Bio-Thera Solutions Announces Presentation of BAT8009 (B7-H3-ADC) at the 2nd Annual ADC Target Selection Summit

GUANGZHOU, China–(BUSINESS WIRE)–#B7H3ADC–Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced that Jin-Chen Yu, SVP, Research will present a talk on BAT8009 (B7-H3-ADC) at the 2^nd Annual ADC Target Selection Summit taking place December 6 – 8, 2022 in Boston, MA.

The talk, entitled �A Novel B7-H3 ADC With Strong Bystander Effect Demonstrates Superior Tumor-Inhibition Activity,” will present preclinical data that highlight advantages demonstrated by BAT8009 as a potential treatment for cancer patients. BAT8009 is currently being evaluated in a Phase 1 clinical trial.

BAT8009 is a new ADC being developed with Bio-Thera’s next-gen ADC platform that utilizes a systemically stable cleavable linker, a potent Topoisomerase 1 inhibitor (Exatecan) as the payload, and high DARs that takes advantage of the bystander effect to increase efficacy. Other new ADC assets developed using this next-gen ADC platform include BAT8006 (Folate-Receptor-alpha-ADC), BAT8007 (Nectin4-ADC), BAT8008 (Trop2-ADC) and BAT8010 (Her2-ADC). All of these ADC assets are currently in, or about to begin, Phase 1 clinical trials.

About BAT8009

BAT8009 is an investigational B7-H3-ADC being evaluated in multiple tumor types. B7-H3 is a naturally occurring receptor that is overexpressed in many types of cancer, including lung, liver, esophageal and ovarian cancer. BAT8009 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8009 is currently being evaluated in a Phase 1 evaluating the pharmacodynamics and safety of BAT8009 (more information on the Phase 1 clinical trial is available at https://clinicaltrials.gov/ct2/show/NCT05405621).

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.

Contacts

Bio-Thera Solutions, Ltd.:

Bert E. Thomas IV +1.410.627.1734

bethomas@bio-thera.com