Bio-Thera Solutions Announces Expansion of Partnership with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), through Exclusive Commercialization and License Agreement in Canada

GUANGZHOU, China, Oct. 9, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced an expansion of its partnership with Intas Pharmaceuticals for BAT2506, a proposed golimumab biosimilar, through an exclusive commercialization and license agreement for Canada.

BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-), a pro-inflammatory molecule. Binding of golimumab to TNF- 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 the Canada for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

"We are pleased to expand our partnership with Accord for BAT2506 by adding Canadian commercialization rights to the partnership," said Bert Thomas, Senior Vice President of Business Development at Bio-Thera. "Canada is an important market for Bio-Thera, and this partnership is the beginning of a concerted effort to bring our biosimilar products to Canada."

"Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our North American growth strategy," said Chrys Kokino, President of North America Accord. "We're investing heavily in biosimilars through external partnerships plus our own clinical efforts, because we believe in their vast potential to drive patient- and provider-centric solutions. Accord is committed to ensuring that Canadians from coast to coast will have greater access to these vital medications. Bio-Thera's global experience makes them an excellent partner." 

"In Canada, where the demand for sustainable healthcare solutions continues to grow, the introduction of new biosimilars represents both an economic and clinical opportunity. By expanding treatment options while reducing costs for provincial drug plans, hospitals, and patients, Accord aims to support a more resilient healthcare system. This collaboration with Bio-Thera underscores our commitment to working with Canadian healthcare providers, regulators, and policymakers to ensure timely access and seamless integration of biosimilars into patient care across the country," Mike Reid, President Accord Canada

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 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).

About Intas Pharmaceuticals

Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas' biosimilars are manufactured at Intas Pharmaceuticals' state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit us at www.intaspharma.com.  

About Accord BioPharma, Inc.

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com.

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

2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.

3. TOFIDENCE is a trademark of Biogen MA Inc.

4. Avzivi® is a registered trademark of Sandoz AG

5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.

Contact

Bert E. Thomas IV

Phone: +1.410.627.1734

Email: bethomas@bio-thera.com

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SOURCE Bio-Thera Solutions, Ltd

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