> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/sintilimab-e2618eaf-967e-401c-aed4-7546875a6d3e
> Record changed: 2026-10-13

# Sintilimab

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297829)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297829)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297829)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297829)

**Drug name**

Sintilimab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297829)

### Brand names (2)

- tyvyt
- Tyvyt

### Other names (31)

- albumin bound paclitaxel cisplatin sintilimab
- anti pd 1 monoclonal antibody ibi308
- ANTI-PD-1 MONOCLONAL ANTIBODY IBI308
- ibi 308
- IBI 308 injection
- IBI-308
- ibi308
- Ibi308
- IBI308
- IBI308 200mg
- immunoglobulin g4 anti human programmed cell death protein 1 human monoclonal ibi308 gamma 4 chain disulfide with human monoclonal ibi308 kappa chain dimer
- IMMUNOGLOBULIN G4, ANTI-(HUMAN PROGRAMMED CELL DEATH PROTEIN 1) (HUMAN MONOCLONAL IBI308 .GAMMA.4-CHAIN), DISULFIDE WITH HUMAN MONOCLONAL IBI308 .KAPPA.-CHAIN, DIMER
- Immunotherapy (Sintilimab)
- sintilimab
- Sintilimab
- Sintilimab (18 cycles)
- Sintilimab (9 cycles)
- sintilimab (after the change)
- Sintilimab (approved)
- sintilimab (before the change)
- Sintilimab (M1b)
- Sintilimab (PD-1 Antibody)
- sintilimab \[INN\]
- SINTILIMAB \[USAN\]
- Sintilimab \[WHO-DD\]

And 6 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 2072873-06-2

**ChEMBL ID**

CHEMBL4297829

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297829)

**FDA ingredient codes (UNII)**

- 8FU7FQ8UPK

## Regulatory information

### Other regulatory facts

**Patents**

0

**Designations**

2

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

## Pharmacology

### Drug classification

**Pharmacology name**

sintilimab

**Type**

Antibody

**Drug name stem**

\-mab

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action (2)

- **Mechanism**  
Programmed cell death protein 1 antagonist

**Action type**  
Antagonist

**Target**  
Programmed cell death protein 1

**Protein identifier**  
Q15116
- **Action**  
Binding

**Action type**  
Binding

**Target**  
programmed cell death 1 (CD279)

**Gene symbol**  
PDCD1

**Protein identifier**  
Q15116

**Median affinity**

9.6

**Affinity units**  
pKd

**Primary target**  
Yes

### Open Targets mechanisms

- **Mechanism**  
Programmed cell death protein 1 antagonist

**Action type**  
Antagonist

**Target**  
Programmed cell death protein 1

### Investigated indications (64)

- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000178

**Subject identifier**  
D013274
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000181

**Subject identifier**  
D002294
- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Hodgkin Disease

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000183

**Subject identifier**  
D006689
- **Condition**  
Squamous Cell Carcinoma of Head and Neck

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000199

**Subject identifier**  
D000077195
- **Condition**  
Lymphoma, T-Cell, Peripheral

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000211

**Subject identifier**  
D016411
- **Condition**  
Immunoblastic Lymphadenopathy

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000255

**Subject identifier**  
D007119
- **Condition**  
Carcinoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000313

**Subject identifier**  
D002277
- **Condition**  
Adenocarcinoma, Clear Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000348

**Subject identifier**  
D018262
- **Condition**  
Carcinoma, Renal Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000349

**Subject identifier**  
D002292
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000365

**Subject identifier**  
D015179
- **Condition**  
Lymphoma, Large B-Cell, Diffuse

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000403

**Subject identifier**  
D016403
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000503

**Subject identifier**  
D013274
- **Condition**  
Glioblastoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000519

**Subject identifier**  
D005909
- **Condition**  
Lymphoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000574

**Subject identifier**  
D008223
- **Condition**  
Mesothelioma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000588

**Subject identifier**  
D008654
- **Condition**  
Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Neuroblastoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000621

**Subject identifier**  
D009447
- **Condition**  
Carcinoma, Renal Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000681

**Subject identifier**  
D002292
- **Condition**  
Sarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000691

**Subject identifier**  
D012509
- **Condition**  
Small Cell Lung Carcinoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000702

**Subject identifier**  
D055752
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000707

**Subject identifier**  
D002294
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000708

**Subject identifier**  
D002294
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001061

**Subject identifier**  
D002583
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001416

**Subject identifier**  
D002583

And 39 more, listed on the interactive page.

