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Shanghai, China; Cambridge, Massachusetts, USA; and Rotterdam, NetherlandsMay 8, 2026 /PRNewswire/ — Harbour BioMed (stock code: 02142.HK), a global biopharmaceutical company dedicated to the discovery and development of innovative antibody therapies for immune diseases, oncology, and other areas, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for HBM7004, allowing the initiation of a first-in-human (FIH) Phase I clinical trial in the United States. The study will evaluate the safety, tolerability, pharmacokinetic profile, and preliminary anti-tumor activity of HBM7004 in patients with advanced solid tumors.
HBM7004 is a novel B7H4xCD3 bispecific antibody, developed from Harbour BioMed’s bispecific immune cell engager platform (HBICE®), offering a differentiated solution for cancer immunotherapy from both efficacy and safety perspectives. The development of this product further demonstrates the flexibility and plug-and-play advantages of HBICE®. In preclinical studies, HBM7004 exhibited an intratumoral B7H4-dependent T cell activation mechanism. In various animal model experiments, HBM7004 showed potent anti-tumor effects, excellent in vivo stability, and low systemic toxicity. Additionally, in preclinical models, HBM7004 demonstrated strong synergistic effects when combined with a B7H4x4-1BB bispecific antibody under low effector cell-to-target cell ratios, revealing an encouraging therapeutic window.
Dr. Wang Jinsong, Founder, Chairman, and CEO of Harbour BioMed, stated: “The FDA’s approval of the IND for the B7H4xCD3 bispecific antibody HBM7004 marks a significant step forward in advancing our innovative pipeline for patients with advanced solid tumors. This program reflects our ongoing focus on leveraging our industry-leading proprietary technology platforms to develop differentiated biologic therapies addressing major unmet medical needs in oncology. We are confident in the therapeutic potential of HBM7004 and look forward to further evaluating its clinical benefits in patients with advanced solid tumors.”
About Harbour BioMed
Harbour BioMed (stock code: 02142.HK) is a global biopharmaceutical company dedicated to the research and development of innovative drugs for immune diseases, oncology, and other areas. The company rapidly expands its innovative drug pipeline through independent research, collaborative development, and diversified international partnerships.
Harbour BioMed’s proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in dual, two-light-chain (H2L2), and heavy-chain-only (HCAb) formats. The immune cell engager (HBICE®) developed based on the HCAb antibody platform can achieve anti-tumor efficacy unattainable by traditional drug combination therapies. Meanwhile, the HCAb PLUSTM technology, also based on the HCAb antibody platform, provides comprehensive new molecular solutions for the development of innovative multi-specific drugs in different disease areas. Furthermore, leveraging the Harbour Mice® platform, Harbour BioMed has launched the first fully human AI HCAb model driven by its Hu-mAtrIxTM artificial intelligence (AI) platform—a fully human HCAb generation and screening model—accelerating the development of innovative therapies.
Harbour Mice®, HBICE®, HCAb PLUSTM, the single B cell cloning screening platform, and AI technology together form Harbour’s next-generation innovative therapeutic antibody research and development engine. For more information, please visit: www.harbourbiomed.com.