· CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing USYMRO? to the reference product Stelara?
Guangzhou, China– June , 2024 –Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for USYMRO? (ustekinumab), a biosimilar monoclonal antibody referencing Stelara?. The CHMP’s positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for USYMRO?.
“Bio-Thera is committed to being one of the premier biosimilar developers and manufacturers in the world,” said Shengfeng Li, CEO of Bio-Thera Solutions. “The positive CHMP recommendation for USYMRO? builds on Bio-Thera’s track record of accomplishment as a biosimilar developer and manufacturer.”
This positive CHMP opinion on USYMRO? was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of USYMRO? was conducted and supports biosimilarity with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of USYMRO? with both the EU and US reference product in healthy volunteers. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared USYMRO? with the reference product to confirm equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with severe plaque psoraisis. The totality of evidence demonstrated USYMRO? is a biosimilar of the reference biologic.
Bio-Thera and Gedeon Richter entered into a license and commercialization agreement for USYMRO? (BAT2206) in October of 2024. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Gedeon Richter will have the right to commercialize the medicine upon approval and successful Marketing Authorization Holder Transfer in the EU, the UK and Switzerland.
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), Crohn’s disease (CD), and Ulcerative colitis (UC). 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 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? in the US, and BAT1806/TOFIDENCETM (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.helizi.cn/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).
Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to USYMRO? / 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 undertake 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) USYMRO? is a registered trademark of Gedeon Richter Plc
2) STELARA? is a registered trademark of Johnson and Johnson
3) QLETLI? is a registered trademark of Bio-Thera Solutions, Ltd.
4) BETAGRIN? is a registered trademark of Bio-Thera Solutions, Ltd.
5) STARJEMZA? is a registered trademark of Hikma Pharmaceuticals.
6) TOFIDENCE? is a trademark of Organon LLC
7) AVZIVI? is a registered trademark of Sandoz
8) POBEVCY? is a registered trademark of Bio-Thera Solutions, Ltd.
