Bio-Thera Solutions and Tabuk Pharmaceuticals partner to bring BAT2206 to Saudi Arabia

Bio-Thera Solutions Inc., a Chinese biopharmaceutical company, has announced a strategic partnership with Tabuk Pharmaceutical Manufacturing Company, a leading player in the Middle East and North Africa (MENA) pharmaceutical market. The collaboration aims to commercialize BAT2206, a proposed biosimilar to Stelara (ustekinumab), in Saudi Arabia. The agreement grants Tabuk exclusive rights to manufacture, distribute, and market BAT2206 in the Kingdom.

This initiative highlights Bio-Thera’s global ambitions and leverages Tabuk’s robust regional presence and manufacturing capabilities to deliver advanced therapeutic solutions to patients in Saudi Arabia.

Advancing Treatment for Autoimmune Diseases

BAT2206, developed by Bio-Thera, mirrors Stelara, a human monoclonal antibody targeting interleukin-12 (IL-12) and interleukin-23 (IL-23). These cytokines are instrumental in inflammatory and immune responses, contributing to chronic inflammation seen in diseases such as Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

By inhibiting IL-12 and IL-23, BAT2206 offers a potential treatment alternative for patients who have not responded to existing therapies. Regulatory applications for BAT2206 have been submitted to the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA), and the United States Food and Drug Administration (FDA), signaling the drug’s global aspirations.

Strategic Partnership to Localize Biosimilars

Under the partnership, Tabuk Pharmaceuticals will manage marketing authorization, manufacturing, registration, importation, and promotion of BAT2206 in Saudi Arabia. Meanwhile, Bio-Thera will oversee the drug’s development and provide commercial supply from its manufacturing facilities in Guangzhou, China.

This collaboration aligns with Saudi Arabia’s Vision 2030 goals, emphasizing the localization of advanced pharmaceutical products to strengthen the country’s biopharmaceutical industry. Ismail Shehada, CEO of Tabuk Pharmaceuticals, expressed confidence in the alliance, stating that it supports the company’s commitment to delivering innovative health solutions and enhancing local production capabilities.

A Growing Portfolio of Biosimilars

Bio-Thera Solutions has built a strong reputation as a pioneer in next-generation antibody discovery and biosimilar development. The company’s portfolio includes QLETLI and BETAGRIN (Bevifibatide Citrate Injection) in China, and TOFIDENCE/BAT1806 and Avzivi/Pobevcy in the U.S., EU, and China. With over 20 candidates in clinical trials, the company is dedicated to addressing unmet medical needs across cancer, autoimmune, and cardiovascular diseases.

Dr. Shengfeng Li, CEO of Bio-Thera, emphasized the significance of the partnership, noting that Tabuk’s leadership in the MENA region positions them as an ideal collaborator to ensure access to BAT2206 for patients in Saudi Arabia.

Meeting Regional Healthcare Needs

This partnership not only strengthens Tabuk’s leadership in biosimilar manufacturing and distribution but also underscores Saudi Arabia’s commitment to enhancing healthcare infrastructure. The introduction of BAT2206 will provide cost-effective and localized therapeutic options for autoimmune disease management, potentially improving patient outcomes and reducing dependency on imported biologics.

Future Prospects

As regulatory approvals are sought for BAT2206 across major markets, the collaboration between Bio-Thera and Tabuk Pharmaceuticals reflects a broader trend of biopharmaceutical innovation driving regional healthcare transformation. By combining global expertise with localized manufacturing and distribution capabilities, this partnership marks a significant step forward in addressing the growing demand for biosimilars in the MENA region.