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CASI获得抗CD19 T细胞治疗产品全球独家商业权益

CASI Pharmaceuticals, Inc. (纳斯达克股票代码:CASI) 是一家美国纳斯达克上市的生物医药公司,在中国、美国及世界其他地区拥有药物开发、产品加速上市和创新疗法探索平台。CASI宣布与合源生物科技(天津)有限公司(以下简称“合源生物”)正式签署许可协议,获得其CNCT19项目全球独家商业权益。CNCT19 是自体抗CD19 T细胞治疗产品,由合源生物开发。此后,合源生物将继续开展CNCT19项目的研发工作,CASI将加入项目指导委员会。在未来,CASI将根据协议,在项目研发进展到重大里程碑阶段后,向合源生物支付相关费用;进入商业化阶段后根据约定向合源生物支付销售分红。与此协议相关联的凯信远达医药(无锡)有限公司是一家CASI占股80%的合资公司将通过旗下一家全资子公司向合源生物投资人民币八千万圆(约合一千一百六十万美圆)作为预付款。

CNCT19针对的CD19靶点是一种广泛表达于 B 细胞活化与增殖的重要膜抗原之一,是所有B细胞共有的表面标志物,也是 B 淋巴细胞系统恶性血液病的有效靶点。来自不同科研机构的以CD19为靶点的嵌合抗原受体(CAR)在儿童及成人复发型B 细胞急性淋巴细胞白血病( B-ALL )、慢性淋巴细胞白血病( CLL )和 B 细胞非霍奇金淋巴瘤( B-NHL )中表现出持续有效的抗肿瘤疗效。CD19在 CAR-T 治疗白血病、淋巴瘤等血液恶性肿瘤的临床试验中是最常用的生物标志物。合源生物已经向 国家药品监督管理局提交了两个 IND,分别用于急性淋巴细胞白血病( ALL )和非霍奇金淋巴瘤( NHL )适应症;预计将于2019年底获得批准。

CASI中国区总裁张炜博士表示“与合源生物的合作令人振奋,初步的数据似乎预示着CNCT19将会是NHL和ALL T细胞治疗领域疗效最好的产品。能够推动细胞治疗的创新和发展,为恶性血液肿瘤患者提供解决方案,我们为此项投资感到兴奋!我们期待与合源生物的专家一起推进临床研发,CASI也将做好项目商业化的准备工作。”

CASI首席医学官Alexander Zukiwski表示“合源生物在临床注册方面已经完成了大量的工作,已经递交了ALL和NHL两个IND申请,并且已经确认了一期和二期临床试验参与的中心。一旦获得临床试验批准,临床项目可立即开展。”

关于CASI

CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and accelerating the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world. CASI’s product pipeline features (i) an autologous anti-CD19 t-cell therapy product (CNCT19) being developed for the treatment of B-ALL and NHL; (ii) an anti-CD38 monoclonal antibody being developed for the treatment of multiple myeloma and other CD38 positive hematological cancers (CID-103); (iii) China rights to three U.S. Food and Drug Administration (FDA)-approved drugs (EVOMELA® (melphalan hydrochloride for injection) approved by China’s National Medical Products Administration (NMPA) for marketing, ZEVALIN®(ibritumomab tiuxetan) and MARQIBO® (vincristine sulfate LIPOSOME injection) approved by NMPA for registration confirmatory trials in China; and (iv) a portfolio of FDA-approved and pending abbreviated new drug applications (ANDAs). CASI has offices in Rockville, Maryland and a wholly owned subsidiary in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com.


关于合源生物(Juvantas)

Juventas Cell Therapy is a China-based domestic company located in Tianjin City, China engaged in cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat cancer patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma. Through its commercial collaboration with CASI, Juventas intends to be the first domestic company to launch a CD19 CAR-T in China. Wei-Wu He Ph.D. is the chairman and a founding shareholder of Juventas. A committee of independent directors of CASI negotiated the terms of the investment and license agreements and recommended that the board of directors approve the transaction. Dr. He did not participate in the committee’s deliberations or the board of directors’ approval of the transaction.