Recently, TQB6457 Injection, a Class 1 innovative drug developed by Chia Tai Tianqing Pharmaceutical Group, a core subsidiary of China Biologic Products Holdings, Inc. (1177.HK), has been granted clinical trial implied approval by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of advanced malignant tumors. As the world’s first fixed-dose combination of a CCR8 monoclonal antibody and a PD‑1 antibody to enter clinical research, this product is designed to replace combination therapy with a single agent, helping to improve medication adherence among patients with advanced tumors and overcome treatment limitations.

CCR8 is a promising target specifically and highly expressed on the surface of regulatory T cells (Tregs) in the tumor microenvironment, and plays a key role in recruiting Tregs to tumor sites. PD‑1 is a canonical immune checkpoint protein; tumor cells can trigger immunosuppression by binding PD‑1 via PD‑L1. As a dual-targeted combination, TQB6457 can precisely target both CCR8 and PD‑1 simultaneously. On the one hand, it depletes tumor-infiltrating FOXP3(+)CCR8(+) Treg cells and relieves Treg‑mediated immunosuppression. On the other hand, it blocks the PD‑1/PD‑L1 pathway and activates the body’s anti‑tumor immune response, achieving a “1+1>2” synergistic anti‑tumor effect through complementary mechanisms.

Preliminary clinical data show that the combination of CCR8 antibody and PD‑1 antibody demonstrates a favorable safety profile, with manageable and tolerable toxicity when combined with chemotherapy, and preliminary synergistic efficacy has been observed. Its expected efficacy is superior to PD‑1 antibody monotherapy.
While retaining the potential efficacy advantages of combination therapy, TQB6457 significantly shortens patient infusion time and simplifies administration procedures in clinical practice. For sequential administration, the total fluid volume of the fixed‑dose combination is lower than that of traditional combination regimens, which can reduce safety risks for patients with heart failure and other conditions requiring restricted fluid