)--Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy..

)--Daitotamab deruxtecan（Dato DXd）的Daiichi Sankyo（TSE:4568）和AstraZeneca（LSE/STO/Nasdaq:AZN）生物制剂许可证申请（BLA）已被美国接受并获得优先审查，用于治疗先前接受过全身治疗（包括EGFR定向治疗）的局部晚期或转移性表皮生长因子受体突变（EGFR突变）非小细胞肺癌（NSCLC）成年患者。。

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.

Datopotamab deruxtecan是由Daiichi Sankyo发现并由Daiichi Sankyo和AstraZeneca联合开发的特异性工程TROP2定向DXd抗体-药物偶联物（ADC）。

The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is July 12, 2025.

美国食品和药物管理局（FDA）优先审查药物申请，如果获得批准，将通过证明安全性或疗效改善，预防严重疾病或提高患者依从性，从而显着改善现有选择。《处方药使用费法案》（PDUFA）的日期是2025年7月12日，是FDA监管决定的行动日期。

Datopotamab deruxtecan was previously .

Datopotamab deruxtecan以前是。

granted

已授予

Breakthrough Therapy Designation (BTD) by the FDA for this patient population.

FDA针对该患者人群的突破性治疗指定（BTD）。

TROPION-Lung05

TROPION-Lung05

phase 2 trial and supported by data from the

第二阶段试验，并得到

TROPION-Lung01

TROPION-Lung01

phase 3 trial. In addition, the BLA is supported by the

第3阶段试验。此外，BLA由

TROPION-PanTumor01

TROPION-PanTumor01

phase 1 trial. In a pooled analysis of patients with previously treated advanced or metastatic EGFR-mutated NSCLC in the TROPION-Lung05 and TROPION-Lung01 trials

第一阶段试验。在TROPION-Lung05和TROPION-Lung01试验中，对先前接受过治疗的晚期或转移性EGFR突变NSCLC患者进行了汇总分析

presented

介绍

at the European Society for Medical Oncology (ESMO) Asia 2024 Congress, datopotamab deruxtecan demonstrated clinically meaningful tumor response. The safety profile of datopotamab deruxtecan was consistent with previous reports from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety concerns identified..

在欧洲肿瘤内科学会（ESMO）亚洲2024年大会上，达托帕单抗（datopotamab deruxtecan）表现出具有临床意义的肿瘤反应。达托帕单抗-德鲁替康的安全性与之前来自TROPION-Lung05和TROPION-Lung01试验的报告一致，没有发现新的安全问题。。

Treating advanced EGFR-mutated non-small cell lung cancer presents a significant challenge due to the limited efficacy of available treatments once the disease has progressed following front-line therapies, including the use of an EGFR tyrosine kinase inhibitor,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo..

治疗晚期EGFR突变的非小细胞肺癌是一项重大挑战，因为一旦疾病在一线治疗后进展，包括使用EGFR酪氨酸激酶抑制剂，可用治疗的疗效有限，”第一三共研发全球负责人Ken Takeshita医学博士说。。

If approved, datopotamab deruxtecan could become the first TROP2 directed antibody drug conjugate for lung cancer, providing a promising option for patients.”

如果获得批准，达托单抗-德鲁替康可能成为第一个针对TROP2的肺癌抗体-药物偶联物，为患者提供了一个有希望的选择。”

Acquired resistance to front-line therapies and, ultimately, disease progression are unfortunate realities for most patients with advanced EGFR-mutated non-small cell lung cancer,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “

对于大多数晚期EGFR突变的非小细胞肺癌患者来说，获得对一线治疗的耐药性以及最终的疾病进展是不幸的现实，”阿斯利康肿瘤学研发执行副总裁Susan Galbraith博士说。“”

This Priority Review, and the previously granted Breakthrough Therapy Designation, recognize the potential for datopotamab deruxtecan to provide a much-needed option to patients whose disease has become resistant to current treatments.”

