Guangzhou – November 06, 2026 -- China's National Medical Products Administration (NMPA) has approved Bio-Thera Solutions' BAT2506, the first golimumab biosimilar cleared in the country, the Shanghai-listed company (688177.SH) said.
ASHULI is cleared for rheumatoid arthritis and ankylosing spondylitis
BAT2506 will be sold in China under the brand name ASHULI. The NMPA approved it for two indications: rheumatoid arthritis and ankylosing spondylitis.
Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α). Binding to TNF-α reduces the inflammatory markers CRP, IL-6, ICAM-1, MMP-3 and VEGF.
Bio-Thera adds its sixth approved biosimilar in China
CEO Shengfeng Li said ASHULI is the company's sixth biosimilar approved in China. He said biosimilars "have an important role in expanding patient access to important biologics."
Bio-Thera cites strong demand in China for affordable biologics, given the number of patients with autoimmune diseases such as rheumatoid arthritis and ankylosing spondylitis. The company expects ASHULI to improve clinical accessibility of biological agents.
Commercialization deals span the US, Europe, Canada and emerging markets
Bio-Thera has signed commercialization agreements with multiple partners for BAT2506. They cover the US, Europe and Canada, as well as the Middle East and North Africa, Latin America and Southeast Asia.
The golimumab biosimilar is already marketed under other names outside China: GOTENFIA in the EU and IMMGOLIS (golimumab-sldi) in the US.