Bio-Thera Solutions' BAT1806 (Tocilizumab) Injection TOFIDENCE Receives FDA Approval as First Chinese-Developed Monoclonal Antibody Biosimilar

Bio-Thera Solutions, Ltd. (SSE Code: 688177), hereinafter referred to as “Bio-Thera” or the “Company,” is a science-driven, innovative global biopharmaceutical company headquartered in Guangzhou, China. The Company is dedicated to developing next-generation innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmic conditions, and other major diseases that threaten human life or health. The Company’s partner, Biogen (NASDAQ: BIIB), recently received notification from the U.S. Food and Drug Administration (FDA) that TOFIDENCE (BAT1806/BIIB800), a biosimilar developed by Bio-Thera referencing RoActemra® (tocilizumab), has been approved by the FDA for intravenous infusion to treat moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Dr. Li Shengfeng, Founder and Chairman of Bio-Therastated, “We are delighted that TOFIDENCE has received marketing approval from the U.S. FDA. TOFIDENCE is the first product of Bio-Thera to obtain U.S. FDA marketing approval, and it is also the first monoclonal antibody drug independently developed and manufactured by a Chinese pharmaceutical company to receive such approval. This represents a very important milestone for Bio-Thera. We will remain true to our original aspiration and continue to develop and advance safe, effective, and affordable biologics to benefit patients worldwide.”

In April 2021, Bio-Thera and Biogen entered into a collaboration agreement for TOFIDENCE (BAT1806/BIIB800), under which Biogen will commercialize TOFIDENCE, developed by Bio-Thera, in all countries except China (including Hong Kong, Macao, and Taiwan).

The U.S. FDA’s approval of the marketing application for TOFIDENCE (BAT1806/BIIB800) was based on comprehensive analytical results, as well as preclinical and clinical data: Extensive analytical characterization of TOFIDENCE’s structural, physicochemical, and biological properties demonstrated its similarity to the reference product, Actemra®. Phase I clinical studies of TOFIDENCE evaluated the pharmacokinetics, safety, and immunogenicity of TOFIDENCE versus tocilizumab in healthy subjects. Phase III clinical studies of TOFIDENCE assessed the safety, efficacy, pharmacokinetics, and immunogenicity of TOFIDENCE versus tocilizumab in patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate. A series of analytical results and clinical study data all indicate that TOFIDENCE is comparable to the reference product in terms of efficacy, safety, and immunogenicity, establishing it as a biosimilar to tocilizumab.

TOFIDENCE (tocilizumab) is a biosimilar developed by Bio-Thera with reference to Actemra® (tocilizumab), indicated for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. TOFIDENCE is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R). It specifically binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits signal transduction mediated by sIL-6R and mIL-6R. Shiruili® (tocilizumab) was approved for marketing in China in January 2023, becoming the first tocilizumab biosimilar approved by the National Medical Products Administration (NMPA) of China.

Bio-Thera is a science-driven, innovative global biopharmaceutical company headquartered in Guangzhou, China. The company is dedicated to developing next-generation innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmic conditions, and other life-threatening or health-compromising diseases. As a leader in the research and development of next-generation antibody therapeutics, Bio-Thera has advanced multiple drug candidates into late-stage clinical trials. Among these, GLEOSTA® (adalimumab), PUVEHIA® (bevacizumab), and TOCILIZUMAB BIO-THERA® (tocilizumab) have been approved for marketing in China. TOFIDENCE has received approval in the United States. Currently, more than 20 products in Bio-Thera’s pipeline are at various stages of clinical development, with its oncology portfolio primarily focused on cancer immunotherapy in the post-PD-1 era and the development of antibody-drug conjugates (ADCs). Upholding patient well-being as its core value, Bio-Thera strives to provide safe, effective, and affordable high-quality medicines through innovative R&D to address urgent unmet medical needs.