Sugemalimab receives positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use
October 18, 2025
Source: drugdu
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On the morning of October 17, CStone Pharmaceuticals announced on the Hong Kong Stock Exchange that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, recommending the approval of sugemalimab monotherapy for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) whose tumor cells express PD-L1 ≥1%, have no epidermal growth factor receptor (EGFR)-sensitive mutations or ALK or ROS1 genomic alterations, and have not progressed after platinum-containing chemoradiotherapy (CRT).
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