24 May, 2022
Genor Biopharma obtains IND approval to commence the phase I/II clinical trial of GB261

Shanghai, China, May 24, 2022 - Genor Biopharma (Stock code: 6998.HK) announced today that the company has obtained the IND approval from the National Medical Products Administration (NMPA) for the phase I/II clinical trials of GB261, a CD20/CD3 bispecific antibody.


This clinical trial was accepted by the Center for Drug Evaluation of the National Medical Products Administration (CDE) on March 18, 2022 for the treatment of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).


Genor Biopharma's GB261 (a novel and innovative bispecific CD20/CD3 T-cell Engager) has already been successfully administered to the first patient in the first human clinical trial (FIH) in Australia in October 2021.



About GB261 (CD20/CD3BsAb)

GB261 is the first T-Cell Engager with ultra-low affinity to bind CD3 and has Fc-enabled functions (ADCC and CDC). GB261 significantly inhibits rituximab-resistant cancer cell proliferation in both in vitro assays and in vivo models. Thus, GB261 is a highly potent bispecific therapeutic antibody for B cell malignancies. It has potential to be a better and safer T-cell engager with competitive advantages over other CD3/CD20 agents.