CSTONE PHARMA-B(02616): Sugriva monoclonal antibody phase III small cell lung cancer new indication approved by UK MHRA

CSTONE PHARMA-B(02616) announced that the new indication application for sugemalimab has been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) in adult patients with tumor cell PD-L1 expression 1%, no sensitizing mutations in epidermal growth factor receptor (EGFR) or ALK, ROS1 gene alterations, and no disease progression after platinum-based chemoradiotherapy (CRT). Following the approval by the European Commission (EC), sugemalimab's new indication for stage III NSCLC has been approved by the UK MHRA, making it the second indication approval for the product in the UK. This approval is based on the GEMSTONE-301 multicenter, randomized, double-blind phase III clinical study, which demonstrated statistically significant improvement in progression-free survival (PFS) and clinically meaningful extension in overall survival (OS) for patients with stage III NSCLC treated with sugemalimab. Sugemalimab has entered into commercial partnerships in Europe, the Middle East, Africa, Latin America, covering over sixty countries and regions. Commercialization efforts overseas are actively ongoing. Dr. Jiyang Yang, CEO, Chief R&D Officer, and Executive Director of CStone Pharma, said, "Since its approval and launch in Europe in July 2024, sugemalimab has become one of the only two PD-(L)1 antibodies approved for stage III NSCLC in Europe, covering the full course from stage III to stage IV NSCLC. The commercial footprint of sugemalimab has expanded to over sixty countries and regions globally, with marketing authorizations granted or in the approval process in over ten countries, and successful inclusion in reimbursement schemes in multiple countries, once again proving the clinical value and pharmacoeconomic benefits of sugemalimab." Dr. Qingmei Shi, Chief Medical Officer of CStone Pharma, stated, "The approval of sugemalimab's new indication for stage III NSCLC by the MHRA is a further acknowledgment of its clinical value by international regulatory agencies, which will strongly promote the global commercial potential of this product. We are also proud of CStone Pharma's efficient execution capabilities, valuable global registration experience, and successful adaptation to the mature regulatory systems in Europe and the UK. Currently, the combination of sugemalimab with chemotherapy for stage IV NSCLC has received a recommendation for first-line treatment in the highest grade [I, A] in the European Society for Medical Oncology (ESMO) Dynamic Clinical Guidelines for Non-Drive Gene-Positive Metastatic Non-Small Cell Lung Cancer, and we look forward to the new indication for stage III NSCLC also receiving this authoritative guideline recommendation in the near future. In addition, CStone Pharma will further promote the registration application of sugemalimab for new indications such as gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC)."