China's regulatory clearance for SKB118 marks a dual-jurisdiction entry into clinical development for a PD-1 x VEGF bispecific antibody that is already enrolling patients in the United States, positioning Sichuan Kelun-Biotech Biopharmaceutical Co. (HKEX: 6990) alongside its US partner in a coordinated global oncology program. The SKB118 investigational new drug approval, issued by China's Center for Drug Evaluation as a clinical trial notice under the National Medical Products Administration, follows US FDA clearance of the same molecule — developed by Crescent Biopharma under the code CR-001 — in January 2026.
The molecule: dual-target design in a crowded immunotherapy field
SKB118, also known as CR-001, is a tetravalent bispecific antibody designed to simultaneously block two mechanistically distinct targets: PD-1, the immune checkpoint receptor central to T-cell exhaustion in the tumor microenvironment, and VEGF, the pro-angiogenic cytokine that supports tumor vascular development. The rationale for combining these two axes is not novel in concept — anti-VEGF agents and checkpoint inhibitors have been co-administered in approved regimens across several tumor types — but encoding both activities into a single bispecific molecule introduces distinct pharmacological properties that neither monotherapy can replicate.
In preclinical studies, the company reported that SKB118 demonstrated cooperative binding behavior: PD-1 engagement increased in the presence of VEGF, suggesting a conditional, context-dependent pharmacology rather than simple additive blockade. The company also noted robust preclinical anti-tumor activity, though the translation of such findings to clinical outcomes in bispecific formats has been inconsistent across the field.