In March 2018, BAT4306F, the recombinant glycosylation-modified anti-human-CD20 monoclonal antibody solution for injection, approved for phase I clinical trials in China.
BAT4306F is a next generation anti-CD20 monoclonal antibody. The CD20 receptor is a validated drug target with monoclonal antibodies approved to treat lymphoma, rheumatoid arthritis, multiple sclerosis and lupus. With a modified glycosylation, BAT4306F has an enhanced ADCC (antibody dependent cell-mediated cytotoxicity) effect. Binding to a different epitope compared to Mabthera, BAT4306F directly induces B cell apoptosis. In models of lymphoma, BAT4306F demonstrated potent in vitro and in vivo efficacy.
At present, Phase I clinical trial evaluating the pharmacokinetics and safety of BAT4306F is proceeding as planned.
