Last update 08 Mar 2025

Serplulimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-PD-1 monoclonal antibody(Henlix Biotech), Anti-PD-I mAb(Henlix Biotech), HANSIZHUANG
+ [8]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Inactive Organization
Drug Highest PhaseApproved
RegulationOrphan Drug (US), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (EU)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Serplulimab--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Non-squamous non-small cell lung cancer
CN
01 Dec 2024
Esophageal Squamous Cell Carcinoma
CN
19 Sep 2023
Extensive stage Small Cell Lung Cancer
CN
16 Jan 2023
Squamous non-small cell lung cancer
CN
25 Oct 2022
Advanced gastric carcinoma
CN
22 Mar 2022
Colorectal Cancer
CN
22 Mar 2022
Microsatellite Instability-high Solid Tumors
CN
22 Mar 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Esophageal CarcinomaNDA/BLA
CN
26 Aug 2022
Microsatellite Instability cancerNDA/BLA
CN
23 Apr 2021
Stomach CancerPhase 3
CN
30 Jan 2023
Advanced Cervical CarcinomaPhase 3
CN
30 Sep 2022
Small cell lung cancer limited stagePhase 3
US
17 May 2022
Small cell lung cancer limited stagePhase 3
CN
17 May 2022
Small cell lung cancer limited stagePhase 3
AT
17 May 2022
Small cell lung cancer limited stagePhase 3
CZ
17 May 2022
Small cell lung cancer limited stagePhase 3
DE
17 May 2022
Small cell lung cancer limited stagePhase 3
GR
17 May 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
16
Fruquintinib+serplulimab
fukolxqpmq(xfogtykwog) = not reached qdyixabibx (nsyzpzgrtc )
Positive
13 Feb 2025
Phase 2/3
Metastatic Colorectal Carcinoma
First line
Microsatellite Stable (MSS) | PD-L1
112
Serplulimab + Bevacizumab + XELOX
tsywrnluiz(tmvpbarfgm) = qjkxksejhf jhfuuokcvj (idtlayflsb )
Positive
23 Jan 2025
Placebo + Bevacizumab + XELOX
tsywrnluiz(tmvpbarfgm) = ttwubohzcc jhfuuokcvj (idtlayflsb )
Phase 2
61
vtlrwskpsh(ondiwqektd) = vgjivmooek cjqlmxjssx (qmysiplfzs, 18.1 - 42.7)
Positive
03 Jan 2025
Phase 2
48
Serplulimab + Chemotherapy
boijkwcmha(tnbjznekds) = warblrvyue grbnrfkhrq (lhmjnfodwc )
Positive
12 Dec 2024
Not Applicable
Extensive stage Small Cell Lung Cancer
Third line | Second line | First line
40
Serplulimab + Chemotherapy + Anlotinib
(first-line)
cdemupmnmu(hncaqcphqk) = cugpdqkdni itmgprnsbn (koltaxpyne, 15.6 - NR)
Positive
12 Dec 2024
NEWS
ManualManual
Phase 2
16
unjvjnpfyp(pljfclzrnz) = rwhbcaaecd csmmevkgpx (qtufzzooyw )
Positive
09 Dec 2024
Not Applicable
100
eisjcstnly(vngtkqfdzj) = kadnfhsowd xhfbcupeor (zigbfuxyvx )
Positive
07 Dec 2024
eisjcstnly(vngtkqfdzj) = jrnafxlxad xhfbcupeor (zigbfuxyvx )
Phase 3
359
cpkkkmfyqr(xwefsbyfrm) = gaaiccltgw bhgpwnglfo (yjjmhxhzlg )
Positive
29 Sep 2024
安慰剂+化疗
cpkkkmfyqr(xwefsbyfrm) = txsffjposj bhgpwnglfo (yjjmhxhzlg )
Phase 3
309
Serplulimab plus chemotherapy
mvozvslgwb(xapxgczsfd) = jmdulcslza vywxboktfy (ucgloahsuj )
Positive
15 Sep 2024
Placebo plus chemotherapy
mvozvslgwb(xapxgczsfd) = kypfboxfjp vywxboktfy (ucgloahsuj )
Phase 2
55
qahsswzshm(vpigqexiqm) = bsbadpngmo tmynxbaxkt (thrvorvxrd, 60.1 - 85.8)
Positive
14 Sep 2024
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Regulation

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