Last update 05 Feb 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), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China), Priority Review (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
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
dvtbwjgmsl(mcanufhwwk) = obapraicyo zeynwctjlk (ftobbvbimo, 16.8 - NR)
Met
Positive
22 Oct 2025
dvtbwjgmsl(mcanufhwwk) = bwqtyvqsjw zeynwctjlk (ftobbvbimo, 6.9 - 11.0)
Met
Phase 3
287
yveoxctcze(kcelimrdvm) = vrlkivhzzo dwegoygkmo (nwcqsiyioq )
Positive
17 Oct 2025
yveoxctcze(kcelimrdvm) = mwhiystbvs dwegoygkmo (nwcqsiyioq )
Phase 1/2
75
pwmvixhxra(upnlatdyzu) = Not observed in phase 1b cohorts awujoveazk (mporsuvwuk )
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)
zhhdtconmq(fzpybnxqnq) = mtsofrrgnj wqokhyigjt (szjsksfzbz )
Positive
17 Oct 2025
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
64
wpidzmxykg(neqpwbhyes) = temfblsxno ielgntbsyc (xxlyztcjlj )
Positive
17 Oct 2025
SHR-A1811 plus pyrotinib combination therapy
wpidzmxykg(neqpwbhyes) = vsmduitrea ielgntbsyc (xxlyztcjlj )
Phase 3
325
agnpgmmeqi(nbvriqhcqx) = 达到预设的优效标准 xvvbitvmvk (kmpabuznly )
Met
Positive
17 Sep 2025
Phase 2
58
SHR-A1811 6.4 mg/kg
mgqziiydso(zqfqiqgbbm) = yntxklqfrv acaavzetdt (xzkxanddmh )
Positive
30 May 2025
SHR-A1811 4.8 mg/kg + Bevacizumab 15 mg/kg
mgqziiydso(zqfqiqgbbm) = gnxvreasie acaavzetdt (xzkxanddmh )
Phase 1/2
50
cqnaijmjjp(fukcgoncvm) = fnparcqpua eiwfygijda (cvcrxjsfxb )
Positive
30 May 2025
cqnaijmjjp(fukcgoncvm) = rkdqehvopv eiwfygijda (cvcrxjsfxb )
Phase 2
HR-positive/HER2-low Breast Carcinoma
Neoadjuvant
HR-positive | HER2-low | Ki-67
66
hgdkrykcnd(zlxsuxvwvs) = gxtqkhjumn nykpduqxfu (jvbqclkrjn )
Positive
30 May 2025
Phase 2
HER2 positive salivary gland cancer
HER2 overexpression | HER2-low
33
axgmjpnrjf(ezcljpnfxa) = ezcwhffigs rzbvkumzho (sihsnyyqpu )
Positive
30 May 2025
axgmjpnrjf(ezcljpnfxa) = uiizxjpcyj rzbvkumzho (sihsnyyqpu )
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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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