# Serplulimab

Serplulimab (Hetronifly, Accord Healthcare S.L.U.) has 4 EU-approved indications in 3 tumour types. 1 needs a biomarker result: PD-L1 (1).

## Approved indications

### Small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + carboplatin and etoposide | 1st line, advanced | - |

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + carboplatin and nab-paclitaxel | 1st line, advanced | Squamous only |
| EGFR/ALK/ROS1 negative | + carboplatin and pemetrexed | 1st line, advanced | Non-squamous only; Not candidates for surgery or radiotherapy (if locally advanced) |

### Oesophageal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 CPS ≥ 5 | + fluoropyrimidine- and platinum-based chemotherapy | 1st line, advanced | Squamous cell carcinoma only |

## Products

### Hetronifly

- Company: Accord Healthcare S.L.U.
- Target: PD-1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF12
- EU approval: 3 Feb 2025
- Label revised: 8 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/hetronifly-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/hetronifly

Mechanism (SmPC section 5.1): Serplulimab binds PD-1 and blocks its interaction with PD-L1 and PD-L2, potentiating T-cell and anti-tumour responses.

## Label wording

- **Serplulimab** (Hetronifly), Small cell lung cancer, 1st line, advanced: “HETRONIFLY in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Non-small cell lung cancer, 1st line, advanced: “HETRONIFLY in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have:
 locally advanced NSCLC who are not candidates for surgery or radiotherapy, or  metastatic NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Non-small cell lung cancer, 1st line, advanced: “HETRONIFLY in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Oesophageal cancer, 1st line, advanced: “HETRONIFLY in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-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/serplulimab