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Shanghai, China; Cambridge, Massachusetts, USA; and Rotterdam, NetherlandsJune 10, 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 China National Medical Products Administration (NMPA) has accepted its Investigational New Drug (IND) application for HBM7004, intended for the treatment of advanced solid tumors.
HBM7004 is a novel B7H4xCD3 bispecific antibody, developed using 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 highlights the flexibility and plug-and-play advantages of HBICE®. In preclinical studies, HBM7004 demonstrated a tumor-intrinsic B7H4-dependent T cell activation mechanism. In various animal model experiments, HBM7004 exhibited potent anti-tumor effects, excellent in vivo stability, and low systemic toxicity. Additionally, in preclinical models, the combination of HBM7004 with a B7H4x4-1BB bispecific antibody showed strong synergy at low effector-to-target cell ratios, revealing an encouraging therapeutic window.
Dr. Wang Jinsong, Founder, Chairman, and CEO of Harbour BioMed, stated: “Following the recent IND clearance for HBM7004 by the U.S. FDA, we are pleased that the NMPA has also accepted the IND application for HBM7004 for the treatment of advanced solid tumors. HBM7004 is a differentiated next-generation immunotherapy developed using our proprietary technology platform to address the significant unmet clinical needs in oncology. Based on encouraging preclinical data, we look forward to working closely with regulatory authorities to advance the clinical evaluation of this therapy in China.”
About Harbour BioMed
Harbour BioMed (stock code: 02142.HK) is a global biopharmaceutical company focused on 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 and development, co-development, and diversified international collaborations.
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 from the HCAb antibody platform enables anti-tumor efficacy unattainable with 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 multispecific 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—to accelerate 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.