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FDA has approved recently the HB0025 project submitted by Huaota for clinical trials. HB0025 is the world's first FDA-approved clinical trial for a bispecific fusion protein targeting PD-L1/VEGF. HB0025 was independently developed by Huaota and has global patents.

HB0025 is a bispecific fusion protein formed by connecting the second Ig-like domain of the extracellular portion of VEGFR1 to the N-terminus of the heavy chain of IgG1 anti-PD-L1 monoclonal antibody through a flexible linker. It binds simultaneously to both PD-L1 and VEGF with high specificity and affinity. A large number of studies have shown that blocking the PD-1/PD-L1 signaling pathway can relieve the immunosuppressive effect mediated by this signaling pathway, activating cytotoxic T lymphocytes, and therefore inhibiting tumor growth. Blocking the VEGF/VEGFR signaling pathway can inhibit tumor growth by suppressing endothelial cell proliferation and angiogenesis. In addition, blocking the VEGF/VEGFR signaling pathway can also improve the tumor microenvironment by increasing infiltration of cytotoxic T lymphocytes in the tumor microenvironment, which is beneficial for immunotherapy. Therefore, blocking the above two signaling pathways at the same time can exert a synergistic anti-tumor effect. Preclinical studies have shown that HB0025 has a synergistic effect on the blockade of the above two signaling pathways. Better efficacy was seen comparing to use of either single-drug or the combinational use of two drugs.