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NMPA approves Harbour BioMed IND application for HBM7004 in advanced solid tumors

The bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy with the potential to enhance both efficacy and safety

21 Aug 2026
Olivia Long
Editorial Team

Harbour BioMed has announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM7004 for the treatment of patients with advanced solid tumors in China.

This regulatory milestone follows recent clearance by the U.S. Food and Drug Administration (FDA) and supports the Company’s strategy to advance differentiated cancer immunotherapies for patients with limited treatment options.

HBM7004: A novel B7H4xCD3 bispecific antibody

HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the Company’s HBICE® platform. This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy with the potential to enhance both efficacy and safety in the treatment of advanced solid tumors.

The development of HBM7004 further demonstrates the HBICE® platform’s versatility and plug-and-play advantages for generating innovative bispecific antibody candidates.

Preclinical data support clinical development in solid tumors

In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity.

Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window for combination strategies.

“We are very pleased to receive NMPA approval of IND application for HBM7004, which marks another important milestone in our commitment to advancing novel immunotherapies for patients with advanced solid tumors,” said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed.

“This approval, together with the recent FDA clearance, underscores the strength of our HBICE® platform and its ability to generate differentiated bispecific candidates with promising preclinical profiles. We are now one step closer to bringing HBM7004 into the clinic in China, and we look forward to advancing this program to address the needs of cancer patients with limited treatment options.”

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Frequently asked questions

Show frequently asked questions

What is HBM7004 and how is Harbour BioMed using it to treat advanced solid tumors in China?

HBM7004 is a novel B7H4xCD3 bispecific antibody developed on Harbour BioMed’s HBICE® platform. It is designed to provide a differentiated cancer immunotherapy approach with potential to enhance efficacy and safety in advanced solid tumors. The NMPA in China has approved the IND application, enabling clinical development of HBM7004 for patients with advanced solid tumors.

How do NMPA and FDA approvals support Harbour BioMed’s HBICE platform and cancer immunotherapy strategy?

The NMPA approval of the IND for HBM7004, together with recent FDA clearance, validates Harbour BioMed’s strategy to advance differentiated cancer immunotherapies for patients with limited treatment options. These regulatory milestones underscore the strength, versatility, and plug-and-play advantages of the HBICE® platform in generating innovative bispecific antibody candidates with promising preclinical profiles.

What preclinical data support the development of HBM7004 for advanced solid tumors and combination therapies?

Preclinical studies show that HBM7004 induces intratumor B7H4-dependent T cell activation, with strong anti-tumor efficacy, notable in vivo stability, and reduced systemic toxicity in multiple animal models. In preclinical combination models, HBM7004 demonstrated strong synergy with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window for combination strategies in solid tumors.

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