Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (SKB BIO; 06990) has obtained Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for SKB118 (CR-001), a tetravalent bispecific antibody targeting PD-1 and VEGF for the treatment of advanced solid tumours.
The clearance, issued by the Center for Drug Evaluation, authorises SKB BIO to initiate domestic clinical trials of SKB118. The molecule combines checkpoint inhibition (PD-1) with anti-angiogenic activity (VEGF blockade), aiming to restore T-cell–mediated tumour recognition while simultaneously restricting tumour vasculature. Pre-clinical studies showed enhanced PD-1 binding and robust anti-tumour activity, suggesting potential synergy with other modalities such as antibody–drug conjugates.
SKB118 is being co-developed under a December 2025 strategic partnership with U.S.-based Crescent Biopharma. Crescent granted SKB BIO exclusive rights to research, develop, manufacture and commercialise SKB118 in Greater China. In January 2026, the U.S. Food and Drug Administration cleared Crescent’s IND application, enabling the global ASCEND Phase 1/2 study (NCT07335497), which is now enrolling up to 290 patients with locally advanced or metastatic solid tumours.
Management reiterated that SKB118 remains in early-stage development and may not ultimately achieve successful commercialisation. Shareholders and prospective investors are advised to exercise caution when dealing in SKB BIO securities.