Baiaotai Biopharmaceutical Co., Ltd. (stock code: 688177) is a global biopharmaceutical enterprise based on science and innovation located in Guangzhou, China, hereinafter referred to as "Baiaotai" or "the Company". The company announced today that the article "Evaluating the Phase 3 Clinical Study of BAT1806/BIIB800 during the Second Treatment Phase (TP2, Weeks 24-48)" co authored with Bojian has been published in the Arthritis Research&Therapy journal. BAT1806/BIIB800 is a product developed by BioNTech and referenced by Yamero ®  The biosimilar drug developed with tocilizumab has been launched in Europe and America under the brand name TOFIDENCE ™.

In a phase 3 clinical study, rheumatoid arthritis patients with insufficient response to methotrexate were randomly assigned to three treatment groups in a 1:1:2 ratio: (1) using the original drug for intravenous injection of 8mg/kg every 4 weeks until week 48; (2) Treat with the original drug until week 24, then switch to using BAT1806/BIIB800 until week 48; (3) Treat with BAT1806/BIIB800 until week 48. The efficacy evaluation criteria for TP2 (weeks 24-48) include ACR20/50/70 response rate and DAS28 changes from baseline. In addition, pharmacokinetics, safety, and immunogenicity were evaluated and compared. During the TP2 period, the original drug (Yameiro) was also evaluated after the 24th week ®） The potential impact of converting to treatment with BAT1806/BIIB800 reflects the interchangeability of drugs in clinical practice.

The results of the Phase 3 clinical TP2 study showed that rheumatoid arthritis patients with insufficient response to methotrexate were treated with the original drug (Yamero) ®） After switching to using BAT1806/BIIB800, its clinical efficacy, safety, immunogenicity, and pharmacokinetics are still comparable to the original drug treatment group.

Yang Xiaolei, Medical Director of Rheumatology and Immunology at Baiaotai, said, "We are pleased to publish TOFIDENCE in the Arthritis Research&Therapy journal ™ The research results of the conversion between BAT1806/BIIB800 and the original drug also confirm TOFIDENCE ™ The high similarity between BAT1806/BIIB800 and the original drug. We hope that this research result can dispel the possibility of patients who have previously used the original drug switching to TOFIDENCE ™ Concerns about the safety and efficacy of BAT1806/BIIB800

In April 2021, Bojian and Baiaotai signed a commercialization and licensing agreement for the development, production, and commercialization activities of BAT1806/BIIB800. Bojian has exclusive rights to register, produce, and commercialize BAT1806/BIIB800 in all countries except for China (including Hong Kong, Macau, and Taiwan).