Taizhou, Zhejiang, China, September 28, 2021—Hisun Biopharmaceutical Co., Ltd. (hereinafter referred to as "HisunBio"), a wholly-owned subsidiary of BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "Bioray") announced that the National Medical Products Administration (NMPA) of China approved the application for marketing of its own human-mouse chimeric monoclonal antibody targeting human tumor necrosis factor-α (TNF-α), Infliximab for Injection (Anbaite®) on September 24. The National Medicine Permission Number (NMPN) of Anbaite® is S20210039. 

The indications of Anbaite® include rheumatoid arthritis, Crohn's disease in adults and children over 6 years old, fistulizing Crohn's disease, AS (ankylosing spondylitis), psoriasis, and adult ulcerative colitis. Anbaite® is the second biosimilar for infliximab to enter China market. It also becomes the third commercialized biologics from BioRay following the launch of Anbainuo® and Anjianning® (Adalimumab). Including Anshuzheng® (Tofacitinib Citrate Tablets), BioRay has entered the 'Four-An' era, expanding its leadership in the treatment of immune diseases. 

Anbaite® is a recombinant human-mouse chimeric monoclonal antibody targeting TNF-α. As an important cytokine, TNF-α is indispensable for immune homeostasis and fighting against various pathogens. However, it has also been found that the overexpression of TNF-α plays a great role in the pathogenesis of autoimmune diseases. The expression level of tumor necrosis factor-α is relatively low in healthy tissues. When its concentration increases pathologically, TNF-α could impair immune homeostasis by promoting excessive inflammation, resulting in damages to tissues and organs. Anbaite® can specifically bind to both soluble (sTNF-α) and transmembrane tumor necrosis factor-α (tmTNF-α) with high-affinity, which blocks the binding of tumor necrosis factor with its receptor to alleviate inflammation and autoimmune disease. 

Anbaite® is the biosimilar of infliximab for injection (Remicade®). Remicade® was granted marketing authorization in China in 2006. The efficacy and safety of Remicade® have been fully verified by its extensive clinical use. Its peak sale reached $9.24 billion. According to the data from Fierce Pharma, the global sale of Remicade® was $4.196 billion in 2020, ranking among top 20 worldwide. The infliximab for injection has been recommended as one of the options to treat related diseases by guidelines such as those in the “Chinese experts’ consensus on the treatment of psoriasis with biological agents (2019)”. Additionally, it has also been enlisted on the negotiated drug catalog by “China National Drug Catalog for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2020 Edition)” to further guarantee the drug's accessibility. 

As a drug supported by National Science and Technology Programs, Anbaite® has been approved for all indications of Remicade® in China. The number of people suffering from those indications exceeds 10 million in China and keeps increasing. With its approval by National Medical Products Administration, Anbaite® will help alleviate the huge unmet medical needs. BioRay will also take this opportunity to enrich its product pipelines for the treatment of immune diseases, sharpen its leading edge in the field, and continue to develop affordable high-quality products, bringing more treatment options to patients and helping them improve their health and life quality.