Trastuzumab Rezetecan: First Approval

US National Library of Medicine. erb-b2 receptor tyrosine kinase 2. 2025. https://www.ncbi.nlm.nih.gov/gene/2064. Accessed 4 Aug 2025.

Bai X, Sun P, Wang X, et al. Structure and dynamics of the EGFR/HER2 heterodimer. Cell Discov. 2023;9(1):18.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Oh DY, Bang YJ. HER2-targeted therapies: a role beyond breast cancer. Nat Rev Clin Oncol. 2020;17(1):33–48.

Article  PubMed  CAS  Google Scholar 

Meric-Bernstam F, Johnson AM, Dumbrava EEI, et al. Advances in HER2-targeted therapy: novel agents and opportunities beyond breast and gastric cancer. Clin Cancer Res. 2019;25(7):2033–41.

Article  PubMed  CAS  Google Scholar 

Suzhou Shengdia Biopharmaceutical Co., Ltd. Trastuzumab rezetecan for injection: Chinese prescribing information. 2025.

Zhang T, Xu J, Yin J, et al. SHR-A1811, a novel anti-HER2 antibody-drug conjugate with optimal drug-to-antibody ratio, efficient tumor killing potency, and favorable safety profiles. PLoS ONE. 2025;20(6): e0326691.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Hengrui Medicine. The first ADC independently developed in China and approved for use in HER2-mutated non-small cell lung cancer, Avida®, is launched [media release]. 30 May 2025. https://www.hengrui.com/.

National Medical Products Administration. The State Food and Drug Administration conditionally approved the marketing of Rekang trastuzumab for injection [media release]. 29 May 2025. https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250529142716124.html.

Li Z, Wang Y, Sun Y, et al. Trastuzumab rezetecan, a HER2-directed antibody–drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025;26(4):437–46.

Article  PubMed  Google Scholar 

Jiangsu HengRui Medicine Co., Ltd.,. Hengrui Pharma announces positive data of two ADC programs at the AACR Annual Meeting 2023 [media release]. 10 Apr 2023. http://www.hengrui.com.

Yao H, Yan M, Tong Z, et al. Safety, efficacy, and pharmacokinetics of SHR-A1811, a human epidermal growth factor receptor 2-directed antibody-drug conjugate, in human epidermal growth factor receptor 2-expressing or mutated advanced solid tumors: a global phase I trial. J Clin Oncol. 2024;42(29):3453–65.

Article  PubMed  CAS  Google Scholar 

Li Z, Song Z, Hong W, et al. SHR-A1811 (antibody-drug conjugate) in advanced HER2-mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study. Signal Transduct Target Ther. 2024;9(1):1–10.

Article  PubMed  PubMed Central  Google Scholar 

Li JJ, Wang ZH, Chen L, et al. Efficacy and safety of neoadjuvant SHR-A1811 with or without pyrotinib in women with locally advanced or early HER2-positive breast cancer: a randomized, open-label, phase II trial. Ann Oncol. 2025;36(6):651–9.

Article  PubMed  CAS  Google Scholar 

Liu CG, Niu N, Qiu F, et al. SHR-A1811 in combination with pyrotinib as neoadjuvant treatment for HER2-positive breast cancer (HER2+ BC): preliminary results from MUKDEN 07 [abstract no. 276P]. Ann Oncol. 2024;35(Suppl 2):S331.

Article  Google Scholar 

Yan M, Lv H, Li H, et al. HER2-ADC trastuzumab rezetecan (SHR-A1811) in HER2-positive breast cancer with brain metastases: update results from REIN trial. [abstract no. 1017]. J Clin Oncol. 2025;43(16 Suppl).

Article  Google Scholar 

US National Institutes of Health. ClinicalTrials.gov identifier NCT05769010. 2024. http://clinicaltrials.gov/. Accessed 7 Aug 2025.

Liu Z, Jiao D, Zhu J, et al. SHR-A1811 as neoadjuvant therapy for HR-positive, HER2-low breast cancer: a single-arm, phase II clinical study [abstract no. 594]. J Clin Oncol. 2025;43(16 Suppl).

Liang Y, Zhang Q, Liao L, et al. SHR-A1811 plus adebrelimab in unresectable or metastatic triple-negative breast cancer: results from a phase 1b/2 expansion cohort [abstract no. 1103]. J Clin Oncol. 2025;43(16 Suppl).

Kong B, Jiang J, Chen G, et al. SHR-A1811 in patients (pts) with HER2-expressing advanced gynecological cancers (Gynecol C): a phase 2 study [abstract no. 5612]. J Clin Oncol. 2025;43(16 Suppl).

Li J, Luo S, Liu T, et al. Phase I trial of SHR-A1811 in HER2-expressing advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) and colorectal cancer (CRC) [abstract no. 684P]. Ann Oncol. 2023;34(Suppl 2):S478.

Article  Google Scholar 

Chen G, Ji D, Guo Y, et al. SHR-A1811 in HER2-expressing salivary gland cancers: preliminary efficacy and safety results [abstract no. 6006]. J Clin Oncol. 2025;43(16 Suppl).

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