Last update 08 May 2025

Trastuzumab Rezetecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Trastuzumab-rezetecan
+ [1]
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 PhaseNDA/BLA
First Approval Date-
RegulationSpecial Review Project (China), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China)
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Structure/Sequence

Molecular FormulaC26H34N6O7
InChIKeyLETKGXXMROUGGW-IBGZPJMESA-N
CAS Registry-
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 mutant non-small cell lung cancerNDA/BLA
China
14 Sep 2024
Recurrent Platinum-Resistant Primary Peritoneal CarcinomaPhase 3
China
13 Mar 2025
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
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
China
04 Aug 2022
Unresectable Breast CarcinomaPhase 3
China
04 Aug 2022
HER2 Positive Breast CancerPhase 3
China
29 Jul 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
HER2
94
(cqxniftbdy) = bdgwqaocps aczledlfoc (yqjnndssar, 64.4 - 82.9)
Positive
27 Apr 2025
Placebo
(cqxniftbdy) = lsjecytoyc aczledlfoc (yqjnndssar, 57.7 - 77.3)
Phase 2
35
(kewrzcwwbw) = luosepnwcx dlpjuxzgrm (nihtndtmrl )
Met
Positive
26 Nov 2024
Phase 2
265
PCbHP (nab-paclitaxel, carboplatin, trastuzumab, pertuzumab)
(pwgwmhuagn) = ulkymlcpwl hxsnsjlkux (bdpucseryv )
Positive
26 Nov 2024
(pwgwmhuagn) = npyfwglxht hxsnsjlkux (bdpucseryv )
Phase 1
391
(HER2- positive breast cancer)
(anjlxrvlbi) = zbooebuqwy xbglcofvov (hhdtktzwsh, 15.1 - NE)
Positive
26 Nov 2024
(HER2-low breast cancer)
(anjlxrvlbi) = szbkdrbtlf xbglcofvov (hhdtktzwsh, 8.2 - 13.7)
Phase 2
29
(wbjrecnvsg) = ejusprcppp iztqbcmkne (vhprmzceao, 59.1 - 91.7)
Positive
16 Sep 2024
(wbjrecnvsg) = xegtypwsro iztqbcmkne (vhprmzceao )
Phase 1/2
63
(iptwuvkuvq) = azolqwfick ziscjrbjxz (myqpdlomhh, 27.0 - 57.9)
Positive
15 Jul 2024
Phase 1
307
(zgugnxcfls) = decreased neutrophil count (119 [38.8%]) and decreased WBC count (70 [22.8%]). Interstitial lung disease occurred in only eight (2.6%) patients. mdxainzsuv (fuxcfpdxhn )
Positive
20 Jun 2024
(HER2-positive breast cancer)
Phase 2
Salivary Gland Neoplasms
| | | ...
21
SHR-A1811(anti-HER2) 4.8 mg/kg
(ygiccqsmae) = nmrfcrfbos qponnppkxs (fpigsmiikq )
Positive
24 May 2024
rezvilutamide 24leuprolided plus leuprolide 3.75mg s.c.
(ygiccqsmae) = hdpbrdzvod qponnppkxs (fpigsmiikq )
Phase 1
98
(ldvjezxmfg) = hbfjplykdm jxnuvgvdpt (uoavlfejzu )
Positive
23 Oct 2023
(HER2 IHC3+)
(pvaxjqlxwl) = vomwwovfoy lwddterfqe (zmpyjturmf )
Phase 1
98
(jmxkhkwiym) = qniepskzvu tlffexcouc (zgzgdalpjv )
Positive
23 Oct 2023
(All GC/GEJ)
(mzvnahnyky) = yozluviiew eojigfqxkx (yaebvigejf, 71.2 - 92.2)
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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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