Drug · Monoclonal Antibody
Serplulimab
CI-DRUG-00000809Explore in graph →CHEMBL4594550 Phase 3
Regulatory
Approvals (1)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | — | Small cell lung cancer (SCLC) 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). Non-small cell lung carcinoma (NSCLC) 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. Oesophageal squamous cell carcinoma (OSCC) 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. | approved | Feb 3, 2025 | ema |
Data updated 7 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 68 | 35 | 15 | 95 | 1 | EU | Feb 3, 2025 | Feb 14, 2018 |
| Malignant Lung Neoplasm | Phase3 | Phase 3 | 15 | 9 | 3 | 21 | 0 | — | — | Sep 12, 2019 |
| Malignant Gastric Neoplasm | Phase3 | Phase 3 | 8 | 4 | 1 | 9 | 0 | — | — | Dec 12, 2019 |
| Malignant Rectal Neoplasm | Phase3 | Phase 3 | 6 | 3 | 1 | 6 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (97)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT05787613 | A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients | active not recruiting | Phase 2 | 132 | Shanghai Henlius BiotechINDUSTRY | 1 | Aug 6, 2025 | clinicaltrials |
| NCT06781281 | NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer. |