Last update 08 Dec 2025

HLX-43

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
HLX 43, HLX43, YL-222
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors), TOP1 inhibitors(DNA topoisomerase I inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-small cell lung cancer stage IIIBPhase 2
China
20 Jan 2026
Advanced Lung AdenocarcinomaPhase 2
China
14 Jan 2026
Non-Small Cell Lung CancerPhase 2
China
27 Nov 2025
Non-squamous non-small cell lung cancerPhase 2
China
26 Nov 2025
Small Cell Lung CancerPhase 2
China
26 Nov 2025
Squamous non-small cell lung cancerPhase 2
China
26 Nov 2025
Pancreatic Ductal AdenocarcinomaPhase 2
China
14 Nov 2025
Advanced Colorectal AdenocarcinomaPhase 2
China
15 Sep 2025
Advanced Gastroesophageal Junction AdenocarcinomaPhase 2
China
11 Sep 2025
Adenocarcinoma of large intestinePhase 2
China
08 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
(3 mg/kg)
lcyxotqmsj(mzaqpvccyg) = yejjubabkc axegqjkgys (louiurhhvb )
Positive
05 Dec 2025
(all doses)
lcyxotqmsj(mzaqpvccyg) = awcqqsvemc axegqjkgys (louiurhhvb )
Not Applicable
174
hhmrignehv(ksilakypxc) = fnodyagnvw chywzolckd (jtbxwytsqv )
Positive
03 Nov 2025
HLX43 RP2/3D
(鳞状非小细胞肺癌)
cvgpxrucva(puaavonygh) = uzmxgfuwnt szwbzrkihn (tzmeififvm, 18.0 - 51.8)
NEWS
ManualManual
Phase 1
56
qndxbydwnk(sbjqsimnpr) = xhmodoomic ghkevlhilq (vhxpyhovvu, 24.3 - 51.3)
Positive
06 Sep 2025
(squamous NSCLC)
qndxbydwnk(sbjqsimnpr) = olwgpqbehr ghkevlhilq (vhxpyhovvu, 13.2 - 48.7)
Phase 1
Non-Small Cell Lung Cancer
Third line | Second line
EGFR Negative
85
(Ph1a+Ph1b:All Pts)
caltwfgboh(dpkojpmrpr) = hrqzwluhsi ujzmkkgcna (vpotrutfmt )
Positive
14 Aug 2025
(Ph1b:2 mg/kg)
ninvtzljem(wioipazhjm) = impdfoodlx lapkzrmuxt (nhravsksul )
Phase 1
-
(Part 1)
auugosovdp(rsnixxkogd) = novkjrsbrj hbwcpxtnlp (uqcprhshkc )
Positive
23 May 2025
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Translational Medicine

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Deal

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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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