China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for HB0025, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF). The BsAb will be assessed in combination with the standard of care (SOC) for the treatment of advanced solid tumors, including non-small cell lung cancer, small-cell lung cancer, gastric cancer, cervical cancer, biliary tract cancer, and others.
Mechanism of Action and Development
HB0025 is a bispecific fusion protein formed by linking the second Ig-like domain outside the membrane of VEGFR1 with the heavy chain N of the IgG1 anti-PD-L1 monoclonal antibody (mAb) through a flexible linker. This innovative design allows the drug to bind to PD-L1 and VEGF with high specificity and affinity. HB0025 previously obtained clinical approvals in China and the United States in December 2020 and January 2021, respectively. Both clinical and preclinical studies have demonstrated the potential efficacy and safety of HB0025 against a variety of tumors, with positive therapeutic signals observed in ongoing clinical studies.
Market and Competitive Landscape
Currently, there is no drug on the market that simultaneously inhibits the PD-1/PD-L1 and VEGF/VEGFR pathways. However, Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) combined with the anti-VEGF mAb bevacizumab has been approved to treat hepatocellular carcinoma in China. Additionally, a Tecentriq/bevacizumab/chemotherapy regimen has been approved to treat first-line metastatic non-small cell lung cancer in the US. Meanwhile, Akeso Biopharma’s (HKG: 9926) AK112, a bispecific antibody (BsAb) targeting PD-1 and VEGF, is undergoing a Phase III clinical study in China, indicating a growing interest in dual-target therapies for cancer treatment.
Future Prospects
The clinical trial approval from the NMPA is a significant milestone for Zhejiang Huahai Pharmaceutical, as it positions the company to further explore the potential of HB0025 in treating advanced solid tumors. With its unique mechanism of action and demonstrated therapeutic potential, HB0025 has the potential to offer new treatment options for patients with various types of cancer, enhancing the company’s position in the oncology market.-Fineline Info & Tech
