Durvalumab

Key combination for the treatment of Small Cell Lung Cancer MADRID and CAMBRIDGE, Mass., March 12, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that the Mexican Patent Office has issued a decision to grant for its patent application MX/a/2021/011610, entitled “Combinations of iadademstat for cancer therapy”. The allowed claims protect the use of iadademstat in combination with PD-1 or PD-L1 inhibitors for the treatment of cancer, including small cell lung cancer (SCLC). Following formal grant, the patent is expected to provide protection until at least 2040, not including any potential patent term extensions. With this decision, Oryzon has now secured patent protection for these combinations in Australia, Europe, Japan, Mexico and Russia, while corresponding patent applications remain under examination in other jurisdictions. “This decision further strengthens the global intellectual property protection around iadademstat and its use in combination therapies,” said Neus Virgili, Oryzon’s Chief IP Officer. “Securing protection in additional countries supports the development of iadademstat with immune checkpoint inhibitors such as atezolizumab and durvalumab, an approach we are exploring in small cell lung cancer.” Iadademstat is currently being investigated in combination with PD-L1 inhibitors in extensive-stage SCLC (ES-SCLC) in two ongoing clinical trials. One is a Phase I/II study evaluating iadademstat in combination with atezolizumab or durvalumab, conducted and sponsored by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Oryzon, and carried out at more than 30 clinical sites across the United States. The other is an open-label Phase Ib study sponsored and conducted by Yale University, evaluating iadademstat in combination with atezolizumab and stereotactic body radiation therapy (SBRT), followed by maintenance therapy with atezolizumab and iadademstat in patients with residual, progressive or recurrent ES-SCLC. About Oryzon Founded in 2000 and headquartered in Barcelona, Spain, Oryzon (ISIN: ES0167733015) is a clinical-stage biopharmaceutical company and a European leader in epigenetics, with a strong focus on personalized medicine for central nervous system (CNS) disorders and oncology. Oryzon’s team comprises highly experienced pharmaceutical professionals based in Barcelona, Boston, and New Jersey. The Company has an advanced clinical portfolio built around two LSD1 inhibitors: iadademstat, its oncology/hematology program, with several ongoing Phase I and II studies and outstanding preliminary results in first-line acute myeloid leukemia, including a 100% overall response rate (ORR) presented at ASH 2025; and vafidemstat, its lead CNS program, which is Phase III–ready. In addition, Oryzon is advancing a broader epigenetics pipeline targeting other mechanisms, including HDAC6, for which a clinical candidate, ORY-4001, has been nominated for potential development in Charcot–Marie–Tooth disease (CMT) and amyotrophic lateral sclerosis (ALS). The Company also operates a robust platform for biomarker identification and target validation across a range of malignant and neurological diseases. For more information, visit About Iadademstat Iadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). Iadademstat has shown encouraging safety and strong clinical activity in combination with azacitidine in a Phase IIa trial in elder 1L AML patients (ALICE trial) (see Salamero et al., ASH 2022 oral