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 EGFRsensitising 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/....
About Sugemalimab
The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody.
The EC has approved sugemalimab for two indications:
• In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations (this indication has also been approved by the Medicines and Healthcare products Regulatory Agency [MHRA]);
• Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
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/....
About Sugemalimab
The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody.
The EC has approved sugemalimab for two indications:
• In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations (this indication has also been approved by the Medicines and Healthcare products Regulatory Agency [MHRA]);
• Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
