Huahai Pharmaceutical's Subsidiaries Receive IND Approval for HB0030, a TIGIT-Targeting Monoclonal Antibody, for Advanced Solid Tumors

On August 3, Huahai Pharmaceutical issued an announcement stating that the clinical trial application for HB0030 Injection, submitted by its subsidiaries Huaota and Huabo Biopharm, has been approved by the National Medical Products Administration (NMPA) for the treatment of advanced malignant solid tumors.

HB0030 is a humanized IgG1 monoclonal antibody targeting TIGIT (T-cell immunoglobulin and ITIM domain protein) that binds to TIGIT with high affinity, thereby blocking the interaction between TIGIT and its ligands (e.g., CD155). TIGIT is highly expressed on the surface of immunosuppressive Treg cells (regulatory T cells), CD4+ and CD8+ T cells, and NK cells (natural killer cells), and its binding to the ligand CD155 induces immunosuppression.

Upon binding to TIGIT on the surface of T cells and NK cells, HB0030 effectively blocks the interaction between TIGIT and CD155, thereby reversing immune suppression and reactivating the tumor-killing activity of T cells and NK cells. Meanwhile, due to its potent ADCC/CDC activity (ADCC refers to antibody-dependent cellular cytotoxicity; CDC refers to complement-dependent cytotoxicity), HB0030 can also deplete Treg cells via ADCC/CDC effects, further alleviating Treg-mediated immune suppression and enhancing anti-tumor efficacy. Additionally, the activation of NK cells and macrophages increases the release of inflammatory cytokines, which activates other immune cells and further potentiates the anti-tumor effect.

Currently, no anti-TIGIT agents have been approved for market. Tiragolumab, a monoclonal antibody developed by Roche, is the most advanced in development and is currently in Phase III clinical trials. In January 2021, the FDA granted Breakthrough Therapy designation to the combination of Tiragolumab and Tecentriq (an anti-PD-L1 monoclonal antibody) for the treatment of NSCLC (non-small cell lung cancer) with high PD-L1 expression.

Vibostolimab, developed by Merck, is also currently in a Phase III clinical trial in combination with pembrolizumab (an anti-PD-1 monoclonal antibody) for the treatment of NSCLC. In China, anti-TIGIT antibodies developed by five companies, including BeiGene and Innovent Biologics, have already entered clinical trials.

In May 2021, Huaota and Huabo Biopharm submitted a clinical trial application for HB0030 Injection to the National Medical Products Administration (NMPA), which was accepted. Recently, the NMPA approved the drug for clinical trials. As of June 30, 2021, the company had incurred cumulative R&D expenses of approximately RMB 35.793 million.