presentation & The Lancet Haematology, 2024, 11(7):e487-e498). Iadademstat is currently being evaluated in combination with azacitidine and venetoclax in 1L AML in an investigator-initiated study (IIS) led by OHSU and in combination with gilteritinib in the company-sponsored Phase Ib FRIDA trial in relapsed/refractory FLT3-mutant AML, with highly encouraging preliminary safety and efficacy data recently reported at ASH-2025 for both trials: 100% ORR and 90% strict CR in 1L AML, and 67% CCR (at the dose under expansion) in R/R AML. Additional studies in hemato-oncology include an IIS in MDS, and trials in myeloproliferative neoplasms and 1L AML both sponsored and conducted by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) signed between Oryzon and the NCI. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). Iadademstat is in two trials in ED-SCLC: a Phase I/II randomized trial in 1L in combination with ICI sponsored by NCI and led by the Memorial Sloan Kettering Cancer Center, and an IIS trial in 1L/2L in combination with ICI and radiotherapy. In addition, Oryzon has expanded iadademstat’s clinical development into non-oncological hematology indications, with trials in sickle cell disease (approved by EMA, enrolling) and essential thrombocythemia (approved by EMA). Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU. FORWARD-LOOKING STATEMENTS This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events, or otherwise. This document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, and/or the restated text of the Securities Market Law, approved by Law 6/2023 of 17 March, and its implementing regulations. Nothing in this document constitutes investment advice. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any jurisdiction. The shares of Oryzon Genomics, S.A. may not be offered or sold in the United States of America except pursuant to an effective registration statement under the Securities Act of 1933 or pursuant to a valid exemption from registration. Spain Oryzon IR & Media, Europe & US Patricia Cobo/Mario Cordera Emili Torrell Sandya von der Weid Atrevia Chief BD Officer LifeSci Advisors, LLC +34 91 564 07 25 +34 673 33 97 65 +34 93 515 1313 +41 78 680 05 38 pcobo@atrevia.com mcordera@atrevia.com etorrell@oryzon.com svonderweid@lifesciadvisors.com

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.. 阿斯利康和第一三共的Enhertu（trastuzumab deruxtecan）补充生物制品许可申请（sBLA）已在美国获得受理，并被授予优先审评资格，用于治疗经新辅助HER2靶向治疗后仍有残留侵袭性疾病的HER2阳性乳腺癌成年患者。The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the third quarter of 2026.. 美国食品药品监督管理局（FDA）对申请的药物给予优先审查，如果获批，这些药物将通过展示安全性或疗效的改进、预防严重疾病或提高患者依从性，提供比现有治疗方案显著的改进。《处方药使用者费用法案》日期，即FDA作出监管决定的行动日期，预计在2026年第三季度。Enhertu was recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. Enhertu最近在这一适应症上获得了FDA授予的突破性疗法认定（BTD）。BTD旨在加速用于治疗严重疾病并满足显著未满足医疗需求的潜在新药的开发和监管审评。The sBLA also is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. 该补充生物制品许可申请（sBLA）也正在Orbis项目下进行审查，该项目为参与的国际合作伙伴提供了一个同时提交和审查肿瘤药物的框架。Around one in five breast cancers are considered HER2-positive, a subtype that is often associated with aggressive disease and poor prognosis.1-3 Currently, approximately half of patients with HER2-positive early breast cancer have residual disease following neoadjuvant treatment (before surgery), putting them at an increased risk of disease recurrence.4-9 Despite receiving additional treatment in the post-neoadjuvant setting with current standards of care, some patients still experience tumour progression to metastatic disease, where the five-year survival rate drops from nearly 90% to approximately 30%.10,11. 