CASI Pharmaceuticals, Inc. and BioInvent International AB announced the first-patient-in in China Phase 1 dose-escalation and expansion study of BI-1206, a first-in-class fully human monoclonal antibody (mAb) that targets Fc RIIB, in combination with rituximab in patients with relapsed/refractory Non-Hodgkin's Lymphoma (NHL). The study design is to assess the safety, tolerability, pharmacology, and clinical activity of BI-1206. The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021.

Ethics committee approval from a leading investigational site was granted in January 2022. BI-1206 is currently being investigated outside of China in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL), which includes patients with follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab.

A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda(R) (pembrolizumab) in solid tumors. Earlier this year, the U.S. FDA granted Orphan Drug Designation, for BI-1206, for the treatment of follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma.