CAMBRIDGE, Massachusetts; ROTTERDAM, Netherlands; SHANGHAI, China, June 10, 2026
Harbour BioMed announced that the National Medical Products Administration (NMPA) of China has accepted the Investigational New Drug (IND) application for HBM7004, a novel B7H4xCD3 bispecific antibody being developed for the treatment of advanced solid tumors. The regulatory milestone follows the recent U.S. FDA IND clearance for the program and represents an important step toward initiating clinical evaluation of the investigational therapy in China. The company believes HBM7004 has the potential to offer a differentiated approach to cancer immunotherapy by enhancing anti-tumor efficacy while maintaining a favorable safety profile.
HBM7004 Leverages Proprietary HBICE® Bispecific Antibody Platform
HBM7004 was developed using Harbour BioMed’s proprietary HBICE® platform and is designed to target both B7H4 and CD3 simultaneously. The bispecific antibody aims to activate T cells in a B7H4-dependent manner within the tumor microenvironment, directing immune responses against cancer cells. The program further demonstrates the flexibility and plug-and-play capabilities of the HBICE® platform, which is focused on creating next-generation immune cell engager therapies for oncology indications with significant unmet medical needs.
Preclinical Data Demonstrated Strong Anti-Tumor Activity and Safety Profile
According to Harbour BioMed, preclinical studies showed that HBM7004 generated robust anti-tumor activity across multiple animal models while maintaining strong in vivo stability and reduced systemic toxicity. The company also reported that HBM7004 demonstrated a significant synergistic effect when combined with a B7H4x4-1BB bispecific antibody, particularly at low effector-to-target cell ratios. These findings suggest a potentially favorable therapeutic window and support the continued advancement of the candidate into human clinical studies.
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Regulatory Progress Supports Clinical Development Strategy
The NMPA’s acceptance of the IND application marks another regulatory achievement for Harbour BioMed as it expands development of its oncology pipeline globally. Company leadership highlighted that the milestone follows the recent FDA IND clearance for HBM7004 and reinforces confidence in the program’s scientific foundation. Harbour BioMed plans to work closely with regulatory authorities as it advances HBM7004 into clinical evaluation, aiming to develop innovative immunotherapies capable of addressing significant unmet needs among patients with advanced solid tumors.
Source: Harbour BioMed press release
