Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of America

GUANGZHOU, China, Feb. 10, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, for the United States of America.

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), a pro-inflammatory molecule. Binding of golimumab to TNF-a 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 United States and Europe for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506.  Intas Pharmaceuticals, through its US-specialty division Accord BioPharma, will be responsible for commercializing the product in the United States of America.  Bio-Thera will receive an upfront payment of $21 million USD, as well as further development and commercial milestones of up to $143.5 million USD.

"Accord BioPharma is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506," said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in USA."

"Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our U.S. growth strategy," said Chrys Kokino, U.S. President of 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. Bio-Thera's global experience makes them an excellent partner."

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 ADCs. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@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.
6. BETAGRIN^® is a registered trademark of Bio-Thera Solutions, Ltd.

Contact
Bert E. Thomas IV
Phone: +1.410.627.1734
Email: [email protected]

SOURCE Bio-Thera Solutions, Ltd