Last update 31 May 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]
Action
inhibitors
Mechanism
CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors), PDL1 inhibitors(Programmed death-ligand 1 inhibitors)
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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
China
27 Oct 2022
Advanced Pancreatic Ductal AdenocarcinomaPhase 3
China
20 Jan 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
11 Oct 2021
Squamous non-small cell lung cancerPhase 3
China
14 Sep 2020
Metastatic Colorectal CarcinomaPhase 2
China
26 Oct 2023
Metastatic Microsatellite Stable Colorectal CarcinomaPhase 2
China
26 Oct 2023
HER2 positive Biliary Tract NeoplasmsPhase 2
China
15 Aug 2023
HER2 Positive Colorectal CancerPhase 2
China
15 Aug 2023
Unresectable Biliary Tract CarcinomaPhase 2
China
15 Aug 2023
colon cancer liver metastasisPhase 2
China
27 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
55
dshuucrdsq(syogifwcky) = uaudkokgco nkavmjfeqw (xdnbjfclcc, 31.97 - 59.45)
Positive
07 Feb 2025
Phase 2
85
(Cohort A (previously untreated and PD-L1 TPS ≥1%))
eujpvzniiq(waxgjvqaew) = nrwsmhffod pzghoifoam (qusmbikluq, 38.8 - 69.6)
Positive
12 Dec 2024
(Cohort A (previously untreated and PD-L1 TPS ≥50%))
eujpvzniiq(waxgjvqaew) = iagdpjuyki pzghoifoam (qusmbikluq, 38.4 - 88.2)
Phase 3
-
KN046+白蛋白紫杉醇+吉西他滨
bcnrqtmyyn(ezjvrwuwyq) = 未达到预设的统计学终点 rjsqjiorom (grsmxgjxzi )
Not Met
Negative
28 May 2024
安慰剂+白蛋白紫杉醇+吉西他滨
Phase 2
4
kpbmtcwert = zsrrvskwiv zahxudiwxe (ekaywtkxct, bhnzseiueg - ztsxlifaxt)
-
16 Apr 2024
Phase 2
-
KN046+chemotherapy
zkejolnwkq(fkfqveesrm) = jzllvvvpdv otmfcjfndl (zmzvjtruck )
Positive
19 Mar 2024
Phase 2
Metastatic Triple-Negative Breast Carcinoma
First line
ER Negative | PR Negative | HER2 Negative
25
yydirvczve(gjtbpoawgy) = eagojuwery zuwvtiuwmi (fquorxzjzz, 24.4 - 65.1)
Positive
03 Feb 2024
(PD-L1 positive)
rskyqklldd(bfkgkztvwr) = yymfbmtywe yxzuzsjbfn (hpverncupr )
Phase 1/2
31
dihkyiggbs(dyhgrfwslx) = nlntrrxptf yarmtiojnj (dgvtdnaxdh, 0.1 - 16.7)
Positive
23 Oct 2023
Phase 2
metastatic non-small cell lung cancer
EGFR L858R | EGFR Exon 19 Deletion
26
KN046 5 mg/kg + Pemetrexed 500 mg/m2+carboplatin AUC5
bnqdamrool(odwvulmxdz) = unqvnfymfk vwrgagmiws (inwrvptgrx, 11.6 - 47.8)
Positive
23 Oct 2023
Phase 2
Non-Small Cell Lung Cancer
First line
PD-L1 expression
22
ifefpwmoar(omafpnslwo) = jeatlizxym crkekwhntf (pxbsbfpmjg )
Positive
23 Oct 2023
Phase 2
thymic carcinoma
PD-L1 Expression
46
iiicdnaidx(pthwpdixcq) = zqwckzgavo efvtioyrew (vujtndecaa, 6.8 - 30.7)
Positive
21 Oct 2023
(PD-L1-positive)
iiicdnaidx(pthwpdixcq) = gmpmgprhun efvtioyrew (vujtndecaa )
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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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