BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as "BIO-THERA" or the "Company". The Company is focused on developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company's partner, Bojian (NASDAQ: BIIB), recently received notification from the European Commission that it has granted marketing approval to BIO-THERA for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and other diseases. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in April 2024 for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

The European Commission's approval of the marketing application for TOFIDENCE (BAT1806/BIIB800) was based on comprehensive analytical results, supported by preclinical and clinical data: TOFIDENCE has been extensively characterized and analyzed for structural, physicochemical, and biological characteristics demonstrating similarity to the originator; TOFIDENCE's Phase I clinical TOFIDENCE's Phase I clinical study evaluated the pharmacokinetic profile, safety and immunogenicity of TOFIDENCE in healthy subjects in Europe and the U.S. and demonstrated a high degree of similarity to the original drug; TOFIDENCE's Phase III clinical study evaluated the safety, efficacy, pharmacokinetic profile, efficacy, and immunogenicity of TOFIDENCE compared to the original drug in moderate to severe rheumatoid arthritis patients who had insufficient methotrexate response. , efficacy, pharmacokinetic profile and immunogenicity, further demonstrating a high degree of similarity to the original drug.

In April 2021, BIO-THERA and Bojian entered into a commercialization and license agreement for the development, manufacturing and commercialization activities of TOFIDENCE (BAT1806/BIIB800). Under the agreement, Bojian has exclusive rights related to the registration, manufacturing and commercialization of BAT1806/BIIB800 in all countries except China (including Hong Kong, Macau and Taiwan).

Dr. Shengfeng Li, Founder of BIO-THERA, commented, "We are very pleased that TOFIDENCE has received marketing approval from the European EMA. TOFIDENCE is the first product of BIO-THERA that has received marketing approval from the European EMA, which is a very important milestone for BIO-THERA. We will continue to develop and advance safe, effective and affordable biologics to benefit patients worldwide."

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