Bio-Thera Solutions Announces First Patient Dosed in Australia for BAT6021, an ADCC-enhanced Monoclonal Antibody Targeting TIGIT for the Treatment of Solid Tumors

Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6021, a monoclonal antibody with enhanced ADCC targeting TIGIT in cancer cells.

“BAT6021 is Bio-Thera’s third IO asset that has entered Phase 1 study in a month.” said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. “We plan to explore combinations of BAT6021 with our other oncology assets to treat a broad range of cancers.” Dr. Shengfeng Li continued, “we are very pleased to see BAT6021 enter clinical study in Australia, as this is an important step for bringing this innovative and highly differentiated anti-TIGIT antibody to cancer patients.”

BAT6021 has demonstrated highly potent single-agent and combinatorial anti-tumor activity in vivo pharmacology studies. The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT6021 is designed to assess the safety and tolerability of BAT6021 as a single agent and in combination with BAT1308, a novel anti-PD-1 antibody in advanced solid tumor patients. Key objectives in the study include determining maximum tolerated dose and recommended phase 2 dose (RP2D), pharmacokinetics and preliminary anti-tumor activity in the monotherapy and combination therapy. Disease-specific expansion cohorts will be enrolled at the RP2D in Australia, China and other countries to further evaluate the safety and efficacy of BAT6021 in a series of malignancies.

Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, CD47, and IO bispecifics targeting synergistic targets like PD-L1/CD47.

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 BAT6021 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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