Bio-Thera Solutions Announces Enrollment Completed in Phase 1 Study for BAT2022, a Broadly Potent Neutralizing Bi-specific Antibody Against SARS-CoV-2

Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced today that enrollment for the Phase I clinical study of BAT2022 has been completed, showing that BAT2022 is well-tolerated and there were no DLT observed up to the dose of 1500mg, the highest dose tested. BAT2022 is a broadly potent neutralizing bi-specific antibody against SARS-CoV-2. Plasma concentrations of BAT2022 were analyzed and determined, showing very favorable PK parameters, and more importantly, the plasma levels of BAT2022 in the clinical study have shown a very high neutralizing titer in a pseudotyped ex vivo assay of pharmacodynamics. This data suggests that BAT2022 can be developed not only as a therapeutic for COVID-19 patients, but also as a potential prophylactic to healthy people at higher risk of infection, such as healthcare workers, and immunocompromised individuals, such as seniors.

As the SARS-CoV-2 virus continues to evolve throughout the pandemic and variants continue to emerge, some have become more contagious, virulent, or more resistant to the current vaccines and neutralizing antibodies, such as omicron, which is highly transmissible and resistant to most of our current countermeasures. Therefore, novel antibodies that maintain their neutralization strength and breadth against the abovementioned resistant variants and possibly future emerging variants are urgently needed. By utilizing its proprietary IDEAL (Intelligent Design and Engineered Antibody Libraries) platform, the Bio-Thera team has discovered and developed BAT2022, a broadly potent neutralizing bi-specific antibody against SARS-CoV-2. BAT2022 binds simultaneously with high affinity to two non-overlapping epitopes on the Receptor-Binding Domain (RBD) of SARS-CoV-2 virus and competitively blocks the binding of RBD to human Angiotensin-Converting Enzyme 2 (ACE2). Preclinical study results were recently published in Virology: Current Research (Zhang, H., et al. "Broadly Potent Neutralizing Bispecific Antibody against SARS-CoV-2." Virology: Current Research 6:S1,2022). Data from the article showed that BAT2022 potently neutralizes all of the SARS-CoV-2 mutants (Alpha, Beta, Gamma, Delta, and Omicron) tested, with IC50 values ranging from 20-160 pM, and specifically, a IC50 value of 30 pM was obtained for Omicron BA.2.76, which is currently circulating in many parts of China. In a mouse model of SARS-CoV-2, BAT2022 shows strong prophylactic and therapeutic effects. Prophylactically, a single dose of BAT2022 completely protected mice from body weight loss, as compared to up to 20% loss of body weight in placebo-treated mice; in all mice treated with BAT2022 either prophylactically or therapeutically, the lung viral titers were reduced to undetectable levels, as compared to around 1 × 10⁵ PFU/g lung tissue in placebo-treated mice. These preclinical data, together with the phase 1 clinical data, strongly suggest that BAT2022 is a potential candidate for prophylactic and therapeutic use against SARS-CoV-2.

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 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 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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