Approval based on DESTINY-Lung02 and DESTINY-Lung05 results which showed

根据DESTINY-Lung02和DESTINY-Lung05的结果进行批准

Enhertu demonstrated clinically meaningful efficacy in previously treated patients

Enhertu在先前接受治疗的患者中表现出临床上有意义的疗效

Fourth approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu

阿斯利康和第一三共的Enhertu在中国获得第四次批准

across three different tumour types

跨越三种不同的肿瘤类型

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy..

阿斯利康（AstraZeneca）和第一三共（Daiichi Sankyo）的Enhertu（曲妥珠单抗-德鲁替康）已在中国获得有条件的批准，作为单一疗法，用于治疗肿瘤具有激活HER2（ERBB2）突变且先前接受过全身治疗的不可切除，局部晚期或转移性非小细胞肺癌（NSCLC）的成年患者。。

The conditional approval by the National Medical Products Administration (NMPA) was based on the positive results of the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials. Full approval for this indication will depend on the clinical benefit of a confirmatory trial.

国家医疗产品管理局（NMPA）的有条件批准是基于DESTINY-Lung02和DESTINY-Lung05 II期试验的积极结果。该适应症的完全批准将取决于验证性试验的临床益处。

Each year in China, more than one million people are diagnosed with lung cancer, accounting for more than 40% of the world’s lung cancer patients – the majority are diagnosed with advanced disease.1,2,3 Approximately 2% to 4% of patients with NSCLC have tumours with activating HER2 mutations.4,5

在中国，每年有100多万人被诊断出患有肺癌，占世界肺癌患者的40%以上，其中大多数被诊断出患有晚期疾病。1,2,3大约2%至4%的非小细胞肺癌患者患有激活HER2突变的肿瘤。4,5

Ying Cheng, MD, PhD, Director of Jilin Lung Cancer Centre, China, and principal investigator of DESTINY-Lung05, said: “While there have been many advancements in the treatment of non-small cell lung cancer in China in recent years, patients with HER2-mutant disease have had few treatment options and none directed towards this specific type of lung cancer.

中国吉林肺癌中心主任、DESTINY-Lung05首席研究员Ying Cheng博士说：“虽然近年来中国在非小细胞肺癌的治疗方面取得了许多进展，但HER2突变型疾病患者的治疗选择很少，也没有针对这种特定类型的肺癌的治疗选择。

This approval of Enhertu offers an important new targeted treatment for patients with this aggressive form of disease.”.

Enhertu的批准为患有这种侵袭性疾病的患者提供了重要的新靶向治疗。”。

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval of Enhertu represents the first HER2-directed therapy approved in China for the treatment of HER2-mutant metastatic non-small cell lung cancer, marking an important step forward in how the disease can be treated.

阿斯利康肿瘤业务部执行副总裁戴夫·弗雷德里克森（DaveFredrickson）表示：“Enhertu的这一批准代表了中国首次批准用于治疗HER2突变型转移性非小细胞肺癌的HER2定向治疗，标志着在如何治疗该病方面迈出了重要的一步。

It also reinforces the importance of testing for predictive biomarkers in lung cancer at the time of diagnosis, including HER2 mutations, to ensure patients can receive the most appropriate treatment for their specific disease.”.

它还强调了在诊断时测试肺癌预测性生物标志物（包括HER2突变）的重要性，以确保患者可以针对其特定疾病接受最合适的治疗。”。

Kiminori Nagao, Head of the Asia, South & Central America Business Unit, Daiichi Sankyo, said: “Since our initial approval of Enhertu for patients with HER2-positive metastatic breast cancer in China last year, we have remained committed to bringing this innovative antibody drug conjugate to more patients in China, especially those that have previously not been eligible for treatment with a HER2-directed therapy.

第一三共（Daiichi Sankyo）亚洲、南美和中美洲业务部门负责人Kiminori Nagao表示：“自从去年我们首次批准Enhertu用于中国HER2阳性转移性乳腺癌患者以来，我们一直致力于将这种创新的抗体-药物偶联物带给中国更多的患者，特别是那些以前没有资格接受HER2导向治疗的患者。

Today’s milestone marks the fourth approval of Enhertu in China and follows the recent approval for HER2-positive metastatic gastric cancer, reinforcing its benefit across multiple HER2-targetable tumours.”.

今天的里程碑标志着Enhertu在中国的第四次批准，并且在最近批准HER2阳性转移性胃癌之后，增强了其在多种HER2靶向肿瘤中的益处。”。

In DESTINY-Lung02, which included patients from Japan, Korea and Taiwan (China), patients with previously treated HER2-mutant metastatic NSCLC treated with Enhertu (5.4mg/kg) showed a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI] 39.0-59.1), as assessed by blinded independent central review (BICR).

