CASI Pharmaceuticals Announces China NMPA Approval Of CNCT19 (CD19 CAR-T) Clinical Trial Applications

ROCKVILLE, Md. and BEIJING, Dec. 3, 2019 /PRNewswire/ -- CASI Pharmaceuticals, Inc. CASI, a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announces that the China National Medical Product Administration (NMPA), has approved the clinical trial applications for CNCT19 (CD19 CAR-T) in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) submitted by its partner Juventas Cell Therapy Ltd., a biopharmaceutical company focused on cell therapy (Juventas).  CASI previously reported its acquisition of exclusive worldwide commercial rights to CNCT19 from Juventas. Juventas has responsibility for the clinical development of CNCT19.

Larry Zhang, CASI's President, commented, "This is a very exciting milestone for CASI.  CAR-T therapies were first approved in the United States in 2017; there are currently no CAR-T therapies marketed in China.  CNCT19 will be manufactured in China at a cost significantly less than the cost of imported therapies, which ultimately enables us to make it more widely available to the Chinese patient population.  We expect to start enrolling patients in early 2020."

About CNCT19
CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19-targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma.  CASI holds the worldwide commercial rights to CNCT19. Juventas is responsible for the development of CNCT19 with CASI's participation on the program's steering committee.

About Juventas
Juventas Cell Therapy Ltd. is a China-based domestic biopharmaceutical company established in 2018 focused on R&D, clinical translation and commercialization of innovative immune cell therapy.  Juventas' R&D operations are based in Beijing and its GMP facility is located in Tianjin City.  More information on Juventas and its pipeline is available at www.juventas.cn.

About CASI Pharmaceuticals
CASI is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, with a product portfolio that includes approved and investigational assets. The Company recently launched its first commercial product EVOMELA^® (Melphalan for Injection) in China and has a pipeline that includes (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed for the treatment of B-ALL and B-NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of CD38 positive hematological malignancies; (iii) exclusive greater China rights to two U.S. Food and Drug Administration (FDA)-approved hematology oncology drugs, consisting of ZEVALIN^® (Ibritumomab Tiuxetan) and MARQIBO^® (Vincristine Sulfate Liposome Injection); (iv) China rights to an octreotide long acting injectable (LAI) microsphere formulation indicated for the treatment of certain symptoms associated with particular neuroendocrine cancers and acromegaly. In addition, the Company also maintains a portfolio of FDA-approved ANDAs and are currently assessing the development plan in China for a select subset.  More information on CASI is available at www.casipharmaceuticals.com.

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 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.

EVOMELA^®,  Zevalin^® and Marqibo^® are proprietary to Acrotech Biopharma LLC and its affiliates.

SOURCE CASI Pharmaceuticals, Inc.