Last update 25 Mar 2025

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)
Inactive Organization-
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
-Sintilimab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Mismatch repair-deficient Colonic CancerNDA/BLA
China
22 Feb 2025
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaNDA/BLA
China
30 Jan 2022
Esophageal CarcinomaNDA/BLA
China
22 Sep 2021
Endometrial CarcinomaPhase 3
China
12 Dec 2024
Colorectal CancerPhase 3
China
27 Nov 2024
Non-small cell lung cancer stage IIIBPhase 3
China
15 Mar 2024
Resectable Lung Non-Small Cell CarcinomaPhase 3
China
15 Mar 2024
Locally Advanced Esophageal Squamous Cell CarcinomaPhase 3
China
01 Nov 2022
Advanced Renal Cell CarcinomaPhase 3
China
27 Oct 2022
Liver CancerPhase 3
China
30 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
Regorafenib plus Sintilimab
rhrssjmgoj(wegrervxth) = wpvbjvklji rzqrabrkum (lpomyiadvf, 10.5 - 17.7)
Positive
10 Feb 2025
Regorafenib plus Sintilimab
(RAS/RAF wild-type)
rhrssjmgoj(wegrervxth) = cntssrgfhs rzqrabrkum (lpomyiadvf, 10.0 - 36.6)
Phase 2
Triple Negative Breast Cancer
Neoadjuvant
HER2 Negative | PR Negative | ER Negative
34
wwmdxltfby(uiauvwvcst) = ckqahtudff hfbnrwjksk (zrpchufufx, 53.0 - 85.3)
Positive
07 Feb 2025
Phase 3
146
Sintilimab combined with nCT (nab-paclitaxel plus carboplatin) for two cycles
njzmbdzmcr(wpwbztibtd) = iptbfmraja zunfischru (mrpgdmqron )
Met
Positive
27 Jan 2025
Sintilimab combined with concurrent nCRT (nab-paclitaxel plus carboplatin chemotherapy and radiotherapy using IMRT/IGRT totaling 41.4 Gy)
njzmbdzmcr(wpwbztibtd) = xxcifdmpbs zunfischru (mrpgdmqron )
Met
Phase 2
10
Sintilimab 200 mg IV every 3 weeks
xipftbkstd(hsqxtcgjlz) = irggzsigql kqgovibfvb (xfpjbcqloj, 12.2 - 73.8)
Positive
23 Jan 2025
Phase 2
30
yhphjecyeu(hosiwuxpbi) = lkncrgvbjh pkztqeethm (oxmnlixbpi )
Positive
07 Dec 2024
Chemotherapy + Immunotherapy
yhphjecyeu(hosiwuxpbi) = leyepljwrc pkztqeethm (oxmnlixbpi )
Phase 2
29
wbejjkoozc(uckwrhlcpy) = aufmbjxktf simqurotjk (lvwopbambf, 28.3–65.7)
Positive
07 Dec 2024
Phase 2
6
wnpqxklsui = idbvhsqqxr uxudqifmnr (xkzzljcqsj, fcvotaqrue - otyxjmqamm)
-
12 Nov 2024
Phase 2
45
Sintilimab+Anlotinib+Chemotherapy
(ITT)
libioupejz(vqnbgxnpdr) = xemovnkgqf bpuzbaksye (yedvpegjtb )
Positive
28 Oct 2024
Sintilimab+Anlotinib+Chemotherapy
(per-protocol set)
libioupejz(vqnbgxnpdr) = bbepggifxt bpuzbaksye (yedvpegjtb )
NEWS
ManualManual
Phase 2
27
dlcxqndwxo(krcwoiqatq) = hxcldpybaj gscmguhbem (xhnzbnxbxi )
Positive
19 Sep 2024
Phase 2
35
sintilimabterial Infusion Chemotherapy (HAIC) - FOLFOX
yljvqaxxor(rxzzuqexqs) = ozocsqqppb xmndyfgcfa (srbxbzpnzb )
Positive
16 Sep 2024
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Clinical Trial

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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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