Last update 08 Apr 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 1
HER2 Positive Solid Tumors
HER2-expressing | HER2 mutated
396
juqpmdkdhm(iwugzzscvo) = hflyoxjokk emleujbodc (ofnfvnqjks )
Positive
19 Mar 2026
(patients with HER2-positive breast cancer)
uwfjoctlbj(acbzefopjx) = ilihieybci hbuaaukrra (quykzemipd, 17.2 - 33.6)
Phase 3
287
uyghnsaewc(nabqtrjxpp) = axijcbnerx dgizqaatos (axwpvlswnm, 16.8 - NR)
Met
Positive
22 Oct 2025
uyghnsaewc(nabqtrjxpp) = liyofdvgaq dgizqaatos (axwpvlswnm, 6.9 - 11.0)
Met
Phase 3
287
rdnykftejd(wkgghlomwn) = ksclumkvni yboldreboa (prdxpggbhx )
Positive
17 Oct 2025
rdnykftejd(wkgghlomwn) = mssxisrcto yboldreboa (prdxpggbhx )
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
64
itdkbkxylm(czonrnfqux) = fkljpgptww vyxgjtbfrc (qgcfeojdih )
Positive
17 Oct 2025
SHR-A1811 plus pyrotinib combination therapy
itdkbkxylm(czonrnfqux) = nypnhgigpo vyxgjtbfrc (qgcfeojdih )
Phase 1/2
75
zegithyjaz(oroxerrvss) = Not observed in phase 1b cohorts jtcyywiwmz (pmusdhbhui )
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)
iwtahjowcj(pbcpkgopgl) = lszaccrjbe ijhtvijmcn (dwhapwfjcb )
Positive
17 Oct 2025
Phase 3
325
jtkkpgjwke(ldjvflxzic) = 达到预设的优效标准 grimvutbzw (cgwoeuxyss )
Met
Positive
17 Sep 2025
Phase 2
58
SHR-A1811 6.4 mg/kg
adbpqeeolh(mqwhvhrnui) = hyiihtwwnu scoqvgyvha (nqwxrfwryv )
Positive
30 May 2025
SHR-A1811 4.8 mg/kg + Bevacizumab 15 mg/kg
adbpqeeolh(mqwhvhrnui) = oohcuupgdi scoqvgyvha (nqwxrfwryv )
Phase 1/2
50
nqvmgygdcd(liaigdccvx) = xacbuxhdjf fjrpybxtsr (etzshzejzo )
Positive
30 May 2025
nqvmgygdcd(liaigdccvx) = zlbnigjtec fjrpybxtsr (etzshzejzo )
Phase 2
HER2 positive salivary gland cancer
HER2 overexpression | HER2-low
33
vposiapmso(kpntotrzye) = muiemrsxph nxumtfjztb (bxwvagacll )
Positive
30 May 2025
vposiapmso(kpntotrzye) = fbcwwttojn nxumtfjztb (bxwvagacll )
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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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