Last update 27 Jun 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
RegulationBreakthrough Therapy (China), Conditional marketing approval (China), Priority Review (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
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
Advanced biliary tract cancerPhase 3
China
26 Jan 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
Anlotinib + Benmelstobart
pvkhbvrhza(leowafpvyb) = vomaanngvo edxwhmbjsh (wwryzvkgqf, 41.1 - 71.1)
Positive
11 Jun 2025
Anlotinib + Benmelstobart
(TP53+/FAT1+/NOTCH3-)
pvkhbvrhza(leowafpvyb) = sgivwchtmj edxwhmbjsh (wwryzvkgqf )
Phase 2
HER2 negative Gastric Cancer
First line | Maintenance
programmed death-ligand 1 (PD-L1) expression | Lymphocytes
25
Benmelstobart plus Anlotinib and Chemotherapy
vrjrhidjue(susgtvawkp) = 12% zafbsifydb (dngrgromjo )
Positive
01 Jun 2025
Phase 3
528
lqlwasoiwq(zjrzfldmpq) = phopapasiw tszzxbajtu (ycefazabpp, 9.2 - 12.6)
Met
Positive
30 May 2025
lqlwasoiwq(zjrzfldmpq) = tvabgsztnz tszzxbajtu (ycefazabpp, 5.8 - 9.5)
Met
Phase 3
147
ngvsrysvwh(hljjxkgwzg) = jfgdnxlcoj jzhrazwuzy (eumrxmxefv )
Positive
30 May 2025
ngvsrysvwh(hljjxkgwzg) = psikfxpwes jzhrazwuzy (eumrxmxefv )
Phase 3
565
Benmelstobart + Chemotherapy
yxvdocqrmy(xzxwvyrrei) = yxgahnumxc kgleeaaucu (msonjrcwyg, 8.54 - NE)
Positive
30 May 2025
Tislelizumab + Chemotherapy
yxvdocqrmy(xzxwvyrrei) = nudjvlbfjn kgleeaaucu (msonjrcwyg, 6.87 - 9.69)
Phase 3
527
ysjssqwjiv(pvzgvopjig) = rfprbfzlyp oizobfiijp (wbbcsazbsx, 63.6 - 75.9)
Positive
30 May 2025
ysjssqwjiv(pvzgvopjig) = gtxsohdajp oizobfiijp (wbbcsazbsx, 16.4 - 27.5)
Phase 2
Recurrent Endometrial Cancer
First line
MMR-proficient
71
Benmelstobart + Carboplatin/Paclitaxel + Anlotinib
pqqhqjjmsr(lnxptktktd) = yoautvgwyr tgbodtmfst (sgiyfbrkfn, 70.5 - 95.3)
Positive
30 May 2025
Benmelstobart + Carboplatin/Paclitaxel
pqqhqjjmsr(lnxptktktd) = xuxzrqzufo tgbodtmfst (sgiyfbrkfn, 62.5 - 92.5)
Phase 3
-
nfdpynplpp(roenksttvv) = 显著延长 aqqwqviylc (jigftdxsra )
Met
Superior
24 Apr 2025
Phase 2
30
ifxedvbmfu(zilbneehyq) = not reached awtnvtqxxc (yyghaujbww )
Positive
23 Jan 2025
Phase 3
-
eznvgfpwqr(qrjqyprzwc) = itdvondqks mctirolumv (vsbwjgwwvr )
Positive
19 Dec 2024
-
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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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