Bio-Thera wins China approval for Simponi biosimilar to treat autoimmune diseases
The drug, which will be marketed under the brand name Ashuli, is the first biosimilar of Johnson & Johnson’s Simponi (golimumab) to receive marketing authorisation in China.
CHINA—China’s National Medical Products Administration (NMPA) has approved Bio-Thera Solutions’ BAT2506 for treating ankylosing spondylitis and rheumatoid arthritis, expanding patients’ access to biosimilar therapies for autoimmune diseases.
The drug, which will be marketed under the brand name Ashuli, is the first biosimilar to Johnson & Johnson’s Simponi (golimumab) to receive marketing authorization in China.
The approval strengthens Bio-Thera’s position in China’s growing biosimilars market, where demand for more affordable biological medicines continues to rise.
Ankylosing spondylitis and rheumatoid arthritis are chronic inflammatory conditions that often require long-term treatment with biologic medicines, placing considerable pressure on healthcare budgets and patients.
Ashuli offers an alternative to the reference medicine and could improve access to TNF inhibitor treatment as competition expands in China’s biologics market.
Bio-Thera expands its biosimilar portfolio
Bio-Thera Solutions CEO Shengfeng Li welcomed the regulatory decision, noting that Ashuli is the company’s sixth biosimilar approved in China.
He said biosimilars play an important role in widening access to established biological treatments.
The approval also reflects the company’s continued investment in developing and commercialising biosimilar medicines.
Simponi is a human immunoglobulin G1 (IgG1) monoclonal antibody that targets tumour necrosis factor alpha (TNF-α), a protein involved in driving inflammation.
By blocking TNF-α activity, the medicine helps reduce inflammatory responses associated with autoimmune diseases.
Treatment with golimumab is associated with reductions in several 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).
Johnson & Johnson originally developed Simponi, which received US Food and Drug Administration (FDA) approval in 2009 before entering the Chinese market in 2018.
International commercialisation strategy
Beyond China, Bio-Thera has established commercialisation agreements with several pharmaceutical companies to support the international distribution of BAT2506.
The partnerships cover Canada, Europe, Latin America, the Middle East and North Africa, Southeast Asia and the United States.
In February 2025, Bio-Thera signed an exclusive licensing and commercialisation agreement with Intas Pharmaceuticals for the US market.
The agreement forms part of the company’s broader strategy to expand its biosimilar portfolio through regional partnerships rather than relying solely on direct commercial operations.
Based in Guangzhou, China, Bio-Thera Solutions is a commercial-stage biopharmaceutical company developing biosimilars and innovative medicines for autoimmune diseases, cancer, cardiovascular disorders and eye conditions.
The company has advanced more than 20 candidates into clinical trials, with research programmes focused on antibody-drug conjugates (ADCs) and immuno-oncology therapies targeting pathways beyond programmed cell death protein 1 (PD-1).
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