CStone Receives European Commission Approval for Sugemalimab (Cejemly®) as a First-Line Treatment for Non-Small Cell Lung Cancer
Saturday, August 03, 2024
CStone Pharmaceuticals (HKEX: 2616), an innovative biopharmaceutical firm specializing in cancer therapies, has announced that the European Commission has approved sugemalimab (branded as Cejemly®) for use with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) who lack sensitizing EGFR mutations or genomic ALK, ROS1, or RET aberrations. This approval marks sugemalimab as the first anti-PD-L1 monoclonal antibody (mAb) authorized in Europe for first-line NSCLC treatment in combination with chemotherapy, and positions CStone as the first Chinese company to introduce a homegrown anti-PD-L1 mAb to the international market.
The approval is based on the GEMSTONE-302 study, a multicenter, randomized, double-blind Phase 3 trial, which demonstrated that sugemalimab combined with chemotherapy significantly extended progression-free survival and overall survival compared to chemotherapy alone. The study’s findings, published in The Lancet Oncology and Nature Cancer, were also presented at various international conferences. Further long-term data from this study will be presented at the ESMO Annual Meeting 2024 in a poster session (#1318P).
CStone, highlighted that this achievement represents a major milestone for the company and reflects its commitment to becoming a leading global entity in cancer treatment. Sugemalimab is the first product developed by CStone to receive international approval and is the world’s first anti-PD-L1 mAb approved in Europe for use in combination with chemotherapy for both squamous and non-squamous NSCLC. This accomplishment underscores CStone’s high standards in R&D and manufacturing, supporting its global expansion strategy. The company is actively pursuing commercial partnerships in regions including Western Europe, Latin America, the Middle East and Africa, Southeast Asia, and Canada, with plans to finalize these deals soon.
Dr. Yang also shared insights into the approval process, noting the extensive efforts required to address EMA inquiries and meet regulatory requirements. He praised the resilience and dedication of the CStone team throughout this journey.
CStone is preparing submissions for additional 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). The successful approval of sugemalimab aligns with the company’s Pipeline 1.0 strategy and highlights the potential of its Pipeline 2.0 candidates, which are advancing in or nearing international clinical trials. CStone is also exploring combinations of sugemalimab with other therapies, such as antibody-drug conjugates (ADCs) and bi-/trispecific antibodies, to enhance its effectiveness in cancer immunotherapy.
Source: prnewswire.com
