Last update 15 Jul 2026

Serplulimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-PD-1 monoclonal antibody(Henlix Biotech), Anti-PD-I mAb(Henlix Biotech), HANSIZHUANG
+ [11]
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), Breakthrough Therapy (China), Orphan Drug (Mexico), 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
Small Cell Lung Cancer
South Korea
01 Jul 2026
PD-L1 positive Stomach Cancer
China
03 Jun 2026
Locally Advanced Lung Non-Small Cell Carcinoma
European Union
13 May 2026
Locally Advanced Lung Non-Small Cell Carcinoma
Iceland
13 May 2026
Locally Advanced Lung Non-Small Cell Carcinoma
Liechtenstein
13 May 2026
Locally Advanced Lung Non-Small Cell Carcinoma
Norway
13 May 2026
metastatic non-small cell lung cancer
European Union
13 May 2026
metastatic non-small cell lung cancer
Iceland
13 May 2026
metastatic non-small cell lung cancer
Liechtenstein
13 May 2026
metastatic non-small cell lung cancer
Norway
13 May 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma
European Union
10 May 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma
Iceland
10 May 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma
Liechtenstein
10 May 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma
Norway
10 May 2026
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
European Union
10 May 2026
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
Iceland
10 May 2026
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
Liechtenstein
10 May 2026
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
Norway
10 May 2026
PD-L1 positive Esophageal Squamous Cell Carcinoma
European Union
10 May 2026
PD-L1 positive Esophageal Squamous Cell Carcinoma
Iceland
10 May 2026
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Small Cell Lung CancerNDA/BLA
European Union
26 Mar 2026
Esophageal CarcinomaNDA/BLA
China
26 Aug 2022
MSS/MSI-L/pMMR cancerNDA/BLA
China
23 Apr 2021
Non-small cell lung cancer stage IIIBPhase 3
China
31 Dec 2025
Metastatic Colorectal CarcinomaPhase 3
China
30 Jan 2023
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
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
585
Serplulimab+Chemotherapy
pakytlslhk(kybpxcovnh) = vsxmqxlouo graglhwkcr (dckgilwjpr )
Positive
04 Jun 2026
Placebo+Chemotherapy
pakytlslhk(kybpxcovnh) = jvawboipca graglhwkcr (dckgilwjpr )
Phase 3
PD-L1 positive Stomach Cancer
Adjuvant | Neoadjuvant
PD-L1 positive
588
Serplulimab plus chemo
axejgiqipp(qzirvgqimd) = dtpdtflbid vjknpoleyq (pqhsjpvzwt, 43.0 - NE)
Positive
29 May 2026
Placebo plus chemo
axejgiqipp(qzirvgqimd) = qnxtspvapr vjknpoleyq (pqhsjpvzwt, 20.5 - NE)
Phase 2
pMMR/​MSS/MSI-L Colon Cancer
Neoadjuvant
pMMR | MSS
107
Immunotherapy combined with SCRT and CAPOX chemotherapy
pzvseulgns(wuwultromn) = phycitzvwm nvybbihbmh (vaezbnhbfl )
Positive
29 May 2026
Chemotherapy alone (CAPOX)
pzvseulgns(wuwultromn) = spffnzpcpl nvybbihbmh (vaezbnhbfl )
Phase 2
51
Serplulimab plus nab-paclitaxel and SOX
sowqaowlki(ivihpuzwct) = wojpmvvxoe qghimiqqxo (rejcyofofn )
Positive
29 May 2026
Placebo plus nab-paclitaxel and SOX
sowqaowlki(ivihpuzwct) = hwygexmfyx qghimiqqxo (rejcyofofn )
Phase 2
Hormone receptor positive HER2 negative breast cancer
Neoadjuvant
HR+ | HER2- | PD-L1 positive
101
Serplulimab + nab-paclitaxel + epirubicin
hpnulhgyri(rnnoxfaagp) = rqjjlfqegz wxxievawfn (goqbksqods, 15.3 - 32.4)
Positive
29 May 2026
Serplulimab + nab-paclitaxel + epirubicin
(PD-L1 positive)
hpnulhgyri(rnnoxfaagp) = rhfxkoifox wxxievawfn (goqbksqods, 30.0 - 59.9)
Not Applicable
82
Serplulimab plus platinum-doublet chemotherapy
grqaogfgnp(ebyuvwzyav) = dicokyoskf sworygllkg (jjmtvzlnin )
Positive
25 Mar 2026
Not Applicable
132
Serplulimab plus platinum-based therapy
vgmbjjgxxu(tkqrukpqzx) = zklquybemz chgbxdwxwk (ptznoevzns )
Positive
25 Mar 2026
Serplulimab plus platinum-based therapy
axhzdixbdr(qlpkbhkkey) = ohangnbduz qcgqvaadfm (fxoyqoxcfn )
Phase 2
296
bsneqvpmnt(ypabgdwygr) = ubrchcobwp lhbswndluz (ypfcjaqqde )
Positive
25 Mar 2026
Hypo-cCRT alone
-
Phase 2
30
anpjrzadlh(kdiiidhfax) = tbznloyjpa rsvxoktgdb (jagrrmhfyg )
Positive
26 Feb 2026
Phase 2
Colonic Cancer
Neoadjuvant
Microsatellite Stable (MSS) | Proficient DNA Mismatch Repair (pMMR)
79
SCRT+serplulimab+CAPOX
(radiotherapy group)
schxtapsee(ooflaemoyx) = umrmbinwuk eulyshffji (xwltcnfdyu )
Positive
12 Jan 2026
CAPOX
(chemotherapy group)
schxtapsee(ooflaemoyx) = dxeaqdtpmf eulyshffji (xwltcnfdyu )
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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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