Harbour BioMed, a global biopharmaceutical company focused on innovative antibody therapeutics in immunology and oncology, has unveiled its first fully human Generative AI HCAb (Heavy Chain-Only Antibody) Model. The breakthrough, powered by the company’s Hu-mAtrIx™ AI platform built on the Harbour Mice® transgenic mouse platform, marks a major leap in accelerating next-generation biologics discovery. The announcement was made during Harbour BioMed’s Global R&D Day 2025 in Shanghai. The event also launched the Global AI + Pharmaceutical Ecosystem Alliance, a collaborative initiative uniting leading experts, technology providers, and investors to transform drug discovery through artificial intelligence. The new AI HCAb Model establishes a closed-loop workflow integrating AI-driven sequence generation, intelligent screening, and wet-lab validation. This end-to-end process shifts antibody discovery from traditional trial-and-error screening to precise, AI-guided design, significantly enhancing speed and accuracy. HCAbs, with their simple structure and low molecular weight, are ideal for advanced therapies such as bispecific and multi-specific antibodies, antibody-drug conjugates (ADCs), CAR-T cells, and mRNA-based treatments. However, their functional stability without a light chain has been a major challenge. Harbour BioMed’s Harbour Mice® platform, the world’s first to generate fully human functional HCAbs, overcame this barrier. The AI model was trained on 9 million next-generation sequencing (NGS)-derived HCAb sequences and extensive public data. Leveraging a fine-tuned protein language model, it generates novel, high-potential HCAb sequences with optimized target specificity. Candidates undergo multi-stage intelligent screening before synthesis and experimental validation. Results demonstrate the model’s effectiveness: a tenfold increase in candidate generation and a 78.5% success rate in hitting targets among 107 AI-generated binders. Twenty molecules advanced to wet-lab validation, showing high activity, purity, yield, and specificity. On average, these binders achieved over 700 mg/L of yield, with several demonstrating nanomolar binding affinity and cross-species activity in both human and cynomolgus monkey targets. The platform operates as a self-evolving innovation flywheel—AI design, automated validation, and AI re-learning—enabling continuous improvement through feedback from experimental data. This accelerates the development of advanced therapies, including multi-specific antibodies, XDCs, in vivo CAR-T, and inhaled or oral large-molecule drugs. The Global AI + Pharmaceutical Ecosystem Alliance, supported by Fortera Capital, Insilico Medicine, Molecular Mind, Evinova, INNOVEL, Fenglin Group, Taimei Technology, EClinCloud, Deep Intelligent Pharma, and others, aims to create an open, collaborative environment to overcome key challenges in drug discovery. Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, emphasized the alliance’s mission: “Through shared value and collective innovation, we aim to bring transformative therapies to patients faster and more effectively.” Harbour BioMed continues to expand its pipeline using proprietary platforms including Harbour Mice®, HBICE® for bispecific immune cell engagers, and HBICATM for immune modulation, all integrated within a single B-cell cloning system. This powerful combination positions the company at the forefront of next-generation antibody therapeutics.