Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BAT7104, a bispecific antibody that specifically blocks the interaction of human PD-L1 and CD47 with their corresponding receptors.

BAT7104 was designed to inhibit the PD-1/PD-L1 and CD47/SIRP-α pathways. By an “imbalanced” design with finely tuned binding affinity to CD47 and high affinity to PD-L1, BAT7104 is expected to avoid RBC depletion and block CD47 on CD47⁺/PD-L1⁺ tumors in a more selective and tumor-enriched manner. BAT7104 was shown to effectively inhibit both pathways in vitro and demonstrated synergistic activity in inducing complete tumor regression in vivo. In non-human primates (NHP) study, BAT7104 was well tolerated with no adverse effects, suggesting a favorable therapeutic index in future clinical development. “BAT7104 has demonstrated higher anti-tumor activity with better safety profile in preclinical studies”. Commented Dr. Shengfeng Li, CEO, Bio-Thera Solutions. “As the first bispecific antibody of Bio-Thera, we are pleased to see BAT7104 enter clinical development in Australia, and we will continue bringing more innovative anti-tumor drugs to cancer patients.” Dr. Shengfeng Li continued.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT7104 is designed to assess the safety and tolerability of BAT7104. 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. Another early stage Phase 1 clinical study evaluating BAT7104 is being conducted in China in patients with solid tumors and lymphoma. In addition, Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, and TIGIT, all in early stage clinical studies.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and has two approved products, QLETLI^® and POBEVCY^® in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on immuno-oncology, ADC targeted therapies, autoimmune diseases, and other severe and emerging unmet medical needs. For more information, please visit www.bio-thera.com/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 BAT7104 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.

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