GUANGZHOU, China, July 23, 2026 /PRNewswire/ — Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8013, an antibody drug conjugate (ADC) that targets CD25. The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8013 and to determine the recommended Phase 2 dose.
CD25, also known as interleukin-2 receptor alpha chain (IL-2Rα), is a 55 kDa transmembrane glycoprotein encoded by the IL2RA gene, predominantly expressed on activated T and B cells, regulatory T cells (Tregs), and various hematologic malignancies. BAT8013 was developed using Bio-Thera’s anti-CD25 antibody and Bio-Thera’s proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. CD25 is differentially overexpressed on Tregs in the solid tumor microenvironment. Eliminating Tregs using BAT8013 is expected to potentiate the efficacy of other immune-oncology agents like PD-1 and PD-L1 mAbs.
A series of preclinical studies have shown that BAT8013 has good stability and safety and has high anti-tumor activity in combination with Bio-Thera’s PD-1 inhibitor, BAT1308. The small molecule topoisomerase I inhibitor payload carried by BAT8013 has a strong cell membrane penetration ability, so when the target Treg cells are killed, the payload can be released and further kill nearby Treg cells, producing a bystander. BAT8013 has demonstrated high anti-tumor activity and good safety in both in vitro and in vivo pharmacological studies and is a potential “best-in-class” ADC that targets CD25, representing another important milestone in the company’s research and development in the field of innovative oncology drugs.
The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT8013 is designed to assess the safety and tolerability of BAT8013. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. In addition, Bio-Thera Solutions is developing several additional ADCs targeting Folate Receptor alpha, Trop2 and Her2 along with additional innovative oncology assets directed at important IO targets, including novel bispecific targeting PD-L1/4-1BB and PD1/IL15, all in early-stage clinical studies.
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) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and USYMRO® (ustekinumab) in EU, IMMGOLISTM and IMMGOLIS INTRITM (golimumab) in US and GOTENFIA® (golimumab) in EU, TOFIDENCE® (tocilizumab) in the US, 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 BAT8013, 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.
Contact
Bio-Thera Solutions, Ltd.:
Bert E. Thomas IV +1.410.627.1734
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