Biotechnology
Bio-Thera Wins China Approval for Golimumab Biosimilar ASHULI
Add Securities.io to your preferred sources on Google
Bio-Thera Solutions announced on November 6, 2026 that China’s National Medical Products Administration (NMPA) had approved its marketing authorization for BAT2506, a golimumab biosimilar that will be marketed as ASHULI for rheumatoid arthritis and ankylosing spondylitis. The decision adds China to the US and European authorizations already secured for the same development program.
Bio-Thera describes BAT2506 as China’s first approved golimumab biosimilar. Chief executive Shengfeng Li said ASHULI was the company’s sixth biosimilar approved in China, and he linked the decision to its broader commercialization strategy. “Biosimilars have an important role in expanding patient access to important biologics. This NMPA approval demonstrates Bio-Thera’s long-term commitment to developing and commercializing biosimilars,” Li said.
Commercialization agreements for BAT2506 cover the United States, Europe, Canada, the Middle East and North Africa, Latin America and Southeast Asia. The Chinese authorization therefore extends the regulatory reach of a product already supported by an international partner network.
Bio-Thera’s announcement describes golimumab as a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha, a pro-inflammatory molecule, and says binding to that target reduces inflammatory markers including C-reactive protein and interleukin 6.
Distinct Labels In The US And Europe
In the United States, Bio-Thera and Accord BioPharma announced FDA marketing authorization for IMMGOLIS, formerly known as BAT2506, as a Simponi biosimilar for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate and for adults with moderately to severely active ulcerative colitis. The FDA also approved IMMGOLIS INTRI, a biosimilar to Simponi Aria, for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.
On February 13, 2026, STADA and Bio-Thera announced European Commission marketing authorization for Gotenfia, developed under the BAT2506 code. Its European indications include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.
The European authorization covers the 27 EU member states plus Norway, Iceland and Liechtenstein. It was based on analytical, non-clinical and clinical data demonstrating biosimilarity to Simponi. Together, the authorizations show one development program moving through distinct regulatory regimes and indication sets rather than a single identical global label.
Partner Roles And Disclosed Payments
Those arrangements also divide the commercial work. Under the US agreement signed with Intas on February 10, 2025, Bio-Thera is responsible for development, manufacturing and supply, while Intas’s US specialty division, Accord BioPharma, handles commercialization. In Europe, Bio-Thera retains development, manufacture and commercial supply, while STADA holds exclusive commercialization rights in the EU, UK, Switzerland and selected other countries.
Bio-Thera and STADA disclosed the financial terms of their European agreement on May 28, 2024: a US$10 million upfront payment to Bio-Thera and up to US$147.5 million in additional development and commercial milestone payments, subject to certain conditions.
STADA Global Specialty head Bryan Kim said at the time that golimumab generated US$2.2 billion in global sales in 2023, including more than US$1 billion outside the United States. His figures describe the broader golimumab market when the deal was signed, not BAT2506 revenue.
The disclosed payments belong to that European partnership. The November 6 announcement identifies no approval-related payment, Chinese launch date, price or revenue forecast, and the STADA agreement does not establish that the NMPA decision triggers one of its milestones.
ASHULI nevertheless broadens the regulatory base of a product whose international partners rely on Bio-Thera for manufacturing and supply. With China now authorized alongside the United States and Europe, the commercial focus turns from adding approvals to executing a Chinese launch and establishing whether the expanded footprint produces reported product revenue.
