Avalon Pharma And Bio-Thera Execute Exclusive Commercialization Agreement For BAT2406, A Proposed Dupixent Biosimilar, For MENA

Avalon Pharma (Middle East Pharmaceutical Industries Company), a leading Saudi-based pharmaceutical manufacturer and Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, announce today they have executed commercialization and license agreements for BAT2406, a proposed Dupixent biosimilar, for Saudi Arabia and the rest of the MENA region.

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2406. Avalon Pharma will be responsible for seeking regulatory approvals as well as commercialization in the licensed territory.

Mr. Mohamed Maher Al Ghannam, Managing Director & CEO, Avalon Pharma, stated: “This collaboration represents another significant milestone in Avalon Pharma’s journey to becoming a regional leader in specialty pharmaceuticals and biologics. Together with Bio-Thera, we are strengthening our presence in immunology and biosimilars while advancing our long-term ambitions for pharmaceutical localization and future local manufacturing in Saudi Arabia. Through strategic partnerships such as this, we aim to expand access to advanced therapies and build sustainable capabilities that will contribute to the future of healthcare across Saudi Arabia and the wider MENA region.”

“Expanding access to high-quality biologic medicines for patients living with chronic Type 2 inflammatory diseases remains a key priority for Bio-Thera,” said Bert Thomas, Senior Vice President of Business Development and Alliance Management at Bio-Thera Solutions. “Our partnership with Avalon Pharma, a trusted regional partner with deep expertise in specialty pharmaceuticals, will help bring an important treatment option for patients living with Type 2 inflammatory diseases to the region. This collaboration represents another significant step in Bio-Thera’s mission to develop and deliver high-quality biosimilars that improve access to life-changing therapies for patients in MENA and around the world.”

About BAT2406 (dupilumab)
BAT2406 is a proposed biosimilar to dupilumab, a fully human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. Binding to IL-4Rα inhibits IL-4 signaling through the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. IL-4- and IL-13-mediated inflammation is a key driver in the pathogenesis of multiple Type 2 inflammatory diseases, including asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis. IL-4Rα is expressed on multiple immune and structural cell types, including mast cells, basophils, eosinophils, macrophages, lymphocytes, epithelial cells, and goblet cells. By blocking IL-4Rα, dupilumab inhibits IL-4- and IL-13-induced inflammatory responses, including the production of cytokines, chemokines, nitric oxide, and immunoglobulin E (IgE), thereby reducing Type 2 inflammation.

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 six approved products: QLETLI (adalimumab) and BETAGRIN (bevifibatide citrate) Injection in China, STARJEMZA (ustekinumab) in the US and USYMRO (ustekinumab) in EU, IMMGOLISTM and IMMGOLIS INTRITM (golimumab) in US and GOTENFIA (golimumab) in EU, TOFIDENCE (tocilizumab) in the US, 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, visit www.bio-thera.com/en/.

About Avalon Pharma
Avalon Pharma is a leading Saudi pharmaceutical company headquartered in Riyadh, dedicated to advancing healthcare through innovation, scientific excellence, and sustainable growth. As one of the region’s fastest-growing pharmaceutical companies, Avalon Pharma develops, manufactures, and commercializes a diversified portfolio spanning specialty pharmaceuticals, branded prescription medicines, consumer healthcare, and dermatology, addressing the evolving healthcare needs of patients across the Middle East.

At the core of Avalon Pharma’s strategy is a commitment to expanding access to high-value therapies through innovation, strategic partnerships, and advanced manufacturing capabilities. The company continues to strengthen its specialty pharmaceutical portfolio across therapeutic areas while maintaining leadership in consumer health and dermatology, creating a balanced and resilient business model that delivers long-term value.

Avalon Pharma combines world-class manufacturing, robust quality systems, and scientific expertise with a disciplined approach to portfolio development. Its GMP-certified facilities, strong regulatory capabilities, and operational excellence enable the company to deliver healthcare solutions that meet the highest international standards.

Guided by Saudi Vision 2030, Avalon Pharma is investing in pharmaceutical innovation, localization, digital transformation, and talent development to strengthen the Kingdom’s life sciences ecosystem while expanding its regional footprint. Through strategic collaborations with leading global pharmaceutical companies, Avalon Pharma is accelerating the introduction of innovative therapies and reinforcing its position as a trusted regional healthcare partner.

Strategic Focus Areas

• Specialty pharmaceuticals and innovative therapies
• Branded prescription medicines
• Dermatology and dermo-cosmetic solutions
• Consumer health and OTC brands
• Pharmaceutical manufacturing and technology transfer
• Digital health and data-enabled healthcare solutions

Key Facts

• Headquarters: Riyadh, Saudi Arabia
• Markets Served: GCC and the Levant
• Portfolio: 150+ registered products
• Manufacturing: GMP-certified facilities withinternational quality standards
• Certifications: GMP, ISO 9001, ISO 14001
• Founded: 1998

Avalon Pharma is building the next generation of regional pharmaceutical leadership by combining scientific innovation, manufacturing excellence, and strategic partnerships to deliver differentiated healthcare solutions that improve patient outcomes and create sustainable long-term value for all stakeholders.