CStone Pharmaceuticals (HKEX: 2616), a China-based biopharmaceutical company, announced on Sunday that it has submitted a Type II variation application to the European Medicines Agency (EMA) for sugemalimab.

The application seeks approval for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy (CRT).

This marks CStone's second regulatory submission for sugemalimab to the EMA, following its initial approval in Europe for metastatic squamous and non-squamous NSCLC in 2024. If this new indication is approved, sugemalimab would address a critical unmet need in stage III NSCLC, where only one PD-L1 antibody is currently approved in Europe. The drug's dual utility in stage III and IV NSCLC could solidify its role as a cornerstone immunotherapy in lung cancer.

The submission is supported by data from the GEMSTONE-301 Phase III trial, a multicentre, randomised, double-blind study evaluating sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC post-CRT.