GUANGZHOU, China & MOSCOW--(BUSINESS WIRE)--Bio-Thera
Solutions (688177:SH), a commercial-stage biopharmaceutical company
developing a pipeline of innovative therapies and a pipeline of
biosimilars, today announced the company has reached a licensing
agreement with Pharmapark LLC, for BAT2506, its golimumab biosimilar,
under which Pharmapark will have exclusive rights to distribute and
market the drug with a status of a local product in Russia and other CIS
countries.
BAT2506 is a proposed biosimilar to Jansen’s Simponi® which
is currently approved for the treatment of moderately to severely active
rheumatoid arthritis (RA) in adults, in combination with methotrexate
(MTX), active psoriatic arthritis (PsA) in adults, alone or in
combination with MTX and active ankylosing spondylitis (AS) in adults.
Bio-Thera’s BAT2506 will begin a global Phase III study in patients with
PsA in Q4 of 2020. The Phase III global clinical study will include
patients from China, Russia and many other 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) in 2023. Pharmapark
will be responsible for filing the dossier in Russia and other CIS
countries.
This partnership will leverage Pharmapark’s strong local presence, sales
and marketing capabilities in Russia and other CIS countries. Bio-Thera
will be responsible for full development, and commercial supply of
BAT2506 out of its manufacturing facilities in Guangzhou, China.
“Bio-Thera is pleased to partner with Pharmapark to commercialize our
golimumab biosimilar program in Russia and other CIS countries”, said
Dr. Shengfeng Li, CEO of Bio-Thera. “This partnership is the first to
expand Bio-Thera’s presence into Russia, an important pharmaceutical
market for biosimilars and innovative drugs.”
“Partnership with Bio-Thera is an integral part of our strategy to
expand our biosimilar portfolio by partnering with the leading
biosimilar developers. This agreement represents an important milestone
for Pharmapark, and for our patients in Russia and CIS countries that
will soon benefit from an increased access to high quality affordable
medicines.” said Vyacheslav Lebedyansky, CEO of Pharmapark.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical
company in Guangzhou, China, is dedicated to researching and developing
novel therapeutics for the treatment of cancer, autoimmune,
cardiovascular diseases, and other serious unmet medical needs, as well
as biosimilars for existing, branded biologics to treat a range of
cancer and autoimmune diseases. As a leader in the next generation
antibody discovery and engineering, the company has advanced five
candidates into late stage clinical trials and one of which, QLETLI®
(格乐立®), a biosimilar to Humira® (adalimumab), is available to patients with
rheumatoid arthritis, ankylosing spondylitis, or plaque psoriasis in
China. In addition, the company has multiple candidates in early
clinical trials and IND-enabling studies, focusing on innovative targets
in immuno-oncology and autoimmune diseases. For more information,
please visit www.eamlife.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
About Pharmapark LLC:
Pharmapark is a privately-owned Russian biopharmaceutical company that
is focused on development, manufacture and commercialization of
biosimilar products. The company possesses the know-how and has a
successful track record performing complete biotechnological drug
development through commercial production. Pharmapark has successfully
marketed 5 biosimilar products and has in-house pipeline of novel
formulations and biosimilars focused on value-adding treatments.
1 Simponi ® is a registered trademark of Johnson & Johnson Corporation
2 Humira® is a registered trademark of AbbVie Biotechnology Ltd.
3 QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.