# Sugemalimab

Sugemalimab (Cejemly, Cstone Pharmaceuticals Ireland Limited) has 2 EU-approved indications in 1 tumour type. 1 needs a biomarker result: PD-L1 (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| No sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | + platinum-based chemotherapy | 1st line, metastatic | - |
| PD-L1 expression ≥ 1%, EGFR/ALK/ROS1-negative | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiotherapy without progression |

## Products

### Cejemly

- Company: Cstone Pharmaceuticals Ireland Limited
- Target: PD-L1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF11
- EU approval: 24 Jul 2024
- Label revised: 22 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/cejemly-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/cejemly

Mechanism (SmPC section 5.1): Sugemalimab binds to PD-L1, blocking its interactions with PD-1 and CD80 to release the inhibition of anti-tumour immune responses.

## Label wording

- **Sugemalimab** (Cejemly), Non-small cell lung cancer, 1st line, metastatic: “Cejemly in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf)
- **Sugemalimab** (Cejemly), Non-small cell lung cancer, consolidation, locally advanced: “Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/sugemalimab