Guangzhou, China -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that dosing has begun in Phase IA/IIB clinical trial to study efficacy and safety of BAT6026 in patients with moderate to severe atopic dermatitis. 

OX40 is an important autoimmune and inflammatory drug target, as OX40 is highly expressed by activated CD4+ and CD8+ T cells, which play an important role in many inflammatory diseases, such as atopic dermatitis (AD). BAT6026 not only blocks the OX40/OX40L interaction to prevent T cell activation and proliferation, but also specifically depletes activated OX40+ T cells through enhanced ADCC effect. Therefore, BAT6026 is expected to treat many inflammatory diseases, including those mediated by Th2 cells. BAT6026 has an exciting preclinical profile and was shown to be safe and well tolerated in a Phase 1 dose escalation clinical study.

The Phase IA/IIB, multicenter clinical trial of BAT6026 is designed to assess the efficacy and safety of BAT6026 in patients with moderate to severe atopic dermatitis. Key objectives in the study include determining safety, tolerability, pharmacokinetics, and preliminary anti-inflammatory activity.

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 three approved products: QLETLI? in China, and TOFIDENCE?/ BAT1806 and Avzivi?/Pobevcy? in the US and 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 ADCs. For more information, please visit www.9izixun.cn/en/or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT6026 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.