Bio-Thera Solutions, Ltd. (Stock Code: 688177 ) is a global biopharmaceutical company headquartered in Guangzhou, China, based on scientific innovation . Recently, the Company and Accord BioPharma (hereinafter referred to as " Accord " , a US subsidiary of Intas Pharmaceuticals focusing on the development of oncology, immunology, and central nervous system therapies) jointly announced that they have received notification from the US Food and Drug Administration ( FDA ) that two biosimilars developed by Bio-Thera, based on simponicity® golimumab ( BAT2506 ) – IMMGOLIS ™ ( golimumab-sldi ) (subcutaneous injection) and IMMGOLIS INTRI™ ( golimumab-sldi ) (intravenous infusion) – have received FDA approval for marketing in the United States. Among them, IMMGOLIS™ is approved for use in combination with methotrexate for the treatment of adult patients with moderate to severe active rheumatoid arthritis and for the treatment of adult patients with moderate to severe active ulcerative colitis; IMMGOLIS INTRI™ is approved for use in combination with methotrexate for the treatment of adult patients with moderate to severe active rheumatoid arthritis.

In February 2025 , Bio-Thera Solutions and Intas Pharmaceuticals (hereinafter referred to as "Intas" ) entered into a licensing and commercialization agreement for BAT2506 . According to the agreement, Bio-Thera Solutions will be responsible for the research, development, production, and commercial supply of BAT2506 , while Intas will be responsible for the commercialization of BAT2506 in the US market through its US subsidiary , Accord BioPharma . Currently, the company has already established collaborations with Intas in the US, Canada, and India markets for golimumab .

Dr. Shengfeng Li, Founder and General Manager of Bio-Thera Solutions, stated: “ We are delighted that IMMGOLIS™ is the first golimumab biosimilar to receive FDA approval. We will fully support Accord BioPharma in providing commercialization support to bring IMMGOLIS ™ and IMMGOLIS INTRI™ to patients suffering from chronic, disabling autoimmune diseases such as moderate to severe active rheumatoid arthritis or ulcerative colitis, meeting their urgent need for affordable golimumab biosimilars. ”

Chrys Kokino, President of Accord BioPharma North America, stated: “ This exclusive commercialization agreement with Bio-Thera Solutions further strengthens our biosimilar pipeline, which is crucial . We are pursuing a two-pronged approach, continuously increasing our investment in biosimilars . We firmly believe that biosimilars hold immense potential in reshaping the treatment landscape, putting patients and healthcare providers at the center . Bio- Thera Solutions’ global experience makes them an exceptional partner. ”

ABOUT IMMGOLIS / IMMGOLIS INTRI

IMMGOLIS ™ (golimumab) injection is a golimumab biosimilar developed by Bio-Thera Solutions in accordance with the relevant guidelines for biosimilars issued by the China NMPA , the US FDA , and the European EMA . Golimumab is an antibody targeting TNF-α , specifically binding to soluble and transmembrane human TNF-α with high affinity , blocking the binding of TNF-α to its receptor TNFR , thereby inhibiting TNF-α activity. Currently, the company's golimumab has been approved for marketing by the European EMA and the US FDA , and its marketing authorization application has been accepted by ANVISA in Brazil and the China NMPA . IMMGOLIS ™ is not suitable for (contraindicated for) the following patient groups: adult patients with active psoriatic arthritis (including those using regimens combined with methotrexate); adult patients with active ankylosing spondylitis; and pediatric patients with moderate to severe active ulcerative colitis weighing ≥15 kg . IMMGOLIS INTRI™ is not indicated (contraindicated) for the treatment of the following patient groups: children aged 2 years and older with active psoriatic arthritis; adults with active ankylosing spondylitis; and children aged 2 years and older with active polyarticular juvenile idiopathic arthritis.

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 three regions: the US, the US, and the UK; and Golimumab (European brand name: Gotenfia® , US brand name: IMMGOLIS ™ ) has been approved in the US. 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).

About Accord

Accord BioPharma, Inc. , the U.S. specialty pharmaceutical division of Intas Pharmaceuticals , is dedicated to providing affordable, accessible, and patient-centered treatments in oncology, immunology, and critical care. Accord focuses on improving the patient experience, considering not only the biological properties of drugs but also the patient's perspective to develop high-quality therapies that truly impact patients' lives. Accord believes biosimilars improve accessibility to biologics that have historically been inaccessible to many patients due to high costs. Accord aims to offer one of the industry's most comprehensive portfolios of biosimilars. For more information, please visit AccordBioPharma.com .

Bio-Thera Solutions Forward-Looking Statement

This press release contains forward-looking statements relating to IMMGOLIS ™ , IMMGOLIS INTRI ™ , 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 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 .

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