Last update 29 Mar 2025

Nofazinlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
CS 1003, CS-1003, CS1003
+ [1]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Nofazinlimab--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Hepatocellular CarcinomaPhase 3
United States
13 Dec 2019
Advanced Hepatocellular CarcinomaPhase 3
China
13 Dec 2019
Advanced Hepatocellular CarcinomaPhase 3
Italy
13 Dec 2019
Advanced Hepatocellular CarcinomaPhase 3
Poland
13 Dec 2019
Advanced Hepatocellular CarcinomaPhase 3
Spain
13 Dec 2019
Advanced Hepatocellular CarcinomaPhase 3
Taiwan Province
13 Dec 2019
Liver CancerPhase 3--
LymphomaPhase 1
China
29 Oct 2018
Advanced cancerPhase 1
Australia
09 May 2018
Advanced Malignant Solid NeoplasmPhase 1
Australia
26 Apr 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
107
Nofazinlimab 60 mg Q3W
uhxhbixjux(vuwmoxsrcs) = none wjbkcclrld (zznllkyhrw )
Positive
04 Sep 2024
(Phase 1b)
Phase 1
20
Lenvatinib+CS1003
eeigjceqdl(nyarfwehsy) = Confirmed ORR was changed from 30.0% to 45.0% (95% CI: 23.06%, 68.47%) with 9 pts achieving partial response. axxxmrblgs (bveyfdfbki )
Positive
02 Jun 2022
Phase 1
36
(MSI-H/dMMR tumors or MEL + arm A)
zsspbdlpai(bzmhntnmov) = 5 (9.3%) pts had AEs leading to discontinuation of CS1002 and CS1003. kinsqujssu (cciszpnbuz )
Positive
09 Dec 2021
(MSI-H/dMMR tumors or MEL + arm B)
Phase 1
33
CS1003 200 mg+CS1002 0.3 mg/kg
hnjrxafhgu(vjnmrprvvp) = Two (6.1%) pts experienced AEs leading to discontinuation of CS1002 and CS1003. loyxkhyryy (qcakecevbs )
Positive
16 Sep 2021
CS1003 200 mg+CS1002 1 mg/kg
Phase 1
19
CS1003+lenvatinib
uagkdhwxnt(kuceksckwc) = iybmwasdqq cnjluoxmlt (wkmjzzrbzq )
Positive
17 Sep 2020
Phase 1
108
CS1003 200 mg Q3W
rautmeunug(hhlpvcwhkr) = 41% (12/29) and 47% (14/30) pts had all-grade treatment-related adverse events (TRAEs), respectively. The TRAE profiles were comparable in both cohorts overall with two Grade (G) ≥ 3 events (G3 dermatitis and G4 Type 1 diabetes mellitus in cohort B), and the rest were G1/2. jqjrifirck (sdxsmctuua )
-
17 Sep 2020
CS1003 400 mg Q6W
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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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