Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2506, a Proposed Biosimilar to Simponi®, in the European Union

• The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2506 as a biosimilar to reference product Simponi^®
• The BAT2506 MAA is based on a robust analytical, non-clinical and clinical data package comparing BAT2506 to the reference product Simponi^®

GUANGZHOU, China, Feb. 7, 2025 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the EMA has accepted the MAA for BAT2506, a proposed biosimilar to Simponi^® (golimumab), seeking a commercial license in the European Union(EU). The reference medicine golimumab has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

"The acceptance of the EMA MAA for BAT2506 marks another milestone for Bio-Thera as it is the first golimumab biosimilar developed by a Chinese company to be submitted to the EMA for approval," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Bio-Thera is committed to developing biosimilars for products like golimumab for patients around the world that are in need of affordable treatments."

The MAA for BAT2506 is 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 BAT2506 was conducted and supports biosimilarity to the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2506 with both, the EU and US, reference product in healthy volunteers, while a randomized, double-blind, multi-dose, two-arm, parallel group Phase 3 confirmatory study compared BAT2506 to the EU golimumab reference product to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Active Psoriatic Arthritis.

Bio-Thera Solutions and STADA Arzneimittel AG entered into a commercialization and license agreement to develop, manufacture and commercialize BAT2506 on May 28th, 2024. Under the agreement, Bio-Thera Solutions maintains responsibility for development, manufacturing, and supply of BAT2506. STADA has exclusive regulatory and commercial rights to BAT2506 in the EU, the UK, Switzerland and select other countries.

About BAT2506 (golimumab)
BAT2506 is a proposed biosimilar to Simponi^® which 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. The reference medicine golimumab has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

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 four approved products: QLETLI^® and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE^®/ BAT1806 and Avzivi^® / Pobevcy^® in the US, EU 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 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).

Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to BAT2506 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. 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. Simponi^® is a registered trademark of Johnson & Johnson Corporation
2. QLETLI^® is a registered trademark of Bio-Thera Solutions, Ltd.
3. TOFIDENCE^® is a registered trademark of Biogen International GMBH
4. Avzivi^® is a registered trademark of Sandoz AG
5. POBEVCY^® is a registered trademark of Bio-Thera Solutions, Ltd.

Bio-Thera Solutions, Ltd. Contact
Bert E. Thomas IV
+1.410.627.1734
bethomas@bio-thera.com

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