Schaffhausen, Switzerland, 16/12/25 - Ewopharma is pleased to report an important new regulatory milestone for sugemalimab licensed from Chinese partner CStone Pharmaceuticals. In late November 2025, the European Commission (EC) granted approval for a new indication for sugemalimab as monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC).
This applies to patients whose tumours express PD-L1 on ≥1% of tumour cells and who do not carry EGFR-sensitising genetic mutations, or ALK, or ROS1 genomic aberrations, and whose disease has not progressed following platinum-based chemoradiotherapy (CRT). The EC had already approved the use of sugemalimab in combination with chemotherapy for the treatment of metastatic (Stage IV) NSCLC in July 2024.
Reto Schaberl, Director Business Development & Specialty Pharma at Ewopharma, comments:
“This approval, following a positive opinion from the European Medicines Agency in October, represents an additional authorised indication for patients whose disease has not progressed following platinum-based
chemoradiotherapy. It adds a further authorised indication beyond the metastatic setting, as reflected in the approved label.”
Further information can be found at the European Commission webpage:
https://ec.europa.eu/health/documents/community-register/html/h1833.htm.
Sugemalimab Achieves New Regulatory Milestone: European Commission Approves Stage Ⅲ NSCLC Indication
