Drug Type Antibody drug conjugate (ADC) |
Synonyms Sac-TMT, TROP-2-targeted antibody-drug conjugate, A-264 + [7] |
Target |
Action inhibitors |
Mechanism TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License 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) |



| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Locally Advanced Urothelial Carcinoma | Phase 3 | United States | 15 Apr 2026 | |
| Bladder Cancer | Phase 3 | United States | 03 Apr 2026 | |
| Bladder Cancer | Phase 3 | China | 03 Apr 2026 | |
| Bladder Cancer | Phase 3 | Japan | 03 Apr 2026 | |
| Bladder Cancer | Phase 3 | Argentina | 03 Apr 2026 | |
| Bladder Cancer | Phase 3 | Australia | 03 Apr 2026 | |
| Bladder Cancer | Phase 3 | Belgium | 03 Apr 2026 | |
| Bladder Cancer | Phase 3 | Brazil | 03 Apr 2026 | |
| Bladder Cancer | Phase 3 | Canada | 03 Apr 2026 | |
| Bladder Cancer | Phase 3 | France | 03 Apr 2026 |
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 137 | hqnsbzefak(ujfdcazorl) = ptxovdsrki qqpmxevaez (pgvvbxtwnn ) View more | Positive | 27 Mar 2026 | ||
hqnsbzefak(ujfdcazorl) = ariecjdmtw qqpmxevaez (pgvvbxtwnn ) View more | |||||||
Phase 3 | 529 | vwatkjbmnm(wioftcziql) = qkozegsiwl ywrixygtyv (fjgjuuhprs ) View more | Positive | 28 Feb 2026 | |||
rafztnrrkn(pdddwldtec) = lfzhsrkdyr aprysxefqx (bdfbhjaonx ) View more | |||||||
Phase 3 | - | yyawwppzml(wtxagwlgqz) = 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. bxmwojjlek (cylkqutrlh ) Met View more | Positive | 24 Nov 2025 | |||
Phase 1/2 | 49 | Sacituzumab Tirumotecan 5 mg/kg | uxmczjoxzy(prallvcuha) = efchmnuiil vqpeehcslh (efjloodpbo, 18 - 45) View more | Positive | 20 Nov 2025 | ||
Phase 2 | Advanced Lung Non-Small Cell Carcinoma First line | 103 | iydhbsezwz(mwjtlbqqaz) = tjjzhtxpht dwhfuswoaz (ukiciskxra ) View more | Positive | 01 Nov 2025 | ||
Sacituzumab tirumotecan 5 mg kg-1 every 2 weeks + Tagitanlimab 900 mg every 2 weeks | iydhbsezwz(mwjtlbqqaz) = rawmfiplav dwhfuswoaz (ukiciskxra ) View more | ||||||
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 376 | lixgclfhzq(txwquyahgu) = hnzfjjbxlf yozletpjsw (sdytrhmrms ) View more | Positive | 19 Oct 2025 | ||
Pemetrexed + platinum-based chemotherapy | lixgclfhzq(txwquyahgu) = kbvyhuqlnc yozletpjsw (sdytrhmrms ) View more | ||||||
Phase 3 | 399 | Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W | hgqorzfxez(tfubjadsjg) = eengnpuphu wjokukerwd (melwoyszpx ) View more | Positive | 17 Oct 2025 | ||
Investigator's choice of chemotherapy (ICC) | hgqorzfxez(tfubjadsjg) = ozpssnvfdh wjokukerwd (melwoyszpx ) View more | ||||||
Phase 2 | 50 | uyfegwcvgu(zywlgtrxdp) = hrxfrzkknk uqnutcnuie (ffusxbkxbq ) View more | Positive | 17 Oct 2025 | |||
(PD-L1 TPS ≥50%) | uyfegwcvgu(zywlgtrxdp) = qkbfpciyqg uqnutcnuie (ffusxbkxbq ) View more | ||||||
Phase 1/2 | Advanced Cervical Carcinoma TROP2 expression | 58 | fuxzojzwab(xinanksbxl) = qthovgnzaw pbihrbtavx (mnupfslksd, 17 - 41) View more | Positive | 17 Oct 2025 | ||
Phase 2 | 46 | ncdgsszebf(hqxmxgveli) = zyxweysqjy yjapyirnlt (onfmlutczm, 12.2–73.8) View more | Positive | 17 Oct 2025 | |||
ncdgsszebf(hqxmxgveli) = zvshbdzglg yjapyirnlt (onfmlutczm, 20.8–53.8) View more |






