China NMPA Accepts Clinical Trial Application For CASI's CD19 CAR-T-Product

ROCKVILLE, Md., Sept. 16, 2019 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products, announces that the Chinese National Medical Product Administration (NMPA), the Chinese FDA, has accepted the clinical trial application for CNCT19 (CD19 CAR-T) for investigation in relapsed B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL).  CASI owns the exclusive worldwide license and commercial rights to CNCT19.

Wei-Wu He, Ph.D., CASI's Chairman and CEO, commented, "CAR-T therapies were first approved in the United States in 2017, and have dramatically improved survival rates for patients suffering from varying B-cell malignancies. The efficacy data generated by the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China, for our CNCT19 technology to date is comparable to the current CAR-T therapies available in the U.S. This drug will be manufactured locally in China at a cost significantly less than the cost of imported therapies from outside of China, ultimately making CNCT19 more widely available to the Chinese patient population. With exclusive global rights, we intend to partner outside of China so that we can similarly make this drug accessible to even more patients."

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 license and commercialization 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 company located in Tianjin City, China focused on 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 patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.

About CASI

CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products. CASI's product pipeline features (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed for the treatment of B-ALL and NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of hematological malignancies; (iii) three U.S. Food and Drug Administration (FDA)-approved hematology oncology drugs in-licensed from Acrotech Biopharma L.L.C. and its affiliates for which CASI has exclusive rights to the greater China market, consisting of EVOMELA^® (Melphalan for Injection), ZEVALIN^® (Ibritumomab Tiuxetan) and MARQIBO^® (Vincristine Sulfate Liposome Injection); and (iv) a portfolio of FDA-approved and pending abbreviated new drug applications (ANDAs), including entecavir and tenofovir disoproxil fumarate (TDF) indicated for the treatment of hepatitis B virus.  CASI has offices in Rockville, Maryland and a wholly owned subsidiary in Beijing, China through which our China operations are conducted. 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 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.

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

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SOURCE CASI Pharmaceuticals, Inc.