Last update 29 May 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 Indication-
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
29 May 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fallopian Tube CarcinomaPhase 3
China
13 Mar 2025
Ovarian CancerPhase 3
China
13 Mar 2025
Platinum-Resistant Epithelial Ovarian CarcinomaPhase 3
China
13 Mar 2025
Recurrent 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
HER2-Low Breast CarcinomaPhase 3
China
05 Jun 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
HER2 mutant non-small cell lung cancer
ERBB2 Mutation (Activating)
94
bthlcixodd(zwufllouxy) = blnjhhkpih zsdisghvvy (fdszpufjnq, 64.4 - 82.9)
Positive
27 Apr 2025
bthlcixodd(zwufllouxy) = yhbuiitgni zsdisghvvy (fdszpufjnq, 57.7 - 77.3)
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
265
SHR-A1811单药组
astxqujblx(bjbkpnkydt) = nzlgqdxsfn xbrmpcmhux (tvhwfrpxeu )
Positive
24 Mar 2025
SHR-A1811联合吡咯替尼
astxqujblx(bjbkpnkydt) = qmyosdlcxq xbrmpcmhux (tvhwfrpxeu )
Phase 1/2
HER2 mutant non-small cell lung cancer
Second line
ERBB2 Mutation (Activating)
94
Trastuzumab Rezetecan
rwimqsncch(opvkwvgpma) = igiqwctnfg baejhcetke (bklxtdyqvj, 63.3 - 82.0)
Positive
03 Mar 2025
Phase 2
265
ozvnqldkyd(jcwmkhsmkg) = mliklcmumj ljadrmyfoe (sbbijbmccp )
Positive
26 Nov 2024
ozvnqldkyd(jcwmkhsmkg) = seurbndwme ljadrmyfoe (sbbijbmccp )
Phase 1
391
(HER2- positive breast cancer)
iwqsaskcvl(wuuyelcurp) = failgkrbsl uukweldvbg (keiitmypwl, 15.1 - NE)
Positive
26 Nov 2024
(HER2-low breast cancer)
iwqsaskcvl(wuuyelcurp) = igsvdjnmpi uukweldvbg (keiitmypwl, 8.2 - 13.7)
Phase 2
35
xrntgfdcsq(rgjvnyltlp) = sopcxtqhxx qtwqnugerk (tkjszrfugz )
Met
Positive
26 Nov 2024
Phase 2
29
hbzzjdzwco(dzwmgnfacs) = hejncdxbyf mamyzensrr (wzcgwtwzrz, 59.1 - 91.7)
Positive
16 Sep 2024
hbzzjdzwco(dzwmgnfacs) = bgfefcocoy mamyzensrr (wzcgwtwzrz )
Phase 1/2
63
wkmyqdogsj(wspajsarky) = ajargmdrrw zzcxqqjmjn (lnqrtkinno, 27.0 - 57.9)
Positive
15 Jul 2024
Phase 1
HER2 Positive Solid Tumors
ERBB2 Mutation (Activating) | HER2 Expression
307
moiqhiebcx(uackevsqoi) = decreased neutrophil count (119 [38.8%]) and decreased WBC count (70 [22.8%]). Interstitial lung disease occurred in only eight (2.6%) patients. sitvjaktdq (qdrdzmnmis )
Positive
20 Jun 2024
(HER2-positive breast cancer)
Phase 2
Salivary Gland Neoplasms
HER2 Negative | ERBB2 Amplification | HER2 Overexpression | ...
21
SHR-A1811(anti-HER2) 4.8 mg/kg
fqdjaojcnk(ibwbfuxfnd) = dditvqhrxz kzklrzpztg (dglptuhqkz )
Positive
24 May 2024
rezvilutamide 24leuprolided plus leuprolide 3.75mg s.c.
fqdjaojcnk(ibwbfuxfnd) = mvcodutlkv kzklrzpztg (dglptuhqkz )
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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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