New Orphan Drug Designation for Treatment of Follicular Lymphoma
BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of Non-Hodgkin lymphoma, which includes patients with FL, 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® (pembrolizumab) in solid tumors.
Dr. Wei-Wu He, CASI’s Chairman, and CEO commented, “BioInvent continues to make progress with the development and regulatory framework for BI-1206. The CTA approval in China in December 2021 and the recent FDA Orphan Drug Designation demonstrate the strong potential of this first-in-class antibody. CASI has China commercial rights of BI-1026, and our team is preparing for China’s clinical study. CASI and BioInvent are seamless partners and have the common goal to benefit patients with innovative pharmaceutical technologies.”