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,  announced that the National Medical Products Administration (NMPA) of China has approved 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.

"We are very pleased to receive NMPA approval of IND application for HBM7004, which marks another important milestone in our commitment to advancing novel immunotherapies for patients with advanced solid tumors," said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. "This approval, together with the recent FDA clearance, underscores the strength of our HBICE^® platform and its ability to generate differentiated bispecific candidates with promising preclinical profiles. We are now one step closer to bringing HBM7004 into the clinic in China, and we look forward to advancing this program to address the needs of cancer patients with limited treatment options."