### Open Targets indications (148)

- **Condition identifier**  
EFO\_0000178

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000181

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000182

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000183
- **Condition identifier**  
EFO\_0000199

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000255

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000313

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000348

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000349

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000403

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000503

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000519

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000574

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000616

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000621

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000681
- **Condition identifier**  
EFO\_0000702

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000707

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000708

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001061

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001416

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0002618

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0002913

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003826

**Highest recorded phase**  
2

And 123 more, listed on the interactive page.

### Reported adverse events (71)

- **Event**  
abdominal infection

**Reports**  
3

**Reporting signal score**

11.669
- **Event**  
abdominal pain

**Reports**  
17

**Reporting signal score**

18.1127
- **Event**  
adrenal insufficiency

**Reports**  
6

**Reporting signal score**

16.3508
- **Event**  
alanine aminotransferase increased

**Reports**  
22

**Reporting signal score**

47.4406
- **Event**  
anaemia

**Reports**  
36

**Reporting signal score**

63.8602
- **Event**  
ascites

**Reports**  
5

**Reporting signal score**

8.65812
- **Event**  
aspartate aminotransferase increased

**Reports**  
22

**Reporting signal score**

49.9324
- **Event**  
blood bilirubin increased

**Reports**  
10

**Reporting signal score**

22.606
- **Event**  
blood creatinine increased

**Reports**  
7

**Reporting signal score**

8.53214
- **Event**  
cardiotoxicity

**Reports**  
3

**Reporting signal score**

6.87168
- **Event**  
cerebral radiation injury

**Reports**  
1

**Reporting signal score**

7.86259
- **Event**  
constipation

**Reports**  
12

**Reporting signal score**

12.3325
- **Event**  
cytokine increased

**Reports**  
1

**Reporting signal score**

9.24878
- **Event**  
cytokine release syndrome

**Reports**  
3

**Reporting signal score**

6.69213
- **Event**  
cytopenia

**Reports**  
4

**Reporting signal score**

9.58312
- **Event**  
decreased appetite

**Reports**  
31

**Reporting signal score**

60.7928
- **Event**  
dermatitis

**Reports**  
5

**Reporting signal score**

11.7464
- **Event**  
diarrhoea

**Reports**  
43

**Reporting signal score**

50.2813
- **Event**  
endocrine toxicity

**Reports**  
1

**Reporting signal score**

6.47672
- **Event**  
fatigue

**Reports**  
32

**Reporting signal score**

26.6971
- **Event**  
gastrointestinal disorder

**Reports**  
7

**Reporting signal score**

10.0885
- **Event**  
gastrointestinal haemorrhage

**Reports**  
8

**Reporting signal score**

9.42674
- **Event**  
gastrointestinal toxicity

**Reports**  
3

**Reporting signal score**

8.58975
- **Event**  
gingival bleeding

**Reports**  
3

**Reporting signal score**

6.14527
- **Event**  
granulocyte count decreased

**Reports**  
2

**Reporting signal score**

7.48963

And 46 more, listed on the interactive page.

### Trial references (272)

- NCT02937116  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02937116)
- NCT03568539  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03568539)
- NCT03732430  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03732430)
- NCT04085185  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04085185)
- NCT04353830  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04353830)
- NCT04400851  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04400851)
- NCT05024968  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05024968)
- NCT05245916  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245916)
- NCT03116152  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03116152)
- NCT03748134  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03748134)
- NCT03940001  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03940001)
- NCT03946969  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03946969)
- NCT03985046  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03985046)
- NCT04212598  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04212598)
- NCT04514835  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04514835)
- NCT04548440  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04548440)
- NCT04602013  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04602013)
- NCT04625543  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04625543)
- NCT05174325  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05174325)
- NCT05244798  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05244798)
- NCT05495152  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05495152)
- NCT06078657  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06078657)
- NCT06152978  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06152978)
- NCT06161909  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06161909)
- NCT06190639  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06190639)

And 247 more, listed on the interactive page.

