China’s National Medical Products Administration (NMPA) has granted marketing authorisation for Bio-Thera Solutions’ BAT2506 to treat ankylosing spondylitis and rheumatoid arthritis.
Set to be marketed under the brand name Ashuli, the therapy represents the first Simponi (golimumab) biosimilar approved in the country.
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The regulatory clearance comes amid pronounced domestic demand for affordable biological therapies in China, where large patient populations live with autoimmune conditions such as ankylosing spondylitis and rheumatoid arthritis.
Ashuli provides a new lower-cost option aimed at enhancing patient accessibility to biological medicines.
Bio-Thera Solutions CEO Shengfeng Li said: “We are proud to have another biosimilar approved by NMPA. Ashuli is Bio-Thera’s sixth biosimilar approved in China. Biosimilars have an important role in expanding patient access to important biologics.
“This NMPA approval demonstrates Bio-Thera’s long-term commitment to developing and commercialising biosimilars.”
Simponi functions as a human immunoglobulin G1 (IgG1) monoclonal antibody designed to target tumour necrosis factor alpha (TNF-α), a pro-inflammatory molecule.
When the therapy binds to TNF-α, it leads to reductions in inflammatory markers, including C-reactive protein (CRP), Intercellular Adhesion Molecule 1 (ICAM-1), Interleukin 6 (IL-6), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF).
It was originally developed by Johnson & Johnson (J&J) and was first approved by the US Food and Drug Administration (FDA) in 2009. It was later approved in China in 2018.
Bio-Thera Solutions has entered into commercialisation agreements with multiple partners to distribute BAT2506 internationally.
These partnerships cover Canada, Europe, Latin America (LATAM), the Middle East and North Africa (MENA), Southeast Asia, and the US, extending the therapy’s reach to autoimmune patients globally.
In February 2025, the company signed an exclusive licence and commercialisation agreement with Intas Pharmaceuticals for the Simponi biosimilar in the US.
Based in Guangzhou, China, Bio-Thera Solutions is a commercial-stage biopharmaceutical company that develops biosimilars and new therapies for autoimmune diseases, cancer, cardiovascular disorders, eye conditions, and other severe unmet medical needs.
The company has advanced over 20 candidates into clinical trials, concentrating on antibody-drug conjugates (ADCs) and post-programmed cell death 1 (PD-1) immuno-oncology.
