Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8009, an antibody drug conjugate (ADC) that targets B7-H3 (CD276). 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 BAT8009 and to determine the recommended phase 2 dose.

B7-H3 is an immunomodulatory transmembrane N-linked glycoprotein that is overexpressed in a number of solid tumors including small cell lung cancer, non-small cell lung cancer, breast cancer, and others but has a limited distribution and a lower level of expression in normal human tissues. Differences in expression levels make B7-H3 an potential target for ADC drug development. BAT8009 was developed using Bio-Thera’s proprietary anti-B7-H3 antibody and ADC linker-payload that includes a cleavable and systemically stable linker and a small molecule topoisomerase I inhibitor. The small molecule topoisomerase I inhibitor payload carried by BAT8009 has a strong cell membrane penetration ability, so when the target cancer cells are killed, the payload can potentially be released and further kill nearby cancer cells, producing a bystander effect and overcoming the heterogeneity of the tumor. BAT8009 has demonstrated high anti-tumor activity and good stability and safety in both in vitro and in vivo pharmacological studies and is a potential “best-in-class” ADC that targets B7-H3. BAT8009 is the second ADC drug using Bio-Thera’s proprietary new ADC platform administered to patients, representing another important milestone in the company’s research and clinical development in the field of innovative oncology drugs.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT8009 is designed to assess the safety and tolerability of BAT8009. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. Of note, Bio-Thera Solutions is developing several additional ADCs targeting Folate Receptor, HER2 and two other targets along with additional innovative oncology assets directed at important IO targets, including PD-1/CD47, OX40, CTLA-4, and TIGIT assets that are 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 BAT8009 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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