CSTONE PHARMA-B(02616)The EU Commission approves the use of Sugriva monoclonal antibody for the treatment of stage III non-small cell lung cancer.

CSTONE PHARMA-B (02616) announced that the European Commission (EC) has approved a new indication for sugolimab: as a monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have tumor cells expressing PD-L1 1%, no EGFR sensitive mutations or ALK, ROS1 genomic alterations, and no disease progression after platinum-based chemoradiation therapy (CRT). Dr. Jason Yang, CEO, Chief Scientific Officer, and Executive Director of CStone Pharma-B, stated, "Following the EC's initial approval of sugolimab for first-line treatment of metastatic squamous and non-squamous NSCLC in 2024, this new indication was approved just one year later. This marks the complete coverage of sugolimab from stage III to stage IV NSCLC in Europe, providing a new treatment option for a wider range of patients. CStone Pharma-B will continue to advance the accessibility of sugolimab globally, fulfilling our long-term commitment to patients." Dr. Qingmei Shi, Chief Medical Officer of CStone Pharma-B, emphasized, "This new indication makes sugolimab the second PD-(L)1 antibody approved in Europe for stage III NSCLC, addressing a crucial treatment need in this disease area. We are pleased with the excellent performance of the clinical development and registration team at CStone Pharma-B, whose effective execution ensured the rapid and successful approval of sugolimab under the evaluation pathway of the European Medicines Agency (EMA). We are committed to further enhancing our global capabilities to bring our innovative products to patients worldwide." The EC has approved two indications for sugolimab: - First-line treatment in combination with platinum-based chemotherapy for metastatic NSCLC without EGFR sensitive mutations or ALK, ROS1, RET genomic tumor alterations (this indication has also been approved by the Medicines and Healthcare products Regulatory Agency [MHRA] in the UK); - Monotherapy for adult patients with unresectable stage III NSCLC who have tumor cells expressing PD-L1 1%, no EGFR sensitive mutations or ALK, ROS1 genomic alterations, and no disease progression after platinum-based CRT.