HBM HOLDINGS-B (02142.HK): IND application of HBM7004 for advanced solid tumors approved by NMPA

NewTimeSpace News: On 18 August 2026, HBM Holdings Limited (stock code: 02142) announced in a voluntary announcement that the investigational new drug (IND) application of HBM7004, a novel B7H4xCD3 bispecific antibody for the treatment of advanced solid tumors, has been approved by China's National Medical Products Administration (NMPA). According to the announcement, this represents further progress following the U.S. Food and Drug Administration's (FDA) permission for the Group to initiate a first-in-human Phase I clinical trial in the United States (as disclosed in the Company's announcement dated 8 May 2026).

According to the announcement, HBM7004 was developed from the Group's proprietary HBICE® platform, providing a differentiated solution for cancer immunotherapy from both efficacy and safety perspectives. In preclinical studies, HBM7004 demonstrated tumor-intrinsic B7H4-dependent T cell activation, with robust anti-tumor efficacy, excellent in vivo stability and low systemic toxicity across multiple animal models; it also showed strong synergy with a B7H4x4-1BB bispecific antibody at low effector-to-target cell ratios.

The announcement cautions that the Company cannot guarantee successful development or eventual commercialization of HBM7004, and shareholders and potential investors should exercise caution when dealing in the shares of the Company.

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