Chinese regulators have given the green light to a clinical trial for a novel immunotherapy designed to attack solid tumors from two angles. The investigational new drug approval for SKB118, a bispecific antibody targeting both PD-1 and VEGF pathways, was granted by the Center for Drug Evaluation of the National Medical Products Administration. The study will focus on patients with advanced solid tumors who have limited treatment options.
SKB118 is a tetravalent bispecific antibody that combines two proven cancer-fighting mechanisms in a single therapy. The PD-1 checkpoint blockade is designed to restore the immune system’s T cells, helping them recognize and destroy tumor cells. Simultaneously, blocking VEGF aims to cut off the blood supply that tumors need to grow. In preclinical studies, the drug demonstrated cooperative pharmacology, showing increased binding to PD-1 and stronger signal blockade when VEGF was present, along with robust anti tumor activity. Researchers also noted that the anti VEGF component may help normalize blood vessels around tumors, potentially improving the delivery and effectiveness of combination therapies such as antibody drug conjugates.
The approval in China follows a similar clearance from the U.S. Food and Drug Administration in January 2026. A global Phase I/II clinical trial called ASCEND is already underway, with plans to enroll up to 290 patients with locally advanced or metastatic solid tumors. The Chinese portion of the study will run in parallel, allowing researchers to gather data from diverse patient populations. The drug is being developed under a strategic collaboration between Kelun-Biotech and Crescent Biopharma, with Kelun holding exclusive rights for development and commercialization in Greater China.
Looking ahead, investigators plan to explore combining SKB118 with Kelun-Biotech’s proprietary antibody drug conjugate assets as part of an ADC plus immunotherapy strategy. The goal is to unlock synergistic treatment effects and expand possibilities for patients who have few remaining options. With both U.S. and Chinese trials now active, researchers hope to move quickly toward understanding which patients may benefit most from this dual targeting approach.