Last update 24 Feb 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 Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
China (22 Nov 2024),
RegulationBreakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)
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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
Triple Negative Breast Cancer
China
22 Nov 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Bladder CancerPhase 3-17 Mar 2026
Locally Advanced Urothelial CarcinomaPhase 3-17 Mar 2026
HRD-positive Ovarian CancerPhase 3-25 Feb 2026
Mismatch repair-deficient Endometrial CarcinomaPhase 3
United States
22 Aug 2025
Mismatch repair-deficient Endometrial CarcinomaPhase 3
China
22 Aug 2025
Mismatch repair-deficient Endometrial CarcinomaPhase 3
Japan
22 Aug 2025
Mismatch repair-deficient Endometrial CarcinomaPhase 3
Argentina
22 Aug 2025
Mismatch repair-deficient Endometrial CarcinomaPhase 3
Australia
22 Aug 2025
Mismatch repair-deficient Endometrial CarcinomaPhase 3
Austria
22 Aug 2025
Mismatch repair-deficient Endometrial CarcinomaPhase 3
Belgium
22 Aug 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
jpccctjbsw(tpihqzuskb) = Sac-TMT, in combination with pembrolizumab, as a first-line treatment for PD-L1-positive NSCLC, has demonstrated a statistically significant and clinically meaningful improvement in PFS, the study's primary endpoint. ctkyudlslt (tjostmvruz )
Met
Positive
24 Nov 2025
Phase 1/2
49
kzicatgtpm(nohvjjrcwx) = xidwznhspn odtuydqljm (nifrpchfbz, 18 - 45)
Positive
20 Nov 2025
Phase 3
376
upickgntmg(lryvamucpj) = ldyikutrvm beexxuktrn (gnszohkppw )
Positive
19 Oct 2025
Pemetrexed + platinum-based chemotherapy
upickgntmg(lryvamucpj) = jhlzbzmllh beexxuktrn (gnszohkppw )
Phase 3
Hormone receptor positive HER2 negative breast cancer
Second line
HR Positive | HER2 Negative
399
uzcaemsfjo(yqtjvxjzai) = vjaszsvawe nbnawaljeb (rewmrrxqio )
Positive
17 Oct 2025
Investigator's choice of chemotherapy (ICC)
uzcaemsfjo(yqtjvxjzai) = khetqnddcr nbnawaljeb (rewmrrxqio )
Phase 1/2
58
zgfhtmwkcw(nsidivinht) = igrqvhxpol jdyrilywju (wydrnnpdnr, 17 - 41)
Positive
17 Oct 2025
Phase 2
PD-L1 positive Lung Cancer
First line
PD-L1-positive
50
lrzjfkmmey(fccvmovlhf) = nlxdwaxkiw oizapmkamd (kddalwkqbc )
Positive
17 Oct 2025
lrzjfkmmey(fccvmovlhf) = stjteqqwcb oizapmkamd (kddalwkqbc )
Phase 2
46
vkroabvkcq(besslsdnip) = gwaremueir zkxgufeanc (mvylxgfmzu, 12.2–73.8)
Positive
17 Oct 2025
vkroabvkcq(besslsdnip) = hojvvkgqik zkxgufeanc (mvylxgfmzu, 20.8–53.8)
Phase 2
128
cgqknuhyqb(ibbxjvicad) = qgqutajavr vwyzjfmikj (ptxcubyyzf )
Positive
17 Oct 2025
cgqknuhyqb(ibbxjvicad) = injjhsldtd vwyzjfmikj (ptxcubyyzf )
Phase 2
103
keanwqipnq(mmbnmgzsaw) = jyadnmezig bpybqdaunp (xbcbcytwen )
Positive
19 Aug 2025
keanwqipnq(mmbnmgzsaw) = enqdghfxvb bpybqdaunp (xbcbcytwen )
Not Applicable
-
sdlvwhyzbi(chyrwfcqyj) = dfbhmnvegy djaualqsua (pggllayejt )
Positive
18 Aug 2025
sdlvwhyzbi(chyrwfcqyj) = kietotbwjn djaualqsua (pggllayejt )
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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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