CStone Pharmaceuticals has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a new indication of sugemalimab as a monotherapy for adult patients with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC).

The approval covers patients whose tumours express PD-L1 on at least 1 percent of tumour cells, who do not have sensitising EGFR mutations or ALK and ROS1 genomic aberrations and whose disease has not progressed following Platinum-based Chemoradiotherapy (CRT).

According to the company, the decision further strengthens sugemalimab’s position in Europe. Since securing European Union approval in July 2024, the therapy has become one of only two PD-(L)1 antibodies approved for Stage III NSCLC in the region, offering treatment coverage across both locally advanced, unresectable Stage III and metastatic Stage IV NSCLC.

Dr Jason Yang, CEO, President of R&D, and Executive Director at CStone, said the therapy’s commercial presence now spans more than 60 countries and regions worldwide, with additional market access applications either approved or under regulatory review in over ten countries. He added that inclusion in multiple national reimbursement systems underscores the drug’s clinical value and pharmacoeconomic benefits.

Dr Qingmei Shi, Chief Medical Officer at CStone, described the MHRA decision as a significant endorsement from a leading international regulatory authority. She noted that the approval enhances the therapy’s global commercial potential and reflects the company’s capabilities in global clinical development and regulatory execution.

Sugemalimab, when combined with chemotherapy for Stage IV NSCLC, has also received the highest-level [I, A] recommendation in the first-line setting for both squamous and non-squamous NSCLC in the European Society for Medical Oncology (ESMO) Non-Oncogene-Addicted Metastatic NSCLC Living Guideline. The company expects the newly approved Stage III indication to be considered for inclusion in the guideline in the near future.

CStone added that it will continue to advance regulatory filings for sugemalimab in additional indications, including gastric cancer and esophageal squamous cell carcinoma.