Last update 28 Jun 2025

Prolgolimab/nurulimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
BCD 217
Target
CTLA4 x PD-1
Action
inhibitors
Mechanism
CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Therapeutic Areas
NeoplasmsSkin and Musculoskeletal Diseases
Active Indication
Malignant melanoma, metastaticMelanoma, Cutaneous MalignantUnresectable Melanoma
Inactive Indication-
Originator Organization
Biocad Medical, Inc.
Active Organization
Biocad Medical, Inc.
Inactive Organization
Biocad CJSCBiocad CJSCShanghai Pharmaceuticals Holding Co., Ltd.Shanghai Pharmaceuticals Holding Co., Ltd.
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

Related

4
Clinical Trials associated with Prolgolimab/nurulimab
NCT05751928
/ RecruitingPhase 3
A Randomized Study of the Efficacy and Safety of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) Versus Standard Adjuvant Therapy With Pembrolizumab in Patients With Resectable Stage III Skin Melanoma.
CTRI/2022/12/048223
/ Active, not recruitingPhase 3
A Double-Blind Placebo-Controlled ComparativeRandomized Clinical Study of the Efficacy and Safety ofBCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-LineTreatment in Subjects with Unresectable/MetastaticMelanoma - OCTAVA
NCT05732805
/ Active, not recruitingPhase 3
A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma
100 Clinical Results associated with Prolgolimab/nurulimab
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100 Translational Medicine associated with Prolgolimab/nurulimab
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100 Patents (Medical) associated with Prolgolimab/nurulimab
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100 Deals associated with Prolgolimab/nurulimab
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Malignant melanoma, metastaticPhase 3
Belarus
Biocad Medical, Inc.
02 Aug 2022
Malignant melanoma, metastaticPhase 3
India
Biocad Medical, Inc.
02 Aug 2022
Malignant melanoma, metastaticPhase 3
Russia
Biocad Medical, Inc.
02 Aug 2022
Melanoma, Cutaneous MalignantPhase 3
Belarus
Biocad Medical, Inc.
02 Aug 2022
Melanoma, Cutaneous MalignantPhase 3
India
Biocad Medical, Inc.
02 Aug 2022
Melanoma, Cutaneous MalignantPhase 3
Russia
Biocad Medical, Inc.
02 Aug 2022
Unresectable MelanomaPhase 3
Belarus
Biocad Medical, Inc.
02 Aug 2022
Unresectable MelanomaPhase 3
India
Biocad Medical, Inc.
02 Aug 2022
Unresectable MelanomaPhase 3
Russia
Biocad Medical, Inc.
02 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NCT05751928 (BCD-217-3 | NEO-MIMAJOR, ESMO2024)
ManualManual
Phase 3
Melanoma
Neoadjuvant
57
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Positive
14 Sep 2024
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Translational Medicine

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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.
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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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