China Clears First Secukinumab Biosimilar
The approval of BAT2306 as YOUZHUOMEI adds a lower-cost option for psoriasis and related conditions, with launch timing still unannounced.
Updated on Nov. 4, 2026 in Biotech
China's National Medical Products Administration approved Bio-Thera Solutions' BAT2306, a biosimilar to COSENTYX, which will be marketed as YOUZHUOMEI for psoriasis, ankylosing spondylitis, and psoriatic arthritis. The approval is announced and approved, with commercialization already in place for the Middle East and North Africa, Latin America, and Southeast Asia. Separately, Biocon Limited licensed commercialization rights for its STELARA biosimilar YESINTEK to Janssen Sciences Ireland in nine additional markets.
Why it matters
Both deals show biosimilar developers expanding into new markets as reference biologics face competition in regions beyond their original approvals. The BAT2306 approval is the first secukinumab biosimilar cleared in China, marking a new entrant in that national market.
Biosimilars are approved by demonstrating similarity to a reference biologic, and BAT2306 is the first secukinumab biosimilar cleared in China. The source provides no comparative efficacy or pricing figures for either product.
The players
Bio-Thera Solutions
A Chinese biopharmaceutical company developing biosimilars, including BAT2306 for the secukinumab reference product.
Biocon Limited
An Indian biopharmaceutical company that develops biosimilars, including YESINTEK for the STELARA reference product.
Janssen Sciences Ireland
The licensee receiving commercialization rights to YESINTEK in nine additional markets, a unit tied to the Janssen pharmaceutical group.
The details
Biosimilars are lower-cost versions of biologic drugs, which are large protein molecules produced in living cells rather than by chemical synthesis. BAT2306 targets secukinumab, the reference biologic sold as COSENTYX, which blocks interleukin-17A, an immune signaling protein involved in psoriasis and related inflammatory conditions. YESINTEK is a biosimilar to STELARA (ustekinumab), which targets interleukin-12 and interleukin-23, immune messengers that drive Crohn's disease, ulcerative colitis, and psoriasis.
Timeline
October 26, 2026: NMPA approval of BAT2306 announced by Bio-Thera Solutions.
October 26, 2026: Biocon announced the license agreement with Janssen Sciences Ireland.
2025: STELARA recorded $6.08 billion in worldwide sales.
The Tech Race
Bio-Thera's BAT2306 is the first secukinumab biosimilar approved in China, placing it ahead of other developers in that national market for this reference product. Biocon's Janssen agreement shows a parallel race to secure commercial partners across more than a dozen regions for its STELARA biosimilar.
Patients in the covered markets may eventually have access to lower-cost alternatives to COSENTYX and STELARA, though launch timing depends on regulatory approval in each country. The source gives no pricing or availability dates for either product.
The takeaway
Watch for the first commercial launch of YOUZHUOMEI in China, which the source does not date. Track regulatory approvals in the nine YESINTEK markets covered by the Janssen agreement, since launches remain subject to approval in each country.
Further reading
Explore more on Biotech developments, including biosimilar approvals and licensing across global markets.
Source note: This article includes information reported by Big Molecule Watch.