大约五分之一的乳腺癌被认为是HER2阳性，这种亚型常与侵袭性疾病和不良预后相关。目前，约一半的HER2阳性早期乳腺癌患者在新辅助治疗（术前）后仍有残留病灶，使他们面临更高的疾病复发风险。尽管在术后接受了当前标准治疗，部分患者仍会出现肿瘤进展为转移性疾病，此时五年生存率从接近90%下降到约30%。Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “While there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing Enhertu to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.”. 阿斯利康肿瘤血液学研发执行副总裁苏珊·加尔布雷思表示：“虽然在治疗HER2阳性早期乳腺癌方面取得了显著进展，但管理复发风险较高的患者仍然具有挑战性。通过此次优先审查，我们离将Enhertu应用于术后辅助治疗更近一步，为更多患者提供实现长期持续疗效的机会以及潜在的治愈途径。”Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease. This Priority Review reinforces the potential of Enhertu to become a new standard of care for HER2-positive early breast cancer based on the results of DESTINY-Breast05.”. 第一三共的全球研发主管武下健（Ken Takeshita）表示：“对于在新辅助治疗后仍有残留侵袭性疾病的患者，确定手术后的额外治疗方案，对进一步降低复发风险和预防疾病进展为转移性癌症至关重要。此次优先审查基于DESTINY-Breast05试验的结果，进一步证实了Enhertu成为HER2阳性早期乳腺癌新护理标准的潜力。”The sBLA is based on data from the DESTINY-Breast05 Phase III trial presented at the European Society for Medical Oncology (ESMO) 2025 Congress and subsequently published in The New England Journal of Medicine.1 该sBLA基于在2025年欧洲医学肿瘤学会（ESMO）大会上公布并随后发表于《新英格兰医学杂志》的DESTINY-Breast05 III期试验数据。In the trial, Enhertu significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared with trastuzumab emtansine (T-DM1; based on a hazard ratio [HR] of 0.47; 95% confidence interval [CI] 0.34-0.66; p<0.0001) as a post-neoadjuvant treatment for patients with HER2-positive breast cancer. 在试验中，与恩美曲妥珠单抗（T-DM1）相比，Enhertu作为HER2阳性乳腺癌患者的新辅助治疗后疗法，显著降低了浸润性疾病复发或死亡的风险（无浸润性疾病生存期 [IDFS]），减少了53%（基于风险比 [HR] 0.47；95%置信区间 [CI] 0.34-0.66；p<0.0001）。Enhertu demonstrated a three-year IDFS rate of 92.4% compared with 83.7% with T-DM1. IDFS findings were consistent across all prespecified subgroups.. Enhertu 显示出三年无病生存率 (IDFS) 为 92.4%，而 T-DM1 为 83.7%。IDFS 结果在所有预设亚组中保持一致。Enhertu also significantly reduced the risk of disease recurrence or death (disease-free survival [DFS]), a key secondary endpoint, by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001). Further, Enhertu lowered the risk of distant disease recurrence (distant recurrence-free interval) by 51% and the risk of brain metastases (brain metastasis-free interval) by 36% compared with T-DM1 (HR 0.64; 95% CI 0.35-1.17).. Enhertu 还显著降低了疾病复发或死亡的风险（无病生存期 [DFS]），这一关键的次要终点相较于 T-DM1 减少了 53%（HR 0.47；95% CI 0.34-0.66；p<0.0001）。此外，与 T-DM1 相比，Enhertu 将远端疾病复发风险（远端无复发生存期）降低了 51%，脑转移风险（无脑转移生存期）减少了 36%（HR 0.64；95% CI 0.35-1.17）。The safety profile of Enhertu observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified. Enhertu 在 DESTINY-Breast05 中观察到的安全性特征与其已知特征一致，未发现新的安全性问题。Regulatory submissions for Enhertu based upon DESTINY-Breast05 are also under review in the EU and Japan. In addition, an sBLA for Enhertu followed by paclitaxel, trastuzumab and pertuzumab (THP) currently is under review in the US for the neoadjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 trial.. 基于DESTINY-Breast05的Enhertu监管提交也正在欧盟和日本接受审查。此外，根据DESTINY-Breast11试验的结果，美国目前正在审查Enhertu联合紫杉醇、曲妥珠单抗和帕妥珠单抗（THP）的补充生物制品许可申请（sBLA），用于HER2阳性早期乳腺癌患者的新辅助治疗。Enhertu is already approved in more than 90 countries as a treatment for patients with HER2-positive metastatic breast cancer. Enhertu已在90多个国家获批用于治疗HER2阳性转移性乳腺癌患者。Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Enhertu 是一种特别设计的 HER2 靶向 DXd 抗体药物偶联物 (ADC)，由第一三共发现，并与阿斯利康联合开发和商业化。