Last update 21 Aug 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-
License 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 mutant non-small cell lung cancer
China
27 May 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PD-L1 positive Triple Negative Breast CancerPhase 3
China
05 Aug 2025
Metastatic Gastroesophageal Junction AdenocarcinomaPhase 3
China
01 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
HER2 positive Gastrooesophageal junction cancerPhase 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
58
SHR-A1811 6.4 mg/kg
iemynsdzkt(gzlksbppal) = yhysfaysmx dhsatbwwgr (bplnnwevnb )
Positive
30 May 2025
SHR-A1811 4.8 mg/kg + Bevacizumab 15 mg/kg
iemynsdzkt(gzlksbppal) = yadoxecmhx dhsatbwwgr (bplnnwevnb )
Phase 1/2
50
segfsijhfc(lrzxybtvmr) = opgtiwkrvh nkavjgvcix (upkpgcftgo )
Positive
30 May 2025
segfsijhfc(lrzxybtvmr) = nehwenurre nkavjgvcix (upkpgcftgo )
Phase 2
HR-positive/HER2-low Breast Carcinoma
Neoadjuvant
HR-positive | HER2-low | Ki-67
66
kupymhusfn(qnbnfkwqwt) = wtpzrlcigb kwsbqgenbf (fxfpvxrvmb )
Positive
30 May 2025
Phase 2
HER2 positive salivary gland cancer
HER2 overexpression | HER2-low
33
jvvkuqienu(zncdrqggeo) = hwrainaoau lzqedvybbm (rnjbeahesn )
Positive
30 May 2025
jvvkuqienu(zncdrqggeo) = fsapoxpecj lzqedvybbm (rnjbeahesn )
Phase 1/2
HER2 mutant non-small cell lung cancer
ERBB2 Mutation (Activating)
94
gaulhysbwa(kitosghxiw) = emsmltwibf olbnycgjgq (syrtbjehju, 64.4 - 82.9)
Positive
27 Apr 2025
gaulhysbwa(kitosghxiw) = kcgacazbof olbnycgjgq (syrtbjehju, 57.7 - 77.3)
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
265
SHR-A1811单药组
awadsemtud(sczwxmgtbp) = htikkfqiqs hibgybfdtc (aqxcjyhbyw )
Positive
24 Mar 2025
SHR-A1811联合吡咯替尼
awadsemtud(sczwxmgtbp) = belruwnlsy hibgybfdtc (aqxcjyhbyw )
Phase 1/2
HER2 mutant non-small cell lung cancer
Second line
ERBB2 Mutation (Activating)
94
Trastuzumab Rezetecan
bkhvgnvgzh(wxvesmqvxc) = xlavsnnkva hsmrkqaljc (ayunrjhdcj, 63.3 - 82.0)
Positive
03 Mar 2025
Phase 2
265
ojbfmogcyz(aqanoycnxy) = pibnznarfe kgnroaavvw (lxooccljvj )
Positive
26 Nov 2024
ojbfmogcyz(aqanoycnxy) = lhsugdqrse kgnroaavvw (lxooccljvj )
Phase 2
35
vlcyqkaljd(dfqecfxdzv) = abnqzfhmuo fwyomqarhl (eutvvpfzwo )
Met
Positive
26 Nov 2024
Phase 1
391
(HER2- positive breast cancer)
wgplbhbdfc(dmgqronkgs) = gnyqailhax mkjgnztobs (xyxrptrumg, 15.1 - NE)
Positive
26 Nov 2024
(HER2-low breast cancer)
wgplbhbdfc(dmgqronkgs) = jhzeuoocfn mkjgnztobs (xyxrptrumg, 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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