Bio-Thera Solutions, Ltd. (Stock Code: 688177 ) , a global biopharmaceutical company based in Guangzhou, China, is a science-driven innovation enterprise . The Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a supplemental application for Avzivi® ( BAT1706 , bevacizumab injection). This approval relates to the Avzivi® manufacturing process , the 4,000 - liter monoclonal antibody solution production line, and the vial formulation production line . This approval will significantly enhance the production capacity of bevacizumab, thereby better meeting the clinical needs of patients worldwide and ensuring a continuous and stable supply of high-quality drugs .

Avzivi® is a bevacizumab injection developed by Bio-Thera Solutions in accordance with the relevant guidelines for biosimilars from the NMPA , FDA , and EMA . It is a humanized monoclonal antibody belonging to the vascular endothelial growth factor ( VEGF ) inhibitor class. It works by binding to VEGF , blocking the binding of VEGF to its receptor, thereby blocking the signaling pathway of angiogenesis and inhibiting tumor cell growth. Currently, BAT1706 (bevacizumab injection) has received marketing approval from the Chinese NMPA , the US FDA , the European EMA , and the Brazilian ANVISA . Its registered brand name in China is Pubeixi® , in Europe and the US it is Avzivi® , and in Brazil it is Bevyx® .

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, Betanilide® ( 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 three regions: the US, the US, and the UK; 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 BAT1706 or Bio-Thera Solutions and its product line. 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 to reflect new information and events, changes in the company’s views or other circumstances after the date of this press release .

https://bydrug.pharmcube.com/news/detail/61146ba62a324f72c43e6ed3298ec402