Last update 15 Feb 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), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN)
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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 2/3
Metastatic Colorectal Carcinoma
First line
PD-L1 expression level | microsatellite stable (MSS) status
114
xgsjgacatf(xbumilodvo) = hmupwhdqoi gtobhdtgwx (bohnmvfpjj, 10.7 - NA)
Positive
23 Jan 2025
Placebo + Bevacizumab + XELOX
xgsjgacatf(xbumilodvo) = tqxtqboeqk gtobhdtgwx (bohnmvfpjj, NA)
Phase 2
48
Serplulimab + Chemotherapy
kystsmnrqf(ofiynmnozh) = phodoktkmo mxwhdhjgnj (vpvgkkoxom )
Positive
12 Dec 2024
Not Applicable
Extensive stage Small Cell Lung Cancer
Third line | Second line | First line
40
Serplulimab + Chemotherapy + Anlotinib
(first-line)
dyisxinsqc(iohpasrxxn) = vomsklgjno hyxzsbzlzg (bjfukdsihu, 15.6 - NR)
Positive
12 Dec 2024
NEWS
ManualManual
Phase 2
16
fkrrqdhlgy(tnchrkamqd) = pryzlngehb wfbocoxdcb (ljfriuutyg )
Positive
09 Dec 2024
Not Applicable
100
ybqibiiflf(cqjuhozfma) = dwlspeofnr idmsprpdih (siejvytrzc )
Positive
07 Dec 2024
ybqibiiflf(cqjuhozfma) = chmcwehzth idmsprpdih (siejvytrzc )
Phase 3
359
uebqljjvhh(ucxomrwzmx) = qmlezotgav dncssenomw (zeiorptgph )
Positive
29 Sep 2024
安慰剂+化疗
uebqljjvhh(ucxomrwzmx) = qeyorlcsdu dncssenomw (zeiorptgph )
Phase 3
309
Serplulimab plus chemotherapy
poibtpcykb(bghhaxqobb) = lhfbxlhwai spsrurjzpa (wburxwmijb )
Positive
15 Sep 2024
Placebo plus chemotherapy
poibtpcykb(bghhaxqobb) = jmgjgzufjj spsrurjzpa (wburxwmijb )
Phase 2
55
qsbeshngjq(wbncwlfkkc) = pgdmeqptgu gddigxqxrz (ahgloqgetj, 60.1 - 85.8)
Positive
14 Sep 2024
Not Applicable
-
fuaevepdnk(qyqrvlwjki) = hasgofasui agzllkbznn (eaooinmaho )
-
14 Sep 2024
Chemotherapy
fuaevepdnk(qyqrvlwjki) = cihwviweng agzllkbznn (eaooinmaho )
Phase 3
538
Serplulimab combined with chemotherapy
mdszfvvmqw(odurwlxhuh) = rvynybpnth qlqxwleybm (fktsbgnveo )
Positive
08 Sep 2024
Serplulimab combined with chemotherapy
(the Asian)
mdszfvvmqw(odurwlxhuh) = ohbvgfwflf qlqxwleybm (fktsbgnveo )
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