IBI315

**IBI315** is a recombinant fully human IgG1 bispecific monoclonal antibody that simultaneously targets **PD-1** on T cells and **HER2** on tumor cells. Developed by **Innovent Biologics** in partnership with **Hanmi Pharmaceutical**, it blocks PD-1/PD-L1 and HER2 signaling pathways while physically bridging T cells to HER2-expressing tumor cells to enhance cytotoxicity. Preclinical studies demonstrate superior antitumor efficacy over parental antibodies or combinations, inducing **GSDMB-mediated pyroptosis** in tumor cells, T cell activation via IFNγ feedback, and immune cell recruitment, particularly in **HER2-positive gastric cancer**. It is in early clinical development for **HER2-expressing advanced solid tumors**[1][3][6][8].

Brand names

Fidasimtamab

Other names

anti-PD-1/anti-HER2 bispecific antibody