GUANGZHOU, China --- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical
company developing a pipeline of innovative therapies and biosimilars, today
announced an expansion of its partnership with Intas Pharmaceuticals for BAT2506, a
proposed golimumab biosimilar, through an exclusive
commercialization and license agreement for Canada.
BAT2506 is a proposed golimumab
biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal
antibody that targets tumor necrosis factor alpha (TNF-), a pro-inflammatory
molecule. Binding of golimumab to TNF- results in reductions in C-reactive
protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1
(ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth
Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in the Canada for
several indications, including rheumatoid arthritis, psoriatic arthritis,
ankylosing spondylitis, and ulcerative colitis.
“We are pleased to expand our partnership with Accord
for BAT2506 by adding Canadian commercialization rights to the partnership”,
said Bert Thomas, Senior Vice President of Business Development at Bio-Thera.
“Canada is an important market for Bio-Thera, and this partnership is the
beginning of a concerted effort to bring our biosimilar products to Canada.”
“Our exclusive commercialization
agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component
of our North American growth strategy,” said Chrys Kokino, President of North
America Accord. “We’re investing heavily in biosimilars through external
partnerships plus our own clinical efforts, because we believe in their vast
potential to drive patient- and provider-centric solutions. Accord is committed to ensuring that
Canadians from coast to coast will have greater access to these vital
medications. Bio-Thera’s global experience makes them an excellent
partner.”
“In Canada, where the demand for sustainable healthcare solutions continues to grow, the introduction of new biosimilars represents both an economic and clinical opportunity. By expanding treatment options while reducing costs for provincial drug plans, hospitals, and patients, Accord aims to support a more resilient healthcare system. This collaboration with Bio-Thera underscores our commitment to working with Canadian healthcare providers, regulators, and policymakers to ensure timely access and seamless integration of biosimilars into patient care across the country” Mike Reid, President Accord Canada.
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 five approved
products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection
in China, STARJEMZA® (ustekinumab) in the US and Usymro®(ustekinumab) in EU,
and TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US
and in EU, a/k/a POBEVCY® in China. 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 antibody-drug conjugates (ADCs).
For more information, please visit www.bio-thera.com/en/ or
follow us on X @bio_thera_sol) and
WeChat (Bio-Thera).
About Intas Pharmaceuticals
Intas
Pharmaceuticals is a pioneer in biosimilars, having developed and launched one
of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of
making quality biosimilars accessible to the masses. Being the most affordable
treatment option, Intas' products like Neukine (filgrastim), Pegasta
(Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas
(bevacizumab) have transformed the management of their respective therapies.
Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy,
fulfilling its commitment to provide quality cancer care to the masses. Intas'
biosimilars are manufactured at Intas Pharmaceuticals' state of the art
European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology
plant located near Ahmedabad, Gujarat. For more information, visit us at www.intaspharma.com.
About Accord BioPharma, Inc.
Accord BioPharma, Inc., the U.S. specialty division of
Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric
therapies in oncology, immunology, and critical care. With a focus on improving
the patient experience, Accord BioPharma goes beyond the biology of medicine to
see disease from the patients' perspective and develop high-quality therapies
that impact patients' lives. Accord BioPharma believes in the ability of
biosimilars to increase access to a number of biologic medicines, that in the
past may not have been considered for patients due to their high costs. Accord
BioPharma looks forward to providing one of the deepest biosimilar portfolios
in the industry. For more information, visit AccordBioPharma.com.
Bio-Thera Cautionary Note Regarding
Forward-Looking Statements
This news release contains
certain forward-looking statements relating to BAT2506, 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 challenges in obtaining 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.