这项优先审查以及之前授予的突破性治疗指定，认识到达托巴单抗deruxtecan有可能为疾病对当前治疗产生耐药性的患者提供急需的选择。”

Daiichi Sankyo and AstraZeneca are evaluating datopotamab deruxtecan alone and in novel combinations as treatment for patients with NSCLC in seven phase 3 trials including the

第一三共公司和阿斯利康公司正在七项三期试验中评估达托帕单抗-德鲁西坦单独或新型组合治疗 NSCLC 患者的效果，这些试验包括

TROPION-Lung14

TROPION-Lung14

and

和

TROPION-Lung15

TROPION-Lung 15

trials of datopotamab deruxtecan alone and with osimertinib, AstraZeneca’s EGFR tyrosine kinase inhibitor (TKI), as treatment for patients with advanced or metastatic EGFR

单独使用达托单抗和奥西替尼（阿斯利康的EGFR酪氨酸激酶抑制剂（TKI））治疗晚期或转移性EGFR患者的试验

About TROPION-Lung05

关于TROPION-Lung05

is a global, multicenter, single-arm, open-label phase 2 trial evaluating the efficacy and safety of datopotamab deruxtecan in patients with locally advanced or metastatic NSCLC with actionable genomic alterations who have progressed on at least one TKI (with or without other systemic therapies) and on or after one regimen of platinum-based chemotherapy.

是一项全球性，多中心，单臂，开放标签的2期临床试验，评估达托单抗deruxtecan对局部晚期或转移性NSCLC患者的疗效和安全性，这些患者具有可行的基因组改变，这些患者在至少一种TKI（有或没有其他全身治疗）和一种铂类化疗方案上或之后取得进展。

Patients receiving up to four prior lines of treatment with tumors with one or more genomic alterations including EGFR, ALK, ROS1, NTRK, BRAF, RET or MET were eligible for the trial..

接受过多达四种先前治疗方案的患者，其肿瘤具有一种或多种基因组改变，包括EGFR，ALK，ROS1，NTRK，BRAF，RET或MET，符合试验条件。。

The primary trial endpoint of TROPION-Lung05 is objective response rate (ORR) as assessed by blinded independent central review (BICR). Secondary efficacy endpoints include duration of response (DoR), disease control rate (DCR), clinical benefit rate, progression-free survival (PFS), time to response (TTR), overall survival (OS) and safety..

TROPION-Lung05的主要试验终点是通过盲法独立中央审查（BICR）评估的客观缓解率（ORR）。次要疗效终点包括反应持续时间（DoR），疾病控制率（DCR），临床获益率，无进展生存期（PFS），反应时间（TTR），总生存期（OS）和安全性。。

TROPION-Lung05 enrolled 137 patients globally in Asia, Europe and North America. For more information visit

TROPION-Lung05在亚洲，欧洲和北美招募了137名患者。有关更多信息，请访问

About TROPION-Lung01

关于TROPION-Lung01

TROPION-Lung01

TROPION-Lung01

is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan versus docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment.

是一项全球性，随机，多中心，开放标签的3期临床试验，评估达托单抗-德鲁替康与多西紫杉醇在成人局部晚期或转移性非小细胞肺癌患者中的疗效和安全性，无论是否有可行的基因组改变，均需要在事先治疗后进行全身治疗。

Patients with actionable genomic alterations were previously treated with an approved targeted therapy and platinum-based chemotherapy. Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor..

具有可行基因组改变的患者先前接受了批准的靶向治疗和铂类化疗。没有已知可行基因组改变的患者先前曾同时或顺序接受铂类化疗和PD-1或PD-L1抑制剂治疗。。

The dual primary endpoints of TROPION-Lung01 are PFS as assessed by BICR and OS. Key secondary endpoints include investigator-assessed PFS, ORR, DoR, TTR, and DCR as assessed by both BICR and investigator, and safety.

