Guangzhou – Feb 26, 2025 – Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative drugs, today announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application for BAT4406, an ADCC-enhanced fully humanized anti-CD20 monoclonal antibody for the treatment of Aquaporin-4 (AQP4) antibody-positive Neuromyelitis Optica Spectrum Disorder(NMOSD).
In July 2025, the Independent Data Monitoring Committee (IDMC) recommended the early study termination for the pivotal Phase II/III clinical trial of BAT4406F in NMOSD based on positive interim analysis results. Following this recommendation, Bio-Thera decided to close patient enrollment ahead of schedule. NMOSD is a rare autoimmune disease clinically characterized by high relapse rates and severe disability. Its core clinical manifestations include significant vision loss, visual field defects, and even blindness due to optic neuritis, as well as paraplegia and bladder and bowel dysfunction resulting from myelitis. NMOSD was included in the First List of Rare Diseases published by the National Health Commission in 2018. Consequently, the development of novel therapeutic agents for NMOSD has become an urgent clinical need.
In addition, a Phase 2/3 registrational clinical study of BAT4406F for the treatment of Minimal Change Disease / Focal Segmental Glomerulosclerosis (MCD/FSGS) is currently enrolling patients across top-tier hospitals in China. This study is the first registrational trial in China targeting these indications. MCD and FSGS are two common pathological types of primary Nephrotic Syndrome (NS), accounting for approximately 10%‑25% and 5%‑10% of adult NS cases in China, respectively. Although the exact pathogenesis of MCD/FSGS remains to be fully elucidated, immune-mediated podocyte injury is considered as a key common factor in both conditions. While corticosteroids serve as the cornerstone of treatment for MCD/FSGS, most patients in clinical practice experience relapse after steroid therapy and require long-term steroid dependence. BAT4406F has the potential to become the first CD20-targeting monoclonal antibody approved globally for these indications.
"The acceptance of the NDA filing by NMPA for BAT4406F is a milestone in our efforts to bring an innovative therapy to patients suffering from NMOSD," said Bert Thomas, Senior Vice President of Business Development_of Bio-Thera Solutions. " BAT4406F builds on our growing expertise in autoimmune disease and rare orphan disorders and fits well with our autoimmune portfolio. BAT4406F represents a modern approach to targeting NMOSD using a fully humanized monoclonal antibody against the CD20 receptor. We look forward to potential NMPA approval and leveraging our commercial infrastructure to address this challenging condition."
About BAT4406
BAT4406F is a next-generation, glycoengineered fully human anti-CD20 antibody developed through the company's antibody Fc engineering platform. With enhanced ADCC (antibody-dependent cell-mediated cytotoxicity) function, it not only specifically binds to the CD20 molecule on the surface of target B cells and their precursors, but also exhibits high-affinity binding to NK (natural killer) cells, thereby triggering biological effects such as ADCC to achieve B-cell depletion.
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 six approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and USYMRO® (ustekinumab) in EU, Gotenfia® (golimumab) in EU, TOFIDENCE® (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.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).
Bio-Thera Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to BAT4406, 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. 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.
