Last update 08 May 2025

HLX-22

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)
Originator Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 positive Gastrooesophageal junction cancerPhase 3
China
08 Nov 2024
HER2-positive gastric cancerPhase 3
China
08 Nov 2024
Stomach CancerPhase 3
China
30 Jan 2023
HER2-Low Breast CarcinomaPhase 2
China
31 Mar 2025
HR-positive/HER2-low Breast CarcinomaPhase 2
China
18 Mar 2025
Metastatic Gastric CarcinomaPhase 2
China
29 Sep 2021
Advanced Malignant Solid NeoplasmPreclinical
China
31 Jul 2019
Hepatocellular CarcinomaPreclinical
China
31 Jul 2019
HER2 Positive Solid TumorsPreclinical
China
31 Jul 2019
Prostatic CancerPreclinical
China
31 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
62
HLX22 + trastuzumab + XELOX
(yscbpmoocy) = vaqrkmzacb nalagbflcn (zysxsrjrpx, 23.49 - NE)
Positive
23 Jan 2025
placebo + trastuzumab + XELOX
(yscbpmoocy) = wjdhkakrbo nalagbflcn (zysxsrjrpx, 5.7 - 12.7)
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
(Group A)
(dqzitwgeyz) = gfqcmwvfct niizzgalnq (yocqmfocke, 6.8 - NE)
Positive
27 Jun 2024
HLX22 15 mg/kg + HLX02 + XELOX
(Group B)
(dqzitwgeyz) = shidbiupub niizzgalnq (yocqmfocke, 9.9 - NE)
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
(yjxcytcyiq) = paqtgyttnk vuwxtrpfok (bldojgiomh, 6.8 - NE)
Positive
17 Jan 2024
HLX22 15 mg/kg + HLX02 + XELOX
(yjxcytcyiq) = tclohlkmhc vuwxtrpfok (bldojgiomh, 9.9 - NE)
Phase 1
Solid tumor
her2过表达
-
(bhqpqhfqbd) = wtvurjggpn fuxuuwxvcm (zamebuknkh )
Positive
30 Sep 2022
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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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