Toripalimab
As of the edition of 20 October 2026, Toripalimab is an antibody: marketed, first approved in 2023 (US); acts on PDCD1; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Antibody
- Brand name
- Loqtorzi
- First approved
- 27 October 2023 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Topalliance Biosciences; 2 holders in all
- Registered trials
- 513, 22 stopped early
- Disease areas
- Cancer; Digestive system; Lungs and airways; Ear, nose and throat; Mouth and teeth; Skin and connective tissue
US protection
US protection ends in 2035.
US protection ends in 2035, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Coherus Oncology. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Toripalimab.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PDCD1 | Programmed cell death protein 1 | Q15116 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 28 | 2 | 13 | 0 |
| Phase 1 | 55 | 17 | 16 | 6 |
| Phase 2 | 367 | 30 | 189 | 14 |
| Phase 3 | 61 | 8 | 45 | 2 |
| Phase 4 | 2 | 0 | 1 | 0 |
| All trials | 513 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Topalliance Biosciences | Applicant and Lead sponsor of trials | 2018 to now |
| Coherus Oncology | Originator and Lead sponsor of trials | 2020 to now |