年。大劑量化療聯合自體干細胞移植(ASCT)已被證明可提高多發性骨髓瘤患者的完全緩解率并延長中位總生存期,并被認為是符合移植要求患者的標準治療方案1,3。ASCT的優選預處理方案是美法侖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




關于CASI

凱信遠達醫藥(納斯達克股票代碼:CASI)一家美國納斯達克上市的生物醫藥公司,致力于在血液腫瘤領域為中國患者提供先進的疾病治療方案。公司總部位于美國馬里蘭州羅克韋爾市,在北京和江蘇省無錫市設有全資子公司及生產和研發中心。公司目前產品及研發管線覆蓋了多發性骨髓瘤、B細胞非霍奇金淋巴瘤、急性淋巴細胞白血病等多個疾病領域。我們與全球各大關注血液病的科研機構建立了聯系,力求以最快的速度將突破性科研成果進行商業轉化。未來CASI將持續加大研發和新藥引進的投入,延長患者的生命,成為醫生的合作伙伴。



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.


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