“We are pleased that Richter will further strengthen patient access to biosimilars in Europe through bringing USYMRO® to market. As a result of Bio-Thera’s success in gaining EC approval, Richter is expanding its biosimilar portfolio subsequent to the recent EC approvals of its in-house developed denosumab biosimilars” – said Dr. Erik Bogsch, Head of the Biotechnology Business Unit of Richter.
Bio-Thera and Richter entered into a license and
commercialization agreement for USYMRO® (BAT2206) in October 2024.
Under the terms of the agreement, Bio-Thera is responsible for the development
and manufacturing of the product, and Richter obtained exclusive rights to
commercialize the medicine in the EU, the UK and Switzerland and selected other
countries.
About USYMRO® (ustekinumab)
USYMRO® is a biosimilar to Janssen’s Stelara® which
is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and
IL-23 by preventing shared p40 subunit from binding to the IL-12Rβ1 receptor
chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the
surface of immune cells. IL-12 and IL-23 are involved in inflammatory and
immune responses, such as natural killer cell activation, CD4+ T-cell
differentiation and following relative cytokines stimulated release. Abnormal
regulation of IL-12 and IL-23 have been implicated as important contributors to
chronic inflammation, including psoriasis, psoriatic arthritis (PsA), and
Crohn’s disease (CD). Neutralizing human IL-12 and IL-23 by USYMRO® to
prevent the relevant cell signaling in the Th1 or Th17 lineages can effectively
block the pathologic processes of these immune disorders.
About Gedeon Richter Plc.
Richter aspires to be a global innovator in some key scientific fields,
while dedicated to making medicines more accessible worldwide. Founded in 1901,
headquartered in Hungary, with a market capitalization of EUR 4.7bn and sales
of EUR 2.2bn in 2024, it operates Central Europe's largest R&D hub. Its
research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while
Biotechnology and General Medicines strengthen its affordable treatment
portfolio. Committed to sustainable growth, Richter invests in R&D,
manufacturing excellence, and digitalization to advance medical innovation.
Learn more at www.gedeonrichter.com
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 the 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).
For further information:
Investors: Róbert Réthy, CFA +36 20 342 2555
Media: Zsuzsa Beke +36 20 916 4507