通过BICR和OS评估，TROPION-Lung01的双重主要终点是PFS。关键的次要终点包括BICR和研究者评估的研究者评估的PFS，ORR，DoR，TTR和DCR以及安全性。

TROPION-Lung01 enrolled approximately 600 patients in Asia, Europe, North America, Oceania and South America. For more information visit

TROPION-Lung01在亚洲，欧洲，北美，大洋洲和南美招募了大约600名患者。有关更多信息，请访问

About TROPION-PanTumor01

关于TROPION-PanTumor01

is a first-in-human, open-label, two-part, multicenter phase 1 trial evaluating the safety and preliminary efficacy of datopotamab deruxtecan in patients with advanced solid tumors that have relapsed or are refractory to standard treatment or for which no standard treatment is available. The dose escalation portion of the trial enrolled patients with NSCLC to assess the safety and tolerability of datopotamab deruxtecan to determine the recommended dose for expansion (6 mg/kg).

是一项首次在人体内，开放标签，两部分，多中心的1期临床试验，评估达托单抗deruxtecan在复发或标准治疗难治或无标准治疗可用的晚期实体瘤患者中的安全性和初步疗效。该试验的剂量递增部分招募了非小细胞肺癌患者，以评估达托巴单抗deruxtecan的安全性和耐受性，以确定推荐的扩张剂量（6 mg/kg）。

The dose expansion part of TROPION-PanTumor01 enrolled several different cohorts including patients with NSCLC, triple negative breast cancer (TNBC), HR positive, HER2 low or negative breast cancer, small cell lung cancer, urothelial, gastric, pancreatic, castration resistant prostate and esophageal cancer..

TROPION-PanTumor01的剂量扩展部分纳入了几个不同的队列，包括NSCLC，三阴性乳腺癌（TNBC），HR阳性，HER2低或阴性乳腺癌，小细胞肺癌，尿路上皮癌，胃癌，胰腺癌，去势抵抗性前列腺癌和食道癌患者。。

Safety endpoints include dose-limiting toxicities and serious adverse events. Efficacy endpoints include ORR, DoR, TTR, PFS and OS. Pharmacokinetic, biomarker and immunogenicity endpoints also are being evaluated.

安全终点包括剂量限制性毒性和严重不良事件。疗效终点包括ORR，DoR，TTR，PFS和OS。药代动力学，生物标志物和免疫原性终点也正在评估中。

TROPION-PanTumor01 enrolled approximately 900 patients in Asia and North America. For more information visit

TROPION-PanTumor01在亚洲和北美招募了大约900名患者。有关更多信息，请访问

Nearly 2.5 million lung cancer cases were diagnosed globally in 2022.

2022年，全球诊断出近250万例肺癌病例。

Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 80% of cases.

肺癌大致分为小细胞肺癌或非小细胞肺癌，后者约占病例的80%。

Approximately 10% to 15% of patients with NSCLC in the U.S. and Europe, and 30% to 40% of patients in Asia have an EGFR mutation.

在美国和欧洲，大约10%至15%的NSCLC患者和30%至40%的亚洲患者具有EGFR突变。

The majority of EGFR mutations occur in tumors of nonsquamous histology.

大多数EGFR突变发生在非鳞状组织学肿瘤中。

For patients with tumors that have an EGFR mutation, the established first-line treatment in the metastatic setting is an EGFR TKI.

对于具有EGFR突变的肿瘤患者，在转移性环境中建立的一线治疗是EGFR TKI。

While EGFR TKIs have improved outcomes in the first-line setting, most patients eventually experience disease progression and receive subsequent therapies, such as chemotherapy.

虽然表皮生长因子受体抑制剂 TKIs 改善了一线治疗的疗效，但大多数患者最终会出现疾病进展，并接受化疗等后续治疗。

TROP2 is a protein broadly expressed in the majority of NSCLC tumors.

TROP2是一种在大多数NSCLC肿瘤中广泛表达的蛋白质。

There is currently no TROP2 directed ADC approved for the treatment of lung cancer.

目前还没有TROP2指导的ADC被批准用于治疗肺癌。

About Datopotamab Deruxtecan (Dato-DXd)

关于达托帕马·德鲁克斯坦（Dato DXd）

Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, datopotamab deruxtecan is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform.

