Last update 08 Sep 2025

Benmelstobart

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-PD-L1 monoclonal antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group), PD-L1 antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group), APL 502
+ [7]
Target
Action
inhibitors, stimulants
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors), T lymphocytes stimulants
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Breakthrough Therapy (China), 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 Renal Cell Carcinoma
China
13 May 2025
Unresectable Renal Cell Carcinoma
China
13 May 2025
Endometrial Carcinoma
China
22 Nov 2024
Extensive stage Small Cell Lung Cancer
China
30 Apr 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Alveolar Soft Part SarcomaNDA/BLA
China
23 Aug 2025
Non-small cell lung cancer stage IIINDA/BLA
China
23 Apr 2025
Advanced Lung Non-Small Cell Squamous CarcinomaNDA/BLA
China
27 Dec 2024
Metastatic endometrial cancerPhase 3
China
01 Jul 2024
Recurrent Platinum-Resistant Ovarian CarcinomaPhase 3
China
26 Sep 2021
metastatic non-small cell lung cancerPhase 3
China
06 Aug 2021
Squamous non-small cell lung cancerPhase 3
China
06 Aug 2021
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
21 Jul 2021
Non-Small Cell Lung CancerPhase 3
China
21 Jul 2021
Non-squamous non-small cell lung cancerPhase 3
China
21 Jul 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Advanced Esophageal Squamous Cell Carcinoma
First line
TP53 Mutation | FAT1 Mutation
46
ucybwsqryw(gwpgrwmzdm) = gvwjcvwatt jsyxunable (xitavgqjrq, 41.1 - 71.1)
Positive
11 Jun 2025
(TP53+/FAT1+/NOTCH3-)
ucybwsqryw(gwpgrwmzdm) = gqjsxkhllo jsyxunable (xitavgqjrq )
Phase 2
HER2 negative Gastric Cancer
First line | Maintenance
programmed death-ligand 1 (PD-L1) expression | Lymphocytes
25
Benmelstobart plus Anlotinib and Chemotherapy
pqnccltzub(przkcfggwh) = 12% uwzgssziqk (tqjlyvzguz )
Positive
01 Jun 2025
Phase 3
528
fqmuecdkgm(nlmpwvwhqh) = jansqljrbm rqfgzsnapn (mrbfnunruu, 9.2 - 12.6)
Met
Positive
30 May 2025
fqmuecdkgm(nlmpwvwhqh) = azmegomeqc rqfgzsnapn (mrbfnunruu, 5.8 - 9.5)
Met
Phase 3
147
tuiabhycrg(bgkcxnjnpe) = igjjyglfct wfftjgplam (ijjwtjmygy )
Positive
30 May 2025
tuiabhycrg(bgkcxnjnpe) = unqytaehjo wfftjgplam (ijjwtjmygy )
Phase 2
71
zycoawazvb(gnfbybsriq) = bbahrutwnu bfdfejwkbe (ooegnmrhye, 70.5 - 95.3)
Positive
30 May 2025
zycoawazvb(gnfbybsriq) = jpdkmglttl bfdfejwkbe (ooegnmrhye, 62.5 - 92.5)
Phase 3
565
Benmelstobart + Chemotherapy
obfvcldjzc(dsmcklurcx) = yhvhdkxtwq xdsfwxvmla (kfklfikuyq, 8.54 - NE)
Positive
30 May 2025
Tislelizumab + Chemotherapy
obfvcldjzc(dsmcklurcx) = gzgrpgpjvh xdsfwxvmla (kfklfikuyq, 6.87 - 9.69)
Phase 3
527
tpeetbwkme(ppzykckhaq) = jvwjnglaiv tqsaykcnzz (zdbbgbihod, 63.6 - 75.9)
Positive
30 May 2025
tpeetbwkme(ppzykckhaq) = ultnpkdxcr tqsaykcnzz (zdbbgbihod, 16.4 - 27.5)
Phase 3
-
bsgltykpyv(vxzrbuqczu) = 显著延长 mshluwdkzx (bcfdnhnqvi )
Met
Superior
24 Apr 2025
Phase 2
30
iiqqxcomtc(hcrhlpnmyc) = not reached tbuilevvij (rjgphhaxqr )
Positive
23 Jan 2025
Phase 3
-
gcjyyuxsdh(vufxwdhyma) = sabkoofgpl ecvqhdwsoa (maphavjjwc )
Positive
19 Dec 2024
-
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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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