Bio-Thera Solutions Reported the Discovery of a Broad-Spectrum SARS-CoV-2 Neutralizing Antibody with Potential to Treat Many Known Variants of COVID-19

GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (688177.SH) today announced the discovery of a broad-spectrum SARS-CoV-2 neutralizing antibody with the potential to treat COVID-19. The antibody, named BAT2022, is a bi-specific monoclonal antibody. BAT2022 is active against a variety of SARS-CoV-2 variants, including the Delta variant strain. The paper describing the discovery and evaluation of BAT2022 is published on the BioRxiv preprint server (https://www.biorxiv.org/content/10.1101/2021.08.10.455627v1.full.pdf+html) and has not yet been peer-reviewed.

BAT2022 was discovered through Bio-Thera’s proprietary fully synthetic human IDEAL (Intelligently Designed and Engineered Antibody Library) technology platform. BAT2022 utilizes two antibodies, 2F8 and VHH18. 2F8 was isolated from Bio-Thera’s proprietary IDEAL-Vh/Vl library and VHH18 is a single domain nanobody isolated from Bio-Thera’s IDEAL-nanobody library. BAT2022 was constructed by attaching VHH18 to the C-terminal of the Fc of 2F8. VHH18 and 2F8 bind to non-overlapping epitopes of the SARS-CoV-2 spike protein, providing the two-prong attack that appears to be synergistic.

Experiments showed that in the live SARS-CoV-2 virus assay BAT2022 has an IC50 of 30 pM, 13 pM, and 90 pM for wildtype, beta variant, and delta variant, respectively. These results indicate that BAT2022 has the potential to effectively treat the wild-type SARS-CoV-2 virus and all its known variants. BAT2022 demonstrated potent in vivo efficacy against SARS-CoV-2 in a mice model both prophylactically and therapeutically, protecting animals from disease progress and abolishing virus replication in the lungs. The FRNT method was unable to detect any virus titrating in the lungs of the mice dosed with BAT2022, indicating that virus replication was completely inhibited in both the prophylactic and therapeutic experiments with the PRNT assay.

“The data reported in this paper suggest that BAT2022 could potentially be an effective weapon against current variants of SARS-CoV-2, especially for the more contagious Delta variant, and hopefully new variants that emerge in the future” said Dr. Shengfeng Li, Chief Executive Officer of Bio-Thera Solutions. “Bio-Thera is proud to have discovered BAT2022 as part of its effort to fight the SARS-CoV-2 virus and help COVID-19 patients around the world.”

About Bio-Thera Solutions, Ltd.

Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical 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. As a leader in the next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and one of which, QLETLI® (格乐立®), a biosimilar to adalimumab, is available to patients in China. In addition, the company has multiple candidates entering early clinical trials , including differentiated and innovative anti-OX40, anti-TIGIT antibodies. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).

Bio-Thera Solutions Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT2022 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 in vitro or early, small scale clinical trial results may not translate into desired results in vivo or in large scale 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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