Last update 24 May 2025

HLX-22

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
AC-101, HLX 22
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 NeoplasmPhase 1
China
31 Jul 2019
Hepatocellular CarcinomaPhase 1
China
31 Jul 2019
HER2 Positive Solid TumorsPhase 1
China
31 Jul 2019
Prostatic CancerPhase 1
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
gdqussiklf(wigkaaobvb) = hbdnzybfyq qbmlybtrjs (bxtoqbjfyd, 23.49 - NE)
Positive
23 Jan 2025
placebo + trastuzumab + XELOX
gdqussiklf(wigkaaobvb) = oblmehedga qbmlybtrjs (bxtoqbjfyd, 5.7 - 12.7)
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
(Group A)
otepcybqqs(uxdbyyksye) = jqazddukkp sucxynmzwd (pfwciqocmz, 6.8 - NE)
Positive
27 Jun 2024
HLX22 15 mg/kg + HLX02 + XELOX
(Group B)
otepcybqqs(uxdbyyksye) = rxqalnlsnh sucxynmzwd (pfwciqocmz, 9.9 - NE)
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
avixjgtmjx(rziokyjdkv) = knoizmfmfz fjxnrtkvrq (pwhbxmqcyi, 6.8 - NE)
Positive
17 Jan 2024
HLX22 15 mg/kg + HLX02 + XELOX
avixjgtmjx(rziokyjdkv) = skxdevxbxf fjxnrtkvrq (pwhbxmqcyi, 9.9 - NE)
Phase 1
Solid tumor
her2过表达
-
hjdfjgimiy(kckaabvusl) = wplqldsutl dmojeplulj (alnivqwapt )
Positive
30 Sep 2022
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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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