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (5)

- **Component**  
Glycosylation sites (N)

**Sequence**  
Asn-297 $ Asn-297''''
- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
QVQLVQSGAEVKKPGSSVKVSCKASGGTFSSYAISWVRQAPGQGLEWMGLIIPMFDTAGYAQKFQGRVAITVDESTSTAYMELSSLRSEDTAVYYCARAEHSSTGTFDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
DIQMTQSPSSVSASVGDRVTITCRASQGISSWLAWYQQKPGKAPKLLISAASSLQSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQANHLPFTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- **Component**  
Disulfide bridges

**Sequence**  
22-96 $ 22''-96'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'''-194''' $ 134-214' $ 134''-214''' $ 147-203 $ 147''-203'' $ 226-226'' $ 229-229'' $ 261-321 $ 261''-321'' $ 367-425 $ 367''-425''
- **Component**  
Glycosylation sites (N)

**Sequence**  
Asn-297 $ Asn-297''

## Related records

### Trials (569)

- A Biomarker Study for Predicting the Efficacy of Neoadjuvant Sintilimab Plus SOX for Gastric Adenocarcinoma.
- A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
- A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive ESCC
- A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma
- A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer
- A Clinical Study to Observe the Effectiveness and Safety of IBI310, Bevacizumab Combined With Sintilimab in the Treatment of Advanced Hepatocellular Carcinoma
- A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
- A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
- A Dose Escalation and Dose Expansion Clinical Study of STI-7349 in Subjects With Advanced Solid Tumors
- A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC
- A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL
- A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma
- A Phase 1b/2 Study of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors
- A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
- A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
- [A Phase I Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Split Vaccine (Adjuvant)](https://trialight.com/data/trial/a-phase-i-trial-to-evaluate-the-safety-and-immunogenicity-of-db895d55-39fe-4fc1-b4da-86a63dfeace8.md)
- A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)
- A Phase II Clinical Study of Surufatinib Combined With Sintilimab in the Treatment of Advanced Gastric Cancer
- A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy
- A Phase II Study of Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Biomarker-selected Advanced or Metastatic NSCLC

### In development for (68)

- [Angioimmunoblastic T-cell lymphoma](https://trialight.com/data/condition/angioimmunoblastic-t-cell-lymphoma-5b697108-b9cf-53e9-afde-71a36bf55d6b.md) Phase 2
- Angiosarcoma Phase 2
- [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) Phase 2
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 2
- [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) Phase 1
- Carcinoma of esophagus Phase 3
- [Cervical adenocarcinoma](https://trialight.com/data/condition/cervical-adenocarcinoma-013a4346-286c-5c50-bd25-66fde59ac6a0.md) Phase 2
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) Phase 2
- Cervical carcinoma Phase 2
- [Cholangiocarcinoma](https://trialight.com/data/condition/cholangiocarcinoma-3777afe4-5189-5eb1-82f8-0c3446cb902f.md) Phase 2
- Classic Hodgkin lymphoma Phase 3
- Clear cell adenocarcinoma Phase 2
- [Clear cell renal carcinoma](https://trialight.com/data/condition/clear-cell-renal-carcinoma-789eee25-ec64-5771-9b7d-d19544781b11.md) Phase 2
- [Colorectal adenocarcinoma](https://trialight.com/data/condition/colorectal-adenocarcinoma-49107d5a-ece1-5f2b-8783-f2077e298ffa.md) Phase 3
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 3
- [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) Phase 3
- [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) Phase 3
- [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Phase 2
- [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) Phase 2

### Other linked conditions (2)

- [Anaplastic meningioma](https://trialight.com/data/condition/anaplastic-meningioma-bc202df0-3448-5b57-9aab-345abc07fa46.md)
- Grade III meningioma

### Targets (1)

- [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) Programmed cell death protein 1 antagonist

---

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