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). SUZHOU, China, July 26, 2024 /PRNewswire/ -- CStone Pharmaceuticals ('CStone', HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the European Commission (EC) has approved sugemalimab (Brand name: Cejemly®) in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. Sugemalimab has become the first anti-PD-L1 monoclonal antibody (mAb) approved in Europe in combination with chemotherapy as first-line treatment for both squamous and non-squamous NSCLC, making CStone the first innovative biopharmaceutical company to successfully bring a China domestic anti-PD-L1 mAb to the international market.