Post-neoadjuvant treatment for HER2-positive early breast cancer HER2阳性早期乳腺癌的新辅助治疗后的治疗Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.12 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.12 In the US, more than 320,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.13. 乳腺癌是全球第二大常见癌症，也是导致癌症相关死亡的主要原因之一。2022年，全球诊断出超过两百万例乳腺癌病例，导致超过665,000人死亡。在美国，每年诊断出超过320,000例乳腺癌病例，并有超过42,000人死亡。HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.14 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.14 Approximately one in five cases of breast cancer are considered HER2-positive.2-3. HER2是一种在多种肿瘤（包括乳腺癌）表面表达的酪氨酸激酶受体生长促进蛋白。HER2蛋白的过度表达可能是由于HER2基因扩增引起的，并且在乳腺癌中常与侵袭性疾病和不良预后相关。大约五分之一的乳腺癌病例被认为是HER2阳性。For patients with HER2-positive early breast cancer, achieving pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.9 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.4-9. 对于HER2阳性早期乳腺癌患者，通过新辅助治疗达到病理完全缓解（pCR）是长期生存改善的最早指标。然而，大约一半接受新辅助治疗的患者未能实现pCR，这使他们面临更高的疾病复发风险。Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death, and current treatment options have shown limited impact on central nervous system recurrence.11 In the US, around 16,000 patients with HER2-positive early breast cancer receive treatment in the post-neoadjuvant setting (after surgery) each year.15. 尽管在新辅助治疗后的残留病灶接受了额外治疗，但一些患者仍经历侵袭性疾病或死亡，且目前的治疗方案对中枢神经系统复发的影响有限。在美国，每年大约有16,000名HER2阳性早期乳腺癌患者在新辅助治疗后（术后）接受治疗。DESTINY-Breast05 DESTINY-乳腺癌05DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. DESTINY-Breast05是一项全球性、多中心、随机、开放标签的III期临床试验，评估Enhertu（5.4mg/kg）与T-DM1在HER2阳性早期乳腺癌患者中的疗效和安全性，这些患者在接受新辅助治疗后乳腺或腋窝淋巴结中仍有残留浸润性疾病，并具有高复发风险。High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.. 高复发风险被定义为出现无法手术的癌症（新辅助治疗前）或新辅助治疗后病理证实腋窝淋巴结阳性。The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS. IDFS is defined as the time from randomisation until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety.. DESTINY-Breast05 的主要终点是研究者评估的 IDFS。IDFS 定义为从随机化到首次出现侵袭性局部、腋窝或远处复发或任何原因导致死亡的时间。关键次要终点是研究者评估的无病生存期。其他次要终点包括总生存期、无远处复发生存期、无脑转移生存期和安全性。DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov. DESTINY-Breast05 在亚洲、欧洲、北美、大洋洲和南美招募了 1,635 名患者。有关该试验的更多信息，请访问 ClinicalTrials.gov。Enhertu EnhertuEnhertu 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是一种靶向HER2的抗体药物偶联物（ADC）。Enhertu采用第一三共公司的专有DXd ADC技术设计，是第一三共肿瘤学产品组合中的主要ADC，也是阿斯利康ADC科学平台中最先进的项目。Enhertu由一种HER2单克隆抗体通过四肽可裂解连接子连接多个拓扑异构酶I抑制剂有效载荷（一种依沙替康衍生物，DXd）组成。Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test based on the results from the DESTINY-Breast09 trial. Enhertu（5.4mg/kg）联合帕妥珠单抗在美国被批准作为一线治疗，用于不可切除或转移性HER2阳性（IHC 3+或ISH+）乳腺癌成年患者，这是基于DESTINY-Breast09试验的结果，由FDA批准的检测方法确定。Enhertu (5.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a 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）已在全世界90多个国家/地区获批，用于治疗先前接受过基于抗HER2治疗方案的不可切除或转移性HER2阳性（IHC 3+或ISH+）乳腺癌成年患者。这些患者无论是在转移性治疗阶段，还是在新辅助或辅助治疗阶段接受治疗，并在治疗期间或完成治疗后六个月内出现疾病复发，依据的是DESTINY-Breast03试验的结果。Enhertu (5.4mg/kg) is approved in more than 90 countries/regions 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）已在全世界90多个国家/地区获批，用于治疗不可切除或转移性HER2低表达（IHC 1+ 或 IHC 2+/ISH-）的乳腺癌成年患者。这些患者在转移性环境中曾接受过先前的系统治疗，或在完成辅助化疗期间或完成后六个月内出现疾病复发，该批准基于DESTINY-Breast04试验的结果。Enhertu (5.4mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.. Enhertu（5.4mg/kg）已在全世界60多个国家/地区获批，用于治疗不可切除或转移性激素受体（HR）阳性、HER2低表达（IHC 1+ 或 IHC 2+/ISH-）或HER2极低表达（IHC 0且有膜染色）的乳腺癌成年患者，这些患者通过当地或地区批准的检测方法确定，并基于DESTINY-Breast06试验的结果，在转移性环境中接受过一种或多种内分泌治疗后出现疾病进展。