在包括来自日本，韩国和台湾（中国）的患者的DESTINY-Lung02中，先前用Enhertu（5.4mg/kg）治疗的HER2突变转移性NSCLC患者的确诊客观缓解率（ORR）为49.0%（95%置信区间[CI]39.0-59.1），由盲法独立中央审查（BICR）评估。

Median duration of response (DoR) was 16.8 months (95% CI 6.4-non-evaluable [NE]). Median progression-free survival (PFS) was 9.9 months (95% CI 7.4-NE) and median overall survival (OS) was 19.5 months (95% CI 13.6-NE)..

中位缓解时间（DoR）为16.8个月（95%CI 6.4-不可评估[NE]）。中位无进展生存期（PFS）为9.9个月（95%CI 7.4-NE），中位总生存期（OS）为19.5个月（95%CI 13.6-NE）。。

In DESTINY-Lung05, Enhertu (5.4mg/kg) demonstrated a consistent clinically meaningful response in patients in China with previously treated HER2-mutant metastatic NSCLC. Treatment with Enhertu resulted in a confirmed ORR of 58.3% (95% CI 46.1-69.8), as assessed by independent central review (ICR).

在DESTINY-Lung05中，Enhertu（5.4mg/kg）在中国先前接受过HER2突变转移性NSCLC治疗的患者中表现出一致的临床意义反应。根据独立中央审查（ICR）的评估，用Enhertu治疗导致确诊的ORR为58.3%（95%CI 46.1-69.8）。

The safety profile of Enhertu in DESTINY-Lung02 and DESTINY-Lung05 were similar and generally consistent with previous clinical trials of Enhertu in lung cancer with no new safety concerns identified.

Enhertu在DESTINY-Lung02和DESTINY-Lung05中的安全性相似，并且与之前的Enhertu在肺癌中的临床试验基本一致，没有发现新的安全性问题。

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Enhertu是由Daiichi Sankyo发现的一种专门设计的HER2定向抗体-药物偶联物（ADC），由AstraZeneca和Daiichi Sankyo联合开发和商业化。

Enhertu is already approved for the treatment of previously treated unresectable or metastatic HER2-mutant NSCLC in more than 45 countries, including the US, Japan and across the EU.

Enhertu已被批准用于治疗包括美国，日本和整个欧盟在内的45多个国家先前治疗过的不可切除或转移性HER2突变NSCLC。

Notes

HER2-mutant NSCLC

HER2突变NSCLC

Lung cancer is the most common form of cancer globally in both men and women.2 Each year there are approximately 2.5 million people diagnosed with lung cancer globally, with 80-85% diagnosed with NSCLC.2,6 Prognosis is poor for patients with metastatic NSCLC as only approximately 9% will live beyond five years after diagnosis.7.

。

In China, lung cancer is the most commonly diagnosed cancer with more than one million cases diagnosed in 2022.1 It is also the leading cause of cancer-related deaths in China, with more than 733,000 deaths reported in 2022.1

在中国，肺癌是最常被诊断出的癌症，2022年诊断出100多万例。它也是中国癌症相关死亡的主要原因，2022年报告的死亡人数超过733000人

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumour types. Certain HER2 (ERBB2) gene alterations (called HER2 mutations) have been identified in patients with non-squamous NSCLC as a distinct molecular target, and occur in approximately 2% to 4% of patients with this type of lung cancer.4,5 While HER2 gene mutations can occur in a range of patients, they are more commonly found in patients with NSCLC who are younger, female and have never smoked.8 HER2 gene mutations have been independently associated with cancer cell growth and poor prognosis, with an increased incidence of brain metastases.9 Next-generation sequencing has been utilised in the identification of HER2 (ERBB2) mutations.10.

HER2是一种酪氨酸激酶受体生长促进蛋白，在多种肿瘤类型的表面表达。某些HER2（ERBB2）基因改变（称为HER2突变）已被确定为非鳞状NSCLC患者的独特分子靶点，约2%至4%的此类肺癌患者发生HER2基因突变[4,5]。虽然HER2基因突变可能发生在一系列患者中，但更常见于年轻，女性且从未吸烟的NSCLC患者[8]。HER2基因突变与癌细胞生长和预后不良独立相关，脑转移发生率增加[9]。下一代测序已被用于鉴定HER2（ERBB2）突变。

DESTINY-Lung02

DESTINY-Lung02号

DESTINY-Lung02 is a global, randomised Phase II trial evaluating the safety and efficacy of Enhertu in patients with HER2-mutant unresectable and/or metastatic NSCLC with disease recurrence or progression during or after at least one regimen of prior anticancer therapy that must have contained a platinum-based chemotherapy.

DESTINY-Lung02是一项全球性随机II期临床试验，评估Enhertu在HER2突变型不可切除和/或转移性非小细胞肺癌患者中的安全性和有效性，这些患者在至少一种先前的抗癌治疗方案期间或之后必须含有铂类化疗。

Patients were randomised 2:1 to receive Enhertu 5.4mg/kg (n=102) or Enhertu 6.4mg/kg (n=50)..

