HBM Holdings-B (02142) has announced that its Investigational New Drug (IND) application for HBM7004, a novel B7H4xCD3 bispecific antibody designed for advanced solid tumors, has been approved by China's National Medical Products Administration. This milestone follows the company's earlier clearance from the U.S. Food and Drug Administration to initiate a first-in-human Phase I clinical trial in the United States.

HBM7004, developed from the company's proprietary HBICE® platform, offers a differentiated approach to cancer immunotherapy by addressing both efficacy and safety dimensions. The advancement of HBM7004 further underscores the platform's flexibility and plug-and-play capabilities.

Preclinical studies have demonstrated that HBM7004 triggers an intratumoral B7H4-dependent T-cell activation mechanism. Across multiple animal models, the therapy has exhibited potent anti-tumor activity, robust in vivo stability, and reduced systemic toxicity. Moreover, when combined with a B7H4x4-1BB bispecific antibody under low effector-to-target cell ratios, HBM7004 showed strong synergistic effects in preclinical models, revealing a promising therapeutic window.