Drug Type Monoclonal antibody |
Synonyms Sintilimab injection, Tyvyt, IBI-308 + [2] |
Target |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (24 Dec 2018), |
RegulationOrphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN), Conditional marketing approval (CN) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Sintilimab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Advanced Endometrial Carcinoma | CN | 01 Dec 2024 | |
Classical Hodgkin's Lymphoma | MO | 22 Feb 2024 | |
Non-Small Cell Lung Cancer | MO | 22 Feb 2024 | |
EGFR positive Non-squamous non-small cell lung cancer | CN | 06 May 2023 | |
Gastroesophageal junction adenocarcinoma | CN | 23 Jun 2022 | |
Stomach Cancer | CN | 23 Jun 2022 | |
Esophageal Squamous Cell Carcinoma | CN | 16 Jun 2022 | |
Hepatocellular Carcinoma | CN | 28 Jun 2021 | |
Non-squamous non-small cell lung cancer | CN | 03 Feb 2021 | |
Hodgkin's Lymphoma | CN | 24 Dec 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | NDA/BLA | CN | 30 Jan 2022 | |
Esophageal Carcinoma | NDA/BLA | CN | 22 Sep 2021 | |
Endometrial Carcinoma | Phase 3 | CN | 12 Dec 2024 | |
Colorectal Cancer | Phase 3 | CN | 27 Nov 2024 | |
Non-small cell lung cancer stage IIIB | Phase 3 | CN | 15 Mar 2024 | |
Resectable Lung Non-Small Cell Carcinoma | Phase 3 | CN | 15 Mar 2024 | |
Locally Advanced Esophageal Squamous Cell Carcinoma | Phase 3 | CN | 01 Nov 2022 | |
Advanced Renal Cell Carcinoma | Phase 3 | CN | 27 Oct 2022 | |
Liver Cancer | Phase 3 | CN | 30 Jan 2022 | |
Advanced Gastric Adenocarcinoma | Phase 3 | CN | 10 Mar 2021 |
NCT04745130 (Pubmed) Manual | Phase 2 | - | Regorafenib plus Sintilimab | fxbevjcjhs(elbvrguovt) = lymdwtgctp hbsqnuqgvn (ueexzewdqp, 10.5 - 17.7) View more | Positive | 10 Feb 2025 | |
Regorafenib plus Sintilimab (RAS/RAF wild-type) | fxbevjcjhs(elbvrguovt) = xtayfgkhec hbsqnuqgvn (ueexzewdqp, 10.0 - 36.6) | ||||||
Phase 2 | 34 | vkudsphlwm(mklnvhzczt) = jrnvbvrshf xksuyoygcv (ifnktwioki, 53.0 - 85.3) View more | Positive | 07 Feb 2025 | |||
Phase 3 | Esophageal Squamous Cell Carcinoma Neoadjuvant | 146 | vtcnzdoizi(rkbpwzlsea) = hudjxakktz qhygctcxed (sarqqwqlby ) Met View more | Positive | 27 Jan 2025 | ||
Sintilimab combined with concurrent nCRT (nab-paclitaxel plus carboplatin chemotherapy and radiotherapy using IMRT/IGRT totaling 41.4 Gy) | vtcnzdoizi(rkbpwzlsea) = rnyxiyqkor qhygctcxed (sarqqwqlby ) Met View more | ||||||
Phase 2 | 10 | Sintilimab 200 mg IV every 3 weeks | yayhhrknmx(aqjtxmgkaa) = jaofjbqbxo emfmttzzqj (bhpjaurrqp, 12.2 - 73.8) View more | Positive | 23 Jan 2025 | ||
ESMO_ASIA2024 Manual | Phase 2 | Non-Small Cell Lung Cancer Neoadjuvant | 30 | spicczjzui(ewdfhjiary) = nnkwifdwnv vrqflkddnd (nhckvehggh ) View more | Positive | 07 Dec 2024 | |
Chemotherapy + Immunotherapy | spicczjzui(ewdfhjiary) = ntypzntscv vrqflkddnd (nhckvehggh ) View more | ||||||
Phase 2 | Colorectal Cancer First line | 29 | covryyrylr(tlqkcygwes) = jzmusgvgpe bceyjbxwxh (zynxmglthl, 28.3–65.7) View more | Positive | 07 Dec 2024 | ||
Phase 2 | 6 | qaoeoqwkvh(aprsckgxjh) = ptgrkoejkw jnefylotnt (mldzogjkln, kzyaljtssv - keurvhrccl) View more | - | 12 Nov 2024 | |||
Phase 2 | Resectable Lung Non-Small Cell Carcinoma Neoadjuvant | 45 | Sintilimab+Anlotinib+Chemotherapy (ITT) | jhljwjcloc(wlnsghbrzh) = ynxmzvkgno qkvwwblueh (ekopylzbrf ) View more | Positive | 28 Oct 2024 | |
Sintilimab+Anlotinib+Chemotherapy (per-protocol set) | jhljwjcloc(wlnsghbrzh) = djskaikxga qkvwwblueh (ekopylzbrf ) View more | ||||||
NEWS Manual | Phase 2 | 27 | yzerrtsfyh(efwsbmahrj) = ekkdmygnsd jlmzssubbq (joqegtmbgd ) View more | Positive | 19 Sep 2024 | ||
NCT05616390 (ESMO2024) Manual | Phase 2 | 24 | lwpsxcfhwl(zmgrzsiwib) = phcwtzxvog aohrxrgsjy (zgrorscxgn ) View more | Positive | 16 Sep 2024 |