Sichuan Kelun-Biotech Biopharmaceutical Co, Ltd (6990.HK) a China-based biopharmaceutical company, announced on Tuesday that it has received a clinical trial notice from China s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) approving the Investigational New Drug (IND) application for PD-1 x VEGF bispecific antibody SKB118 (also known as CR-001) for the treatment of advanced solid tumours.

In December 2025, Kelun-Biotech and US-based Crescent Biopharma entered into a strategic collaboration for SKB118/CR-001. Under the collaboration, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialise SKB118/CR-001 in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan). In January 2026, Crescent announced the regulatory clearance of the IND application for SKB118/CR-001 by the US Food and Drug Administration (FDA) to initiate its global ASCEND Phase I/II clinical trial (NCT07335497) for the treatment of locally advanced or metastatic solid tumours. The trial is ongoing and expected to initially enrol up to 290 patients.

SKB118 is a tetravalent bispecific antibody being developed for the treatment of solid tumours that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells' ability to recognise and destroy tumour cells, and blocking VEGF is intended to reduce blood supply to tumour cells and to inhibit tumour growth.

Kelun-Biotech says that in preclinical studies, SKB118 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF, as well as robust anti-tumour activity. The company adds that SKB118's anti-VEGF activity may also normalise the vasculature at the tumour site, which has the potential to improve the localisation and effectiveness of combination therapies, such as in combination with antibody-drug conjugates (ADCs).