Cambridge, Massachusetts; Rotterdam, Netherlands; and Shanghai, China, August 18, 2026
Harbour BioMed (HKEX: 02142) announced that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for HBM7004, a novel B7H4xCD3 bispecific antibody being developed for patients with advanced solid tumors. The regulatory approval represents an important step toward advancing HBM7004 into clinical development in China and further expands Harbour BioMed’s pipeline of next-generation antibody-based cancer immunotherapies. HBM7004 was developed using the company’s proprietary HBICE® bispecific antibody platform, which is designed to generate immune cell engagers with differentiated activity against tumor cells. The program is particularly focused on developing a targeted immunotherapy approach that may enhance antitumor activity while limiting systemic toxicity. The NMPA decision follows a recent FDA clearance for HBM7004, providing additional regulatory momentum for the program and supporting its progression toward clinical evaluation.
HBM7004 Advances Bispecific Immunotherapy Development
HBM7004 is designed to target B7H4 and CD3, enabling immune-cell engagement against B7H4-expressing tumor cells. According to Harbour BioMed, the candidate demonstrated an intratumor B7H4-dependent T-cell activation mechanism in preclinical studies. This approach is intended to focus immune activation within the tumor environment while potentially reducing unwanted systemic immune activity. In multiple preclinical animal models, HBM7004 demonstrated strong antitumor activity, high in-vivo stability and reduced systemic toxicity. The company is developing the candidate as part of its broader strategy to create differentiated bispecific antibodies capable of addressing significant unmet needs in oncology. The NMPA IND approval now enables Harbour BioMed to move the program toward clinical-stage development in China, an important transition from preclinical research into human studies.
HBICE® Platform Supports Next-Generation Oncology Pipeline
The development of HBM7004 also highlights the potential of Harbour BioMed’s HBICE® platform for generating immune cell-engaging bispecific antibodies. Built from the company’s heavy chain-only antibody technology, HBICE® is designed to create bispecific molecules capable of connecting immune effector cells with tumor targets. Harbour BioMed reported that HBM7004 demonstrated a synergistic effect in preclinical models when combined with a B7H4x4-1BB bispecific antibody, even at a low effector-to-target cell ratio. These findings provide additional support for investigating differentiated combination strategies around the B7H4 target, although the potential clinical benefit of these approaches will need to be established through human trials. HBM7004 is therefore an important clinical development program for Harbour BioMed, both as an individual candidate and as a demonstration of the flexibility of its antibody-engineering platform.
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Regulatory Progress Expands Harbour BioMed’s Clinical Pipeline
The NMPA approval, together with the previously announced FDA clearance, gives Harbour BioMed an opportunity to advance HBM7004 through clinical development across multiple regulatory regions. The company is developing the candidate for advanced solid tumors, where new targeted immunotherapy approaches remain an important area of research. Harbour BioMed combines its Harbour Mice®, HBICE®, HCAb PLUS™ and Hu-mAtrIx™ AI technologies with internal research capabilities and external collaborations to support antibody discovery and development. The company said the latest regulatory milestone demonstrates the versatility of its technology platforms and strengthens its strategy of developing next-generation therapeutic antibodies. The immediate focus for HBM7004 will be advancing the program into clinical evaluation in China, where its safety, tolerability and antitumor activity will ultimately determine whether the promising preclinical profile can translate into meaningful clinical benefit for patients with advanced solid tumors.
Source: Harbour BioMed press relese
