CStone Announces European Commission Approval of Sugemalimab as First-Line Treatment for Non-Small Cell Lung Cancer

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 including 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).View original content:https://www.prnewswire.co.uk/news-releases/cstone-announces-european-commission-approval-of-sugemalimab-cejemly-as-first-line-treatment-for-non-small-cell-lung-cancer-302207524.html

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