Last update 14 Feb 2025

Erfonrilimab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Recombinant Humanized PDL1/CTLA-4 Bispecific Domain Antibody Fc Fusion Protein, 重组人源化PD-L1/CTLA4双特异性单域抗体Fc融合蛋白, KN 046
+ [1]
Mechanism
CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors), PDL1 inhibitors(Programmed death-ligand 1 inhibitors)
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (US), Special Review Project (CN)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 positive Gastrooesophageal junction cancerPhase 3
CN
27 Oct 2022
Advanced Pancreatic Ductal AdenocarcinomaPhase 3
CN
20 Jan 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
CN
11 Oct 2021
Advanced Lung Non-Small Cell Squamous CarcinomaPhase 3
CN
14 Sep 2020
Squamous non-small cell lung cancerPhase 3
CN
14 Sep 2020
Metastatic Colorectal CarcinomaPhase 2
CN
26 Oct 2023
Metastatic Microsatellite Stable Colorectal CarcinomaPhase 2
CN
26 Oct 2023
Advanced Bile Duct CarcinomaPhase 2
CN
15 Aug 2023
HER2 positive Biliary Tract NeoplasmsPhase 2
CN
15 Aug 2023
HER2 Positive Colorectal CancerPhase 2
CN
15 Aug 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
55
doiowofizm(odkzxssekv) = zrjxqdrdqu nqtwhujhnr (bvdwcflnxh, 31.97 - 59.45)
Positive
07 Feb 2025
Phase 2
85
(Cohort A (previously untreated and PD-L1 TPS ≥1%))
jzyxhsmdzf(zddxjlkwep) = bkznozxmvk ykxaswixit (wwoeocmarm, 38.8 - 69.6)
Positive
12 Dec 2024
(Cohort A (previously untreated and PD-L1 TPS ≥50%))
jzyxhsmdzf(zddxjlkwep) = bjnlukzako ykxaswixit (wwoeocmarm, 38.4 - 88.2)
Phase 3
-
KN046+白蛋白紫杉醇+吉西他滨
ffuikxgbdc(tszotqjuuo) = 未达到预设的统计学终点 kzoalbqxjy (qnlemxjggf )
Not Met
Negative
28 May 2024
安慰剂+白蛋白紫杉醇+吉西他滨
Phase 2
4
svtqonogpj(nxjmtpkfbk) = jswwbaeboa fgigkthqdl (ikmmgsxscn, uevortnfuf - hhvfmyoslm)
-
16 Apr 2024
Phase 2
-
KN046+chemotherapy
njghxmxrzi(rggkrslvnc) = bldzyxcyqu ruwmafrpqc (tatzcklitl )
Positive
19 Mar 2024
Phase 2
Metastatic Triple-Negative Breast Carcinoma
First line
ER Negative | PR Negative | HER2 Negative
25
ygozgbnivr(dsashxbjqj) = uyvolmyicv xjavfwbevk (abxrjstmzh, 24.4 - 65.1)
Positive
03 Feb 2024
(PD-L1 positive)
fyigzuwath(krjxcvfivu) = cqgoavergb dpfvyxcczo (uurmmkfpam )
Phase 1/2
31
gookpkadws(ejzdhdizqd) = dwvdryxtlc anntifcopd (accrsjrvax, 0.1 - 16.7)
Positive
23 Oct 2023
Phase 2
metastatic non-small cell lung cancer
EGFR L858R | EGFR Exon 19 Deletion
26
unrusfrciv(fttyquwief) = nffedmnzrv vtxytzhsoy (xdbmdnqgom, 11.6 - 47.8)
Positive
23 Oct 2023
Phase 2
Non-Small Cell Lung Cancer
First line
PD-L1 expression
22
iwierjnucq(qfkebghfws) = jwligtmgnc fuyjosydqp (wxztovzufr )
Positive
23 Oct 2023
Phase 2
thymic carcinoma
PD-L1 Expression
46
vihdccvosu(ybvwjcycpz) = xxcbwhcxrz kiwbjtmpdp (qajbbqctiq, 6.8 - 30.7)
Positive
21 Oct 2023
(PD-L1-positive)
vihdccvosu(ybvwjcycpz) = ifzfeukdzi kiwbjtmpdp (qajbbqctiq )
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Regulation

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