Enhertu (5.4mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (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）已在全世界70多个国家/地区获得批准，用于治疗肿瘤具有激活HER2（ERBB2）突变的不可切除或转移性非小细胞肺癌（NSCLC）成年患者，这些突变通过当地或地区批准的检测方法检测到，并且患者已基于DESTINY-Lung02和/或DESTINY-Lung05试验的结果接受过先前的系统治疗。Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.. 在中国和美国，这一适应症的持续批准可能取决于在确证性试验中对临床益处的验证和描述。Enhertu (6.4mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 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）已在全世界80多个国家/地区获批，用于治疗先前接受过基于曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性（IHC 3+ 或 IHC 2+/ISH+）胃或胃食管交界处（GEJ）腺癌成年患者，该批准基于DESTINY-Gastric01、DESTINY-Gastric02和/或DESTINY-Gastric06试验的结果。Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.. 在中国，继续批准此适应症可能取决于在确证性试验中对临床益处的验证和描述。Enhertu (5.4mg/kg) is approved in more than 10 countries/regions worldwide 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）已在全世界10多个国家/地区获批，用于治疗先前接受过系统性治疗且基于DESTINY-PanTumor02、DESTINY-Lung01和DESTINY-CRC02试验的有效性结果，没有满意替代治疗方案的不可切除或转移性HER2阳性（IHC 3+）实体瘤成年患者。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在确证性试验中对临床益处的验证和描述。Enhertu clinical development programme Enhertu临床开发计划A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers. 一项全面的全球临床开发计划正在进行中，评估Enhertu作为单一疗法、与其他癌症药物联合或序贯治疗多种HER2靶向癌症的疗效和安全性。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 Datroway (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 Datroway.. 2019年3月，阿斯利康和第一三共达成全球合作，共同开发和商业化Enhertu，并于2020年7月就Datroway（datopotamab deruxtecan）展开合作，但日本地区除外，第一三共在该地区对每种ADC拥有独家权利。第一三共负责Enhertu和Datroway的生产和供应。AstraZeneca in breast cancer 阿斯利康在乳腺癌领域Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.. 基于对乳腺癌生物学的日益深入的理解，阿斯利康正在挑战并重新定义当前乳腺癌分类与治疗的临床模式，致力于为有需要的患者提供更有效的治疗方案——其宏伟目标是终有一天消除乳腺癌作为致死原因。AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. 阿斯利康拥有一个全面的已批准和有前景的在研化合物组合，这些化合物利用不同的作用机制来应对生物多样性丰富的乳腺癌肿瘤环境。With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. 通过Enhertu，阿斯利康和第一三共旨在改善先前接受过治疗的HER2阳性、HER2低表达和HER2超低表达转移性乳腺癌的预后，并正在探索其在更早治疗阶段及新的乳腺癌环境中的潜力。In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway, and next-generation oral SERD and potential new medicine camizestrant.. 在HR阳性的乳腺癌治疗领域，阿斯利康通过基础药物Faslodex（氟维司群）和Zoladex（戈舍瑞林）持续改善患者预后，并致力于通过首创的AKT抑制剂Truqap（卡匹瓦塞替），TROP-2导向的抗体药物偶联物Datroway，以及下一代口服SERD和潜在新药camizestrant重塑HR阳性治疗格局。PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer.. PARP抑制剂Lynparza（奥拉帕利）是一种已被研究用于早期和转移性乳腺癌患者（携带遗传性BRCA突变）的靶向治疗选择。阿斯利康与默沙东（MSD，美国和加拿大地区称为默克公司）继续在这些领域对Lynparza进行研究。阿斯利康还在探索saruparib（一种强效且选择性的PARP1抑制剂）与camizestrant联合使用在BRCA突变、激素受体阳性、HER2阴性的晚期乳腺癌中的潜力。To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). 为了给三阴性乳腺癌（一种侵袭性乳腺癌）患者带来亟需的治疗选择，阿斯利康正与第一三共合作，评估Datroway单药以及与免疫疗法Imfinzi（durvalumab）联合使用的潜力。AstraZeneca in oncology 阿斯利康在肿瘤学领域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 deliver life-changing medicines to patients. 阿斯利康正引领一场肿瘤学的革命，其雄心在于为各种形式的癌症提供治愈方案。通过遵循科学，深入理解癌症及其所有复杂性，发现、开发并交付改变生命的药物给患者。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. 公司的重点是一些最具挑战性的癌症。正是通过不懈的创新，阿斯利康建立了业内最多样化的产品组合和研发管线之一，有望催化医学实践的变革，并改善患者的治疗体验。AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. 阿斯利康有重新定义癌症护理并有朝一日消除癌症作为死亡原因的愿景。AstraZeneca 阿斯利康AstraZeneca (LSE/STO/NYSE: 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/NYSE：AZN）是一家全球领先的、以科学为导向的生物制药公司，专注于肿瘤学、罕见疾病以及包括心血管、肾脏与代谢、呼吸与免疫学在内的生物制药领域处方药的发现、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.. 总部位于英国剑桥的阿斯利康创新药物在全球125多个国家销售，被全球数百万患者使用。请访问astrazeneca.com，并在社交媒体上关注该公司@AstraZeneca。Contacts 联系人For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. 要了解如何联系投资者关系团队的详细信息，请点击这里。要联系媒体，请点击这里。References 参考文献Source:astrazeneca.com 来源：astrazeneca.com