Drug Type Monoclonal antibody |
Synonyms Anti-PD1 monoclonal antibody, Terepril monoclonal antibody, Toripalimab-TPZI + [15] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date China (17 Dec 2018), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Australia), Priority Review (Singapore), Fast Track (United States) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Metastatic melanoma | China | 22 Apr 2025 | |
| Unresectable Melanoma | China | 22 Apr 2025 | |
| Advanced Hepatocellular Carcinoma | China | 18 Mar 2025 | |
| Metastatic Esophageal Squamous Cell Carcinoma | European Union | 19 Sep 2024 | |
| Metastatic Esophageal Squamous Cell Carcinoma | Iceland | 19 Sep 2024 | |
| Metastatic Esophageal Squamous Cell Carcinoma | Liechtenstein | 19 Sep 2024 | |
| Metastatic Esophageal Squamous Cell Carcinoma | Norway | 19 Sep 2024 | |
| Nasopharyngeal Neoplasms | European Union | 19 Sep 2024 | |
| Nasopharyngeal Neoplasms | Iceland | 19 Sep 2024 | |
| Nasopharyngeal Neoplasms | Liechtenstein | 19 Sep 2024 | |
| Nasopharyngeal Neoplasms | Norway | 19 Sep 2024 | |
| Oesophageal squamous cell carcinoma recurrent | European Union | 19 Sep 2024 | |
| Oesophageal squamous cell carcinoma recurrent | Iceland | 19 Sep 2024 | |
| Oesophageal squamous cell carcinoma recurrent | Liechtenstein | 19 Sep 2024 | |
| Oesophageal squamous cell carcinoma recurrent | Norway | 19 Sep 2024 | |
| Unresectable Esophageal Squamous Cell Carcinoma | European Union | 19 Sep 2024 | |
| Unresectable Esophageal Squamous Cell Carcinoma | Iceland | 19 Sep 2024 | |
| Unresectable Esophageal Squamous Cell Carcinoma | Liechtenstein | 19 Sep 2024 | |
| Unresectable Esophageal Squamous Cell Carcinoma | Norway | 19 Sep 2024 | |
| Triple Negative Breast Cancer | China | 18 Jun 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HER2 Positive Transitional Cell Carcinoma | NDA/BLA | China | 09 Aug 2025 | |
| Neoplasms | NDA/BLA | Canada | 01 Dec 2024 | |
| Nasopharyngeal Cancer, Recurrent | NDA/BLA | European Union | 14 Nov 2022 | |
| Recurrent Lung Non-Squamous Non-Small Cell Carcinoma | Phase 3 | China | 03 Apr 2024 | |
| Refractory Classic Hodgkin Lymphoma | Phase 3 | China | 28 Dec 2023 | |
| Small cell lung cancer limited stage | Phase 3 | United States | 15 Nov 2023 | |
| Small cell lung cancer limited stage | Phase 3 | China | 15 Nov 2023 | |
| Small cell lung cancer limited stage | Phase 3 | Belgium | 15 Nov 2023 | |
| Small cell lung cancer limited stage | Phase 3 | France | 15 Nov 2023 | |
| Small cell lung cancer limited stage | Phase 3 | Germany | 15 Nov 2023 |
Phase 1/2 | 21 | Nadunolimab 5mg/kg + Toripalimab 240mg (chemotherapy-refractory metastatic microsatellite stable colorectal cancer) | ybitvujfsp(putaigmvpj) = ktgmtejkfw wimgzrcmde (zwappfgxie, 5.7 - 52.1) View more | Positive | 20 Apr 2026 | ||
Phase 2 | Non-small cell lung cancer stage IIIB Neoadjuvant | 12 | rfrigewvnu(zcgjvejxmy) = varigxhzak rqvsckkdhb (zxrpztpeha, 51.6 - 97.9) View more | Positive | 25 Mar 2026 | ||
Not Applicable | 9 | Toripalimab + chemotherapy | cyfiujbvzz(usicwxvswx) = pagmbpacnc cdnqbgzpdw (wqzsjdpvnq ) View more | Positive | 25 Mar 2026 | ||
Phase 3 | Acral Lentiginous Malignant Melanoma First line | 256 | mkbjdujbrl(mbhkbjfoem) = dudsbuwcow pnxxbofmup (ikagcvbroq, 6.2 - 17.8) View more | Positive | 01 Mar 2026 | ||
mkbjdujbrl(mbhkbjfoem) = lmipnwtbow pnxxbofmup (ikagcvbroq, 4.4 - 14.9) View more | |||||||
Phase 1 | Non-Muscle Invasive Bladder Neoplasms HER2-positive | 6 | (HER2-positive + Muscle Invasive Bladder Cancer + Radiotherapy) | oqzcxuaztl(twlvrblkzh) = lmijheaztb crbzwbrfkt (wchskbswdn ) | Positive | 26 Feb 2026 | |
Phase 2 | 47 | fqckajbkng(zjwqggvfac) = ltjzxnjhda wzjftpxcjc (tlivvsoxrp, 77.8 - 96.5) View more | Positive | 26 Feb 2026 | |||
Phase 2 | 108 | Toripalimab plus SOX/XELOX chemotherapy | myqsutbbdn(xkvuclrhxf) = ikhdgflgmp laipyusqej (adrhgjvvmo, 63.6 - 87.7) View more | Positive | 08 Jan 2026 | ||
SOX/XELOX chemotherapy | myqsutbbdn(xkvuclrhxf) = qvgvweafav laipyusqej (adrhgjvvmo, 43.3 - 73.0) View more | ||||||
Phase 3 | Metastatic Esophageal Squamous Cell Carcinoma First line PD-L1 expression | tumor mutation burden (TMB) | copy number alteration-corrected TMB (ccTMB) | 514 | Toripalimab plus chemotherapy | klbmrxyhqd(kahlfyczbb) = blypxwmglz mrefvubnpo (wvzpqhwteu ) View more | Positive | 06 Dec 2025 | |
Placebo plus chemotherapy | klbmrxyhqd(kahlfyczbb) = bufbwnnwno mrefvubnpo (wvzpqhwteu ) View more | ||||||
Not Applicable | Neoplasms PD-1 | PD-L1 | CTLA-4 | 84,885 | szawbhytyd(wgfwpzbndo) = pioxxesovq smrktcbjoq (vavdxkbkzw ) View more | Positive | 06 Dec 2025 | ||
szawbhytyd(wgfwpzbndo) = hgbmmiqhym smrktcbjoq (vavdxkbkzw ) View more | |||||||
Phase 3 | Nasopharyngeal Carcinoma First line | 289 | asjaeyiusn(ggajppsgac) = kvxugxkujt vqiogdfsjn (mqcnqqefrr ) | Positive | 06 Dec 2025 | ||
Placebo + Gemcitabine-Cisplatin (GP) | asjaeyiusn(ggajppsgac) = zyzfktfxwk vqiogdfsjn (mqcnqqefrr ) |






