Hua Medicine Subsidiaries Huaotaibio and Huabo Bio Receive IND Approval for HB0028 Injection, a Novel PD-L1/TGF-β Bispecific Antibody

Recently, Huaota Biopharmaceuticals and Huabo Biopharm Co., Ltd., subsidiaries of Huahai Pharmaceutical, received the "Drug Clinical Trial Approval Notice" for the HB0028 injection issued by the National Medical Products Administration.

HB0028 is a bispecific antibody targeting programmed death-ligand 1 (PD-L1) and transforming growth factor-β (TGF-β). The anti-PD-L1 portion of HB0028 can block the binding of PD-L1 to its receptors PD-1 and CD80 (B7-1), relieving the immunosuppressive effects mediated by the PD-L1/PD-1 signaling pathway, activating cytotoxic T lymphocytes, and inhibiting tumor growth. Meanwhile, the anti-TGF-β portion of HB0028 can bind to TGF-β, relieving TGF-β-mediated immunosuppression on T cells and natural killer cells, regulatory T cell activation, tumor angiogenesis, and epithelial-to-mesenchymal transition, all factors that promote tumor growth and metastasis. Based on these two mechanisms, preclinical studies have shown that the tumor inhibition rate of HB0028 is significantly higher than that of the individual parent molecules.

In addition, the HB0028 project fuses the TGF-β type II receptor with the C-terminus of the anti-PD-L1 antibody, overcoming the drawback of O-glycosylation that often occurs when similar drugs fuse the TGF-β type II receptor with the N-terminus of the anti-PD-L1 antibody. This also further enhances the efficacy of HB0028.

There are currently no drugs of the same class targeting both PD-L1 and TGF-β on the market.