GUANGZHOU, China, Dec. 24,
2024 /PRNewswire/ -- Bio-Thera
Solutions Inc. (688177:SH), a commercial-stage
biopharmaceutical company developing a pipeline of innovative
therapies and a pipeline of biosimilars, today announced the
company has partnered with Tabuk Pharmaceutical Manufacturing
Company (a fully-owned subsidiary of Astra Industrial Group), a
leading pharmaceutical company in the Middle East and North Africa (MENA) region, for BAT2206, its
ustekinumab biosimilar, under which Tabuk will have exclusive
rights to manufacture, distribute and market the drug in
Saudi Arabia.
BAT2206 is a proposed biosimilar to Jansen's
Stelara®. Bio-Thera has filed for regulatory approval of
BAT2206 with the China National Medical Products Administration
(NMPA), the European Medicines Agency (EMA) and the United States
Food and Drug Administration (FDA).
This partnership will leverage Tabuk's strong local presence,
sales and marketing capabilities in Saudi
Arabia. Under this agreement Tabuk Pharmaceuticals will hold
the marketing authorization and will be responsible to manufacture,
register, import, and promote BAT2206 in Saudi Arabia. Bio-Thera will be
responsible for full development, and commercial supply of BAT2206
out of its manufacturing facilities in Guangzhou, China.
"Bio-Thera is pleased to establish a partnership with Tabuk to
commercialize our ustekinumab biosimilar program in Saudi Arabia", said Dr. Shengfeng Li, CEO of Bio-Thera. "Tabuk is
a leading pharmaceutical company in the MENA region and is a great
partner to ensure patients in Saudi
Arabia have the best access to BAT2206."
Ismail Shehada, CEO of Tabuk
Pharmaceuticals "We are excited to announce our partnership with
Bio-Thera that will enable us to deliver unique and specialized
health solutions aimed at enhancing the well-being of people in
Saudi Arabia. We are confident
that this partnership supports our efforts to manufacture and
localize biosimilar products in the region and strengthen our
market leading position in line with our strategy. This also stands
as a commitment from our side to support the 2030 vision of
Saudi Arabia through localizing
biopharmaceutical products in the Kingdom."
About BAT2206 (ustekinumab)
BAT2206 is a proposed
biosimilar to Jansen'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. In the EU, Stelara® is currently
approved for the treatment of 1) moderate to severe plaque
psoriasis in adults and children above the age of 6 years whose
condition has not improved with, or who cannot use, other systemic
(whole-body) psoriasis treatments, 2) active psoriatic arthritis,
alone or combined with methotrexate, in adults, when the condition
has not improved enough with other treatments called
disease-modifying anti-rheumatic drugs (DMARDs), 3) moderately to
severely active Crohn's disease in adults whose condition has not
improved enough with other treatments for Crohn's disease or who
cannot receive such treatments, 4) moderately to severely active
ulcerative colitis in adults whose condition has not improved
enough with other treatments for ulcerative colitis or who cannot
receive such treatments.
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 four approved
products: QLETLI® and BETAGRIN®(Bevifibatide Citrate Injection)
in China, and TOFIDENCE/ BAT1806 and Avzivi® / Pobevcy® in the
US, EU and 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
ADCs. For more information, please
visit www.bio-thera.com/en/ or follow us on Twitter
(@bio_thera_sol) and WeChat (Bio-Thera).
About Tabuk Pharmaceutical Manufacturing
Company
Tabuk Pharmaceutical Manufacturing Company is a
leading Saudi pharmaceutical company with a regional presence in
the Middle East and North Africa. Tabuk Pharmaceuticals develops,
manufactures, markets and distributes various branded generics, in
addition to manufacturing pharmaceutical products for renowned
international partners at its manufacturing sites in Saudi Arabia, as part of its continuous
efforts to cover the needs of patients by providing high quality
medicines. Tabuk Pharmaceuticals is a major player in the
pharmaceutical sector not only in the Kingdom of Saudi Arabia, but also in the
Middle East and North Africa, thanks to its four
state-of-the-art manufacturing sites located in Tabuk and
Dammam in the Kingdom, as well as
in Sudan and Algeria, and orchestrated by a team of more
than 2,400 employees. Tabuk pharmaceuticals reaches patients in 18
countries in the Middle East and
Africa, in addition to futuristic
plans to expand its presence in the region.
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 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.
1. Stelara® is a registered trademark of Johnson
& Johnson Corporation
2. QLETLI® is a registered trademark of Bio-Thera
Solutions, Ltd.
3. TOFIDENCE™ is a trademark of Biogen
4. Avzivi® is a registered trademark of Sandoz AG
5. POBEVCY® is a registered trademark of Bio-Thera
Solutions, Ltd.
Contact
Bio-Thera Solutions, Ltd.:
Bert E. Thomas IV +1.410.627.1734
bethomas@bio-thera.com
Tabuk Pharmaceutical Manufacturing Company
Wisam Al Khatib
wisam.alkhatib@tabukpharmaceuticals.com
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SOURCE Bio-Thera Solutions, Ltd