Genor BioPharma Co., Ltd.

China · Research

Founded in 2007, Genor Biopharma Co. Ltd (Genor BioPharma, Stock code: 6998.HK) is an innovation-driven 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 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.