On October 28, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported the launch of its first fully human Generative AI HCAb (Heavy Chain-Only Antibody) Model powered by its Hu-mAtrIx AI platform, built upon the Harbour Mice platform. This platform establishes a closed-loop process integrating AI design, intelligent screening, and wet-lab validation.

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The announcement was made at the company’s Global R&D Day 2025 event in Shanghai. During the event, the Global AI + Pharmaceutical Ecosystem Alliance was also officially launched. The alliance brings together leading expertise, cutting-edge technologies, and resources from various sectors, aiming to systematically reshape the entire drug R&D process through artificial intelligence technologies, accelerating the development of innovative therapies for the benefit of patients worldwide.

AI-Driven Precision for Faster and More Accurate Target Identification

The newly released AI HCAb Model establishes a closed-loop workflow that integrates AI-driven sequence generation, design and screening, and wet-lab validation. This end-to-end process transforms antibody discovery from blind screening to AI-driven intelligent selection, dramatically improving efficiency and accuracy in antibody discovery.

HCAb, known for its simple structure and low molecular weight, holds strong potential for advanced applications like bispecific/multi-specific antibodies, ADCs, CAR-T, and mRNA therapies. However, conventional human VH domains struggle to maintain stability without VL pairing.

Harbour BioMed’s Harbour Mice platform — the world’s first transgenic mouse platform that produces fully human functional HCAb — laid the foundation for overcoming this challenge. The key AI design lies in accurately identifying functional, autonomous HCAbs from vast datasets, given the high structural and sequential similarity between HCAb VH sequences and those of conventional (H2L2) antibodies. Harbour BioMed’s HCAb generation model is trained on 9 million NGS-derived HCAb sequences and extensive public data. Using a fine-tuned protein large language model, it enables de novo generation of high-potential HCAb sequences, with secondary optimization for target specificity.

These AI-generated sequences then undergo a multi-stage intelligent screening process, which includes:

AI Classification Model to filter non-HCAb sequences
Multimodal AI Developability Prediction Model (achieving SOTA performance) to assess key developability parameters such as stability, solubility, and aggregation tendency
Only candidates that pass rigorous screening proceed to synthesis and wet-lab validation.

AI HCAb Model Delivers Higher Binders Diversity and Binding Success Rate

The AI HCAb Model demonstrated a tenfold increase in candidate generation and significantly improved success rates. Data show that among 107 de novo generated binder sequences produced by AI HCAb model, 78.5% successfully hit the target, while 20 molecules were further validated in wet-lab assays, demonstrating high activity, purity, yield, and specificity.

These AI-designed binders demonstrated outstanding developability profiles, with an average yield exceeding 700 mg/L. Multiple candidate sequences showed nanomolar-level binding affinity while maintaining binding activity against relevant targets in both humans and cynomolgus monkeys.

Accelerating the Development of Next-Generation Therapies

Harbour BioMed’s AI platform is designed as a self-evolving innovation flywheel driven by continuous learning and feedback: AI design – automated validation – AI re-learning.

This iterative process enables generative AI to create diverse new molecules, while high-throughput automation rapidly characterizes and feeds back experimental data to continuously enhance model intelligence and R&D efficiency.

With this foundation, the AI HCAb Model is expected to accelerate applications of fully human HCAbs across next-generation therapeutic areas — including multi-specific antibodies, XDCs, in vivo CAR-T, and inhaled or oral large-molecule drugs — helping redefine the landscape of biologics discovery.

Building the Future AI + Pharmaceutical Ecosystem

At the event, Harbour BioMed also announced the official establishment of the Global AI + Pharmaceutical Ecosystem Alliance, which brings together leading experts, technology partners, and investors to reshape the entire drug discovery pipeline through AI innovation.

The alliance has gained strong support from government bodies, industry associations, and investors including Fortera Capital, Insilico Medicine, Molecular Mind, Evinova, INNOVEL, Fenglin Group, Taimei Technology, EClinCloud, Deep Intelligent Pharma, and Harbour BioMed.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, said: "The Global AI + Pharmaceutical Ecosystem Alliance aims to create an open, collaborative, and win–win ecosystem. Through shared value and collective innovation, we seek to address the toughest challenges in drug discovery and bring transformative therapies to patients faster and more effectively."

(Press release, Harbour BioMed, OCT 28, 2025, View Source [SID1234657079])