Drug Type Monoclonal antibody |
Synonyms Tirelizumab, Tiselizumab, Tislelizumab (USAN/INN) + [8] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date China (26 Dec 2019), |
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Conditional marketing approval (China), Special Review Project (China) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11487 | Tislelizumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| HER2 Positive Adenocarcinoma of Esophagus | United States | 25 Aug 2026 | |
| HER2 positive Gastrooesophageal junction cancer | United States | 25 Aug 2026 | |
| HER2-positive gastric cancer | United States | 25 Aug 2026 | |
| Esophageal Carcinoma | Japan | 27 Mar 2025 | |
| PD-L1 positive Esophageal Squamous Cell Carcinoma | United States | 03 Mar 2025 | |
| Locally Advanced Gastric Adenocarcinoma | European Union | 19 Dec 2024 | |
| Locally Advanced Gastric Adenocarcinoma | Iceland | 19 Dec 2024 | |
| Locally Advanced Gastric Adenocarcinoma | Liechtenstein | 19 Dec 2024 | |
| Locally Advanced Gastric Adenocarcinoma | Norway | 19 Dec 2024 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | European Union | 19 Dec 2024 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Iceland | 19 Dec 2024 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Liechtenstein | 19 Dec 2024 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Norway | 19 Dec 2024 | |
| Metastatic gastric adenocarcinoma | European Union | 19 Dec 2024 | |
| Metastatic gastric adenocarcinoma | Iceland | 19 Dec 2024 | |
| Metastatic gastric adenocarcinoma | Liechtenstein | 19 Dec 2024 | |
| Metastatic gastric adenocarcinoma | Norway | 19 Dec 2024 | |
| Metastatic Gastroesophageal Junction Adenocarcinoma | European Union | 19 Dec 2024 | |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Iceland | 19 Dec 2024 | |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Liechtenstein | 19 Dec 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HER2 Positive Stomach Adenocarcinoma | NDA/BLA | China | 14 Apr 2026 | |
| HER2 Positive Stomach Adenocarcinoma | NDA/BLA | China | 14 Apr 2026 | |
| stomach adenocarcinoma | NDA/BLA | European Union | 17 Oct 2024 | |
| Squamous Cell Carcinoma | NDA/BLA | China | 06 Sep 2018 | |
| Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | China | 01 Jan 2026 | |
| HER2-expressing Gastroesophageal Junction Adenocarcinoma | Phase 3 | China | 01 Jan 2026 | |
| Colorectal Cancer | Phase 3 | France | 16 Apr 2025 | |
| Colorectal Cancer | Phase 3 | France | 16 Apr 2025 | |
| Lung Cancer | Phase 3 | France | 16 Apr 2025 | |
| Lung Cancer | Phase 3 | France | 16 Apr 2025 |
Not Applicable | Non-Small Cell Lung Cancer Neoadjuvant | 25 | nzftbcrnuv(rgsmypgfsq) = ggyobrtdxm hzptydrtnj (oldbqeljev, 58.3 - 92.9) View more | Positive | 12 Sep 2026 | ||
Not Applicable | Extensive stage Small Cell Lung Cancer First line | 124 | Tislelizumab plus chemotherapy | reyhividgg(tohzjwuzai) = dgmxjhfqzj lgxjgcffft (jhzpthlnqk ) View more | Positive | 12 Sep 2026 | |
Tislelizumab plus chemotherapy (brain metastases) | dlqfildvnt(sxyyuabklt) = lkmxklchvu olfpyluvko (xmoxzlperq, 14.6 - NR) View more | ||||||
Phase 2 | 16 | Tislelizumab plus platinum-based doublet chemotherapy (resectable stage II-IIIB (N2) KRAS-mutant NSCLC) | ylifgqfral(bofyktyfml) = cofjcxfsuk znutrusmrt (duzdusmmqq ) View more | Positive | 12 Sep 2026 | ||
Phase 2 | Non-small cell lung cancer stage III Adjuvant | Neoadjuvant | 33 | utdrunyjed(hxgdzfvojd) = remsszsrpq hjphdtnhuh (faihkaeqid ) View more | Positive | 12 Sep 2026 | ||
(underwent surgery) | fgqylkwqbe(ioupprcleb) = fbrinlviaf mrhebjsjcn (ddtqasbvsk, 38.9 - 81.3) View more | ||||||
Not Applicable | Non-small cell lung cancer stage IIIA Neoadjuvant | 335 | Tislelizumab + Chemotherapy | spgguwrrev(aykvgitfjr) = wfjiwprrmw ojadgydhho (iehokduadf ) View more | Positive | 12 Sep 2026 | |
Concurrent Chemoradiotherapy | spgguwrrev(aykvgitfjr) = jhrchqwlxh ojadgydhho (iehokduadf ) View more | ||||||
Phase 3 | Non-Small Cell Lung Cancer Neoadjuvant | 453 | Tislelizumab 200 mg + chemotherapy | qdicwtuwxo(lpqlsgdfuo) = oqmnyaohro dqrfkegjqh (qefythvhfp ) View more | Positive | 12 Sep 2026 | |
Placebo + chemotherapy | qdicwtuwxo(lpqlsgdfuo) = rqxuynzrzg dqrfkegjqh (qefythvhfp ) View more | ||||||
Phase 2 | 30 | Tislelizumab plus chemotherapy | dxjmuvkfvc(kqqgtetlzf) = cuuynucpcv brknwqotbo (bzljqpkxyb ) View more | Positive | 12 Sep 2026 | ||
Not Applicable | Non-Small Cell Lung Cancer Neoadjuvant | 110 | dwkztqpkzg(gprxttpnun) = osqlsqxvvp fiecbfsznz (wuzzfxctvs ) View more | Positive | 12 Sep 2026 | ||
Phase 2 | 43 | Tislelizumab plus chemotherapy | gzymoevqyd(yqjsqwfumc) = cbrkyklgtj tvgwjpexef (inmsuaxamd ) View more | Positive | 12 Sep 2026 | ||
Phase 2 | Non-small cell lung cancer stage III Neoadjuvant | 29 | Tislelizumab plus nab-paclitaxel and carboplatin | rftdcubiuk(fijrldoggw) = komtudixag zuewpuemtm (fuqmqwszbx ) View more | Positive | 12 Sep 2026 |






