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The
clinical comparative study met its primary endpoint and showed similar efficacy
and comparable safety profile in patients with moderate to severe plaque psoriasis
GUANGZHOU,
China, November 29, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd. (688177:SH),
a commercial-stage biopharmaceutical company developing a pipeline of
biosimilars and innovative assets, today announced results from the Phase 3
study of BAT2206, a proposed biosimilar referencing Stelara® (ustekinumab). The
primary endpoint of this study was improvement from baseline in Psoriasis Area
and Severity Index (PASI) score to Week 12, demonstrating BAT2206 is highly
similar with Stelara® in patients with moderate to severe plaque psoriasis.
In
the US, Stelara® is currently approved for the treatment of patients 6 years or
older with active psoriatic arthritis (PsA), the treatment of patients 6 years
or older with moderate to severe plaque psoriasis (Ps) who are candidates for
phototherapy or systemic therapy, the treatment of moderately to severely
active Crohn’s disease (CD) in adults, and the treatment of moderately to
severely active ulcerative colitis (UC) in adults.
The
BAT2206 clinical trial was a global, multicenter, randomized, double-blind,
parallel-arm, Phase 3 study designed to compare the efficacy, safety, immunogenicity
and PK of BAT2206 with Stelara® in 556 patients with moderate to severe plaque psoriasis.
More information regarding the BAT2206 Phase 3 clinical trial, including
inclusion and exclusion criteria and primary and secondary outcome measures,
can be found here: http://clinicaltrials.gov/study/NCT04728360 Results of the study will be
presented in a future medical meeting or publication.
“We
are pleased to report on our fourth proposed biosimilar with positive Phase 3
study results. These results demonstrate the potential of our proposed
ustekinumab biosimilar to be a safe and effective treatment,” said Shengfeng
Li, Ph.D., chief executive officer at Bio-Thera Solutions. “Bio-Thera is
committed to increasing patient access to innovative medicines through the development
of high-quality biosimilars.”
“I’m
very pleased to have participated in the successful global Phase 3 study of
BAT2206,” commented professor Min Zheng, leading investigator for global phase
3 study of BAT2206. “BAT2206 will provide
a new affordable treatment option for global patients in need. Congratulations
to Bio-Thera Solutions."
Bio-Thera
entered into a commercialization and license agreement with Hikma for BAT2206
in August 2021. Developed by Bio-Thera, BAT2206 will be commercialized by Hikma
in the United States of America.
About BAT2206 (ustekinumab)
BAT2206 is a proposed biosimilar to Janssen’s
Stelara® which is a human monoclonal antibody that inhibits the bioactivity of
human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1
receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are
involved in inflammatory and immune responses, such as natural killer cell
activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have
been implicated as important contributors to the chronic inflammation that is a
hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune
diseases.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading
innovative, global biopharmaceutical company in Guangzhou, China, is dedicated
to researching and developing novel therapeutics for the treatment of cancer,
autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs,
as well as biosimilars for existing, branded biologics to treat a range of
cancer and autoimmune diseases. As a leader in next generation antibody
discovery and engineering, the company has advanced multiple candidates into
late-stage development, including three approved products, QLETLI®, POBEVCY®
and BAT1806 in China and one approved product, TOFIDENCETM (BAT1806), in the
USA. In addition, the company has more
than 20 promising candidates in clinical trials, focusing on immuno-oncology in
the post-PD-1 era and targeted therapies such as ADCs. For more information,
please visit www.xjnhtz.com/en/or follow us on LinkedIn, X (@bio_thera_sol)
and WeChat (Bio-Thera).
Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain
forward-looking statements relating to BAT2206 or the product pipelines in
general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on
any forward-looking statements involves known and unknown risks and
uncertainties. The forward-looking statements include, among others, those
containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,”
“plan,” “promising,” “potentially,” or similar expressions. They reflect the
company's current views with respect to future events that are based on what
the company believes are reasonable assumptions in view of information
currently available to Bio-Thera Solutions, and are not a guarantee of future
performance or developments. Actual results and events may differ materially
from information contained in the forward-looking statements as a result of a
number of factors, including, but not limited to, risks and uncertainties
inherent in pharmaceutical research and development, such as the uncertainties
of pre-clinical and clinical studies. Other risks and uncertainties include
those associated with regulatory approvals, manufacturing, marketing,
competition, intellectual property, product efficacy or safety, changes in
global healthcare situation, changes in the company’s financial conditions, and
changes to applicable laws and regulations, etc. Forward-looking statements
contained herein are made only as of the date of their initial publication.
Unless required by laws or regulations, Bio-Thera Solutions undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events, changes in the company’s views or
otherwise.
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Stelara® is a registered trademark of
Johnson & Johnson Corporation
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QLETLI® is a registered trademark of
Bio-Thera Solutions, Ltd.
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POBEVCY® is a registered trademark of
Bio-Thera Solutions, Ltd.
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TOFIDENCETM is a trademark of Biogen, Inc.
