Chinese regulators have given the green light to begin clinical trials for a new bispecific antibody designed to attack solid tumors through two distinct mechanisms simultaneously. The drug, SKB118, targets both PD-1 and VEGF pathways in a single therapy, offering a potential new option for patients with advanced cancers.
The investigational new drug approval from China’s Center for Drug Evaluation allows Sichuan Kelun-Biotech to launch trials in the country for advanced solid tumors. This follows U.S. regulatory clearance in January 2026 for a global Phase I/II study known as the ASCEND trial, which aims to enroll up to 290 patients with locally advanced or metastatic solid tumors. The drug is being developed in partnership with Crescent Biopharma, which granted Kelun-Biotech exclusive rights for research, development, and commercialization across Greater China.
SKB118 is a tetravalent bispecific antibody that combines two proven cancer-fighting strategies. By blocking PD-1, it helps restore the ability of T cells to recognize and destroy tumor cells. Simultaneously, by inhibiting VEGF, it reduces the blood supply that tumors need to grow. Preclinical studies showed that SKB118 demonstrated cooperative pharmacology with increased binding to PD-1 in the presence of VEGF, along with robust anti-tumor activity. The anti-VEGF component may also normalize blood vessels around tumors, potentially improving how well combination therapies like antibody-drug conjugates reach and affect cancer cells.
Kelun-Biotech plans to explore combining SKB118 with its proprietary ADC assets as part of its broader ADC plus immunotherapy strategy. The company currently has more than 30 ongoing innovative drug projects, with four projects covering eight indications already approved for marketing and more than ten in clinical stages. With this latest approval, the drug’s clinical development now advances simultaneously in China and globally, bringing researchers closer to expanding treatment options for patients facing advanced solid tumors.