患者以2:1的比例随机接受Enhertu 5.4 mg/kg（n=102）或Enhertu 6.4 mg/kg（n=50）治疗。

The primary endpoint of the trial is confirmed ORR as assessed by BICR. Secondary endpoints include disease control rate (DCR), DoR and PFS assessed by investigator and BICR, OS and safety.

。次要终点包括研究者评估的疾病控制率（DCR），DoR和PFS以及BICR，OS和安全性。

DESTINY-Lung02 enrolled 152 patients at multiple sites, including Asia, Europe, Oceania and North America. For more information about the trial, visit clinicaltrials.gov.

DESTINY-Lung02在多个地点招募了152名患者，包括亚洲，欧洲，大洋洲和北美。有关该试验的更多信息，请访问clinicaltrials.gov。

DESTINY-Lung05

DESTINY-Lung05号

DESTINY-Lung05 is an open-label, single-arm Phase II trial evaluating the safety and efficacy of Enhertu (5.4mg/kg) in patients with HER2-mutant metastatic NSCLC with disease progression on or after at least one prior anticancer therapy.

DESTINY-Lung05是一项开放标签的单臂II期临床试验，评估了Enhertu（5.4mg/kg）在HER2突变转移性NSCLC患者中的安全性和有效性，这些患者在至少一次先前的抗癌治疗时或之后疾病进展。

The primary endpoint of the trial is confirmed ORR as assessed by ICR. Secondary endpoints include investigator-assessed confirmed ORR, as well as ICR and investigator-assessed DoR, DCR, PFS and safety.

根据ICR的评估，试验的主要终点被确认为ORR。次要终点包括研究者评估的确诊ORR，以及ICR和研究者评估的DoR，DCR，PFS和安全性。

DESTINY-Lung05 enrolled 72 patients at multiple sites in China. For more information about the trial, visit clinicaltrials.gov.

DESTINY-Lung05在中国多个地点招募了72名患者。有关该试验的更多信息，请访问clinicaltrials.gov。

Enhertu

恩赫蒂

Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers..

Enhertu是HER2定向的ADC。Enhertu采用第一三共专有的DXd ADC技术设计，是第一三共肿瘤学组合中的领先ADC，也是阿斯利康ADC科学平台中最先进的项目。Enhertu由HER2单克隆抗体组成，该抗体通过基于四肽的可切割接头连接到许多拓扑异构酶I抑制剂有效载荷（exatecan衍生物DXd）。。

Enhertu (5.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridisation [ISH]+) breast cancer who have received a (or one or more)  prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial..

。。

Enhertu (5.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial..

Enhertu（5.4mg/kg）已在全球65多个国家获得批准，用于治疗无法切除或转移性HER2-low（IHC 1+或IHC 2+/ISH-）乳腺癌的成年患者，这些患者先前在转移性环境中接受过全身治疗，或者根据DESTINY-Breast04试验的结果，在完成辅助化疗后的六个月内或六个月内出现疾病复发。。

Enhertu (5.4mg/kg) is approved in more than 45 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials.

Enhertu（5.4mg/kg）在全球45多个国家被批准用于治疗无法切除或转移性NSCLC的成年患者，这些患者的肿瘤具有激活的HER2（ERBB2）突变，如通过当地或地区批准的测试所检测到的，并且已经根据DESTINY-Lung02和/或DESTINY-Lung05试验的结果接受了先前的全身治疗。

Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial..

中国和美国对该适应症的持续批准可能取决于验证性试验中临床益处的验证和描述。。

Enhertu (6.4mg/kg) is approved in more than 45 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials.

Enhertu（6.4mg/kg）在全球超过45个国家被批准用于治疗局部晚期或转移性HER2阳性（IHC 3+或2+/ISH+）胃或胃食管交界处（GEJ）腺癌的成年患者，这些患者已经接受了基于DESTINY-Gastric01，DESTINY-Gastric02和/或DESTINY-Gastric06试验结果的先前基于曲妥珠单抗的方案。

Continued approval in China for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population..

中国对该适应症的持续批准将取决于随机对照验证性临床试验是否可以证明该人群的临床益处。。

Enhertu (5.4mg/kg) is approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials.

Enhertu（5.4mg/kg）在美国被批准用于治疗无法切除或转移性HER2阳性（IHC 3+）实体瘤的成年患者，这些患者先前接受过全身治疗，并且根据DESTINY-PanTumor02，DESTINY-Lung01和DESTINY-CRC02试验的疗效结果没有令人满意的替代治疗选择。

Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial..

在美国继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。。

Enhertu development programme

恩赫图发展计划

A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anti-cancer treatments, such as immunotherapy, also are underway.

