Last update 21 Sep 2026

Prolgolimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
BCD-100, Forteca
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization
License Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Uterine Cervical CancerPhase 3
China
20 Jul 2022
Metastatic melanomaPhase 3
Russia
01 Feb 2022
Unresectable MelanomaPhase 3
Russia
01 Feb 2022
Advanced Lung Non-Squamous Non-Small Cell CarcinomaPhase 3
China
13 Sep 2021
Advanced Lung Non-Squamous Non-Small Cell CarcinomaPhase 3
China
13 Sep 2021
Advanced Cervical CarcinomaPhase 3
United States
01 Oct 2019
Advanced Cervical CarcinomaPhase 3
China
01 Oct 2019
Advanced Cervical CarcinomaPhase 3
Russia
01 Oct 2019
Advanced Cervical CarcinomaPhase 3
Turkey
01 Oct 2019
Non-squamous non-small cell lung cancerPhase 3
United States
01 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
271
nurulimab + prolgolimab
jcjgtxdnww(acwdregyox) = felsxwwyaq vllcixxomz (isudjajjzi, 8.4 - NA)
Positive
29 May 2026
jcjgtxdnww(acwdregyox) = zkqcgmplaa vllcixxomz (isudjajjzi, 4.2 - 14.8)
Phase 3
-
Prolgolimab + Nurulimab
tfwjqqzipq(thmdiuthyc): HR = 0.58 (95% CI, 0.38 - 0.9), P-Value = 0.015
Positive
30 May 2025
Nivolumab 1mg/kg + Ipilimumab 3mg/kg
Phase 1/2
Non-Small Cell Lung Cancer
activating mutations | PD-L1 expression
239
qwjdrzjsdl(qbotzbzktu) = tcnvdpfmfs zrvocjwqir (ivvdebvftz )
-
30 May 2025
Phase 2
24
Prolgolimab 1 mg/kg
gkfzffeuyd(hmncfkxvwg) = rdqkuxtbje lraofhwntg (jvhvynoefr )
Positive
30 Mar 2025
Phase 3
292
Prolgolimab + Pemetrexed + Platinum-based chemotherapy
quokzpftod(ydsfrmyiym) = qrcvsmszsx zvvfmhzhqj (qgwstnmxqd, 22.28 - NA)
Positive
01 Feb 2025
Placebo + Pemetrexed + Platinum-based chemotherapy
quokzpftod(ydsfrmyiym) = ltsfugwftd zvvfmhzhqj (qgwstnmxqd, 11.73 - 19.15)
Phase 3
Non-squamous non-small cell lung cancer
First line
EGFR | ALK | PD-L1
291
Prolgolimab + Pemetrexed + Platinum drug
gqvymoxftt(qwetptbryy) = puwvvytftl rsxwqeatzp (otscafosym, 22.28 - NA)
Positive
09 Sep 2024
Placebo + Pemetrexed + Platinum drug
gqvymoxftt(qwetptbryy) = yelahqqgvz rsxwqeatzp (otscafosym, 11.73 - 19.15)
Phase 3
175
Prolgolimab 250 mg Q3W
rkqmcigsha(tqudpfyuvo) = gsguvcnbwn pkftukclky (ufxbzrbhwu, 24.8 - 42.8)
Positive
04 Sep 2024
Prolgolimab 1 mg/kg Q2W
rkqmcigsha(tqudpfyuvo) = wtfluphvzk pkftukclky (ufxbzrbhwu, 21.3 - 46.0)
Phase 2
26
Prolgolimab 1 mg/kg
nnyhgqabgl(pcxrubaoss) = zjhnxnjggr avinqmknta (xwyofikxbu )
Positive
27 Jun 2024
Not Applicable
4
scakibjcoc(lojyhdjdhv) = <1% zkycnyacco (kfwkkmpqve )
-
08 Jun 2023
Phase 2
58
pxclgnihfo(yrojzlnhoe) = hjtytfwota azcamyqorj (iylslyvgfq )
Positive
31 May 2023
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Deal

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Core Patent

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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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