Guangzhou, China– September 10, 2025 –Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the MHRA has approved Qletli® (adalimumab), a biosimilar of Humira®, for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, crohn’s disease, ulcerative colitis, uveitis in adults, and polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis and uveitis in paediatric.
“The approval of Qletli® by MHRA is an important accomplishment for Bio-Thera,” said Shengfeng Li, CEO at Bio-Thera. “Improving patient access to important treatments is the promise of biosimilars and Bio-Thera continues to fulfill that promise through the continued development of our growing biosimilar pipeline of approved products.”
In November 2019, Qletli® was approved by the National Medical Products Administration (NMPA) of China, making it the first adalimumab biosimilar approved in the country and the only one available in two specifications for eight therapeutic indications. Qletli® is also under regulatory review in other countries 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 five approved products: Qletli® (adalimumab) in China and the UK, BETAGRIN® (bevifibatide citrate injection) in China, STARJEMZA® (ustekinumab) in the US and Usymro® (ustekinumab) in EU, and TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY® 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).
Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to Qletli® 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, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful 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.
1) HUMIRA™ is a trademark of AbbVie Biotechnology Ltd.
2) QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
3) BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd.
4) STARJEMZA™ is a trademark of Hikma Pharmaceuticals.
5) USYMRO™ is a trademark of Gedeon Richter Plc
6) TOFIDENCE® is a trademark of N.V. Organon
7) AVZIVI® is a registered trademark of Sandoz AG
8) POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.
2025.9.10
