Harbour BioMed (the “Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, today announced that the National Medical Products Administration (NMPA) of China has accepted the Investigational New Drug (IND) application for HBM7004 for the treatment of advanced solid tumors.

HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the Company’s HBICE^® platform. This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy with the potential to enhance both efficacy and safety. The development of HBM7004 further demonstrated the HBICE^® platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window.

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“Following the recent FDA IND clearance for HBM7004, we are pleased that the NMPA has accepted the IND application for HBM7004 for the treatment of advanced solid tumors,” said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. “HBM7004 exemplifies our strategy of leveraging our proprietary technology platforms to develop differentiated next-generation immunotherapies that address significant unmet medical needs in oncology. Supported by encouraging preclinical data, we look forward to working closely with regulatory authorities and advancing this program toward clinical evaluation in China.”

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