# Trastuzumab rezetecan

Source: https://onco.cc/drugs/trastuzumab-rezetecan/  
OnCo record `trastuzumab-rezetecan` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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%.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Code: SHR-A1811
- Modality: ADC
- Mechanism: Trastuzumab-based antibody, cleavable linker, membrane-permeable TOP1 payload with bystander effect.
- Payload: Rezetecan (SHR9265, camptothecin-derived TOP1 inhibitor), DAR ~6
- Linker: Cleavable tetrapeptide
- Approvals: China 2025: HER2-mutant NSCLC after ≥1 systemic therapy (May 2025)
- Dosing: Intravenous; 4.8 mg/kg every 3 weeks (breast); 4.8-6.4 mg/kg studied
- Toxicity (grade 3+): Neutropenia 40%

## Sources

- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Trastuzumab%20rezetecan

## Connected records

- cancers: [Early HER2-positive breast cancer](https://onco.cc/cancers/her2-positive-early-breast-cancer/), [HER2-low and HER2-ultralow metastatic breast cancer](https://onco.cc/cancers/her2-low-metastatic-breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HER2-positive breast cancer with brain metastases](https://onco.cc/cancers/her2-positive-breast-brain-metastases/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Glenmark Pharmaceuticals (Ichnos Glenmark Innovation)](https://onco.cc/companies/glenmark/), [Jiangsu Hengrui Pharmaceuticals](https://onco.cc/companies/hengrui/)
- trials: [A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer](https://onco.cc/trials/nct06840002/), [A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal](https://onco.cc/trials/nct07676162/), [A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer](https://onco.cc/trials/nct06778031/), [A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer](https://onco.cc/trials/nct07111832/), [A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer](https://onco.cc/trials/nct07051486/), [A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer](https://onco.cc/trials/nct06057610/), [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](https://onco.cc/trials/nct06126640/), [A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor](https://onco.cc/trials/nct07140393/), [A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct07231211/), [A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations](https://onco.cc/trials/nct06430437/), [A Study of SHR-A1811 in Subjects With Ovarian Cancer](https://onco.cc/trials/nct06828354/), [A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer](https://onco.cc/trials/nct07679360/), [A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer](https://onco.cc/trials/nct07110571/), [A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer](https://onco.cc/trials/nct05482568/), [A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.](https://onco.cc/trials/nct06015048/), [A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer](https://onco.cc/trials/nct07196774/), [A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer](https://onco.cc/trials/nct07497386/), [Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor](https://onco.cc/trials/nct07631884/), [HORIZON-Breast01](https://onco.cc/trials/horizon-breast01/), [Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, ](https://onco.cc/trials/nct06199973/), [Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer](https://onco.cc/trials/nct05671822/), [Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer](https://onco.cc/trials/nct06413745/), [Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer](https://onco.cc/trials/nct07670273/), [Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer](https://onco.cc/trials/nct07704177/), [Reverse Triple Negative Immune Resistant Breast Cancer](https://onco.cc/trials/nct05076682/), [Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma](https://onco.cc/trials/nct07102901/), [SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer](https://onco.cc/trials/nct06859775/), [SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen](https://onco.cc/trials/nct06123494/), [SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial](https://onco.cc/trials/nct05814354/), [Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer](https://onco.cc/trials/nct06222879/), [Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab for Biliary Tract Cancer](https://onco.cc/trials/nct07129018/)
- people: [Xichun Hu](https://onco.cc/people/hu-xichun/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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