China's Centre for Drug Evaluation (CDE) has granted priority review to AbbVie and Genmab's Epkinly (epcoritamab) in combination with rituximab and lenalidomide for relapsed/refractory follicular lymphoma (FL). The decision follows positive Phase III EPCORE FL-1 trial results showing 95.7% objective response rate (ORR) and 79% reduction in progression risk versus standard therapy. Epkinly uses Genmab's DuoBody technology to simultaneously engage CD3 on T-cells and CD20 on B-cells, redirecting immune attacks against malignant B-cells.

The bispecific antibody (BsAb) gained US market approval for diffuse large B-cell lymphoma in 2023 and FL in 2024. China's priority designation accelerates regulatory review for this third-generation CD20-targeted therapy, which could provide a new option for patients failing prior treatments. AbbVie and Genmab's 2020 collaboration covers three BsAbs, with Epkinly being the first to reach late-stage development globally.

PharmCube's NextBiopharm® database shows that Epkinly is being devleoped in 19 indications. Click here to request a free trial for NextBiopharm®.