CStone Pharmaceuticals Seeks EMA Approval for Sugemalimab in Stage III NSCLC

CStone Pharmaceuticals ( (HK:2616) ) just unveiled an update.

CStone Pharmaceuticals has submitted a Type II variation application to the European Medicines Agency for sugemalimab, seeking approval for its use in treating unresectable stage III non-small cell lung cancer (NSCLC) post-chemoradiotherapy. This submission follows its earlier approval for metastatic NSCLC in Europe. If approved, sugemalimab could become a key immunotherapy for lung cancer, addressing a critical unmet need in stage III NSCLC. The application is backed by positive results from the GEMSTONE-301 Phase III trial, which demonstrated significant improvements in progression-free and overall survival rates, along with a favorable safety profile.

More about CStone Pharmaceuticals

CStone Pharmaceuticals, established in 2015, is a biopharmaceutical company focused on developing anti-cancer therapies. The company has launched four innovative drugs and secured approvals for 16 new drug applications covering nine indications. CStone’s pipeline includes promising candidates such as antibody-drug conjugates, multispecific antibodies, immunotherapies, and precision medicines. The company is committed to addressing unmet medical needs in China and globally, supported by a management team with extensive experience across the drug development spectrum.

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