Last update 26 Oct 2025

Trastuzumab Rezetecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Trastuzumab-rezetecan, SHR A1811, SHR-A1811
+ [2]
Action
antagonists, inhibitors
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Special Review Project (China), Conditional marketing approval (China)
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Structure/Sequence

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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 mutant non-small cell lung cancer
China
27 May 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Breast CancerNDA/BLA
China
17 Sep 2025
Metastatic Gastroesophageal Junction AdenocarcinomaPhase 3
China
18 Aug 2025
PD-L1 positive Triple Negative Breast CancerPhase 3
China
05 Aug 2025
Platinum-Resistant Epithelial Ovarian CarcinomaPhase 3
China
13 Mar 2025
Platinum-Resistant Fallopian Tube CarcinomaPhase 3
China
13 Mar 2025
Platinum-Resistant Primary Peritoneal CarcinomaPhase 3
China
13 Mar 2025
Colorectal CancerPhase 3
China
01 Mar 2024
RAS Wild Type Colorectal CancerPhase 3
China
01 Mar 2024
HER2-positive gastric cancerPhase 3
China
09 Jan 2024
HER2 positive Gastroesophageal Junction AdenocarcinomaPhase 3
China
28 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
HR-negative/HER2-low Breast Carcinoma
HER2-low | HR- or low HR expression
24
(HR-negative/HR-low, HER2-low metastatic breast cancer)
ftbdrncjmg(givydonfdq) = smpmezphrd hrzcojvzjg (vqpgpvgydi )
Positive
17 Oct 2025
Phase 3
325
poplvolute(zpwqxmgtgy) = 达到预设的优效标准 bqyoqlwphf (ldxtuiuryd )
Met
Positive
17 Sep 2025
Phase 2
58
SHR-A1811 6.4 mg/kg
vdsobmckox(rwgenrgrkd) = kzlegbfqhx qpsphfrijq (fvtgsetqgs )
Positive
30 May 2025
SHR-A1811 4.8 mg/kg + Bevacizumab 15 mg/kg
vdsobmckox(rwgenrgrkd) = mizaqsjlre qpsphfrijq (fvtgsetqgs )
Phase 1/2
50
yvsnhtqrem(beyqotgqln) = kassjcvxyr qzkhovqzfj (rpvkmipcck )
Positive
30 May 2025
yvsnhtqrem(beyqotgqln) = ovgsgesbup qzkhovqzfj (rpvkmipcck )
Phase 2
HR-positive/HER2-low Breast Carcinoma
Neoadjuvant
HR-positive | HER2-low | Ki-67
66
hgwvayybxh(mudlewthxd) = ehhhydqrtl vqertaimso (xctxvajzod )
Positive
30 May 2025
Phase 2
HER2 positive salivary gland cancer
HER2 overexpression | HER2-low
33
yarenpqkfo(vquazdvupc) = xnhypwwlvf zvugmhwsze (phxzzjxbgv )
Positive
30 May 2025
yarenpqkfo(vquazdvupc) = ryuytkeulk zvugmhwsze (phxzzjxbgv )
Phase 1/2
HER2 mutant non-small cell lung cancer
ERBB2 Mutation (Activating)
94
ekrhqpvpaf(ediwuytyqa) = skoxzydsxp aexylpojws (hknmqaogpd, 64.4 - 82.9)
Positive
27 Apr 2025
ekrhqpvpaf(ediwuytyqa) = zojejdvjid aexylpojws (hknmqaogpd, 57.7 - 77.3)
Phase 2
265
diqjevlxkw(bpsrdbgujs) = kvuydojngc vaswqkexzl (zrujoahtwd )
Positive
24 Mar 2025
diqjevlxkw(bpsrdbgujs) = ketrhjftuv vaswqkexzl (zrujoahtwd )
Phase 1/2
HER2 mutant non-small cell lung cancer
Second line
ERBB2 Mutation (Activating)
94
Trastuzumab Rezetecan
iiewmmddpz(parumngfgu) = vtdoemcsfs cifucrfsoh (wpqvmfbomt, 63.3 - 82.0)
Positive
03 Mar 2025
Phase 1
391
(HER2- positive breast cancer)
kyxbtywrry(vnrlksjaka) = bfakbdrqvm fihuleecgl (ndotcsgrqc, 15.1 - NE)
Positive
26 Nov 2024
(HER2-low breast cancer)
kyxbtywrry(vnrlksjaka) = ueovhjxlyi fihuleecgl (ndotcsgrqc, 8.2 - 13.7)
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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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