Targeting PD-L1/TGF-β, Bioge Bio's bifunctional fusion protein obtained clinical approval from FDA

On June 2nd, Boji Biomedical Technology (Hangzhou) Co.
, Ltd.
(hereinafter referred to as Boji Bio) recently announced that the US FDA approved its self-developed PD-L1/TGF-β bifunctional fusion protein (code name: BJ- 005) New Drug Clinical Trial Application (IND), which can carry out clinical trials in the United States
.

This is the second independent research and development product approved by the FDA after the tumor-targeting IL-15 fusion protein (BJ-001) was approved for clinical use in the United States in 2019

BJ-005 is a recombinant dual-function fusion of a humanized anti-programmed death ligand 1 (PD-L1) IgG1 monoclonal antibody and a part of the extracellular domain of human transforming growth factor β (TGF-β) receptor II The fusion protein can simultaneously target PD-L1 and TGF-β, inhibit tumor growth by targeting immune checkpoints and regulating tumor cell growth cytokine pathways, and is used to treat cancer patients
.

BJ-005 is a recombinant dual-function fusion of a humanized anti-programmed death ligand 1 (PD-L1) IgG1 monoclonal antibody and a part of the extracellular domain of human transforming growth factor β (TGF-β) receptor II The fusion protein can simultaneously target PD-L1 and TGF-β, inhibit tumor growth by targeting immune checkpoints and regulating tumor cell growth cytokine pathways, and is used to treat cancer patients
.

Boji Bio is an innovative drug research and development company, which is mainly engaged in the development of biological drugs for tumors and infectious diseases
.

The company has two R&D laboratories in San Francisco, USA and Hangzhou, China

The first drug under development of Boji Biologics to enter clinical development, tumor-targeting IL-5 fusion protein (BJ-001), was approved for clinical use in the United States in 2019
.

The bispecific fusion protein (BJ-005) approved for clinical use this time is its second self-developed product

In response, Dr.
Haizhou Zhang, co-founder and CEO of Boji Biomedicine, said: "Our second self-developed product was approved for clinical trials in the United States, which once again proved Boji Biomedicine's continuous innovation ability and efficient execution
.

This greatly enhances the company’s confidence in fulfilling the established goal of advancing a completely self-innovated product into clinical research every 1-2 years

In response, Dr.