CStone Pharmaceuticals said the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for sugemalimab as monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) with PD-L1 expression on at least 1% of tumor cells, without sensitising EGFR mutations or ALK/ROS1 genomic aberrations, whose disease has not progressed after platinum-based chemoradiotherapy. The company said the approval was based on results from the Phase III GEMSTONE-301 trial.

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