EC Approve SFL Pharmaceuticlas' Cejemly (Sugemalimab) for First Line Treatment of NSCLC

• Sugemalimab becomes the world's first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for first-line treatment of both squamous and non-squamous non-small cell lung cancer (NSCLC), also marking the first successful international approval of a China domestic anti-PD-L1 mAb.
• The European Commission (EC) approval is based on the results of GEMSTONE-302 Phase 3 trial, which demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival and overall survival in treatment-naive patients with metastatic NSCLC.
• CStone has entered into a strategic commercialization partnership with Ewopharma for sugemalimab in Central & Eastern Europe and Switzerland.
• Discussions for commercial partnerships in Western Europe, Latin America, the Middle East, Southeast Asia, etc., are progressing well and are expected to conclude soon.
• CStone is actively preparing to submit additional Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) for new indications, including Stage III NSCLC, first-line Gastric Cancer, first-line Esophageal Cancer, and relapsed/refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL).

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European Comission Cejemly