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Harbour BioMed Wins China Approval for Solid Tumor Drug Trial

China's National Medical Products Administration has cleared Harbour BioMed to begin clinical trials for HBM7004, a bispecific antibody engineered to combat advanced solid tumors. The regulatory green light allows the company to transition its oncology candidate from preclinical research into human testing, marking a significant step for its proprietary immunotherapy platform.

Harbour BioMed Wins China Approval for Solid Tumor Drug Trial
Photo: Bio & News

The drug, HBM7004, utilizes the company's HBICE platform to target B7H4xCD3, a mechanism designed to activate T cells specifically within the tumor environment. Preclinical testing indicated that this approach may improve safety profiles by reducing systemic toxicity while maintaining strong anti-tumor efficacy. Researchers observed that the treatment demonstrated significant stability and synergistic potential when combined with other bispecific antibodies, suggesting a wider therapeutic window for patients currently facing limited options.

Dr. Jingsong Wang, CEO of Harbour BioMed, noted that the NMPA clearance mirrors a recent regulatory approval from the FDA, confirming the viability of their antibody discovery technology. The company intends to initiate clinical procedures in China immediately, aiming to address the high unmet needs of patients with advanced-stage cancers. This development underscores the effectiveness of their HBICE platform in producing differentiated candidates capable of achieving tumor-killing effects that standard combination therapies often struggle to reach.

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