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SAIT101 is a biosimilar version of rituximab, a chimeric monoclonal antibody that targets the CD20 protein found on the surface of B-cells. It was developed by Archigen Biotech Limited, a joint venture established in 2014 between AstraZeneca and Samsung BioLogics. The drug was primarily investigated for the treatment of rheumatoid arthritis, with clinical development including a Phase 1 study in 246 patients and a Phase 3 study completed in 2020. These trials were designed to demonstrate pharmacokinetic and clinical equivalence to the reference products Rituxan and MabThera. Despite successful clinical results showing no significant therapeutic differences from the reference drugs, Samsung BioLogics authorized the liquidation of Archigen Biotech in 2020, leading to the discontinuation of SAIT101 due to a lack of commercial viability in a crowded biosimilar market.
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