Huahai Pharmaceutical's Subsidiary Receives FDA Approval to Initiate Clinical Trials of HB0036, a PD-L1/TIGIT Bispecific Antibody for Advanced Solid Tumors

Recently, Shanghai Huaota Biopharmaceutical Co., Ltd., a subsidiary of Huahai Pharmaceutical, received notification that its clinical trial application for HB0036 injection submitted to the U.S. Food and Drug Administration (hereinafter referred to as "FDA") has been approved.

It is reported that HB0036 is a bispecific antibody targeting programmed death-ligand 1 (PD-L1) and T cell immunoglobulin and ITIM domain (TIGIT). It can simultaneously bind with high specificity to both PD-L1 and TIGIT targets, blocking the immune suppression mediated by them, reactivating the immune system's killing of tumor cells, and ultimately achieving synergistic anti-tumor effects. Preclinical studies have shown that the efficacy of HB0036 is significantly better than that of the monotherapy groups and comparable to the combination of the two monotherapies.

Currently, there are no similar drugs targeting both pathways available on the market either in China or internationally. The combination therapy of Atezolizumab (PD-L1 monoclonal antibody) and Tiragolumab (TIGIT monoclonal antibody), developed by Roche for first-line treatment of non-small cell lung cancer, was granted Breakthrough Therapy Designation (BTD) by the FDA in January 2021.

The latest data released by Roche in December 2021 showed that the combination of Atezolizumab and Tiragolumab significantly reduced the risk of disease progression and death in patients with non-small cell lung cancer who have high expression of PD-L1. In China and abroad, several companies including Shanghai Fosun Henlius Biotech Inc., Pulmix Biotechnology (Zhuhai) Co., Ltd., Nanjing Saint Medicine Co., Ltd., and AstraZeneca are developing bispecific antibodies targeting PD-1/PD-L1 and TIGIT, which are respectively in clinical research or early research stages.

Editor: Eight Corners

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