China Approves First Secukinumab Biosimilar
Bio-Thera Solutions' BAT2306, marketed as YOUZHUOMEI, is cleared for psoriasis, ankylosing spondylitis, and psoriatic arthritis.
Updated on Nov. 4, 2026 in Biotech
China's National Medical Products Administration approved Bio-Thera Solutions' BAT2306, a biosimilar to COSENTYX, announced on October 26, 2026. It is the first secukinumab biosimilar approved in China, and Bio-Thera has also signed commercialization agreements covering the Middle East and North Africa, Latin America, and Southeast Asia.
Why it matters
Biosimilars that match approved biologic therapies can broaden access to treatments for autoimmune conditions in markets where reference products are costly. The Biocon licensing deal similarly extends availability of its YESINTEK biosimilar to STELARA across several additional countries.
The approval is a national regulatory clearance announced by the company, with STELARA's $6.08 billion in 2025 worldwide sales providing the reference-product benchmark for YESINTEK. Launch timing in the covered YESINTEK markets remains pending regulatory approval in each jurisdiction.
The players
Bio-Thera Solutions
A biopharmaceutical company that developed the BAT2306 biosimilar and secured its approval in China.
Biocon Limited
An Indian biopharmaceutical company that licensed commercialization rights for its YESINTEK biosimilar to Janssen.
Janssen Sciences Ireland
The Johnson & Johnson subsidiary that received YESINTEK commercialization rights in nine additional markets.
The details
BAT2306 will be marketed in China as YOUZHUOMEI and is approved for psoriasis, ankylosing spondylitis, and psoriatic arthritis. Separately, Biocon Limited granted Janssen Sciences Ireland commercialization rights for YESINTEK in Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea, and Kazakhstan, with YESINTEK approved for Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Timeline
2025: STELARA reaches $6.08 billion in worldwide sales.
October 26, 2026: NMPA approval of BAT2306 is announced by Bio-Thera Solutions.
October 26, 2026: Biocon announces the Janssen license agreement, with market entry rights taking immediate effect.
Big Picture
The approvals extend a wave of biosimilar entries against STELARA and COSENTYX, the two biologics whose exclusivity erosion is driving competition across Asia, Latin America, and the Middle East. Biosimilar makers are now pursuing regional licensing to expand reach beyond their home markets.
Patients with psoriasis, ankylosing spondylitis, or psoriatic arthritis in China may eventually have a lower-cost option once YOUZHUOMEI is commercially available. Launch timing in each covered market remains subject to local regulatory approval.
The takeaway
Biosimilar approvals across multiple markets can widen patient access to established biologic therapies, though availability depends on each country's regulatory timeline. Readers tracking treatment costs should watch for launch announcements in their region.
Further reading
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Source note: This article includes information reported by Big Molecule Watch.
