CStone’s Sugemalimab Poised for European Approval

CStone Pharmaceuticals (HK:2616) has released an update.

CStone Pharmaceuticals has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for its drug, sugemalimab, as a first-line treatment for NSCLC, potentially marking the first Chinese biopharmaceutical anti-PD-L1 monoclonal antibody to enter the European market. The recommendation is based on Phase 3 clinical trial results showing significant benefits in progression-free and overall survival. This development signifies a key step in CStone’s global strategy, with plans for further registrations in additional cancer indications and ongoing discussions with potential partners to expand global market access.

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