ROCKVILLE, Md. and BEIJING, Dec. 3,
2019 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: 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.
COMPANY
CONTACT:
CASI
Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
|
INVESTOR
CONTACT:
Solebury
Trout
Jennifer
Porcelli
646.378.2962
jporcelli@troutgroup.com
|
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SOURCE CASI Pharmaceuticals, Inc.