SHANGHAI, China, March 17, 2021 -- Genor Biopharma (Stock code: 6998.HK) announced today that the Company has submitted a clinical trial application to the Bellberry Human Research Ethics Committee in Australia for First In Human (FIH) clinical trial of GB261, a novel CD20/CD3 bispecific antibody, in patients with B-cell non-Hodgkin Lymphoma (B-NHL).
About GB261 (CD20/CD3，BsAb)
GB261 is a novel bispecific antibody targeting CD3 and CD20. It is the first T-cell engager with low affinity to bind CD3 and enables Fc functions (ADCC and CDC). Although its binding affinity to CD20 is similar to that of rituximab, GB261 significantly inhibits rituximab-resistant cancer cell proliferation based on in vitro assays and in vivo models. Thus, GB261 is a highly potent bispecific therapeutic antibody for B cell malignancies. It may ultimately provide a better and safer T-cell engager antibody drugs for various cancers.
About Genor Biopharma
Founded in 2007, Genor Biopharma Co. Ltd (Genor BioPharma, Stock code: 6998.HK) is an innovative biopharma company with a pipeline of therapies covering the world's top oncology areas (breast, lung, and gastrointestinal cancer).
Genor Biopharma is creating a fully integrated and end-to-end biopharma innovation company based in China, with global reach. In San Francisco, the cutting-edge bispecific and multi-specific discovery platform (Antibody Therapeutics Inc.) engineers novel and highly differentiated therapeutic antibody candidates with display technology, computer-aided design, and site mutagenesis. The industry leading R&D center located in Shanghai focuses on CMC (Chemistry, Manufacturing and Controls) development. This center is capable of developing comprehensive bioprocesses and formulations, and manufacturing preclinical and clinical materials with advanced analytical, quality control, and quality assurance systems for compliance. In 2016, the GMP commercial manufacturing facility was built and commissioned in Yuxi, Yunan and is currently operating with a highly GMP compliant production team. This commercial facility employs advanced continuous-flow cell culture technologies for high yield manufacturing (~20 g/L) as well as internally-developed cell culture media for cost-effective production. The site produces Phase III and pivotal trial clinical supplies, executes the commercial process validation, and performs the commercial manufacturing after product launch.
Genor Biopharma currently has 10+ drug candidates under development in clinical or New Drug Application (NDA) stages. Among them, the NDA for Geptanolimab (GB226) has been granted for priority review by the Center for Drug Evaluation (CDE) and has successfully passed the NDA pre-approval inspection by the National Medical Products Administration (NMPA), with a product launch targeted for 2021. It is the first PD-1 inhibitor worldwide for peripheral T-cell lymphoma (PTCL) and is expected to bring safe and high-quality therapeutic benefits to patients. The NDA filing for Infliximab (GB242) has also been accepted by CDE and is currently under review by the agency.