GUANGZHOU, China, Nov. 6, 2026 /PRNewswire/ — Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, today announced that the National Medical Products Administration (NMPA) has approved its marketing authorization for BAT2506, a golimumab biosimilar. This approval marks the first golimumab biosimilar approved in China. BAT2506 will be marketed under the name 阿舒立® (ASHULI) and is approved by NMPA for the following indications: rheumatoid arthritis and ankylosing spondylitis.
Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α), a pro-inflammatory molecule. Binding of golimumab to TNF-a results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers.
The demand for affordable biological agents is particularly prominent in China where there are many patients with autoimmune diseases, such as rheumatoid arthritis and ankylosing spondylitis. The approval of 阿舒立® (ASHULI) will bring a new and affordable treatment option to patients and help improve the clinical accessibility of biological agents.
“We are proud to have another biosimilar approved by NMPA. 阿舒立® (ASHULI) is Bio-Thera’s sixth biosimilar approved in China”, said Shengfeng Li, CEO of Bio-Thera Solutions. “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.”
Bio-Thera has signed commercialization agreements with multiple partners for BAT2506, covering countries and regions such as the US, Europe, and Canada as well as the Middle East and North Africa (MENA), Latin America (LATAM) and Southeast Asia, extending the reach of BAT2506 to autoimmune patients around the world.
About Bio-Thera Solutions:
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including six approved products: QLETLI® (adalimumab), BETAGRIN® (bevifibatide citrate) Injection and 优卓美® secukinumab Injection in China in China, STARJEMZA® (ustekinumab) in the US and USYMRO® (ustekinumab) in the EU, TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in the EU, a/k/a POBEVCY® in China, and GOTENFIA® (golimumab) in the EU, IMMGOLIS™ (golimumab-sldi) in the US and 阿舒立® in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit www.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).
Bio-Thera Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to BAT2506, or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.
Bio-Thera Contact:
Bert E. Thomas IV
Phone: +1.410.627.1734
Email: bethomas@bio-thera.com
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SOURCE Bio-Thera Solutions, Ltd
