ABBISKO-B (02256) announced on November 3, 2025, that its oral small-molecule PD-L1 inhibitor, ABSK043, in combination with golecerase—a KRAS G12C inhibitor developed by Shanghai Allist Pharmaceuticals—has completed the first patient dosing in a Phase II clinical trial for treating KRAS G12C-mutated non-small cell lung cancer (NSCLC).

This open-label Phase II study aims to evaluate the safety, tolerability, and efficacy of ABSK043 combined with golecerase in patients with locally advanced or metastatic NSCLC harboring the KRAS G12C mutation. The trial received Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) in August 2025. The successful dosing of the first patient marks a significant milestone in the clinical development of this promising combination therapy.

KRAS is one of the most common oncogenic drivers in human cancers, with the KRAS G12C mutation occurring in approximately 14% of NSCLC patients. As a monotherapy, ABBISKO-B's ABSK043 demonstrated favorable safety and potential antitumor activity in a prior Phase I clinical trial involving patients with advanced solid tumors, particularly showing high response rates in PD-L1 high-expression, EGFR-mutant, and KRAS-mutant subgroups.