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MedsAcross

Molecule

Toripalimab

Programmed Death Receptor-1 Blocking Antibody
Available on requestBiologicOrphanCold chainOncology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Toripalimab is a programmed death receptor-1 blocking antibody indicated in combination with cisplatin and gemcitabine, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Toripalimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Programmed Death Receptor-1 Blocking Antibody, Programmed Death Receptor-1-directed Antibody Interactions
ATC classification
L01FF13 Toripalimab · Cancer medicines (antineoplastics), subgroup L01F, subgroup L01FF
US FDA first approval
27 October 2023
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 8JXN261VVACAS 1924598-82-2Q123397307

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy

Source: US FDA prescribing information

How it works

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Toripalimab-tpzi is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

Source: US FDA prescribing information

Dosing overview

In combination with cisplatin and gemcitabine: 240 mg intravenously every three weeks. As a single agent: 3 mg/kg intravenously every two weeks. First Infusion: Infuse over 60 minutes. Subsequent Infusions: If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes.

Source: US FDA prescribing information

Warnings and precautions

Immune-Mediated Adverse Reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue based on severity and type of reaction. Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue LOQTORZI based on the severity of reaction.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions Infusion-related reactions Complications of Allogeneic HSCT LOQTORZI in Combination with Cisplatin and Gemcitabine The most common adverse reactions (≥ 20%) are nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise. LOQTORZI as a Single Agent The most common adverse reactions (≥ 20%) are fatigue, hypothyroidism and musculoskeletal pain.

Source: US FDA prescribing information

Storage

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Toripalimab, sorted by availability.

MedicineManufacturerRegisterAvailability
Loqtorzi 240 mg/6 mL injectionIntravenous Cold chainCoherus OncologyUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 27 October 2023Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Toripalimab available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Toripalimab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Toripalimab have?

The catalogue lists 1 brand names for Toripalimab, including Loqtorzi.

Is Toripalimab approved by the US FDA?

Yes. The US FDA first approved Toripalimab on 27 October 2023, according to Drugs@FDA.

Is Toripalimab authorised in the European Union?

Yes. Toripalimab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Toripalimab need cold chain shipping?

At least one listed presentation of Toripalimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Toripalimab in?

Toripalimab is classified under ATC code L01FF13 (Toripalimab).

References

  1. LOQTORZI prescribing information (Coherus Oncology). U.S. National Library of Medicine, DailyMed. Retrieved 23 July 2026
  2. Loqtorzi: European public assessment report (EPAR). European Medicines Agency. Retrieved 4 August 2026

Request Toripalimab for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.