China approves Bio-Thera BAT2306 as world's first secukinumab biosimilar
China has approved Bio-Thera's BAT2306 as the first secukinumab biosimilar authorised by a major regulator worldwide, opening a new biosimilar competition category.
Bio-Thera's BAT2306, marketed as YOUZHUOMEI, has received approval from China's National Medical Products Administration as a biosimilar to secukinumab for psoriasis, ankylosing spondylitis and psoriatic arthritis.
The company identifies the decision as the first major-regulator approval of a secukinumab biosimilar, creating a new potential treatment alternative across three immune-mediated inflammatory conditions.
Field | Content |
Article Type | Approvals |
Regulatory Authority | China National Medical Products Administration |
Regulatory Decision | Biosimilar marketing approval |
Company | Bio-Thera Solutions |
Product Development Code | BAT2306 |
Brand Name | YOUZHUOMEI |
Reference Medicine | Secukinumab |
Product Type | Biosimilar monoclonal antibody |
Therapeutic Area | Immunology; inflammatory diseases |
Approved Indications | Psoriasis; ankylosing spondylitis; psoriatic arthritis |
Approval Geography | China |
Regulatory Significance | Reported by Bio-Thera as the first secukinumab biosimilar approved by a major regulator worldwide |
Approval Announcement Date | 22 October 2026 |
English Announcement Date | 26 October 2026 |
Clinical Evidence | Specific comparative clinical study results not provided in supplied summary |
Commercial Launch Timing | Not confirmed in supplied summary |
Pricing | Not disclosed |
What Happened | China's NMPA approved Bio-Thera's BAT2306 as a secukinumab biosimilar for three inflammatory conditions. |
Why It Matters | The approval introduces a biosimilar competitor to secukinumab and could support broader treatment access and price competition in China. |
Market Significance | Bio-Thera describes BAT2306 as the world's first secukinumab biosimilar authorised by a major regulatory authority. |
Key Takeaway | BAT2306 has obtained Chinese marketing approval for psoriasis, ankylosing spondylitis and psoriatic arthritis; international authorisations are not established by this decision. |
What to Watch | Commercial launch, pricing, reimbursement, physician uptake, supply availability and regulatory filings in other markets. |
Primary Source | Bio-Thera Solutions |
Primary Source URL | https://www.bio-thera.com/news/1001462.html |
Relevant Date | 22 October 2026; English announcement 26 October 2026 |
Discover how nuaxia can support your next medical education initiative:
Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector
Contact us on: support@nuaxia.com
Comentários