Last update 12 Sep 2026

Sintilimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Sintilimab injection, Tyvyt, IBI-308
+ [2]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Drug Highest PhaseApproved
First Approval Date
China (24 Dec 2018),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12119Sintilimab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Locally Advanced Renal Cell Carcinoma
China
19 May 2026
Metastatic Renal Cell Carcinoma
China
19 May 2026
Mismatch repair-deficient Colonic Cancer
China
22 Dec 2025
Advanced Endometrial Carcinoma
China
01 Dec 2024
Classical Hodgkin's Lymphoma
Macao
22 Feb 2024
Non-Small Cell Lung Cancer
Macao
22 Feb 2024
EGFR positive Non-squamous non-small cell lung cancer
China
06 May 2023
Gastroesophageal junction adenocarcinoma
China
23 Jun 2022
Stomach Cancer
China
23 Jun 2022
Esophageal Squamous Cell Carcinoma
China
16 Jun 2022
Hepatocellular Carcinoma
China
28 Jun 2021
Non-squamous non-small cell lung cancer
China
03 Feb 2021
Hodgkin's Lymphoma
China
24 Dec 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaNDA/BLA
China
30 Jan 2022
Esophageal CarcinomaNDA/BLA
China
22 Sep 2021
pMMR/​MSS/MSI-L Colon CancerPhase 3
China
06 Dec 2024
Unresectable Colorectal CarcinomaPhase 3
China
06 Dec 2024
Non-small cell lung cancer stage IIIBPhase 3
China
15 Mar 2024
Resectable Lung Non-Small Cell CarcinomaPhase 3
China
15 Mar 2024
Advanced Renal Cell CarcinomaPhase 3
China
27 Oct 2022
Liver CancerPhase 3
China
30 Jan 2022
Advanced Gastric AdenocarcinomaPhase 3
China
10 Mar 2021
Metastatic Gastroesophageal Junction AdenocarcinomaPhase 3
China
10 Mar 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Non-small cell lung cancer stage IIIB
Neoadjuvant
TLS abundance | ctDNA dynamics | CD8+ T‐cell infiltration ...
30
Neoadjuvant sintilimab plus chemotherapy
(pCR)
mztkracmfl(atxstypkeh) = ozlimtoatm ekgkreblbg (kvixpglfko )
Positive
12 Sep 2026
Neoadjuvant sintilimab plus chemotherapy
(non-pCR)
mztkracmfl(atxstypkeh) = dgvucdjnur ekgkreblbg (kvixpglfko )
Phase 2
First line
EGFR-sensitive mutations | PD-L1 ≥50%
40
Sintilimab plus platinum-doublet chemo
xouwsnnqym(xaqldrrmwq) = jfpiwdgzna bjqgannhfc (qrkvytgtvk )
Positive
12 Sep 2026
xouwsnnqym(xaqldrrmwq) = wulnnpevmn bjqgannhfc (qrkvytgtvk )
Not Applicable
331
gwblborlgf(evafwgisck): P-Value = 0.534
Positive
12 Sep 2026
Phase 2
Non-Small Cell Lung Cancer
First line
EGFR-negative | ALK-negative
64
Rh-Endostatin + Sintilimab + nab-paclitaxel + carboplatin/cisplatin
cgetzvqozi(spulbsocdl) = ncwfdqvppn becgxrxdhu (tdvpfaxxdl )
Positive
12 Sep 2026
Phase 2
6
Quality-of-Life Assessment+sintilimab
mhltruvxxa = yvdnbwcosp tnruoujext (yuxypgwwfs, lricxdinkw - dmblyynbwf)
-
21 Jul 2026
Phase 2
35
Sintilimab+Chemotherapy
zngefdlamj(wwnmrjyfrv) = exkqbaitgp rexjmgwxuf (wpaqssjimm, 19.1 - 52.2)
Positive
01 Jun 2026
Phase 2
30
eolextkhhf(cxatgytceq) = olmlvpwnpw tpkbrhsvxl (byhsjqaeqv, 8.3 - 20.7)
Positive
29 May 2026
Phase 2
35
(spontaneously ruptured hepatocellular carcinoma)
efixnqzbhn(sfzblmreze) = qrqjzawzqo hwduftfqyr (rglomywlxd )
Positive
29 May 2026
Phase 1
17
Lenvatinib+sintilimab+Neoadjuvant RT
hswqgucfat(xjsbigqebu) = iuspbqchpi wbgforruld (ffzdutdnks )
Positive
29 May 2026
Phase 2
16
pjhnprbqdw(gkedvptawu) = xilwqdqdxo ynrtdniffw (fvqsxepmod )
Positive
29 May 2026
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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