CStone Pharmaceuticals-B (02616) announced that its new indication application for sugemalimab has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The approval covers the use of sugemalimab as a monotherapy for adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose tumor cells express PD-L1 ≥1%, without EGFR-sensitive mutations or ALK and ROS1 genomic variations, and who have not experienced disease progression after platinum-based chemoradiotherapy (CRT). Following approval by the European Commission (EC), this marks the second indication approval for sugemalimab in the UK.

The approval is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind Phase III clinical trial, which demonstrated that sugemalimab provides statistically significant progression-free survival (PFS) improvement and clinically meaningful overall survival (OS) extension for Stage III NSCLC patients. Sugemalimab has already established four commercialization partnerships in Europe, the Middle East, Africa, and Latin America, covering over 60 countries and regions, with active overseas commercialization efforts underway.

Dr. Yang Jianxin, CEO, Head of R&D, and Executive Director of CStone Pharmaceuticals, stated, "Since its approval in Europe in July 2024, sugemalimab has become one of only two PD-(L)1 antibodies approved for Stage III NSCLC in Europe, achieving full coverage from Stage III to Stage IV NSCLC. Currently, sugemalimab's commercialization network has expanded to over 60 countries and regions worldwide, with market access applications approved or under review in more than ten countries. It has also been successfully included in the reimbursement systems of multiple countries, reaffirming its clinical value and pharmacoeconomic benefits."

Dr. Shi Qingmei, Chief Medical Officer of CStone Pharmaceuticals, commented, "The MHRA's approval of the new Stage III NSCLC indication for sugemalimab further validates its clinical value by international regulatory authorities and will strongly support the product's global commercial potential. We are also proud of the efficient execution, valuable global registration experience, and successful adaptation to the mature regulatory systems of Europe and the UK by CStone’s clinical development and registration team. Currently, sugemalimab combined with chemotherapy for Stage IV NSCLC has received the highest-grade [I, A] recommendation as a first-line treatment in the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for metastatic non-small cell lung cancer without driver gene mutations. We look forward to the new Stage III NSCLC indication also receiving recommendation from this authoritative guideline in the near future. Additionally, CStone will advance registration applications for new indications of sugemalimab in gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC)."