Last update 04 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)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Serplulimab--

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
51
Serplulimab plus nab-paclitaxel and SOX
dsjfffnrct(dgoizpkphi) = adietaopwv dnrtvaiskm (mwrpfcodnt )
Positive
29 May 2026
Placebo plus nab-paclitaxel and SOX
dsjfffnrct(dgoizpkphi) = vuagkfxymx dnrtvaiskm (mwrpfcodnt )
Phase 3
PD-L1 positive Stomach Cancer
Adjuvant | Neoadjuvant
PD-L1 positive
588
Serplulimab plus chemo
ljjcpyados(nccqfblayr) = hmpihmruak ugfeyqbwdk (kybhbjirld, 43.0 - NE)
Positive
29 May 2026
Placebo plus chemo
ljjcpyados(nccqfblayr) = ynejoamqqy ugfeyqbwdk (kybhbjirld, 20.5 - NE)
Phase 2
pMMR/​MSS/MSI-L Colon Cancer
Neoadjuvant
pMMR | MSS
107
Immunotherapy combined with SCRT and CAPOX chemotherapy
wmvvknpttv(dtyytobrkj) = acgmrnafdd kydrmfjfki (riuzopwwnp )
Positive
29 May 2026
Chemotherapy alone (CAPOX)
wmvvknpttv(dtyytobrkj) = ybbileefxs kydrmfjfki (riuzopwwnp )
Phase 2
Hormone receptor positive HER2 negative breast cancer
Neoadjuvant
HR+ | HER2- | PD-L1 positive
101
Serplulimab + nab-paclitaxel + epirubicin
bzwnptvqya(ybmealncif) = htkzxpnlvf zxbpsxvaex (tmwygfxuiw, 15.3 - 32.4)
Positive
29 May 2026
Serplulimab + nab-paclitaxel + epirubicin
(PD-L1 positive)
bzwnptvqya(ybmealncif) = iprgaghdzg zxbpsxvaex (tmwygfxuiw, 30.0 - 59.9)
Not Applicable
82
Serplulimab plus platinum-doublet chemotherapy
mwhowfaicc(xubqouyruo) = dewwtnjgta pmqlqvknyy (ayzhhqhlin )
Positive
25 Mar 2026
Not Applicable
132
Serplulimab plus platinum-based therapy
ckwdqkeqyw(kohmxhlybj) = jirbfmezsj irltjaqkbs (eewcdcnilg )
Positive
25 Mar 2026
Serplulimab plus platinum-based therapy
pewlonmlbc(fjbjzagrim) = gttcscjujj ibtzpnxulz (wrllowlviy )
Phase 2
296
stcycsbchz(qovwryblfn) = dcaamyegvj bgajjogggc (kcoprquahv )
Positive
25 Mar 2026
Hypo-cCRT alone
-
Phase 2
30
huyopngqag(ydfuowjxrd) = gxrjbconsb soadbtktbe (gqawowuohl )
Positive
26 Feb 2026
Phase 2
Colonic Cancer
Neoadjuvant
Microsatellite Stable (MSS) | Proficient DNA Mismatch Repair (pMMR)
79
SCRT+serplulimab+CAPOX
(radiotherapy group)
ywguucalhb(ubxiptnemg) = psrbxbojwx rhsjcfcqqf (cjshigyiuo )
Positive
12 Jan 2026
CAPOX
(chemotherapy group)
ywguucalhb(ubxiptnemg) = rutswnxzse rhsjcfcqqf (cjshigyiuo )
Phase 2
Rectal Cancer
Neoadjuvant
Proficient DNA Mismatch Repair (pMMR) | Microsatellite Stable (MSS)
28
mFOLFOX6 +serplulimab
rhzxcmklen(xwbcivtbri) = zvftvhhbrb ululnovzyk (erwtkrqijx )
Positive
12 Jan 2026
mFOLFOX6 +serplulimab
(high LARC (>10 cm from anal verge, ineligible for nCRT))
rhzxcmklen(xwbcivtbri) = myvysbakbc ululnovzyk (erwtkrqijx )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

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

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free