Drug · Monoclonal Antibody
Sugemalimab
CI-DRUG-00000808Explore in graph →CHEMBL4594535 Approved
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 | Lung Non-Small Cell Carcinoma | 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. 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. | approved | Jul 24, 2024 | ema |
Data updated 14 days 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 3 | 4 | 3 | 3 | 11 | 1 | EU | Jul 24, 2024 | Oct 19, 2017 |
| Malignant Lung Neoplasm | Approved | Phase 3 | 3 | 3 | 2 | 4 | 1 | EU | Jul 24, 2024 | Jan 12, 2021 |
| Non-Hodgkin Lymphoma | Phase3 | Phase 3 | 1 | 0 | 1 | 1 | 0 | — | — | 2027-06 |
| Hodgkin Lymphoma | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 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 (12)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT05700448 | Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma | not yet recruiting | Phase 3 | 150 | CStone PharmaceuticalsINDUSTRY | 0 | May 27, 2026 | clinicaltrials |
| NCT06217757 | Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC | recruiting |