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Last update 17 Sep 2026
Ruzaltatug rezetecan
Last update 17 Sep 2026
Overview
Basic Info
Drug Type Antibody drug conjugate (ADC) |
Synonyms 瑞康芦泽妥塔单抗, SHR A2009, SHR-A2009 + [1] |
Target |
Action antagonists, inhibitors |
Mechanism HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationFast Track (United States), Breakthrough Therapy (China) |
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Structure/Sequence
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Sequence Code 1047126308
Sequence Code 1047126309
Related
12
Clinical Trials associated with Ruzaltatug rezetecanNCT07414953
A Phase Ib Study of the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of HS-10504 Combined Therapy in Advanced Non-small Cell Lung Cancer Patients
NCT07183189
A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations
NCT06671379
A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
100 Clinical Results associated with Ruzaltatug rezetecan
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100 Translational Medicine associated with Ruzaltatug rezetecan
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100 Patents (Medical) associated with Ruzaltatug rezetecan
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100 Deals associated with Ruzaltatug rezetecan
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | China | 29 Jul 2026 | |
| Locally Advanced Lung Non-Small Cell Carcinoma | Phase 3 | China | 30 Oct 2025 | |
| Advanced Malignant Solid Neoplasm | Phase 3 | China | 29 Nov 2024 | |
| Breast Cancer | Phase 2 | China | 20 Feb 2024 | |
| metastatic non-small cell lung cancer | Phase 2 | - | 01 Oct 2023 | |
| Solid tumor | Phase 2 | - | - | |
| EGFR positive non-small cell lung cancer | IND Approval | China | 20 Jul 2026 | |
| Advanced Lung Non-Small Cell Carcinoma | IND Approval | China | 10 Feb 2026 | |
| Advanced cancer | IND Approval | China | 20 Nov 2023 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Not Applicable | Non-Small Cell Lung Cancer EGFR-mutant | 12 | kqxgngcizr(ramnsgpvxt) = odmgdrdwgw infkdoxoxb (yisgxprqty ) View more | Negative | 12 Sep 2026 | ||
vezgrgikwz(ltkthrdpya) = vyudfnocow cakqsshjdm (zofpkkxkem ) View more | |||||||
Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR-mutated | 130 | aoziwfjnvy(vzjtmporeu) = tvvcsilerd isfibdhxjl (jgygpjwusr, 75.7 - 98.1) View more | Positive | 25 Mar 2026 | ||
aoziwfjnvy(vzjtmporeu) = jhmymvyntp isfibdhxjl (jgygpjwusr, 76.6 - 95.6) View more | |||||||
NCT05114759 (ESMO2024) Manual  | Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 103 | fufknawpds(jvuvhhlzpy) = 56.3% of 103 pts, with all occurring in ≥5% being hematotoxicities. ukvoszongm (kthpdbrqgg ) View more | Positive | 14 Sep 2024 | |
(Prior PBC treated) | |||||||
Phase 1 | HR-positive/HER2-low Solid Tumors EGFR mutations | 42 | rmhcscrehe(qxkqdtavrb) = mugzkpdlwi kvmrounsvo (nesjzixdxk ) View more | Positive | 23 Oct 2023 | ||
(1.5 mg/kg) | cpeiqdfida(sxqeyojpwg) = qogxaqbsub aaespxkwpp (byeegbrfai ) View more |
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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.
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Regulation
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