第一三共/阿斯利康Datroway获中国批准用于转移性三阴性乳腺癌

Datroway® Approved in China as First and Only TROP2 Directed Antibody
Drug Conjugate with Overall Survival Benefit for Treatment of Patients with
Metastatic Triple Negative Breast Cancer Who Are Not Candidates for PD-
1/PD-L1 Inhibitor Therapy

• Daiichi Sankyo and AstraZeneca’s Datroway prolonged overall survival in this setting versus chemotherapy,
with an unprecedented median overall survival of approximately two years based on results from the
TROPION-Breast02 phase 3 trial
• Datroway now approved for two breast cancer indications in China

Tokyo – (October 8, 2026) – Datroway® (datopotamab deruxtecan) has been approved in China for the treatment
of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for
PD-1/PD-L1 inhibitor therapy.

Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi
Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca
(LSE/STO/NYSE: AZN).

The approval of Datroway by China’s National Medical Products Administration (NMPA) is based on results from
the TROPION-Breast02 phase 3 trial, which were presented at the 2025 European Society for Medical Oncology
Congress and subsequently published in Annals of Oncology.

In TROPION-Breast02, Datroway demonstrated a statistically significant 5.0 month improvement in median overall
survival (OS) versus investigator’s choice of chemotherapy (hazard ratio [HR]=0.79; 95% confidence interval [CI]:
0.64-0.98; p=0.0291). Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for
those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to
chemotherapy (HR=0.57; 95% CI: 0.47-0.69; p<0.0001) as assessed by blinded independent central review
(BICR). Median progression-free survival (PFS) was 10.8 months for patients treated with Datroway versus 5.6
months for those treated with chemotherapy in patients with metastatic TNBC who are not candidates for PD-
1/PD-L1 inhibitor therapy. Datroway also was associated with more robust treatment responses compared to
chemotherapy, with an objective response rate (ORR) of 63% versus 29% for those treated with chemotherapy.

“One of the greatest challenges in my clinical practice is treating patients at their first metastatic triple negative
breast cancer diagnosis who are not candidates for immunotherapy since there has been limited treatment options
available,” said Zhimin Shao, MD, Director, Fudan University Cancer Institute and Breast Cancer, China, and lead
investigator in China of the TROPION-Breast02 trial. “The approval of Datroway in China introduces an important
new treatment option, which is supported by clinically meaningful improvements in overall survival and
progression-free survival, and offers a significant advancement over the current standard of care.”

The safety profile of Datroway (6 mg/kg) was evaluated in 319 patients with TNBC who received Datroway in
TROPION-Breast02. The most common (20%) adverse reactions, including laboratory abnormalities, were
stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, decreased white blood cells,
constipation, decreased calcium, fatigue, decreased lymphocytes, decreased neutrophils, increased alanine
aminotransferase, increased aspartate aminotransferase, dry eye, decreased albumin, vomiting, decreased
sodium and increased blood alkaline phosphatase. Serious adverse reactions occurred in 5.6% of patients who
received Datroway. Serious adverse reactions in more than 1% of patients who received Datroway included
vomiting and anemia. One patient fatality was attributed to interstitial lung disease/pneumonitis.

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“Patients with metastatic triple negative breast cancer continue to face a poor prognosis, particularly those who are
not eligible for immunotherapy,” said Michio Hayashi, China President, Daiichi Sankyo. “As the only TROP2
directed antibody drug conjugate approved in China with an overall survival benefit in this setting, Datroway offers
a much-needed treatment option supported by robust clinical evidence for patients facing this aggressive disease.
We are proud to bring this innovative medicine to more patients in China.”

“There remains a critical need for innovative treatment options that can help improve outcomes based on the
aggressive nature of triple negative breast cancer,” said Mary Guan, General Manager, China Oncology Business,
AstraZeneca. “This second approval for Datroway in China, and the first TROP2 directed antibody drug conjugate
approved in this setting, expands its use into triple negative breast cancer and marks another important step in our
commitment to addressing the diverse needs of patients across the breast cancer continuum. We will continue to
advance innovation and help improve outcomes for more patients living with breast cancer.”

