Date: 2024-05-28Click:
Guangzhou, China/Bad Vilbel, Germany – 28 May 2024
– Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company
developing a pipeline of innovative therapies and biosimilars, and global
specialty, generic and consumer healthcare medicines company STADA Arzneimittel
AG have reached an exclusive commercialization and license agreement for
BAT2506, a biosimilar candidate to Simponi® (golimumab).
Under the agreement, Bio-Thera Solutions
(“Bio-Thera”) will maintain responsibility for development, manufacturing, and
supply of BAT2506. STADA Arzneimittel AG (“STADA”) will have exclusive
rights to commercialize the product in the European Union (EU), the UK,
Switzerland and selected other countries.
Bio-Thera will receive an upfront payment of US$10 million, as well as further development and commercial milestones of up to US$147.5 million, subject to the fulfillment of certain conditions.
“STADA is one of the premier biosimilar companies in Europe, and we are pleased
to establish a partnership with STADA for BAT2506”, said Dr. Shengfeng Li, CEO
of Bio-Thera. “We look forward to working with STADA to bring BAT2506 to
immunology patients in Europe.”
“With global sales in 2023 of US$2.2 billion,
including more than US$1 billion outside of the US, golimumab represents a
compelling opportunity to broaden patient access to biological treatments and build
scale in immunology alongside our approved adalimumab and ustekinumab
biosimilars. Bio-Thera’s broad expertise in biologic medicines, including with two
biosimilars already approved by the US Food and Drug Administration, makes it
an attractive partner for STADA,” commented STADA’s head of Global Specialty,
Bryan Kim.
Golimumab is a human IgG1 monoclonal antibody
that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule.
Binding of golimumab to TNF-α 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.
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® in China,
and
TOFIDENCE™/ BAT1806 and Avzivi®/Pobevcy® in the US 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.ncchangfang.com/en/ or
follow us on Twitter (@bio_thera_sol)
and WeChat (Bio-Thera).
