A human monoclonal antibody, BAT2206 is currently undergoing regulatory review with several health authorities, including the China National Medical Products Administration (NMPA), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA).
Tabuk Pharmaceuticals CEO Ismail Shehada said: “We are excited to announce our partnership with Bio-Thera that will enable us to deliver unique and specialised health solutions aimed at enhancing the well-being of people in Saudi Arabia.
“We are confident that this partnership supports our efforts to manufacture and localise biosimilar products in the region and strengthen our market leading position in line with our strategy. This also stands as a commitment from our side to support the 2030 vision of Saudi Arabia through localising biopharmaceutical products in the Kingdom.”
Under the agreement, Tabuk will manage the marketing authorisation and oversee the manufacturing, registration, importing, and promotion of the biosimilar in the region.
Meanwhile, Bio-Thera will hold the complete development and commercial supply responsibility of BAT2206 from its facilities in Guangzhou, China.
Bio-Thera Solutions CEO Dr Shengfeng Li said: “Bio-Thera is pleased to establish a partnership with Tabuk to commercialise our ustekinumab biosimilar programme in Saudi Arabia.
“Tabuk is a leading pharmaceutical company in the MENA region and is a great partner to ensure patients in Saudi Arabia have the best access to BAT2206.”
Designed to inhibit the action of human interleukin-12 (IL-12) and interleukin-23 (IL-23), BAT2206 functions by preventing the p40 subunit shared by these cytokines from binding to the IL-12Rβ1 receptor on immune cells. This mechanism is crucial in controlling inflammatory and immune responses.
The therapeutic role of IL-12 and IL-23 is significant, as they are known to contribute to chronic inflammation associated with various autoimmune diseases, including Crohn’s disease and ulcerative colitis.