Datopotamab deruxtecan（Dato DXd）是一种研究性TROP2指导的ADC。datopotamab deruxtecan使用Daiichi Sankyo专有的DXd ADC技术设计，是Daiichi Sankyo肿瘤学管道中的六个DXd ADC之一，也是阿斯利康ADC科学平台中最先进的程序之一。

Datopotamab deruxtecan 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..

Datopotamab deruxtecan由与札幌医科大学合作开发的人源化抗TROP2 IgG1单克隆抗体组成，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）。。

Datopotamab deruxtecan is approved in Japan under the brand name DATROWAY

Datopotamab deruxtecan在日本以DATROWAY品牌获得批准

for the treatment of adult patients with HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy based on the results of the

用于治疗HR阳性，HER2阴性（IHC 0，IHC 1+或IHC 2+/ISH-）的成年患者，这些患者在先前的化疗后无法切除或复发

TROPION-Breast01

TROPION-Breast01

trial. Datopotamab deruxtecan is an investigational medicine in all countries outside of Japan.

审判。Datopotamab deruxtecan是日本以外所有国家的研究药物。

About the Datopotamab Deruxtecan Clinical Development Program

关于达托巴单抗Deruxtecan临床开发计划

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, TNBC and HR positive, HER2 low or negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating datopotamab deruxtecan as a monotherapy and in combination with other anticancer treatments in various settings..

一项全面的全球临床开发计划正在进行中，有20多项试验评估了达托单抗deruxtecan在多种癌症中的疗效和安全性，包括NSCLC，TNBC和HR阳性，HER2低或阴性乳腺癌。该计划包括7项肺癌3期临床试验和5项乳腺癌3期临床试验，评估达托单抗-德鲁替康作为单一疗法以及在各种情况下与其他抗癌治疗相结合。。

About the Daiichi Sankyo and AstraZeneca Collaboration

关于第一三共和阿斯利康的合作

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU

第一三共和阿斯利康达成全球合作，共同开发ENHERTU并将其商业化

, 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.

，但在日本，第一三共对每个ADC拥有专有权。Daiichi Sankyo负责ENHERTU和datopotamab deruxtecan的制造和供应。

About the ADC Portfolio of Daiichi Sankyo

关于第一三共的ADC投资组合

The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

Daiichi Sankyo ADC组合由七个临床开发中的ADC组成，这些ADC由Daiichi Sankyo内部发现的两个不同的ADC技术平台精心打造而成。

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca..

临床开发中最深入的ADC平台是Daiichi Sankyo的DXd ADC技术，其中每个ADC由单克隆抗体组成，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）。DXd ADC投资组合目前由ENHERTU（一种HER2导向的ADC）和datopotamab deruxtecan（Dato DXd）（一种TROP2导向的ADC）组成，它们正在与阿斯利康联合开发并在全球商业化。。

Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo..

Patritumab deruxtecan（HER3 DXd）是一种HER3定向的ADC，ifinatamab deruxtecan（I-DXd）是一种B7-H3定向的ADC，raludotatug deruxtecan（R-DXd）是一种CDH6定向的ADC，正在与Merck＆Co.，Inc，Rahway，NJ，USA联合开发和全球商业化。DS-3939是一种TA-MUC1定向的ADC，由Daiichi Sankyo开发。。

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

。DS-9606是一种CLDN6定向的PBD ADC，是利用该平台进行临床开发的几个计划ADC中的第一个。

Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

Ifinatamab deruxtecan，patritumab deruxtecan，raludotatug deruxtecan，DS-3939和DS-9606是尚未在任何国家批准用于任何适应症的研究药物。安全性和有效性尚未确定。

About Daiichi Sankyo

关于第一三共

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need.

Daiichi Sankyo是一家创新的全球医疗保健公司，致力于社会的可持续发展，发现、开发和提供新的护理标准，以丰富世界各地的生活质量。拥有120多年的经验，第一三共利用其世界一流的科学和技术，为癌症，心血管疾病和其他医疗需求未得到满足的疾病患者创造新的模式和创新药物。