HBM HOLDINGS-B (02142): The clinical trial application for the new drug HBM7004 for the treatment of advanced solid tumors has been approved by the National Medical Products Administration.

HBM HOLDINGS-B (02142) announced that the clinical trial (IND) application for HBM7004 (a novel B7H4xCD3 bispecific antibody for the treatment of advanced solid tumors) has been approved by the National Medical Products Administration of China. This marks another progress following the Group's receipt of permission from the U.S. Food and Drug Administration (FDA) to launch the first-in-human Phase I clinical trial in the United States. It is reported that HBM7004 is a novel B7H4xCD3 bispecific antibody developed from the Group's proprietary HBICE platform, providing differentiated solutions for cancer immunotherapy from both efficacy and safety dimensions. The development of HBM7004 further highlights the flexible applicability and plug-and-play advantages of the HBICE platform. In preclinical studies, HBM7004 exhibited a B7H4-dependent T cell activation mechanism within tumors. In various animal model experiments, HBM7004 demonstrated robust anti-tumor effects, excellent in vivo stability, and low systemic toxicity. Additionally, in preclinical models, HBM7004 showed strong synergy when combined with B7H4x4-1BB bispecific antibodies under conditions of low effector to target cell ratios, indicating an exciting therapeutic window.