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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