Harbour BioMed Announces U.S. FDA IND Clearance for HBM7004 for the Treatment of Advanced Solid Tumors

Harbour BioMed, a Hong Kong-listed biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for HBM7004, a B7H4xCD3 bispecific antibody designed for treating advanced solid tumors. The clearance enables the company to initiate clinical trials in the U.S., marking a significant step in its oncology pipeline. HBM7004 demonstrated in vivo stability and reduced systemic toxicity in preclinical studies. When combined with a B7H4x4-1BB bispecific antibody at low effector-to-target cell ratios, it exhibited strong synergistic effects, suggesting a promising therapeutic window for patients. These findings support Harbour BioMed’s focus on developing differentiated biotherapeutics for unmet needs in oncology. The company leverages its proprietary Harbour Mice® platform, which generates fully human monoclonal antibodies in both conventional and heavy chain-only (HCAb) formats. HBM7004 is part of Harbour BioMed’s HBICE® (HCAb-based immune cell engagers) technology, designed to enhance tumor-killing effects beyond traditional combination therapies. The company also integrates AI-driven antibody discovery, including its Hu-mAtrIx™ platform, to accelerate innovation in therapeutic development. Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, stated that the IND clearance reflects the company’s commitment to advancing novel treatments for advanced solid tumors. Harbour BioMed’s pipeline includes strategic collaborations, internal R&D, and acquisitions to build a robust portfolio in immunology and oncology. The company’s proprietary platforms—Harbour Mice®, HBICE®, and HCAb PLUSTM—enable the development of next-generation antibodies and multi-specific medicines. With this IND clearance, Harbour BioMed aims to evaluate HBM7004’s clinical potential in patients with advanced solid tumors, further solidifying its position as a leader in antibody-based therapeutics.