Global biopharmaceutical company Harbour BioMed (HKEX: 02142), which develops antibody therapeutics in immunology and oncology, said on Tuesday that China's National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for HBM7004 to treat advanced solid tumours.

The NMPA decision follows recent FDA clearance of an IND for the same candidate.

HBM7004 is a B7H4xCD3 bispecific antibody developed using the company's HBICE platform. Preclinical studies showed B7H4-dependent T-cell activation, strong anti-tumour activity, in vivo stability and reduced systemic toxicity across multiple animal models.

The antibody also demonstrated a synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating a favourable therapeutic window.

Harbour BioMed develops fully human monoclonal antibodies using its Harbour Mice platform in both conventional and heavy chain-only formats. Its HBICE bispecific technology is designed to enable tumour-killing effects beyond those achieved by traditional combination therapies, while its HCAb-based Antibody Plus technology supports multi-specific drug development.

The company has also launched a fully human Generative AI HCAb model powered by its Hu-mAtrIx AI platform to accelerate antibody discovery.