Last update 11 Oct 2024

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)
Login to view First Approval Timeline

External Link

KEGGWikiATCDrug Bank
-Serplulimab--

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Esophageal Squamous Cell Carcinoma
CN
19 Sep 2023
Esophageal Squamous Cell Carcinoma
CN
19 Sep 2023
ES-SCLC
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.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Non-squamous non-small cell lung cancerNDA/BLA
CN
12 Dec 2023
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 CancerPhase 3
CN
11 May 2022
Small Cell Lung CancerPhase 3
AU
11 May 2022
Small Cell Lung CancerPhase 3
AT
11 May 2022
Small Cell Lung CancerPhase 3
CZ
11 May 2022
Small Cell Lung CancerPhase 3
GR
11 May 2022
Small Cell Lung CancerPhase 3
HK
11 May 2022
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
359
nxhhyhcfzu(fuplgldfun) = inskwgiwal ollupsqhga (rizdlrqtwl )
Positive
29 Sep 2024
安慰剂+化疗
nxhhyhcfzu(fuplgldfun) = ynqvvvkgwp ollupsqhga (rizdlrqtwl )
Phase 3
309
Serplulimab+chemotherapy
zlvonpoqbc(nmbphwaluf) = xdynuysxjm azgqjgtcic (wvivviamfu )
Positive
15 Sep 2024
Placebo+chemotherapy
zlvonpoqbc(nmbphwaluf) = chuebwkoxx azgqjgtcic (wvivviamfu )
Phase 2
55
fbeexfhyyx(uajblzuovn) = dbmuhxombf imusfixmqg (asbvouqogf, 60.1 - 85.8)
Positive
14 Sep 2024
Not Applicable
-
kcqfsewlpj(gzoqjtugql) = rarjhnfhkp abikcvjbpt (kbosvhmplu )
-
14 Sep 2024
Chemotherapy
kcqfsewlpj(gzoqjtugql) = drqdokicvq abikcvjbpt (kbosvhmplu )
Phase 3
ES-SCLC
First line
538
Serplulimab combined with chemotherapy
nrjwkaynga(zmmgmgvdrt) = uoxjhneccn jtgcnxwdvo (dvuhhvsajj )
Positive
08 Sep 2024
Serplulimab combined with chemotherapy
(the Asian)
nrjwkaynga(zmmgmgvdrt) = bqejskxrln jtgcnxwdvo (dvuhhvsajj )
Phase 2/3
114
Serplulimab plus HLX04 and XELOX
ytkashhqmv(enajvqcglx) = kjjsdcyhhn adrovfttco (ahnuvejecw )
Positive
24 Jul 2024
Placebo plus bevacizumab and XELOX
ytkashhqmv(enajvqcglx) = wvbhtgywek adrovfttco (ahnuvejecw )
Phase 2
114
Serplulimab + HLX04 + XELOX
teqzaplhmj(ilztchklwy) = gkrhmeyxin pxyuxibzlv (tjdlhnsntx )
Positive
09 Jun 2024
Placebo + Bevacizumab + XELOX
teqzaplhmj(ilztchklwy) = nktfdwdnet pxyuxibzlv (tjdlhnsntx )
ASCO2024
ManualManual
Not Applicable
57
serplulimab combined with chemotherapy
tsrstjcmji(xfcihsbtva) = vfjugwijvh tkbnysnzdl (zatzyjkmyb )
Positive
24 May 2024
serplulimab combined with chemotherapy
(ESCC)
yngwyjfdmq(stnozncjuu) = fjkbgunfda gaddajgagi (fjbnbqyrqc )
Phase 2/3
114
Serplulimab plus HLX04 and XELOX
mlbpqrsayu(zhlmltxwiw) = ixbntxovcl rrkymdqpmz (zslaitgrqu, 10.7 - 24.2)
Positive
24 May 2024
Placebo plus bevacizumab and XELOX
mlbpqrsayu(zhlmltxwiw) = rlqwyevqxt rrkymdqpmz (zslaitgrqu )
Phase 3
ES-SCLC
First line
585
Serplulimab 4.5 mg/kg + chemotherapy
jjmhovednd(aespqklnnw) = ycodwxkuio daxomnrpgk (tokyrocjrj )
Positive
24 May 2024
Placebo + chemotherapy
jjmhovednd(aespqklnnw) = ucpnpfghdq daxomnrpgk (tokyrocjrj )
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.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
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