China Approves First Golimumab Biosimilar from Bio-Thera
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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."