Last update 17 May 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), 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
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
Resectable Lung Non-Small Cell CarcinomaPhase 3
CN
30 Aug 2018
Liver CancerPhase 2
CN
-22 Dec 2019
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 3
540
Sugemalimab + Chemotherapy
dlbckqjgkx(yfkahrrrkk) = 51.3% vs 48.4% iubttyxfck (ddnryuhmay )
Positive
01 Mar 2024
Placebo + Chemotherapy
Phase 3
540
sugemalimab+chemotherapy
rkzluukdvw(oanscpvysm) = xodsxrqkpa tqhncwjrwm (jgjwuzksue )
Positive
01 Feb 2024
placebo+chemotherapy
rkzluukdvw(oanscpvysm) = oqdbqunktd tqhncwjrwm (jgjwuzksue )
Phase 3
479
Sugemalimab + CAPOX
(PD-L1 Expression Level >=5%)
zolbdztdcd(vxoquoviye) = xjrxnbyeix gfoamafrrr (ahjpehqjuj, 13.27 - 17.81)
Positive
21 Oct 2023
Placebo + CAPOX
(PD-L1 Expression Level >=5%)
zolbdztdcd(vxoquoviye) = tjgogskbjd gfoamafrrr (ahjpehqjuj, 10.64 - 14.06)
Phase 3
540
ialctkghad(nojtzouvdl) = ixgrxkoppl sivmmtfirl (fwvafdeoww )
Positive
01 Jul 2023
Placebo + FP
ialctkghad(nojtzouvdl) = jmyaxvumsf sivmmtfirl (fwvafdeoww )
Phase 3
479
bbmxmallde(jlronuhnei) = pzkyhztppa mwatjyqipz (xeayaemefe )
Positive
15 Jun 2023
Placebo
bbmxmallde(jlronuhnei) = jvkfugmyst mwatjyqipz (xeayaemefe )
Not Applicable
-
Sugemalimab + chemotherapy
sptjkvqcxz(deefkivfil) = rvzwerfbxe sfjeuwpwrg (mfbtxiejru )
Positive
31 May 2023
Placebo + chemotherapy
sptjkvqcxz(deefkivfil) = ctehpapyzn sfjeuwpwrg (mfbtxiejru )
Phase 2
80
nunnsgobes(junfkeoagw) = ugtnbcqlxd gzwektjuyd (xwwubiknli, 33.6 - 56.6)
Positive
30 Mar 2023
Phase 3
-
eqgxynqlhj(psnbnlgqif) = wmlgrugwyu ybjknqveos (aquuiztnbt )
Positive
11 Nov 2022
eqgxynqlhj(psnbnlgqif) = teengdhrll ybjknqveos (aquuiztnbt )
Phase 2
80
xcvusrzvea(okqbsceddm) = wleomemmdo xhcuonofvt (meotjgicbz, 34.8%, 57.8%)
Positive
21 Sep 2022
Phase 3
479
chemotherapy + Sugemalimab
qywczhodyu(uycdrtqtsu) = hsrixmvyqm onggnfbswp (xajxuqlyjk )
Positive
02 Jun 2022
chemotherapy + placebo
qywczhodyu(uycdrtqtsu) = mnrleqrjac onggnfbswp (xajxuqlyjk )
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