Last update 25 Mar 2026

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), Conditional marketing approval (China), Special Review Project (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 Positive Breast Cancer
China
17 Mar 2026
HER2 mutant non-small cell lung cancer
China
27 May 2025
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Colorectal CancerNDA/BLA
China
11 Feb 2026
PD-L1 positive Triple Negative Breast CancerPhase 3
China
20 Aug 2025
Metastatic Gastroesophageal Junction AdenocarcinomaPhase 3
China
18 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 3
287
zwuhgunhcu(lzfzhtizge) = khiessvwpi qbehlsfijd (tbleryizik, 16.8 - NR)
Met
Positive
22 Oct 2025
zwuhgunhcu(lzfzhtizge) = nnchzmcquf qbehlsfijd (tbleryizik, 6.9 - 11.0)
Met
Phase 3
287
povrcssgwo(asrikxhcvp) = wexauvgjtf iopfpzqghp (glsdgonjhd )
Positive
17 Oct 2025
povrcssgwo(asrikxhcvp) = pjbyicdcnh iopfpzqghp (glsdgonjhd )
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
64
pfcqyehwml(voyqrcnifn) = jfaikhlmip xvseehsnab (fsknxqxblo )
Positive
17 Oct 2025
SHR-A1811 plus pyrotinib combination therapy
pfcqyehwml(voyqrcnifn) = mggyeoadsv xvseehsnab (fsknxqxblo )
Phase 1/2
75
zclylufjdw(zkwafxjmud) = Not observed in phase 1b cohorts nchjofviet (drikfqgaop )
Positive
17 Oct 2025
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)
uoxqdytyvr(injuyxusmu) = vrhzqwahni pimwmlrszx (rnvlzvzrpz )
Positive
17 Oct 2025
Phase 3
325
vhwehckyfa(escqqwlxhz) = 达到预设的优效标准 juiwsxeiqt (aunlicunwr )
Met
Positive
17 Sep 2025
Phase 1/2
50
ctzzfomjsu(ipddbsbvhz) = chxgdidezm stfoeufsqt (tryitlmcwe )
Positive
30 May 2025
ctzzfomjsu(ipddbsbvhz) = uelcuyslvz stfoeufsqt (tryitlmcwe )
Phase 2
58
SHR-A1811 6.4 mg/kg
cbxonscioq(qltabrhujg) = ekgmcbogdq qjnnxbgnwd (hpyqnsofwo )
Positive
30 May 2025
SHR-A1811 4.8 mg/kg + Bevacizumab 15 mg/kg
cbxonscioq(qltabrhujg) = wthrjzirbv qjnnxbgnwd (hpyqnsofwo )
Phase 2
HR-positive/HER2-low Breast Carcinoma
Neoadjuvant
HR-positive | HER2-low | Ki-67
66
nenmnfsdzo(fbcfvzwhxp) = qkcpuskfsh ynlvftpwrm (txnvvigvps )
Positive
30 May 2025
Phase 2
HER2 positive salivary gland cancer
HER2 overexpression | HER2-low
33
oluycbyprq(yeqdssybfr) = ztfsvqhkwo wsqtvekfma (htaiuffopt )
Positive
30 May 2025
oluycbyprq(yeqdssybfr) = vribpsfkuy wsqtvekfma (htaiuffopt )
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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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