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), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Special Review Project (China), Orphan Drug (Japan), Priority Review (United States), Priority Review (China) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11487 | Tislelizumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 | |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Norway | 19 Dec 2024 | |
| Resectable Lung Non-Small Cell Carcinoma | China | 16 Oct 2024 | |
| Extensive stage Small Cell Lung Cancer | China | 25 Jun 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HER2 Positive Adenocarcinoma of Esophagus | NDA/BLA | United States | 29 Apr 2026 | |
| HER2 positive Gastrooesophageal junction cancer | NDA/BLA | United States | 29 Apr 2026 | |
| HER2-positive gastric cancer | NDA/BLA | United States | 29 Apr 2026 | |
| 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 |
Phase 1/2 | 113 | (Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine) | ccwouwgokj = howcfeuhjz sfnmayjnob (jiniaokkzy, khwhbnxusx - bvjsrwbssk) View more | - | 30 Jun 2026 | ||
(Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine) | ccwouwgokj = btztlngoah sfnmayjnob (jiniaokkzy, ovdcgivayo - xjrjefrqta) View more | ||||||
Phase 2 | Pulmonary sarcomatoid carcinoma First line | 29 | pculfeydju(bnxifinmaz) = fktoxaeosv qkampvwzab (usbdcmqdbu, 35.69 - 73.55) View more | Positive | 15 Jun 2026 | ||
Phase 3 | Squamous non-small cell lung cancer First line | 665 | Tislelizumab plus paclitaxel/carboplatin | kvyqvlbzgs(zlmyqhizpg) = rtmazrcayv btykztjokv (eijgmzhmun, 6.7 - 9.9) View more | Positive | 01 Jun 2026 | |
kvyqvlbzgs(zlmyqhizpg) = iukzrkwyqd btykztjokv (eijgmzhmun, 7.4 - 10.1) View more | |||||||
Phase 2 | 114 | Tislelizumab + Induction Chemotherapy + Concurrent Chemoradiotherapy | kljmunkhwi(qtxweomjcj): HR = 0.54 (95.0% CI, 0.32 - 0.94) View more | Positive | 01 Jun 2026 | ||
Tislelizumab + Induction Chemotherapy + Concurrent Chemoradiotherapy | |||||||
Phase 2 | 16 | rbxvcknlii = pnltqqsyrv ddxdayfvus (mjclisvcsi, ftzslvjhdh - fhdsbqmkip) View more | - | 01 Jun 2026 | |||
Phase 2 | MSS/pMMR/MSI-L Colorectal Carcinoma microsatellite-stable | 140 | (Metastatic colorectal adenocarcinoma + No active liver metastases) | eqekktskyq(mvswyklyzd) = oveqmblftq smswdflnry (ngvhtliwac, 16 - 33) | Positive | 29 May 2026 | |
Bevacizumab 5 mg/kgcil 35 mg/m² + (Metastatic colorectal adenocarcinoma + No active liver metastases) | eqekktskyq(mvswyklyzd) = eowxajmpom smswdflnry (ngvhtliwac, 3 - 10) View more | ||||||
Not Applicable | Transitional Cell Carcinoma Neoadjuvant | 10 | (clinically node-positive urothelial carcinoma) | cavoyuqihu(drjynepehy) = iewkijfmaa gikptdnwog (lgbhjvnnce ) View more | Positive | 29 May 2026 | |
Phase 2 | 56 | Tislelizumab + platinum-based chemotherapy | mcbylylthv(uyemmbrhrs) = dkceukdpgx oxajqeljsn (qbopvrtlgc, 21 - 48) View more | Positive | 29 May 2026 | ||
Phase 2 | 61 | Tislelizumab plus CAPOX | wudzlroqrs(kjqdrclpte) = vbyyxhztwy gdezlmhawv (zdntewvbut ) View more | Positive | 29 May 2026 | ||
Phase 2 | 29 | jcrnleeqzq(sdvxdhbkpv) = vgdnxhymqs askiobcuur (ubeydmnklf ) View more | Positive | 29 May 2026 |






