New-generation TROP-2 ADC Dazhuoyou® Launched in China for Previously Treated HR-Positive, HER2-Negative Advanced Breast Cancer

Dosed once every three weeks, Datopotamab Deruxtecan offers a more effective later-line treatment option than chemotherapy for patients with HR-positive, HER2-negative advanced breast cancer

ShanghaiApril 22, 2026 /PRNewswire/ — Datroway^® (generic name: Datopotamab Deruxtecan for injection), the second ADC drug developed and introduced to China through the collaboration between AstraZeneca and Daiichi Sankyo, has been officially launched in China. Initial shipments will gradually become available at hospitals and pharmacies nationwide. In August 2025, Datopotamab Deruxtecan was approved in China based on positive results from the global Phase III TROPION-Breast01 study, for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy and at least one line of chemotherapy in the advanced disease setting.

Breast cancer is one of the most common malignancies among women in China, with over 350,000 confirmed cases in 2022 alone, resulting in approximately 75,000 patient deaths³. About 30% of early-stage breast cancer patients may eventually experience disease recurrence or metastasis³. The 5-year survival rate for advanced breast cancer patients is only 20%, with a median overall survival of 2 to 3 years⁴. Approximately 70% of breast cancer diagnoses are classified as conventional HR+/HER2- breast cancer⁵. In the treatment of HR-positive metastatic breast cancer, endocrine therapy is typically the first-line treatment option⁶. However, after initial treatment, endocrine therapy gradually faces resistance issues, leading to limited efficacy⁷. The current standard treatment after endocrine therapy is chemotherapy, but its response rates and prognosis are suboptimal^6-9.

Professor Xu Binghe, Director of the Drug Clinical Trial Research Center (GCP) at the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, stated: “Breast cancer is one of the cancers with the highest incidence among women in China, imposing a heavy burden on patients, families, and the entire healthcare system. In the treatment of HR+/HER2- metastatic breast cancer, some patients still face the dilemma of disease progression after endocrine therapy and chemotherapy. TROP2, a transmembrane glycoprotein, is highly expressed on the surface of approximately 80% of breast cancer cells, making it an ideal target for breast cancer treatment. Datopotamab Deruxtecan is an antibody-drug conjugate (ADC) precisely targeting TROP2, with a dosing frequency of once every three weeks, providing Chinese patients with a more convenient treatment experience and offering these breast cancer patients a much-needed new treatment option distinct from traditional chemotherapy.”

Ms. Guan Dongmei, General Manager of AstraZeneca China Oncology Business Unit, stated: “The launch and application of Datopotamab Deruxtecan in China signify that this innovative therapy has moved from clinical research to the real world, providing Chinese breast cancer patients with a tangible and accessible new treatment option. As the second ADC drug approved by AstraZeneca in China, it further enriches our portfolio in the precision treatment of breast cancer and offers new potential benefits for patients who still face challenges with previous treatments. We also look forward to innovative drugs with clinical value benefiting a broader population as early as possible to meet unmet treatment needs. In the future, AstraZeneca will continue to explore the therapeutic potential of this drug in other types of breast cancer and lung cancer, bringing more hope to patients.”

About HR-Positive Breast Cancer

Breast cancer is the second most common cancer globally and one of the leading causes of cancer-related deaths worldwide¹⁰. In 2022, over 2 million patients were diagnosed with breast cancer globally, and nearly 665,000 patients died from the disease². Breast cancer is one of the most common malignancies among women in China, with over 350,000 confirmed cases in 2022 alone, resulting in approximately 75,000 patient deaths³. About 30% of early-stage breast cancer patients may eventually experience disease recurrence or metastasis³. The 5-year survival rate for advanced breast cancer patients is only 20%, with a median overall survival of 2 to 3 years⁴.

Approximately 70% of breast cancer diagnoses are classified as conventional HR+/HER2- breast cancer (HER2 scores IHC 0, IHC 1+, or IHC 2+/ISH-)⁵. In the treatment of HR-positive metastatic breast cancer, endocrine therapy is typically the first-line treatment option⁶. However, after initial treatment, endocrine therapy gradually faces resistance issues, leading to limited efficacy⁶. The current standard treatment after endocrine therapy is chemotherapy, but its response rates and prognosis are suboptimal^6-9.

About TROPION-Breast01

TROPION-Breast01 is a global, randomized, multicenter, open-label Phase III study evaluating the efficacy and safety of intravenous Datopotamab Deruxtecan (6 mg/kg) administered once every 21 days compared to investigator’s choice of single-agent chemotherapy (including eribulin, capecitabine, vinorelbine, or gemcitabine) in adult patients with HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) unresectable or metastatic breast cancer who have experienced disease progression during endocrine therapy or are unsuitable for endocrine therapy, and have received 1-2 prior lines of chemotherapy.

After disease progression or discontinuation of Datopotamab Deruxtecan or chemotherapy, patients could receive subsequent treatment at the discretion of their treating physician. Crossover between study groups was not permitted in the study.

The dual primary endpoints of the TROPION-Breast01 study were progression-free survival (PFS) assessed by blinded independent central review (BICR) and overall survival (OS). Key secondary endpoints included objective response rate (ORR), duration of response, investigator-assessed progression-free survival, disease control rate, time to first subsequent treatment, and safety. Results from the interim analysis and final analysis of the TROPION-Breast01 study have been published in the Journal of Clinical Oncology and Annals of Oncology, respectively.

TROPION-Breast01 enrolled 732 patients across Asia, Europe, North America, South America, and Africa. More information can be found on ClinicalTrials.gov.

