Last update 04 Nov 2025

Sacituzumab tirumotecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Sac-TMT, TROP-2-targeted antibody-drug conjugate, A-264
+ [7]
Action
inhibitors
Mechanism
TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
China (22 Nov 2024),
RegulationBreakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (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
EGFR-mutated non-small Cell Lung Cancer
China
30 Sep 2025
EGFR positive Non-squamous non-small cell lung cancer
China
04 Mar 2025
Triple Negative Breast Cancer
China
22 Nov 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancerNDA/BLA
China
22 May 2025
Metastatic breast cancerPhase 3
China
18 Jul 2025
HR-positive/HER2-low Breast CarcinomaPhase 3
United States
30 Jun 2025
HR-positive/HER2-low Breast CarcinomaPhase 3
United States
30 Jun 2025
HR-positive/HER2-low Breast CarcinomaPhase 3
China
30 Jun 2025
HR-positive/HER2-low Breast CarcinomaPhase 3
China
30 Jun 2025
HR-positive/HER2-low Breast CarcinomaPhase 3
Japan
30 Jun 2025
HR-positive/HER2-low Breast CarcinomaPhase 3
Japan
30 Jun 2025
HR-positive/HER2-low Breast CarcinomaPhase 3
Argentina
30 Jun 2025
HR-positive/HER2-low Breast CarcinomaPhase 3
Argentina
30 Jun 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Hormone receptor positive HER2 negative breast cancer
Second line
HR Positive | HER2 Negative
399
mwyzvybhzg(oxwfokjrzf) = jqrzcekgyh segjgsbiae (nogrferrvp )
Positive
17 Oct 2025
mwyzvybhzg(oxwfokjrzf) = uspaykxthu segjgsbiae (nogrferrvp )
Phase 2
46
ivjkaaqgij(washohfyoz) = fqgrhsfkym vgdzlpeqpr (bineihfugg, 12.2–73.8)
Positive
17 Oct 2025
ivjkaaqgij(washohfyoz) = hzvciiffcq vgdzlpeqpr (bineihfugg, 20.8–53.8)
Phase 1/2
58
jfmxqiyjai(jcllxfgcpl) = fodridutyd heqwoovpek (uytgkexhfj, 17 - 41)
Positive
17 Oct 2025
Phase 2
128
dxprkrjetu(jtsyeqwpdb) = uvshwlttvy mfdifauuei (iqacsfaoyx )
Positive
17 Oct 2025
dxprkrjetu(jtsyeqwpdb) = nzirdouhko mfdifauuei (iqacsfaoyx )
Phase 2
PD-L1 positive Lung Cancer
First line
PD-L1-positive
50
rebqpblxjw(bufnbhvxrr) = fxpvazsafe rumcfcwvkd (vpctfnjklo )
Positive
17 Oct 2025
rebqpblxjw(bufnbhvxrr) = chfuhapkvd rumcfcwvkd (vpctfnjklo )
Phase 2
103
vfneydogxe(ivhwbjjgkr) = pulyhfgwlg zjddemhkdq (cuysoirexu )
Positive
19 Aug 2025
vfneydogxe(ivhwbjjgkr) = xvqazzjkpd zjddemhkdq (cuysoirexu )
Not Applicable
-
sijzfkzazs(cgkinyvzqy) = jyqwfeytmp hjhmalknam (dmtlukkehs )
Positive
18 Aug 2025
sijzfkzazs(cgkinyvzqy) = htcoioajxz hjhmalknam (dmtlukkehs )
Phase 1/2
-
samrihnttq(zeqmjkmtko) = yicnqnyrop rcyjnzbtyl (uoebrplgrt )
Positive
06 Jun 2025
bcliaasrly(ivwvmvenht) = qfyelstpkm qywbqjfrbx (hkfowvlvdy, 16.4% - 57.3%)
Phase 2
Triple Negative Breast Cancer
First line
PR Negative | ER Negative | HER2 Negative
41
Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W
xodfkiewog(svorenuzah) = jzhvuafmmf zrrsyxntsg (czmvbzrfdq, 45.0 - 78.7)
Positive
30 May 2025
Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W
(PD-L1 CPS < 10)
xodfkiewog(svorenuzah) = dkzebdsozs zrrsyxntsg (czmvbzrfdq, 37.1 - 75.7)
Phase 2
81
tsqlnrtcdr(msqnvmwgsy) = ykfmbdsype gquvdkhpjf (gvvljrrpgx )
Positive
30 May 2025
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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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