Commercial-stage biopharmaceutical company Bio-Thera Solutions Ltd (SHA:688177) announced on Monday that China's National Medical Products Administration (NMPA) has approved its marketing authorisation for BAT2506, a golimumab biosimilar.

According to Bio-Thera, this approval marks the first golimumab biosimilar approved in China. BAT2506 will be marketed under the name ASHULI, and is approved by the NMPA for the treatment of rheumatoid arthritis and ankylosing spondylitis.

Golimumab is a human IgG1 monoclonal antibody that targets tumour 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.

Bio-Thera has signed commercialisation agreements with multiple partners for BAT2506, covering the United States, Europe, and Canada, as well as the Middle East and North Africa (MENA), Latin America (LATAM) and Southeast Asia.