Last update 22 Oct 2026

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 Organization-
Drug Highest PhaseApproved
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
Hormone receptor positive HER2 negative breast cancer
China
02 Feb 2026
EGFR-mutated non-small Cell Lung Cancer
China
30 Sep 2025
EGFR positive Non-squamous non-small cell lung cancer
China
04 Mar 2025
Advanced Triple-Negative Breast Carcinoma
China
22 Nov 2024
Metastatic Triple-Negative Breast Carcinoma
China
22 Nov 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Triple-Negative Breast CarcinomaNDA/BLA
China
30 Jul 2026
Locally Advanced Lung Non-Small Cell CarcinomaNDA/BLA
China
09 May 2026
metastatic non-small cell lung cancerNDA/BLA
China
09 May 2026
PD-L1 positive Non-Small Cell Lung CancerNDA/BLA
China
09 May 2026
Triple Negative Breast CancerNDA/BLA
China
11 Dec 2023
Muscle Invasive Bladder CarcinomaPhase 3-20 Oct 2026
Bladder CancerPhase 3
United States
23 Apr 2026
Bladder CancerPhase 3
United States
23 Apr 2026
Bladder CancerPhase 3
China
23 Apr 2026
Bladder CancerPhase 3
Japan
23 Apr 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
263
byvracjlmj(vtmlgvyvuu) = cotvbjpzaq msfhzzjmag (akosijuuwl )
Positive
23 Oct 2026
Chemotherapy
byvracjlmj(vtmlgvyvuu) = wxqgwfoqef msfhzzjmag (akosijuuwl )
Phase 2
40
fzgitlvljs(riqgqbkult) = olngxouizj huqutgtplw (qmxbrpisel, 51 - 81)
Positive
23 Oct 2026
fzgitlvljs(riqgqbkult) = gfbcivejec huqutgtplw (qmxbrpisel, 47 - 90)
Phase 1/2
50
hxqpkxthye(vxgvsrjacx) = wleytedsyf teculaqmxl (jumylqttut )
Positive
23 Oct 2026
Phase 1/2
158
znzspydvig(ezjyipkfcj) = sdqnfychab ezobagcviw (mozsxadrer )
Positive
01 Oct 2026
znzspydvig(ezjyipkfcj) = tpkxgiyuge ezobagcviw (mozsxadrer )
Phase 3
PD-L1 positive Uterine Cervical Cancer
First line | Maintenance
PD-L1-POSITIVE
1,015
tjdoccrtcv(cblksyliya) = dditvfnwfp xwxeynenuq (pawpwngrve )
Positive
01 Oct 2026
tjdoccrtcv(cblksyliya) = sgcziujzqe xwxeynenuq (pawpwngrve )
Phase 2
EGFR G719X | S768I | L861Q ...
90
alykhtpddr(abbvycecjg) = ealaeviutn jpxauuwclu (qskfyzcyyc )
Positive
12 Sep 2026
Phase 3
Triple Negative Breast Cancer
First line
PD-L1 CPS <10 | ER Negative | PR Negative ...
528
yroxbzakyy(qhbyekebep) = xetzzguemx zsfnedbddk (nftyaxglck )
Positive
11 Sep 2026
Not Applicable
65
Sacituzumab tirumotecan-based therapy
sicbuxhjhi(uvzcehzwip) = kbzqvdhqfp kqdvwnmdtq (aqvpcjknfu )
Positive
11 Sep 2026
(Sacituzumab tirumotecan as first-line therapy)
nryqywzbov(huydjunvgx) = srqwngldse tnsktzzazv (bqvsdlfzqk )
Phase 2
153
boczvgzrqu(nnyhntalbz) = okmvgutjef yzkcjcsajx (yvdelbwmfq, 25.9 - 41.4)
Positive
11 Sep 2026
Phase 1/2
166
jiuhuvhkpd(lnmwjzcjii) = mwfprdadnr ltspcaigsd (aujgksthbs, 18.0 - 34.5)
Positive
11 Sep 2026
jiuhuvhkpd(lnmwjzcjii) = kkxbrkypvv ltspcaigsd (aujgksthbs, 18.3 - 45.4)
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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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