Harbour BioMed has received approval from China’s National Medical Products Administration (NMPA) for the Investigational New Drug (IND) application of HBM7004, its novel bispecific antibody candidate being developed for the treatment of advanced solid tumours.

HBM7004 is a B7H4xCD3 bispecific antibody developed using Harbour BioMed’s proprietary HBICE platform. The candidate is designed to selectively activate T cells within B7H4-expressing tumours, with the aim of enhancing anti-tumour activity while limiting systemic toxicity.

In preclinical studies, HBM7004 demonstrated B7H4-dependent intratumour T-cell activation. The candidate also showed strong anti-tumour efficacy and in-vivo stability across multiple animal models, alongside reduced systemic toxicity.

Preclinical data further indicated a potential synergistic effect when HBM7004 was combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, supporting the potential for a wider therapeutic window.

The NMPA approval follows recent clearance of HBM7004 by the US FDA, further advancing the candidate toward clinical development in major markets.

Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed, said the NMPA approval marks another milestone in the company’s efforts to develop novel immunotherapies for patients with advanced solid tumours. He added that the China approval, together with the recent FDA clearance, highlights the potential of the HBICE platform to generate differentiated bispecific antibody candidates.

With regulatory clearance now secured in China, Harbour BioMed plans to advance HBM7004 into clinical development and evaluate its potential as a treatment option for patients with advanced solid tumours and limited therapeutic choices.