About Datopotamab Deruxtecan

Datopotamab Deruxtecan is a TROP2-targeted antibody-drug conjugate (ADC). It is designed based on Daiichi Sankyo’s proprietary DXd ADC technology platform and is one of six DXd ADCs in Daiichi Sankyo’s oncology pipeline, as well as one of the most advanced projects in AstraZeneca’s ADC science platform. Datopotamab Deruxtecan consists of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, conjugated via a cleavable tetrapeptide linker to multiple topoisomerase I inhibitor payloads (an exatecan derivative, DXd).

Based on the results of the TROPION-Breast01 study, Datopotamab Deruxtecan (6 mg/kg) has been approved in the United States, the European Union, Japan, and China for the treatment of adult patients with HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) unresectable or metastatic breast cancer who have received prior endocrine therapy and chemotherapy.

About the Datopotamab Deruxtecan Clinical Development Program

A comprehensive global clinical development program is ongoing, including over 20 studies evaluating the efficacy and safety of Datopotamab Deruxtecan in treating various cancers, including non-small cell lung cancer, triple-negative breast cancer, and HR-positive, HER2-negative breast cancer. This includes 7 Phase III lung cancer studies and 5 Phase III breast cancer studies, designed to evaluate Datopotamab Deruxtecan as monotherapy and in combination with other drugs for multiple cancers.

About the AstraZeneca and Daiichi Sankyo Collaboration

AstraZeneca and Daiichi Sankyo entered into global collaborations in March 2019 and July 2020, respectively, to jointly develop and commercialize Trastuzumab Deruxtecan and Datopotamab Deruxtecan. Daiichi Sankyo maintains exclusive rights for each ADC product in the Japanese market. Daiichi Sankyo is responsible for the manufacturing and supply of Trastuzumab Deruxtecan and Datopotamab Deruxtecan.

About AstraZeneca’s Research in Breast Cancer

Driven by a deepening understanding of breast cancer biology, AstraZeneca is challenging and redefining current breast cancer classifications and clinical treatment paradigms to provide more precise and effective treatment options for patients in need. AstraZeneca is ambitious, aiming to one day eliminate breast cancer as a cause of death.

AstraZeneca has developed a range of approved and investigational innovative drugs covering multiple mechanisms of action to address the highly heterogeneous tumor biology of breast cancer.

With the HER2-targeted antibody-drug conjugate Trastuzumab Deruxtecan, AstraZeneca and Daiichi Sankyo are committed to improving outcomes for patients with HER2-positive, HER2-low, and HER2-ultralow metastatic breast cancer and are exploring its potential in earlier lines of treatment and other stages of breast cancer.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with cornerstone drugs fulvestrant and goserelin, and aims to reshape the treatment of HR-positive breast cancer through the first-in-class AKT inhibitor capivasertib, the TROP2-targeted ADC Datopotamab Deruxtecan, and the next-generation oral SERD camizestrant.

The PARP inhibitor olaparib is a targeted therapy that has been studied in patients with early and metastatic breast cancer with germline BRCA mutations. AstraZeneca and Merck (Merck is the company name of Merck & Co., Inc., headquartered in Rahway, New Jersey, USA) will continue relevant research on olaparib in these areas and explore its potential in early-stage disease treatment. AstraZeneca is also exploring the efficacy and safety of Saruparib (a potent PARP1-selective inhibitor) in combination with camizestrant for the treatment of BRCA-mutated, HR-positive, HER2-negative advanced breast cancer.

To provide much-needed treatment options for patients with triple-negative breast cancer (an aggressive form of breast cancer), AstraZeneca is evaluating the potential effects of Datopotamab Deruxtecan as monotherapy and in combination with the immunotherapy drug durvalumab.

About AstraZeneca’s Research in Oncology

AstraZeneca is leading a revolution in oncology, committed to providing a diverse range of cancer treatment options, exploring the complexity of oncology through science, and discovering, developing, and delivering life-changing medicines to patients.

AstraZeneca focuses on the most challenging cancers. Through continuous innovation, AstraZeneca has built an industry-leading diverse portfolio and pipeline, continuously driving changes in medical practice and transforming the patient experience.

AstraZeneca aims to redefine cancer treatment and ultimately conquer cancer.

References

1. Bardia A, Jhaveri K, Im SA, Pernas S, De Laurentiis M, Wang S, Martínez Jañez N, Borges G, Cescon DW, Hattori M, Lu YS, Hamilton E, Zhang Q, Tsurutani J, Kalinsky K, Rubini Liedke PE, Xu L, Fairhurst RM, Khan S, Denduluri N, Rugo HS, Xu B, Pistilli B; TROPION-Breast01 Investigators. Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: Primary Results From TROPION-Breast01. J Clin Oncol. 2025 Jan 20;43(3):285-296. doi: 10.1200/JCO.24.00920. Epub 2024 Sep 12. PMID: 39265124; PMCID: PMC11771365.
2. Wang S. et al. Ann Oncol. 2024; 35 (suppl_4): S1418-S1425
3. National Cancer Institute. Surveillance, Epidemiology and End Results Program. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed January 2025.
4. Manohar P, et al. Updates in endocrine therapy for metastatic breast cancer. Cancer Biol Med. 2022 Feb 15; 19(2):202–212.
5. Yuan P, et al. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019;112:57–65.
6. Jerusalem G, et al. Everolimus Plus Exemestane vs Everolimus or Capecitabine Monotherapy for Estrogen Receptor–Positive, HER2-Negative Advanced Breast Cancer. JAMA Oncol. 2018;4(10):1367–1374.
7. American Cancer Society. Key Statistics for Breast Cancer. Available at: https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html. Accessed April 2025.

Statement: This article involves products or indications that have not yet been approved in mainland China. AstraZeneca does not recommend any use of unapproved drugs.