Genor Biopharma has successfully set up an early discovery platform with first in class (FIC)/differentiated T-cell Engager (T-cell Engager) bi-specific/multi-specific antibodies in immune-oncology / bispecific antibody-drug conjugates (BsADC). The focus is to conduct molecular research that have the potential to become global best-in-class (BIC) products and have the greatest potential to produce clinical and commercially viable drugs.
Our R&D process starts with strategic target identification and selection, focusing on targets with proven or high potential clinical benefits. Once the targets have been identified, we fully leverage our research hubs in Shanghai and San Francisco to advance our synergized discovery and research efforts.
We strategically design the clinical trials of our drug candidates, critically select the registration pathways, diligently conduct our clinical trials to ensure speed of execution and data quality, maintain constructive dialogues with the regulatory authorities to achieve optimal clinical development efficiency, and accelerate the approval process of our drug candidates.
At present, the Company has achieved rapid application, approval and promotion of clinical trials of product pipelines in China and Australia.
- Based on in-depth perception of product science, mechanisms and features, developed the registration and clinical development strategies, and continuously enhanced communication with industry leaders in relevant treatment fields, drug regulatory authorities, drug review agencies, and clinical research centers.
- Relying on plentiful experience and extensive resources, efficient, quality and speedy accomplishment was made in the layout and establishment of the research center, project initiating and management, selection and recruitment of, and the entering of agreements with patients and subjects.
Genor Biopharma’s strong Chemistry, Manufacturing and Controls (CMC) capabilities resulted from approximately one decade of relentless development efforts. It 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, and have supported our and our collaborators’ IND applications for more than 20 antibodies with the NMPA and/or planned IND applications with the FDA.
The Company continued to promote efficient innovation and development in technology, research and development, processes, management and other areas. In addition to solving the industry pain points such as low heterologous pairing rate, high polymer content, removal of homodimer impurities, unstable intermediates, difficulty in activity analysis methods and difficulty in the development of formulations, especially high-concentration formulations, the Company’s CMC team demonstrated industry-leading strength and rapid execution in the process technology development of GB261 (CD20/CD3, BsAb), GB263T (EGFR/cMET/cMET, TsAb) and other products.