Last update 23 Apr 2025

PM-8002

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
BNT327, PM 8002, PM8002
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (China)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Extensive stage Small Cell Lung CancerPhase 3
United States
03 Feb 2025
Extensive stage Small Cell Lung CancerPhase 3
Australia
03 Feb 2025
Extensive stage Small Cell Lung CancerPhase 3
United Kingdom
03 Feb 2025
Non-Small Cell Lung CancerPhase 3
United States
07 Jan 2025
Non-Small Cell Lung CancerPhase 3
Australia
07 Jan 2025
Non-Small Cell Lung CancerPhase 3
Turkey
07 Jan 2025
Non-Small Cell Lung CancerPhase 3
United Kingdom
07 Jan 2025
Triple Negative Breast CancerPhase 3
China
11 Jun 2024
Non-squamous non-small cell lung cancerPhase 3
China
26 Jun 2023
Advanced breast cancerPhase 2-01 Apr 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
8
nyaqmlrcke(mdoxgvhdpk) = Stomatitis was reported in 6/8 patients (Grade 3 in 2 patients), which led to a dose reduction of BNT325 in 3 patients nzmataqupa (cxkrnkuleu )
Positive
27 Apr 2025
Phase 2
50
BNT327 30 mg/kg + Platinum-Etoposide
pfvcjdamsp(wxsgidkcgu) = lbasdcprrd djmxmnwxdl (inkprufebb )
Positive
26 Mar 2025
Phase 2
Small Cell Lung Cancer
Second line
PD-L1 | VEGF-A
70
zmakykmpmh(kymweqvaje) = echkfifywg lcfdatubwc (wxadfmggfb, 29.4 - 54.4)
Positive
26 Mar 2025
Phase 1/2
42
zmxlgnqcpa(gbchwizfss) = kihyqorwdh gbmyoubnah (cdvprvlyjh )
Positive
10 Dec 2024
Phase 1/2
Triple Negative Breast Cancer
First line
PD-L1 | ER Negative | PR Negative ...
42
vzpfizesag(cmzjnshrhl) = phtakarlcn jpyenbdavj (dpulxbmfjr, 63.2 - 89.7)
Positive
16 Sep 2024
Phase 1/2
53
PM8002/BNT-327
qghfllqsep(gkwcugzpxm) = nwruehzmlg asshtlmizn (lxqbmdmjya )
Positive
15 Sep 2024
Phase 2
64
PM8002+carboplatin+pemetrexed
ufwivwvcjn(hcijrjazdw) = hphovstpjf cimicmspjd (kfcctbigqc, 41.8 - 67.2)
Positive
14 Sep 2024
PM8002+carboplatin+pemetrexed
(PD-L1 TPS<1%)
ufwivwvcjn(hcijrjazdw) = vosqsnnwzj cimicmspjd (kfcctbigqc, 18.6 - 55.9)
Phase 1/2
61
zxrkjyhjbh(upirbmhfnb) = kkmulwlvhg szosfgqlls (zbtoizeude )
Positive
24 May 2024
(Treatment-naive)
zxrkjyhjbh(upirbmhfnb) = ulikvifhqe szosfgqlls (zbtoizeude )
Phase 1/2
87
onnymtezoi(levklmytlr) = uzvispuutq fauxobvnhc (gfoaeqxqez )
Positive
24 May 2024
(PROC)
onnymtezoi(levklmytlr) = kmyrlwihdh fauxobvnhc (gfoaeqxqez )
Phase 1/2
Triple Negative Breast Cancer
ER Negative | PR Negative | HER2 Negative
25
Albumin-Bound Paclitaxel+PM8002
kbmqgqgefh(kxwwdahapk) = zmxnbmhdpp krhlleskpj (dxgavjhuna )
Positive
26 May 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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