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 committed to 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 today announced that its partner, Bojian (NASDAQ: BIIB), has recently begun marketing and selling TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar in the United States.

TOFIDENCE™, a biosimilar developed by BIO-THERA with reference to Amero® (tocilizumab), was approved by the U.S. FDA in September 2023 for the treatment of moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.TOFIDENCE™ is currently available in the U.S. as an intravenous infusion of 80 mg/4 ml, and is sold as an intravenous injection of 80 mg/4 ml. sales, 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL.

In April 2021, BIO-THERA and Bojian entered into a commercialization and licensing 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 and General Manager of BIO-THERA, commented, "TOFIDENCE™ is the first monoclonal antibody drug independently developed and manufactured by a local Chinese pharmaceutical company that has received marketing approval from the U.S. FDA, and it is also BIO-THERA's first product to be marketed and sold in the U.S. The launch of the U.S. commercialization of TOFIDENCE™ is a significant milestone for the company. milestone, and we will continue to work hard and look forward to providing safe, effective and affordable biologics to patients in need around the world."

https://mp.weixin.qq.com/s?__biz=MzIzNTc3NTM5NA==&mid=2247485249&idx=1&sn=80b43d9fc661ebec352a73701a8c1f35&chksm=e8e0b38cdf973a9af6f1d74265e8b9e222d0a5fe3c4ce1c76a7d6e70313578cabf7e9e940b4c&mpshare=1&scene=1&srcid=0507bVspW6m9ujeiYG3tZUXj&sharer_shareinfo=db85c0582af77775526c2d602b9455b8&sharer_shareinfo_first=db85c0582af77775526c2d602b9455b8#rd