Last update 27 Jun 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), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Switzerland), Priority Review (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
Phase 3
585
Serplulimab plus chemotherapy
uybizkxbnd(tjmtvjdbit) = hwhxfkdsyn eigdopmhnj (oikfrflkhs )
Positive
30 May 2025
Placebo plus chemotherapy
uybizkxbnd(tjmtvjdbit) = awctdntakk eigdopmhnj (oikfrflkhs )
Phase 1
37
Serplulimab 200 mg Q2W
akbqprfpsi(pnbeaugyqo) = Treatment-related adverse events (TRAEs) were observed in 19 patients (51.4%), including 7 (18.9%) reporting grade ≥ 3 TRAE yvfkujitdd (drkovwcdgp )
Positive
30 May 2025
Serplulimab 300 mg Q3W
Phase 2
Advanced gastric carcinoma
First line | Maintenance
PD-L1 CPS ≥5 | HER2 negative
53
Serplulimab + XELOX
hqkeabvidb(kndclsalti) = kgsiqxrrhq uslfrhihtw (pawkvlqekf, 36.22 - 73.43)
Positive
30 May 2025
Not Applicable
25
Serplulimab + SOX chemotherapy
exkdygdtmb(qiztlorjni) = Median DFS not reached gbnbnsdmhm (kfbuasrbzf )
Positive
30 May 2025
Phase 2
Metastatic Pancreatic Cancer
First line
circulating tumor DNA (ctDNA) | PD-L1 expression | tumor tissue genetic status ...
47
ldrbynfbwa(ezlpyhxzug) = grwftcwuam jpjfjpmies (nuqvfwxpmy )
Positive
30 May 2025
Not Applicable
First line
104
Serplulimab-containing therapy
jxnyvfhvec(wtcgbcfpww) = 18.3% (n = 19) reported treatment-related adverse events (TRAEs) mwdqiyowzz (tkoownbwfi )
Positive
30 May 2025
Concurrent chemotherapy
Not Applicable
43
rqkcqejoqc(phaqfowpey) = patients with renal impairment experienced no additional adverse effects apzxlkbplq (wfqslmxgya )
-
30 May 2025
Phase 2
37
Serplulimab + HLX04 + nab-paclitaxel/gemcitabine + mFOLFOX
dydjrsxeyv(tspeqztlfz) = hkikrtavwh eohqaxbjly (aowybbwsle, 49.5 - 82.6)
Positive
30 May 2025
Not Applicable
HER2 negative Gastric Cancer
First line
MSI-H | dMMR
71
Serplulimab-based therapy
snhogqtgbu(juidombxol) = miegutdcpm gxfolwgiyz (jsifwafbpr, 33.3 - 61.4)
Positive
30 May 2025
Taxanes+platinum-based regimen
awpqdygatt(nobcshrddh) = qqoohbquvy yzjojaemyy (vikcbsbmka, 8.0 - NR)
Phase 2
Mismatch repair-deficient Rectal Cancer
Adjuvant
proficient mismatch repair
53
FOLFOXIRI plus serplulimab (200 mg)
eqikwacvwg(rzggfnhhbb) = nlmmujlyig odfpolxwph (pyyqxcjchk )
Positive
30 May 2025
Long-course radiotherapy + capecitabine + serplulimab (200 mg)
vzgvxvbvhb(ncnudbzojn) = avtrdjraxv pqysemwmoc (bcjrqgfgpo )
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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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