GUANGZHOU, China ---(Businesswire)--- Bio-Thera
Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company
developing a pipeline of innovative therapies and a pipeline of biosimilars,
today announced the company has entered into a licensing and supply agreement with Biomm
SA, for BAT2206, its ustekinumab biosimilar, under
which Biomm will have exclusive rights to distribute and market the drug in Brazil. Bio-Thera and Biomm’s partnership was
initiated around a licensing and supply agreement for Biomm to distribute and
market BAT1706, a bevacizumab biosimilar, in Brazil.
BAT2206 is a proposed biosimilar to Janssen’s Stelara®1, which is currently
approved in Brazil for the treatment of active
psoriatic arthritis (PsA) in adults, alone or in combination with methotrexate;
the treatment of patients 6 years or older with moderate to severe plaque
psoriasis who have not responded, or who have a contraindication, or who are
intolerant to other systemic therapies, including cyclosporine, methotrexate
and ultraviolet A radiation associated with psoralen administration ( PUVA ),
for the treatment of adult patients with moderate to severe active Crohn's
disease, who have had an inadequate response, loss of response or who have been
intolerant to conventional therapy or anti-TNF-alpha or who have
contraindications for such therapies and or the treatment of adult patients
with moderate to severe active ulcerative colitis, who had an inadequate response,
loss of response or who have been intolerant to conventional therapy or therapy
with biological drugs or who have contraindications for such therapies.
Bio-Thera’s BAT2206 has completed a Phase I study and is currently being evaluated in a global
Phase III clinical study, which includes patients from China and Eastern
European countries. Bio-Thera intends to file for regulatory approval with the
China National Medical Products Administration (NMPA), the European Medicines
Agency (EMA) and the United States Food and Drug Administration (FDA). Biomm
will be responsible for filing the dossier in Brazil.
This partnership will leverage Biomm’s strong local presence, sales and
marketing capabilities in Brazil. Bio-Thera will be responsible for completing global development and
commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China.
“Bio-Thera is pleased to expand our partnership with Biomm to commercialize
our ustekinumab biosimilar program in Brazil”, said Dr. Shengfeng Li, CEO of Bio-Thera. “By expanding our partnership with Biomm, Bio-Thera is doubling its
commitment to providing Brazilian patients with increased access to important
biotherapeutics at affordable prices.”
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 and eye diseases, and other severe and emerging
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. In addition, the company has 25
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.zc1980.com/en/or follow us on Twitter (@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, for example, the
development processes could be lengthy and high in vitro affinity may not
translate to desired results in vivo or successful 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. POBEVCY® is
a registered trademark of Bio-Thera Solutions, Ltd.
4. 施瑞立® is a registered trademark of Bio-Thera Solutions, Ltd.
June 16, 2023
