Drug · Monoclonal Antibody

Toripalimab

CI-DRUG-00000598Explore in graph →NCIt C131334 CHEMBL4297843 CIViC Approved

Regulatory

Approvals (4)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory4 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as LOQTORZI (DIN 02562219) under ATC L01FF13 TORIPALIMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 26, 2026	health-canada-dpd
EU EMA	—	Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.	approved	Sep 19, 2024	ema
US FDA	Nasopharyngeal Carcinoma	in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC)	approved	Oct 27, 2023	openfda

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 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	186	106	34	325	4	CA, EU, US	Oct 27, 2023	2016-08
Malignant Nasopharyngeal Neoplasm	Approved	Phase 3	21	13	6	25	1	US	Oct 27, 2023	Jun 28, 2020
Malignant Breast Neoplasm	Phase4	Phase 4	13	10	1	19	0	—	—	Dec 21, 2018
Malignant Lung Neoplasm	Phase3	Phase 3	19	10	6	37

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
High1
Chemotherapy + Toripalimab

Clinical trials

Trials with this intervention (335)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 301–335 of 335 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04716751	Toripalimab Combined With Chemotherapy in Primary Tracheal Squamous Cell Carcinoma	unknown	Phase 2	15	Shanghai Pulmonary Hospital, Shanghai, ChinaOTHER	0	Jan 26, 2021	clinicaltrials
NCT03985891	The Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer(JSFOL)

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Programmed cell death protein 1 antagonist
Targets: 1 gene
UNII: 8JXN261VVA
Aliases: Anti-PD-1 Monoclonal Antibody JS001, Anti-pd-i mab-shanghai junshi, CHS-007, JS 001, JS-001, JS001, Loqtorzi, TAB 001, TAB-001, TAB001, Teriprizumab, Toripalimab, Toripalimab-tpzi, Treprizumab, Tripleitriumab, Triprizumab, Tuoyi

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FF13	TORIPALIMAB
DIN (Health Canada)	02562219	LOQTORZI
DPD drug code