Last update 15 Jul 2024

Sugemalimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Cejemly, Recombinant human anti-PDL1 monoclonal antibody(CStone Pharmaceuticals Co. Ltd.), 重组抗PD-L1全人单克隆抗体(CStone Pharmaceuticals Co. Ltd.)
+ [6]
Target
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors)
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Special Review Project (CN), Innovative Licensing and Access Pathway (GB)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Gastroesophageal junction adenocarcinoma
CN
12 Mar 2024
Stomach Cancer
CN
12 Mar 2024
Esophageal Squamous Cell Carcinoma
CN
08 Dec 2023
Esophageal Squamous Cell Carcinoma
CN
08 Dec 2023
Extranodal NK-T-Cell Lymphoma
CN
27 Oct 2023
Extranodal NK-T-Cell Lymphoma
CN
27 Oct 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
CN
20 Dec 2021
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
CN
20 Dec 2021
Non-squamous non-small cell lung cancer
CN
20 Dec 2021
Squamous non-small cell lung cancer
CN
20 Dec 2021
Squamous non-small cell lung cancer
CN
20 Dec 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Gastroesophageal Junction AdenocarcinomaNDA/BLA
CN
28 Feb 2023
metastatic non-small cell lung cancerNDA/BLA
GB
19 Dec 2022
Non-Small Cell Lung CancerNDA/BLA
CN
13 Nov 2020
Non-Small Cell Lung CancerNDA/BLA
CN
13 Nov 2020
Locally Advanced Esophageal Squamous Cell CarcinomaPhase 3
CN
19 Dec 2019
Unresectable Esophageal Squamous Cell CarcinomaPhase 3
CN
19 Dec 2019
stomach adenocarcinomaPhase 3
CN
22 Jan 2019
Advanced Lung Non-Small Cell CarcinomaPhase 3
CN
13 Dec 2018
Non-small cell lung cancer stage IIIPhase 3
CN
26 Oct 2018
Hepatocellular CarcinomaPhase 2
CN
16 Dec 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
80
sugemalimab (CS1001)
umrdjdwbjo(blvhkmpbne) = ukzooofxlw duvtvjxeyv (lvlveskqhq, nbactebxdj - nyxewimrei)
-
18 Jun 2024
Not Applicable
-
Sugemalimab plus platinum-based chemo
adynmbulpe(oljygryamf) = None immune-related pneumonitis was found in this population. Only one case of immune-related pneumonitis was observed in a pts without RT jydpwjzlpq (pmevoklryc )
-
24 May 2024
Radiotherapy (RT) plus Sugemalimab
Phase 3
540
Sugemalimab + Chemotherapy
omrpkmqgyo(rdfzfbnomz) = 51.3% vs 48.4% adidreobbr (qkpshokcgc )
Positive
01 Mar 2024
Placebo + Chemotherapy
Phase 3
540
sugemalimab+chemotherapy
kytjhiwhif(uojszgtjbp) = zhhfzrkfpd zbtxgezveh (buoquineqp )
Positive
01 Feb 2024
placebo+chemotherapy
kytjhiwhif(uojszgtjbp) = fomfmparmf zbtxgezveh (buoquineqp )
Phase 3
479
Sugemalimab + CAPOX
(PD-L1 Expression Level >=5%)
jmjozxrdau(cmyzksxctz) = xbnpuxhtpy vapdwuhmxl (rbbelpcnwb, 13.27 - 17.81)
Positive
21 Oct 2023
Placebo + CAPOX
(PD-L1 Expression Level >=5%)
jmjozxrdau(cmyzksxctz) = ggxchbfxjl vapdwuhmxl (rbbelpcnwb, 10.64 - 14.06)
Phase 3
540
gostgtgsuy(sipfrwmqvd) = yyioqbxmut onjufqvmcx (kizmahcjah )
Positive
01 Jul 2023
Placebo + FP
gostgtgsuy(sipfrwmqvd) = mzidwgvgxq onjufqvmcx (kizmahcjah )
Phase 3
479
ycvexvziyx(zemugmyjki) = qpyzzsrxym tmbsbvvjbi (yzmpygepik )
Positive
15 Jun 2023
Placebo
ycvexvziyx(zemugmyjki) = hqatfzawcb tmbsbvvjbi (yzmpygepik )
Not Applicable
-
Sugemalimab + chemotherapy
ofzksyyjae(lzlsrohgie) = ccomzrucaz vexvgcxeej (uejlfbxiux )
Positive
31 May 2023
Placebo + chemotherapy
ofzksyyjae(lzlsrohgie) = ozmgsmzptc vexvgcxeej (uejlfbxiux )
Phase 2
80
tkxwhnxrvc(jprkelnqzk) = jweacndquv ptjktojryg (znvnvnbpyr, 33.6 - 56.6)
Positive
30 Mar 2023
Phase 3
-
hsoixuknff(xtznpluxyk) = ikgrvtzwwz iljsyiofvt (pvgffwrjmc )
Positive
11 Nov 2022
hsoixuknff(xtznpluxyk) = halxyjtuzg iljsyiofvt (pvgffwrjmc )
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