The "High-Throughput Fully Human Monoclonal Antibody Development Integrated Platform HitmAb^®" is the company's proprietary core technology for discovering fully human monoclonal antibodies. This platform efficiently screens monoclonal antibodies and identifies the most promising candidates for specific indications. Leveraging HitmAb^® as its foundation, Trinomab has developed an exclusive, high-efficiency system for screening and identifying fully human monoclonal antibodies tailored to particular disease treatments.

The platform incorporates advanced technologies, including antigen design, target antibody labeling, flow cytometry sorting, gene amplification and sequencing, and cell transfection. Operating in a high-throughput mode, HitmAb^® rapidly isolates single B cells or plasma cells to screen large populations of human monoclonal antibody pools. It then extracts the specific antibody expression genes, which are subsequently cloned and expressed as recombinant therapeutic antibodies for large-scale production in a CHO system.

These recombinant fully human monoclonal antibodies exhibit high adaptability in the human body, along with advantages such as low immunogenicity, high specificity, high affinity, and superior safety. The HitmAb^® platform overcomes the time-consuming, labor-intensive, and complex challenges of traditional antibody development methods (e.g., vector cloning), enabling high-throughput and efficient antibody discovery.

Monoclonal antibodies derived from the HitmAb^® platform are fully human, having been presented and matured in a human immune tolerance environment. As a result, they minimize endogenous immunogenicity issues common in non-human antibody drugs and reduce anti-drug antibody (ADA) responses during clinical applications. Compared to antibodies from phage libraries or transgenic animal technologies, HitmAb^®-derived antibodies undoubtedly offer excellent safety and therapeutic potential for patients.

The "High-Efficiency Antibody Expression CHO-GS Cell Platform" is a house-improved CHO-GS cell line with optimized monoclonal antibody (mAb) production system. The platform possesses two core advantages: (I) having the high-expressing ability of recombinant proteins with high titer and yield and (II) having the antibiotic-free selection marker for the safe of cell line development. Thus, the GHO-GS cell platform demonstrates not only being an advanced system for cell line development with high expressing titer but also having the possibility to lower the production cost in the future.

The "Process Development Platform" is an integrated processing development system consisting of the multiple processing components, which are critical to turn lab-scale processes into GMP manufacture ones with quality and robustness. The process development platform includes cell culture processes, antibody purification processes, formulation development processes, and quality analysis.This integrated platform is one of key elements of CMC (Chemistry, Manufacturing, and Controls) development to fully comply the GMP requirements for drug manufacture. Its proper function will ensure the processing performance such the process scalability, product (DS/DP) qualities, and manufacturing cost at final commercial production.

The "Bioanalytical Platform" is a fully developed analytical abilities with different analytical instruments to perform the tests and exam the target molecule purity and structure-function apects. a key technological platform developed by the company through its long-term research in fully human monoclonal antibodies. It enables efficient detection of specific critical parameters of target mAb that are required during processing development and GMP production. In addition, analytical platform provides those sensitive and specific analytical methods for non-clinical studies (such as pharmacokinetics, toxicology, and pharmacodynamics in monkeys, mice, rabbits, and dogs), as well as to support the analytical needs from various stages of clinical research. This platform allows for scientific, reliable, and comprehensive evaluation of systemic drug exposure, in-vivo activity, and immunogenicity. Specific analytes include drug concentrations in blood or tissues, biomarkers, anti-drug antibodies (ADA), and neutralizing antibodies against drugs (NAb).