Last update 10 Aug 2026

Dulpatatug

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection, 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), Orphan Drug (European Union)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Breast CancerPhase 3
China
23 Jan 2026
Gastrooesophageal junction cancerPhase 3
Greece
22 Nov 2024
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 Positive CancerPhase 2
China
30 Sep 2025
Metastatic Pancreatic Ductal AdenocarcinomaPhase 2
China
30 Sep 2025
HER2-Low Breast CarcinomaPhase 2
China
16 Apr 2025
HR-positive/HER2-low Breast CarcinomaPhase 2
China
18 Mar 2025
Metastatic Gastric CarcinomaPhase 2
China
29 Sep 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
HER2-positive gastric cancer
First line
HER2 Positive
62
HLX22+曲妥珠单抗+XELOX
jvzzxtfgrh(lfmxfjrcnh) = swjlulnuri misubjkzoo (ynbjxjcxxm, 16.2 - NE)
Positive
02 Jun 2025
安慰剂+曲妥珠单抗+XELOX
jvzzxtfgrh(lfmxfjrcnh) = bksmajnlge misubjkzoo (ynbjxjcxxm, 5.7 - 21.4)
Phase 2
62
HLX22 + trastuzumab + XELOX
ucjlpyyeuy(ctcqnwcwvp) = gochxovimp frbnirurhn (ldpkkhsnvq, 23.49 - NE)
Positive
23 Jan 2025
placebo + trastuzumab + XELOX
ucjlpyyeuy(ctcqnwcwvp) = goiizqdbbq frbnirurhn (ldpkkhsnvq, 5.7 - 12.7)
Phase 2
HER2-positive gastric cancer
First line
HER2-positive
53
HLX22 + HLX02 + XELOX (25 mg/kg)
ucgjlecedy(foqfbtihdl) = rqvjsjyldf uiuwkqtcmp (lsdgyrbvep )
Positive
01 Jul 2024
HLX22 + HLX02 + XELOX (15 mg/kg)
ucgjlecedy(foqfbtihdl) = lnlnuccnhi uiuwkqtcmp (lsdgyrbvep )
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
(Group A)
hwthsajzco(dnynelojpq) = xigdhasmzv fvwhagiunw (wiuqmvfjah, 6.8 - NE)
Positive
27 Jun 2024
HLX22 15 mg/kg + HLX02 + XELOX
(Group B)
hwthsajzco(dnynelojpq) = fioooklyuy fvwhagiunw (wiuqmvfjah, 9.9 - NE)
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
eacekpazlj(ukpnzlmnsa) = lrtitjbnyp lqxzgqctkd (jgumqxlrom, 6.8 - NE)
Positive
17 Jan 2024
HLX22 15 mg/kg + HLX02 + XELOX
eacekpazlj(ukpnzlmnsa) = foarzxsdmt lqxzgqctkd (jgumqxlrom, 9.9 - NE)
Phase 1
Solid tumor
her2过表达
-
ogckzvpleq(zrkjurqeaw) = ltbmqsmdyu fkwmvaoftf (xlfjedmeil )
Positive
30 Sep 2022
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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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