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Hengrui's HER2 ADC, approved in China for lung cancer and showing Enhertu-scale results in breast cancer, part of a wave of Chinese ADCs heading for global trials.
NMPA approval May 2025 for HER2-mutant NSCLC (HORIZON-Lung: ORR 74.5%, PFS 11.5 months). HORIZON-Breast01 (HER2+ breast after trastuzumab/taxane): PFS 30.6 vs 8.3 months vs pyrotinib + capecitabine (HR 0.22). Also active in HER2-low breast cancer and as neoadjuvant therapy; global phase 1 (HORIZON-X) reported 2026. ILD ~3-5%.
Trastuzumab rezetecan (SHR-A1811) carries a camptothecin-derived TOP1 inhibitor; exatecan shown as the class representative.
Trastuzumab-based antibody, cleavable linker, membrane-permeable TOP1 payload with bystander effect. Connects to HER2.
1.Trastuzumab rezetecan's antibody arm binds HER2 on the surface of the cancer cell.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE search: trastuzumab rezetecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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HER2-mutant NSCLC source
| Region | Year | Indication |
|---|---|---|
| China | 2025 | HER2-mutant NSCLC after ≥1 systemic therapy (May 2025) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia | - | 40% |
| Nausea | 60% | - |
| Interstitial lung disease | 4% | - |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Trastuzumab rezetecan" OR ABSTRACT:"Trastuzumab rezetecan" OR TITLE:"SHR-A1811" OR ABSTRACT:"SHR-A1811") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trastuzumab rezetecan, not a curated reading list.
Shares A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors., HORIZON-Breast01, A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer, HER2-positive breast cancer with brain metastases.
Shares Reverse Triple Negative Immune Resistant Breast Cancer, Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer, A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer, A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer.
Shares A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor, A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer, Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab for Biliary Tract Cancer, A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer.
Shares A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer, A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer, SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer, Jiangsu Hengrui Pharmaceuticals.
Shares Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma, Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer, Jiangsu Hengrui Pharmaceuticals.
Shares HER2-positive breast cancer with brain metastases, HER2-low and HER2-ultralow metastatic breast cancer, Early HER2-positive breast cancer, HER2.
Shares Xichun Hu, HER2-low and HER2-ultralow metastatic breast cancer, HER2, Antibody-drug conjugate (ADC).
Shares A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy, HER2-positive breast cancer with brain metastases, Early HER2-positive breast cancer, HER2.