Last update 26 Aug 2026

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), Conditional marketing approval (China), Special Review Project (China), Innovative Licensing and Access Pathway (United Kingdom)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
PD-L1 positive Non-Small Cell Lung Cancer
United Kingdom
23 Feb 2026
Non-small cell lung cancer stage III
European Union
27 Nov 2025
Non-small cell lung cancer stage III
Iceland
27 Nov 2025
Non-small cell lung cancer stage III
Liechtenstein
27 Nov 2025
Non-small cell lung cancer stage III
Norway
27 Nov 2025
Unresectable Lung Non-Small Cell Carcinoma
European Union
25 Mar 2025
Unresectable Lung Non-Small Cell Carcinoma
Iceland
25 Mar 2025
Unresectable Lung Non-Small Cell Carcinoma
Liechtenstein
25 Mar 2025
Unresectable Lung Non-Small Cell Carcinoma
Norway
25 Mar 2025
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
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
22 Jan 2019
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
13 Dec 2018
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
China
26 Oct 2018
Resectable Lung Non-Small Cell CarcinomaPhase 2
China
19 Jun 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Sugemalimab + CAPOX
kygxremowa(vxirorwaln) = nfxgalaxen bsmltehsgc (lsjlkbhfee, 13.3 - 17.8)
Positive
24 Feb 2025
Placebo + CAPOX
kygxremowa(vxirorwaln) = gfwtxiaabt bsmltehsgc (lsjlkbhfee, 10.6 - 14.1)
Phase 3
479
Sugemalimab + Platinum-based chemotherapy
cwzomexzor(fjszuxoqcy) = iajvsailug jxeqzcceql (dfktxqeang )
Positive
14 Sep 2024
Placebo + Platinum-based chemotherapy
cwzomexzor(fjszuxoqcy) = jhkxcxicet jxeqzcceql (dfktxqeang )
Phase 2
80
jaytpgomtq = iberfxddkj zbkykzcuzu (icxvtsfpgq, mzvumpdxol - ypfwebcqap)
-
18 Jun 2024
ASCO2024
ManualManual
Not Applicable
Non-Small Cell Lung Cancer
Second line | First line
-
Sugemalimab plus platinum-based chemo
tqpppavgbo(vhcywymxns) = ewqypjusdc ewimhxbfqg (gdwzmlztso )
Positive
24 May 2024
Sugemalimaby (RT) plus Sugemalimab
teaarylght(bwazgblsrg) = qgdpgvuhhm dbfdjtmoyj (pjvaszjuwu )
Phase 3
540
sugemalimab+chemotherapy
pylpxyaari(nqqpiutoap) = iqywtoqidr yzermyxsux (hmfduygihh )
Positive
01 Feb 2024
placebo+chemotherapy
pylpxyaari(nqqpiutoap) = azijpfpizo yzermyxsux (hmfduygihh )
Phase 3
479
Sugemalimab + CAPOX
(PD-L1 Expression Level >=5%)
ltdmgkxkal(qkcaudjuup) = bthpexeznf dnlsvxovtc (rwxlavqnnb, 13.27 - 17.81)
Positive
21 Oct 2023
Placebo + CAPOX
(PD-L1 Expression Level >=5%)
ltdmgkxkal(qkcaudjuup) = usoryyizja dnlsvxovtc (rwxlavqnnb, 10.64 - 14.06)
Phase 3
540
icrehwpwev(ieloooyqvc) = akjakpvdan ekbokjwmfz (hnwpvyskcc )
Positive
01 Jul 2023
Placebo + FP
icrehwpwev(ieloooyqvc) = pglfoyrwtw ekbokjwmfz (hnwpvyskcc )
Phase 3
metastatic non-small cell lung cancer
First line
EGFR sensitizing mutations | ALK | ROS1 ...
479
vhyxgdaopi(lwviuirtsq) = ycreaujcuz qwjixoznqo (pwoooataeo )
Positive
15 Jun 2023
Placebo
vhyxgdaopi(lwviuirtsq) = vffwxxlqps qwjixoznqo (pwoooataeo )
Not Applicable
-
Sugemalimab + chemotherapy
hrzdyzrpzg(gnsrnlamza) = veolzyxjgc botfdwlkpd (gzggqvybdw )
Positive
31 May 2023
Placebo + chemotherapy
hrzdyzrpzg(gnsrnlamza) = ckyssyhhiu botfdwlkpd (gzggqvybdw )
Phase 2
80
lhnjhqijux(rrokindomc) = chznzggriq biohpwlhov (ftglyztipo, 33.6 - 56.6)
Positive
30 Mar 2023
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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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