China approves Bio-Thera's Ashuli as its first golimumab biosimilar

Bio-Thera has secured Chinese regulatory approval for Ashuli, the country's first golimumab biosimilar, expanding domestic biosimilar competition in rheumatoid arthritis and ankylosing spondylitis.

Bio-Thera announced on 6 November 2026 that China's National Medical Products Administration had approved BAT2506, marketed as Ashuli, for rheumatoid arthritis and ankylosing spondylitis, establishing the first approved golimumab biosimilar in China.

The TNF-alpha-targeting monoclonal antibody becomes Bio-Thera's sixth approved biosimilar in its domestic market and represents a new China-specific regulatory milestone, separate from earlier international authorisations and from the company's previously reported BAT2306 secukinumab biosimilar approval.

Field	Content
Article Type	Approvals
Company	Bio-Thera Solutions
Product Brand	Ashuli
Development Code	BAT2506
Active Ingredient	Golimumab
Product Type	Biosimilar monoclonal antibody
Reference Biologic	Golimumab reference product
Molecular Target	Tumour necrosis factor alpha
Target Abbreviation	TNF-alpha
Regulatory Authority	National Medical Products Administration
Regulatory Authority Abbreviation	NMPA
Country	China
Announcement Date	6 November 2026
Approval Type	Marketing authorisation
Regulatory Status	Approved in China
First-in-Market Status	First golimumab biosimilar approved in China
Approved Indication One	Rheumatoid arthritis
Approved Indication Two	Ankylosing spondylitis
Therapeutic Area	Immunology and inflammatory diseases
Biosimilar Portfolio Milestone	Bio-Thera's sixth approved biosimilar in China
International Regulatory Context	Separate earlier approvals in other markets under different brand names
Domestic Commercial Launch Date	Not specified in supplied summary
Comparative Clinical Evidence	Not detailed in supplied summary
Mechanism of Action	TNF-alpha inhibition
Previous Distinct Bio-Thera Approval	BAT2306 secukinumab biosimilar
Previous Approval Timing	October 2026
Relationship to BAT2306	Different active ingredient, reference biologic and regulatory event
What Happened	China's NMPA approved Bio-Thera's BAT2506 golimumab biosimilar under the Ashuli brand.
Why It Matters	The approval creates a new domestic biosimilar option targeting TNF-alpha-mediated inflammatory diseases.
Regulatory Significance	Marks China's first approval of a golimumab biosimilar.
Commercial Significance	Expands Bio-Thera's approved biosimilar portfolio and potential domestic market opportunities.
Key Takeaway	Ashuli is now authorised in China for rheumatoid arthritis and ankylosing spondylitis.
What to Watch	Commercial launch, pricing, reimbursement, hospital adoption and competitive developments in the Chinese TNF-alpha inhibitor market.
Primary Source	Bio-Thera Solutions
Primary Source URL	https://www.prnewswire.com/news-releases/bio-thera-announces-nmpa-approval-of-bat2506-the-first-golimumab-biosimilar-approved-in-china-302931732.html
Relevant Date	6 November 2026

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