Last update 29 May 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
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Inactive Organization
Drug Highest PhaseApproved
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China)
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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
China
01 Dec 2024
Esophageal Squamous Cell Carcinoma
China
19 Sep 2023
Extensive stage Small Cell Lung Cancer
China
16 Jan 2023
Squamous non-small cell lung cancer
China
25 Oct 2022
Advanced gastric carcinoma
China
22 Mar 2022
Colorectal Cancer
China
22 Mar 2022
Microsatellite Instability-high Solid Tumors
China
22 Mar 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Esophageal CarcinomaNDA/BLA
China
26 Aug 2022
Microsatellite Instability cancerNDA/BLA
China
23 Apr 2021
Stomach CancerPhase 3
China
30 Jan 2023
Advanced Cervical CarcinomaPhase 3
China
30 Sep 2022
Small cell lung cancer limited stagePhase 3
United States
17 May 2022
Small cell lung cancer limited stagePhase 3
China
17 May 2022
Small cell lung cancer limited stagePhase 3
Austria
17 May 2022
Small cell lung cancer limited stagePhase 3
Czechia
17 May 2022
Small cell lung cancer limited stagePhase 3
Germany
17 May 2022
Small cell lung cancer limited stagePhase 3
Greece
17 May 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Phase 2
24
第一周期新辅助斯鲁利单抗 300 mg + SOX方案;二、三周期采用斯鲁利单抗联合同步放化疗
jobukpcgqp(hkqebetmnb) = ygkkwuafdf yzkocrnoek (wwsosezivh )
Positive
09 May 2025
NEWS
ManualManual
Not Applicable
Stomach Cancer
Neoadjuvant
30
斯鲁利单抗+SOX+胸腺法新
(A组(12例仍在接受新辅助治疗)、B组(7例已完成新辅助治疗,等待手术中)和C组(11例已完成手术治疗))
vkqjrpzuot(lxuloukskt) = nwhvvqtrqz gppqzstphj (tbwgydabxy )
Positive
09 May 2025
Not Applicable
39
Serplulimab plus chemotherapy
vrcobadkaj(ldjpszzlwu) = riqvtylhfa swbnkqfkmh (jmkdfjliuu, 3.1 - 7.2)
Positive
03 Mar 2025
Second-line serplulimab plus chemotherapy
vrcobadkaj(ldjpszzlwu) = ciqagavmcp swbnkqfkmh (jmkdfjliuu, 6.9 - NR)
Phase 2
16
pajmgzhrnf(wwakjhxnrr) = not reached irlwcnkosw (ehumhqdbtn )
Positive
13 Feb 2025
Phase 2/3
Metastatic Colorectal Carcinoma
First line
Microsatellite Stable (MSS) | PD-L1
112
Serplulimab + Bevacizumab + XELOX
mmmwqzdjgq(mjiinnuxig) = whjurwplqj mgycdhvpyw (wbvketffew )
Positive
23 Jan 2025
Placebo + Bevacizumab + XELOX
mmmwqzdjgq(mjiinnuxig) = rkblyrcrhy mgycdhvpyw (wbvketffew )
Phase 2
61
vixpvxcqpd(hwcaotltpl) = dkqupcbbjc kynadwcene (wbmpuggjrb, 18.1 - 42.7)
Positive
03 Jan 2025
Phase 2
44
wldmqvlrjs(gkdaytzekj) = orgrvoeicu hlyaknjngm (ufsmtietic )
Positive
20 Dec 2024
Not Applicable
Extensive stage Small Cell Lung Cancer
Third line | Second line | First line
40
Serplulimab + Chemotherapy + Anlotinib
(first-line)
xgllpxzmku(dgasdqkyxq) = swjnyerlxi pbtzlhldmd (rosuisnaze, 15.6 - NR)
Positive
12 Dec 2024
Phase 2
48
Serplulimab + Chemotherapy
kegeccwvci(lxnafkmfoz) = hdxihmwshl gdlahaotch (bgngsficvx )
Positive
12 Dec 2024
NEWS
ManualManual
Phase 2
16
shrhfgaknp(qzxxgrxsng) = qfadamljnm hwvzotbwou (bnrivtxakt )
Positive
09 Dec 2024
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Core Patent

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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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