BEIJING, Nov. 8, 2023
/PRNewswire/ -- CASI Pharmaceuticals Inc. (Nasdaq: CASI), a
biopharmaceutical company focused on developing and commercializing
innovative therapeutics and pharmaceutical products, is thrilled to
announce a major milestone in its partnership with Juventas Cell
Therapy Ltd. (Juventas). The China National Medical Products
Administration (NMPA) has granted market approval for Juventas'
investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19),
for the treatment of relapsed and refractory B-cell acute
lymphoblastic leukemia (r/r B-ALL) in China.
Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product
comprised of a unique CD19 scFv(HI19a)structure and utilizes
leading CMC manufacturing techniques. Inaticabtagene Autoleucel has
demonstrated a high level of efficacy, with durable remissions, and
substantially improved safety profile with reduced CAR-T related
toxicities in the pivotal clinical study for the treatment of
adults with r/r B-ALL.
This approval is based on the clinical results from a
single-arm, multi-center, pivotal study of 39 adult patients with
r/r B-ALL in China. The 9.3-month
follow up data demonstrated very high durable response, overall
response rate ("ORR"): 82.1%, complete response rate ("CR"): 66.7%
within 3 month after infusion and median duration of response (DoR)
has not reached. The safety profile shown the decreased severity of
CAR T-Cell related adverse events in patients with r/r B-ALL. Given
the currently available treatment options in China, Inaticabtagene Autoleucel will be the
first treatment CAR-T therapy option with a positive benefit-risk
ratio for adult patients with r/r B-ALL and potentially be a
best-in-class CAR-T product.
This pivotal development not only marks a significant
achievement for CASI and Juventas but also represents a remarkable
advancement in the field of hematology-oncology and cell therapy.
CNCT19 is the first CD19-directed CAR-T product with Chinese
independent intellectual property rights, making it a trailblazer
in the Chinese biopharmaceutical landscape. It is also the first
commercialized cell therapy product in China designed to treat B-ALL.
Dr. Wei-Wu He, Chairman and CEO
of CASI, expressed his enthusiasm for the commercial and clinical
significance of CNCT19. He stated, "The approval of CNCT19
represents a transformative moment not only for CASI and Juventas
but for all B-ALL patients in China. We are committed to making this
groundbreaking therapy accessible to those in need and aspire to
extend its reach globally. CNCT19 offers new hope to patients
battling relapsed B-ALL, and this partnership between CASI and
Juventas aims to ensure that this innovative therapy reaches those
in need across China and
beyond."
About Juventas Cell Therapy Ltd.
Established in June 2018, Juventas
Cell Therapy Ltd., a biopharmaceutical company powered by
cutting-edge cell and gene technologies, has become the leader of
innovative CGT drug development in China. Juventas' innovation is stemmed from
its integrated R&D platforms including CAR, iPSCs, and
gene-editing technologies. With more than 10 drug candidates in its
pipeline, featured with solo, dual, or multiple target autologous
CAR-T and universal cellular products, Juventas is well on its way
to fulfil its mission - providing novel solutions to unmet clinical
needs in the treatment of blood cancers, solid tumors, and other
diseases. In November 2023, Juventas'
first core product - Inaticabtagene Autoleucel (CNCT19) was
approved by NMPA, for the treatment of adult B-cell relapsed and
refractory acute lymphoblastic leukemia (B-ALL).
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company
focused on developing and commercializing innovative therapeutics
and pharmaceutical products in China, the United
States, and throughout the world. The Company is focused on
acquiring, developing, and commercializing products that augment
its hematology oncology therapeutic focus as well as other areas of
unmet medical need. The Company intends to execute its plan to
become a leader by launching medicines in the greater China market, leveraging the Company's
China-based regulatory and
commercial competencies and its global drug development expertise.
The Company's operations in China
are conducted through its wholly owned subsidiary, CASI
Pharmaceuticals (China) Co., Ltd.,
located in Beijing, China. More
information on CASI is available at
www.casipharmaceuticals.com.
Forward-Looking Statements
This announcement contains forward-looking statements. These
statements are made under the "safe harbor" provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These
forward-looking statements can be identified by terminology such as
"will," "expects," "anticipates," "future," "intends," "plans,"
"believes," "estimates," "confident" and similar statements. Among
other things, the business outlook and quotations from management
in this announcement, as well as the Company's strategic and
operational plans, contain forward-looking statements. The Company
may also make written or oral forward-looking statements in its
periodic reports to the U.S. Securities and Exchange Commission
(the "SEC"), in in its annual report to shareholders, in press
releases and other written materials and in oral statements made by
its officers, directors or employees to third parties. Statements
that are not historical facts, including statements about the
Company's beliefs and expectations, are forward-looking statements.
Forward-looking statements involve inherent risks and
uncertainties. A number of factors could cause actual results to
differ materially from those contained in any forward-looking
statement, including but not limited to the following: the risk
that we may be unable to continue as a going concern as a result of
our inability to raise sufficient capital for our operational
needs; the possibility that we may be delisted from trading on The
Nasdaq Capital Market if we fail to satisfy applicable continued
listing standards; the volatility in the market price of our
ordinary shares; the risk of substantial dilution of existing
shareholders in future share issuances; the difficulty of executing
our business strategy on a global basis including China; our inability to enter into strategic
partnerships for the development, commercialization, manufacturing
and distribution of our proposed product candidates or future
candidates; legal or regulatory developments in China that adversely affect our ability to
operate 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 U.S. Food and Drug
Administration, European Medicines Agency, PRC National Medical
Products Administration, 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 risks relating to the
need for additional capital and the uncertainty of securing
additional funding on favorable terms; the risks associated with
our product candidates, and the risks associated with our other
early-stage products under development; the risk that result in
preclinical and clinical models are not necessarily indicative of
clinical results; uncertainties relating to preclinical and
clinical trials, including delays to the commencement of such
trials; our ability to protect our intellectual property rights;
the lack of success in the clinical development of any of our
products; and our dependence on third parties; the risks related to
our dependence on Juventas to conduct the clinical development of
CNCT19 and to partner with us to co-market CNCT19; risks related to
our dependence on Juventas to ensure the patent protection and
prosecution for CNCT19; risks relating to the commercialization, if
any, of our proposed products (such as marketing, safety,
regulatory, patent, product liability, supply, competition and
other risks); risks relating to interests of our largest
shareholder and our Chairman and CEO that differ from our other
shareholders; and risks related to the development of a new
manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd.
Further information regarding these and other risks is included in
the Company's filings with the SEC. All information provided herein
is as of the date of this announcement, and the Company undertakes
no obligation to update any forward-looking statement, except as
required under applicable law. We caution readers not to place
undue reliance on any forward-looking statements contained
herein.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
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SOURCE CASI Pharmaceuticals