Bio-Thera Solutions, Ltd. (SSE: 688177 ) is a global, science-driven biopharmaceutical company located in Guangzhou, China, hereinafter referred to as " Bio-Thera " or " the Company " . The Company's marketing authorization application for its product, darpubayimab injection (hereinafter referred to as "BAT4406F" ), for the treatment of neuromyelitis optica spectrum disorder (NMOS D ) positive for anti-aquaporin 4 (AQP4) antibodies, has recently been accepted by the National Medical Products Administration.

In July 2025, the interim analysis of the pivotal Phase II/III registration clinical trial of BAT4406F in neuromyelitis optica spectrum disorders (NMOSD) showed significant benefit in the experimental group, leading to a recommendation from the Independent Data Monitoring Committee (IDMC) to "terminate the trial early," thus ending participant recruitment early. The BLA application was completed in early February 2026. NMOSD is a rare autoimmune disease characterized by high relapse and high disability rates. Its core clinical manifestations include severe visual loss, visual field defects, and even blindness due to optic neuritis, as well as paraplegia and bladder/rectal dysfunction caused by myelitis. NMOSD was included in the first batch of rare disease catalogs published by the National Health Commission of China in 2018, and the development of novel therapeutics for NMOSD has become an urgent clinical problem.

In addition, a Phase II/III registration clinical trial of BAT4406F for minimal change disease/focal segmental glomerulosclerosis (MCD/FSGS) is currently recruiting patients in several top-tier hospitals across China. This study is the first registration study in my country for this indication. MCD and FSGS are two common pathological types of primary nephrotic syndrome (NS), with MCD accounting for approximately 10%-25% of adult NS cases in my country and FSGS accounting for approximately 5%-10%. The pathogenesis of MCD/FSGS is not fully understood, but immune podocyte injury is considered a common key factor in the pathogenesis of both. Glucocorticoids are the foundation of treatment for MCD/FSGS, but clinically, many patients experience relapse after hormone therapy and require long-term hormone dependence. BAT4406F is expected to become the world's first CD20 monoclonal antibody drug approved for this indication.

Regarding BAT4406F

BAT4406F is a new generation of glycosylated, fully human anti-CD20 antibody developed based on the company's antibody Fc engineering platform. It has ADCC enhancement function, which not only specifically binds to CD20 molecules on the surface of target cells B cells and precursor cells, but also has high affinity for NK natural killer cells, inducing biological effects such as ADCC (antibody-dependent cell-mediated cytotoxicity), thereby achieving the purpose of eliminating B cells .

About Bio-Thera

Bio-Thera Solutions is a global, science-driven biopharmaceutical company based in Guangzhou, China. The company is dedicated to developing next-generation innovative drugs and biosimilars for the treatment of cancer, autoimmune diseases, cardiovascular diseases, ophthalmological diseases, and other life-threatening or health-threatening conditions. The company is committed to becoming a leading global developer of antibody drugs and has already facilitated the approval and launch of multiple drugs. Among them, Betanistatin® ( Vitamin Citrate) has been approved for marketing in China; Adalimumab (UK brand name: Qletli® , China brand name: Geleli® ) has been approved for marketing in both China and the UK; Tocilizumab (US brand name: TOFIDENCE™, China brand name: Shiruili® ) has been approved for marketing in five regions: China, the US, Europe, Switzerland, and the UK; Bevacizumab (US brand name: Avzivi® , China brand name: Pubeixi® , Brazil brand name: Bevyx® ) has been approved for marketing in four regions: China, the US, Europe, and Brazil; Ustekinumab (US brand name: STARJEMZA™, Europe brand name: Usymro® ) has been approved in the US and Europe; and Golimumab (European brand name: Gotenfia® ) has been approved in Europe . TOFIDENCE™ has become the first monoclonal antibody drug developed, manufactured, and approved for marketing by the US FDA by a Chinese pharmaceutical company. The company also has several other drug candidates in late-stage clinical trials, primarily focusing on post-PD-1 era tumor immunotherapy and antibody-drug conjugate (ADC) targeted therapy development in the oncology field. Bio-Thera prioritizes patient well-being as its core value, providing safe, effective, and affordable high-quality medicines through innovative research and development to meet pressing treatment needs. For more information, please visit our website www.bio-thera.com, or follow us on X (@bio_thera_sol) and WeChat official account (百奥泰).

Bio-Thera Solutions Forward-Looking Statement

This press release contains forward-looking statements related to BAT4406F or Bio-Thera Solutions and its product lines. Readers are cautioned not to place undue reliance on these forward-looking statements, as certain important factors could affect the Company’s actual results. These forward-looking statements include, but are not limited to, statements containing intentions, wills, possibilities, potentialities, forecasts, plans, estimates, expectations, and similar expressions. They should be considered as reasonable assumptions made by Bio-Thera Solutions based on information available as of the date of this press release and do not guarantee future performance or developments. Actual results and events may differ materially from the information contained in the forward-looking statements due to a variety of factors, including, but not limited to, the possibility that the product may not be accepted or approved, and the inherent risks and uncertainties in drug research, development, and commercialization, such as the risks and uncertainties of preclinical and clinical studies and the possibility of regulatory approval. Other risk factors include risks and uncertainties related to manufacturing, distribution, marketing, competition, intellectual property, drug efficacy and safety, changes in national and global financial and healthcare conditions, changes in the Company’s financial condition, and changes in applicable laws and regulations. Any forward-looking statements contained in this press release are only valid as of the date of the statement. Unless required by law, Bio-Thera has no obligation to update any forward-looking statements contained in this press release to reflect new information and events, changes in the company’s views or other circumstances after the date of this press release.

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