Bio-Thera and Intas Pharmaceuticals Engage in Strategic Licensing Deal for BAT2506 in the U.S. Market

Bio-Thera Solutions' Milestone Agreement with Intas Pharmaceuticals

In an important development within the biopharmaceutical landscape, Bio-Thera Solutions, a prominent player based in Guangzhou, China, has officially entered into an exclusive commercialization and licensing agreement with Intas Pharmaceuticals for its product BAT2506. BAT2506 is a proposed biosimilar referencing Simponi® (golimumab), designed specifically for the United States market. This strategic alliance marks a significant step for both companies in expanding access to essential therapies in immunology.

Overview of BAT2506 and Golimumab

BAT2506 is a biosimilar version of golimumab, which acts as a human IgG1 monoclonal antibody targeting tumor necrosis factor alpha (TNF-a), a key pro-inflammatory molecule. By binding to TNF-a, golimumab helps reduce levels of various inflammatory markers, including C-reactive protein (CRP) and interleukin 6 (IL-6). The reference drug is approved for multiple conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis in the U.S. and Europe.

In light of the growing demand for effective treatments for inflammatory diseases, this agreement with Intas is set to further boost Bio-Thera's reach in the bio-pharmaceutical field, particularly in the U.S., where access to biosimilars can alleviate the financial burden on patients.

Terms of the Licensing Agreement

Under the newly formed agreement, Bio-Thera will oversee the development, manufacturing, and supply of BAT2506, while Intas Pharmaceuticals, through its U.S. division Accord BioPharma, will handle the commercialization efforts. Bio-Thera Solutions will receive an upfront payment totaling $21 million USD, with additional developmental and commercial milestone payments that could amount to $143.5 million USD.

Dr. Shengfeng Li, CEO of Bio-Thera, expressed enthusiasm regarding the partnership, stating, "Accord BioPharma is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506. This partnership aligns with our goal of introducing more immunology biosimilars to patients in the U.S. market."

Chrys Kokino, U.S. President of Accord BioPharma, shared similar sentiments, indicating that the exclusive commercialization agreement with Bio-Thera strengthens Accord's biosimilar pipeline, ensuring its position as a pivotal growth component in the U.S.

About Bio-Thera Solutions

Established in Guangzhou, Bio-Thera Solutions is a trailblazer in developing novel biopharmaceuticals aimed at treating complex medical conditions, including autoimmune diseases and cancer. The company has successfully brought several candidates into late-stage development, signifying its commitment to addressing significant medical challenges through innovative therapies. Currently, Bio-Thera is navigating the clinical pathways for over 20 candidates, with a keen focus on immuno-oncology and targeted therapies that follow the PD-1 paradigm.

About Intas Pharmaceuticals

Intas Pharmaceuticals has emerged as a key player in the domain of biosimilars, with a notable footprint in India. The company is recognized for its commitment to affordability and accessibility, producing a range of competitive biosimilars that have transformed treatment landscapes for various diseases. Their latest offerings, backed by cutting-edge manufacturing facilities, align with their mission to provide high-quality cancer care to a broader audience.

In summary, this strategic partnership between Bio-Thera and Intas Pharmaceuticals not only enhances their market presence in the U.S. but also signifies a commitment to advancing patient care by increasing access to effective treatment options. As the biosimilars market continues to evolve, collaborations like these hold the potential to reshape healthcare delivery and improve outcomes for patients requiring innovative therapies.