Huahai Pharmaceutical's Subsidiary Receives FDA Approval for HB0025 Injection Clinical Trial

On December 22, a subsidiary of Huahai PharmaceuticalSubsidiary Huaota to the United StatesThe Investigational New Drug (IND) application submitted to the FDA has been approved.

In November 2020, Huaota’s Investigational New Drug (IND) application for HB0025 injection was accepted by the FDA; currently, the FDA has completed its review and approved the drug to proceed with clinical trials. HB0025 injection is the world’s first approvedClinical trial: a bispecific fusion protein capable of simultaneously blocking the PD-1/PD-L1 and VEGF/VEGFR signaling pathwaysProtein. The HB0025 project is independently developed by Huaota and holds global patents.

To date, Huahai Pharmaceutical has incurred a total of RMB 42.47 million in R&D expenses for the HB0025 injection development project.HB0025 is a bispecific fusion protein formed by linking the second Ig-like domain of the extracellular region of VEGFR1 to the N-terminus of the heavy chain of an IgG1 anti-PD-L1 monoclonal antibody via a flexible linker, capable of simultaneously achieving high specificity and high affinity.binds to the two targets, PD-L1 and VEGF. Numerous studies have shown that blocking the PD-1/PD-L1 signaling pathway can relieveIn addition to the immunosuppressive effects mediated by this signaling pathway, it activates cytotoxic T lymphocytes, thereby inhibiting tumor growth;Blocking the VEGF/VEGFR signaling pathway can inhibit the proliferation of vascular endothelial cells and the formation of new blood vessels, thereby achieving inhibitionthe purpose of tumor growth. Furthermore, blocking the VEGF/VEGFR signaling pathway can also improve the tumor microenvironment and enhance cellularInfiltration of cytotoxic T lymphocytes into the tumor microenvironment is beneficial for immunotherapy. Therefore, simultaneous blockade of the aforementioned two pathwaysSignaling pathways can exert synergistic anti-tumor effects. Preclinical studies have shown that HB0025 blocks the above two signaling pathwaysThe combination demonstrates synergistic effects, with efficacy significantly superior to monotherapy and also outperforming the combination of the two individual drugs.

Currently, there are no marketed drugs that simultaneously block both the PD-1/PD-L1 and VEGF/VEGFR signaling pathways.The combination therapy of Atezolizumab (anti-PD-L1 monoclonal antibody) and Bevacizumab (anti-VEGF monoclonal antibody), developed by Roche, has been approved by the FDA and the National Medical Products Administration for the treatment of unresectable hepatocellular carcinoma. Atezolizumab(Anti-PD-L1 monoclonal antibody) in combination with Bevacizumab (anti-VEGF monoclonal antibody) and chemotherapy has also been approved by the FDA for first-lineFirst-line treatment for metastatic non-squamous non-small cell lung cancer without EGFR or ALK mutations. There are also numerous agents targeting PD-1/PD-L1The combination of monoclonal antibodies and targeted VEGF/VEGFR drugs is currently undergoing clinical studies. The target developed by Akeso Biopharma in ChinaThe bispecific antibody AK112 targeting PD-1 and VEGF is currently in clinical trials.

Source: Huahai Pharmaceutical Announcement