一项全面的全球临床开发计划正在评估Enhertu单药治疗多种HER2靶向癌症的疗效和安全性。与免疫疗法等其他抗癌治疗相结合的试验也正在进行中。

Daiichi Sankyo collaboration

第一三共合作

AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and datopotamab deruxtecan 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 datopotamab deruxtecan..

阿斯利康（AstraZeneca）和第一三共（Daiichi Sankyo）于2019年3月达成全球合作，共同开发Enhertu，并于2020年7月将其商业化，但在日本，第一三共（Daiichi Sankyo）对每个ADC拥有专有权。Daiichi Sankyo负责Enhertu和datopotamab deruxtecan的制造和供应。。

AstraZeneca in oncology

阿斯利康肿瘤学

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and delver life-changing medicines to patients.

阿斯利康（AstraZeneca）正在领导一场肿瘤学革命，致力于为各种形式的癌症提供治疗方法，遵循科学理解癌症及其复杂性，为患者发现、开发和开发改变生命的药物。

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

该公司专注于一些最具挑战性的癌症。正是通过不断的创新，阿斯利康建立了行业内最多样化的投资组合和渠道之一，有可能促进医学实践的变化并改变患者的体验。

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

阿斯利康的愿景是重新定义癌症护理，并有一天消除癌症作为死亡原因。

AstraZeneca

阿斯利康

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

阿斯利康（LSE/STO/Nasdaq:AZN）是一家全球科学领先的生物制药公司，专注于肿瘤学，罕见病和生物制药（包括心血管，肾脏和代谢以及呼吸和免疫学）处方药的发现，开发和商业化。

Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. .

阿斯利康的创新药物总部位于英国剑桥，在125多个国家销售，全球数百万患者使用。请访问astrazeneca.com并在社交媒体@astrazeneca上关注该公司。。

Contacts

联系人

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

有关如何联系投资者关系团队的详细信息，请单击此处。有关媒体联系人，请单击此处。

References

参考文献

1. WHO. International Agency of Cancer Research. Cancer Today. China. 2022. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed October 2024.

。国际癌症研究机构。今天的癌症。中国。2022年。网址：https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf.2024年10月访问。

2. WHO. International Agency of Cancer Research. Cancer Today. Lung. 2022. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed October 2024.

2、谁。国际癌症研究机构。今天的癌症。肺。2022年。网址：https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.2024年10月访问。

3. Fan H, et al. Incidence and survival of non-small cell lung cancer in Shanghai: a population-based cohort study. BMJ Open. 2015;5:e009419.

3.Fan H等。上海非小细胞肺癌的发病率和生存率：一项基于人群的队列研究。BMJ开放。；5： e009419。

4. Liu S, et al. Targeting HER2 Aberrations in Non–Small Cell Lung Cancer with Osimertinib. Clinical Cancer Research. 2018;24(11):2594-2604.

4.Liu S等人。用Osimertinib靶向非小细胞肺癌中的HER2畸变。临床癌症研究。2018年；24（11）：2594-2604。

5. Riudavets M, et al. Targeting HER2 in non-small-cell lung cancer (NSCLC): a glimpse of hope? An updated review on therapeutic strategies in NSCLC harbouring HER2 alterations. ESMO Open. 2021;6(5):100260.

5.Riudavets M等人。靶向HER2治疗非小细胞肺癌（NSCLC）：一线希望？关于携带HER2改变的NSCLC治疗策略的最新综述。ESMO打开。2021年；6（5）：100260。

6. American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed October 2024.

6、美国癌症协会。肺癌的关键统计数据。网址：https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html.2024年10月访问。

7. American Cancer Society. Lung Cancer Survival Rates. Available at: https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed October 2024.

7、美国癌症协会。肺癌生存率。网址：https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html.2024年10月访问。

8. Pillai RN, et al. HER2 mutations in lung adenocarcinomas: A report from the Lung Cancer Mutation Consortium. Cancer. 2017;123:4099-105.

8.Pillai RN等人。肺腺癌中的HER2突变：肺癌突变协会的报告。癌症。2017年；123:4099-105。

9. Offin M, et al. Frequency and outcomes of brain metastases in patients with HER2-mutant lung cancers. Cancer. 2019;125:4380-7.

9.Offin M等人。HER2突变型肺癌患者脑转移的频率和结果。癌症。2019年；125:4380-7年。

10, Hechtman J, et al. The Past, Present, and Future of HER2 (ERBB2) in Cancer: Approaches to Molecular Testing and an Evolving Role in Targeted Therapy. Cancer Cytopathology. 2019;127(7): 428-431

10，Hechtman J等人。HER2（ERBB2）在癌症中的过去，现在和未来：分子检测方法和靶向治疗中不断发展的作用。癌症细胞病理学。2019年；127（7）：428-431