BEIJING, Feb. 16,
2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: CASI), a biopharmaceutical company specializing in the
development and commercialization of innovative therapeutic and
pharmaceutical products, proudly announced the administration of
the first dose of FOLOTYN® (Pralatrexate Injection) to a
patient in China. This remarks a
pivotal step in CASI's commitment to addressing critical medical
needs in peripheral T-cell lymphoma in China market.
FOLOTYN® (Pralatrexate) is a dihydrofolate reductase
inhibitor indicated for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma ("PTCL"). Compared with
methotrexate, pralatrexate could be more effectively internalized
into tumor cells which may translate to a greater anti-cancer
effect. Clinical studies have demonstrated that pralatrexate has
significant activity against PTCL1. With the results of
an overall response rate ("ORR") of 52% and a median
progression-free survival ("PFS") of 4.8 months from the Chinese
registrational study2, in comparison to an ORR of 29%
and a median PFS of 3.5 months from the PROPEL study3 in
the US. Pralatrexate was approved in the
United States, Japan and
China as treatment for PTCL.
Pralatrexate is a promising treatment option for Chinese patients
with relapsed or refractory PTCL.
Dr. Wei-Wu He, CEO of CASI,
expressed his enthusiasm for this milestone, "The dosing of the
first patient with FOLOTYN® in China marks a significant achievement for
CASI. It reflects our unwavering commitment to bringing advanced
therapeutic options to patients, particularly in therapeutic areas
with substantial unmet medical needs. This is a proud moment for
our team and a step forward in our mission to transform patient
care through innovation."
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.
FOLOTYN® is proprietary to Acrotech
Biopharma Inc and its affiliates.
Reference
1. Casanova, M., et al. Critical
appraisal of pralatrexate in the management of difficult-to-treat
peripheral T cell lymphoma. Ther Clin Risk
Manag. 2011; 7: 401–408.
2. Hong X., et al.
Pralatrexate in Chinese Patients with Relapsed or Refractory
Peripheral T-cell Lymphoma: A Singlearm, Multicenter Study. Target
Oncol. 2019 Apr;14(2):149-158.
3. O'Connor OA, et
al. Pralatrexate in patients with relapsed or refractory peripheral
T-cell lymphoma: results from the pivotal PROPEL study. J Clin
Oncol, 2011, 29(9):1182-1189.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
www.casipharmaceuticals.com
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SOURCE CASI Pharmaceuticals