CStone (HKEX: 2616) announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for the anti-PD-L1 monoclonal antibody sugemalimab. The therapy can now be used as a monotherapy for adults with unresectable Stage III non-small cell lung cancer (NSCLC), showing PD-L1 expression on ≥1% of tumor cells and no sensitizing EGFR, ALK, or ROS1 aberrations, and whose disease has not progressed following platinum-based chemoradiotherapy. It is the second indication for sugemalimab approved in the United Kingdom and follows approval by the European Commission.
Sugemalimab was evaluated in the GEMSTONE-301 study, a multicenter Phase III trial demonstrating statistically significant improvements in progression-free survival and overall survival among patients with Stage III NSCLC. CStone reported that four commercialization partnerships have been established across Europe, the Middle East, Africa, and Latin America, extending sugemalimab’s reach to over 60 countries and regions. Market access approvals have been granted or are under review in more than ten countries.
The product has been approved by the European Commission and the MHRA for use in combination with platinum-based chemotherapy for metastatic NSCLC, and as a monotherapy for unresectable Stage III NSCLC in specific patient populations. In China, five indications have been approved, including first-line treatment for metastatic NSCLC in combination with chemotherapy, unresectable Stage III NSCLC where disease has not progressed following platinum-based chemoradiotherapy, relapsed or refractory extranodal NK/T-cell lymphoma, certain types of esophageal squamous cell carcinoma, and gastric or gastroesophageal junction adenocarcinoma under specific conditions.
CStone focuses on therapies for oncology and autoimmune/inflammatory disorders. The company has launched four innovative drugs and secured approvals for 20 new drug applications covering nine indications. Its pipeline features 16 candidates, including antibody-drug conjugates, multispecific antibodies, immunotherapies, and precision medicines.