Guangzhou, China – July 2025 – Bio-Thera Solutions, Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Independent Data Monitoring Committee (IDMC) has recommended early study termination for the pivotal Phase II/III trial of BAT4406F in neuromyelitis optica spectrum disorder (NMOSD) based on positive interim analysis results. Following this recommendation, Bio-Thera has decided to close patient enrollment ahead of schedule. BAT4406F is an ADCC-enhanced, fully humanized anti-CD20 monoclonal antibody developed by Bio-Thera.

The randomized, double-blind, placebo-controlled phase II/III clinical trial, led by Professor Chen Xiangjun of Huashan Hospital, Fudan University (China), is being conducted across 45 sites in China. Following a formal review of interim data, the IDMC concluded that BAT4406F demonstrated statistically significant efficacy, meeting the pre-defined superiority criteria, and recommended early trial termination due to compelling efficacy. Based on this recommendation, Bio-Thera has decided to close enrollment ahead of schedule and begin preparation to file for regulatory approval from NMPA. In addition, Bio-Thera intends to explore the safety and efficacy of BAT4406F in other indications.

Neuromyelitis optica spectrum disorder (NMOSD) is a rare, severe autoimmune disease characterized by high relapse rates and progressive disability. The condition primarily attacks the optic nerves and spinal cord, leading to devastating clinical outcomes: Optic neuritis (ON) causes rapid vision loss, visual field deficits, and potential permanent blindness. Transverse myelitis results in paralysis, sensory deficits, and bowel or bladder dysfunction. NMOSD was included in China's First National Rare Disease Catalog by the National Health Commission in 2018 due to the significant disease burden that patients experience.

Current treatment options remain limited, creating substantial unmet medical needs for this debilitating neurological disorder. The development of novel NMOSD therapies remains a critical unmet medical need. BAT4406F has demonstrated statistically significant efficacy in its pivotal trial, achieving pre-specified superiority endpoints while maintaining a favorable safety profile.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® in the US, and BAT1806/TOFIDENCETM (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY® in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit www.iuvbook.com/en/ or follow us on X(@bio_thera_soln) and WeChat (Bio-Thera).

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT4406F 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 undertake 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.

1)     QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.

2)     BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd.

3)     STARJEMZA® is a registered trademark of Hikma Pharmaceuticals.

4)     TOFIDENCE™ is a trademark of Organon LLC

5)     AVZIVI® is a registered trademark of Sandoz

6)     POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.