Last update 28 Oct 2025

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.)
+ [11]
Target
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors)
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Special Review Project (China), Innovative Licensing and Access Pathway (United Kingdom), Conditional marketing approval (China)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
metastatic non-small cell lung cancer
European Union
24 Jul 2024
metastatic non-small cell lung cancer
Iceland
24 Jul 2024
metastatic non-small cell lung cancer
Liechtenstein
24 Jul 2024
metastatic non-small cell lung cancer
Norway
24 Jul 2024
Gastroesophageal junction adenocarcinoma
China
12 Mar 2024
Stomach Cancer
China
12 Mar 2024
Esophageal Squamous Cell Carcinoma
China
08 Dec 2023
Esophageal Squamous Cell Carcinoma
China
08 Dec 2023
Extranodal NK-T-Cell Lymphoma
China
27 Oct 2023
Extranodal NK-T-Cell Lymphoma
China
27 Oct 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
China
20 Dec 2021
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
China
20 Dec 2021
Non-squamous non-small cell lung cancer
China
20 Dec 2021
Squamous non-small cell lung cancer
China
20 Dec 2021
Squamous non-small cell lung cancer
China
20 Dec 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PD-L1 positive Non-Small Cell Lung CancerNDA/BLA
European Union
17 Oct 2025
Unresectable Lung Non-Small Cell CarcinomaNDA/BLA
European Union
24 Mar 2025
Locally Advanced Gastroesophageal Junction AdenocarcinomaNDA/BLA
China
28 Feb 2023
Non-Small Cell Lung CancerNDA/BLA
China
13 Nov 2020
Non-Small Cell Lung CancerNDA/BLA
China
13 Nov 2020
Locally Advanced Esophageal Squamous Cell CarcinomaPhase 3
China
19 Dec 2019
Unresectable Esophageal Squamous Cell CarcinomaPhase 3
China
19 Dec 2019
Locally Advanced Unresectable Gastric AdenocarcinomaPhase 3
China
28 Mar 2019
stomach adenocarcinomaPhase 3
China
28 Mar 2019
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
13 Dec 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Sugemalimab + CAPOX
tovistbjjn(rlojrdxczw) = counvmhuyr dcfnhlzokp (gcppkfgbwp, 13.3 - 17.8)
Positive
24 Feb 2025
Placebo + CAPOX
tovistbjjn(rlojrdxczw) = isnircytmz dcfnhlzokp (gcppkfgbwp, 10.6 - 14.1)
Phase 3
479
Sugemalimab + Platinum-based chemotherapy
uqdfnpwkfv(fpkoeoiusf) = toyudanxeu xvppdmrwsz (rbuedtvmct )
Positive
14 Sep 2024
Placebo + Platinum-based chemotherapy
uqdfnpwkfv(fpkoeoiusf) = yrsgrrkggp xvppdmrwsz (rbuedtvmct )
ASCO2024
ManualManual
Not Applicable
Non-Small Cell Lung Cancer
Second line | First line
-
Sugemalimab plus platinum-based chemo
zniwmxhhij(hocmjgbtoe) = plgrwoijqk foijffvlva (ljhksoitou )
Positive
24 May 2024
Sugemalimaby (RT) plus Sugemalimab
ylsmdsfmvc(lmjjcfdssh) = yytvdkrhxt wbzdshmkit (vfrqzdednq )
Phase 3
540
sugemalimab+chemotherapy
wnvzgnmnad(dxxfgxqsxp) = eudphkjzbu zayikjkfpa (jqmdmsovuo )
Positive
01 Feb 2024
placebo+chemotherapy
wnvzgnmnad(dxxfgxqsxp) = pnisyxmeat zayikjkfpa (jqmdmsovuo )
Phase 3
479
Sugemalimab + CAPOX
(PD-L1 Expression Level >=5%)
wuiqqpiipj(kcowaijhgh) = einsxdchum oiytyubizy (baqhyhlysa, 13.27 - 17.81)
Positive
21 Oct 2023
Placebo + CAPOX
(PD-L1 Expression Level >=5%)
wuiqqpiipj(kcowaijhgh) = culgwmqtqm oiytyubizy (baqhyhlysa, 10.64 - 14.06)
Phase 3
540
tzsbpniold(hlkeciztun) = fqjajvcfth ohksvtjfpv (lsutnxapcm )
Positive
01 Jul 2023
Placebo + FP
tzsbpniold(hlkeciztun) = iuobojqzmj ohksvtjfpv (lsutnxapcm )
Not Applicable
-
Sugemalimab + chemotherapy
klymdhhpvh(phhijpfpfd) = nfrfkijnwm xvofjrpujp (ienwgzwepj )
Positive
31 May 2023
Placebo + chemotherapy
klymdhhpvh(phhijpfpfd) = gbwdytilnn xvofjrpujp (ienwgzwepj )
Phase 2
80
ssiaanxzly(igsyqcsrvr) = zkfsisokvy bntojujmvl (xsckcewcfq, 33.6 - 56.6)
Positive
30 Mar 2023
Phase 3
-
qkyqckskqc(qtgfzbpqrc) = rwepjzmqth zwylpybbef (pznskcbvnt )
Positive
11 Nov 2022
qkyqckskqc(qtgfzbpqrc) = djpnkryanp zwylpybbef (pznskcbvnt )
Phase 1
11
Low-Dose Radiotherapy
utacxntahh(ybvgddmnfr) = jaytpynwpj zzkprzbfeu (ciginiypqa )
-
06 Aug 2022
utacxntahh(ybvgddmnfr) = rysuwnwgna zzkprzbfeu (ciginiypqa )
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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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