Datroway (6 mg/kg) is approved in more than 35 countries/regions, including China, EU, Japan and the U.S. for
the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1
inhibitor therapy. Additional reviews are underway in Australia, Canada, Israel and Switzerland as part of Project
Orbis.

About TROPION-Breast02
TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and
safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine,
carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for
whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as
patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage
disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients
with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such
as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are OS and PFS as assessed by BICR. Secondary endpoints
include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and
safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For
more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 365,000 diagnoses globally
each year.1,2 In China, there are an estimated 56,000 diagnoses of TNBC each year.1,2 TNBC is diagnosed more
frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.3,4,5
Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median
OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.3,6,7

While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of
HER2, TNBC tests negative for all three.3 Due to its aggressive nature and absence of common breast cancer
receptors, TNBC is characteristically difficult to treat.3 For patients with metastatic disease with PD-L1 expressing
tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the first-line setting.8,9
However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy,
chemotherapy was the standard first-line treatment.10

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TROP2 is a protein broadly expressed in several solid tumors, including TNBC.11 TROP2 is associated with
increased tumor progression and poor survival in patients with breast cancer.12,13

About Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC.
Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Datroway is one of seven DXd ADCs in
the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific
platform. Datroway is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in
collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an
exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway (6 mg/kg) is approved in more than 35 countries/regions worldwide for the treatment of adult patients
with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the
results from the TROPION-Breast02 trial.

Datroway (6 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients
with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who
have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on
the results from the TROPION-Breast01 trial.

Datroway (6 mg/kg) is approved in Brazil, Russia, Singapore and the U.S. for the treatment of adult patients with
locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior
EGFR-directed therapy and platinum-based chemotherapy, based on the results from TROPION-Lung05 and
TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and
description of clinical benefit in a confirmatory trial.

About the Datroway Clinical Development Program
A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy
and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program
includes eight phase 3 trials in lung cancer, five phase 3 trials in breast cancer, one phase 3 trial and one phase
2/3 trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer
treatments in various settings.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu®
in March 2019 and Datroway in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for
each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway.

About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of nine ADCs in clinical development crafted from ADC technology
discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each
ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an
exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway,
which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-
DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed
and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed
by Daiichi Sankyo.

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Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a
novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody
attached to an immune-oncology optimized cytotoxic payload.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025
are investigational medicines that have not been approved for any indication in any country. Safety and efficacy
have not been established.

About Daiichi Sankyo
Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator,
transforming the lives of people through its strength in science and technology. The company discovers and
develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the
enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an
industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies
to deliver practice-changing medicines to patients, healthcare professionals and society. For more information,
please visit www.daiichisankyo.com.

MEDIA CONTACTS: INVESTOR RELATIONS CONTACT:
Global: [email protected]
Jennifer Brennan
[email protected]
+ 1 908 900 3183 (mobile)

Japan:
[email protected]

REFERENCES
1 O’Reilly D, et al. World J Clin Oncol. 2021;12(3):164-182.
2 World Health Organization. Global Status Report on Cancer 2026. Accessed September 2026.
3 American Cancer Society. Triple-Negative Breast Cancer. Accessed September 2026.
4 Martinez M, et al. Breast Cancer Res Treat. 2017;166(1):185-193.
5 Vargas L, et al. Cancer Epidemiol Biomarkers Prev. 2019;28(11):1771-1783.
6 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed September 2026.
7 Huppert L, et al. Ther Adv Med Oncol. 2022;14:1-25.
8 Cortes J, et al. N Engl J Med. 2022;387:217-226.
9 Geurts V, et al. Curr Treat Options Oncol. 2023;24:628-643.
10 Punie K, et al. Oncologist. 2025;30(3):oyaf034.
11 Rossi V, et al. Front Immunol. 2024;15:1447280.
12 Lin H, et al. Exp Mol Pathol. 2013:94(1):73-78.
13 Goldenberg D, et al. Oncotarget. 2018;9(48):28989-29006.

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