Camizestrant

阿斯利康是在1999年瑞典阿斯特拉（Astra AB）与英国捷利康（Zeneca Group PLC）的合并中诞生的，这家合并后的企业历经了二十余年的风雨洗礼，在肿瘤、心血管、代谢疾病等领域不断创新。阿斯利康在中国的业绩连续多年位居跨国药企榜首（2025年收入66.54亿美元，约占全球收入的11%），更在2026年初豪掷千亿重注中国市场。本篇文章将深入阿斯利康的发展历程、核心产品迭代、全球市场布局及未来战略，看其从“合并求生”到“创新引领”的道路。 CORPORATE CULTURE 发展历程 01 阿斯利康的诞生，是20世纪末全球制药行业整合浪潮中的重要事件。其源头可追溯至1913年瑞典阿斯特拉公司的创立——这家最初以生产心脏药物Digtotal和营养补充剂Glukofos为主的小公司，它凭借在一战期间的进口替代机会逐渐壮大，并于1943年推出经典局部麻醉药利多卡因.至今仍是医学中最常用的基础药物之一，成为行业知名品牌。另一边的英国帝国化学工业集团（ICI）于1926年成立，1993年剥离制药业务成立捷利康公司。捷利康继承了ICI在青霉素研发中的经验，逐渐成为全球领先的制药企业，其产品涵盖心血管、消化等领域。 然而到了1980年代，全球化工巨头纷纷剥离非核心业务。时间来到了1999年，为应对全球制药市场的竞争压力，阿斯特拉与捷利康宣布合并，成立阿斯利康。合并后的企业整合了双方在研发、生产及市场渠道的优势，总部设于英国伦敦，研发总部位于瑞典，形成了“英美双核心”的全球化布局。此次合并不仅让阿斯利康一跃成为全球第三大制药巨头，更为其后续的创新发展奠定了基础。 核心产品迭代 02 1. 合并时的核心产品 Losec （洛赛克） 两家合并初期，阿斯利康的核心产品主要来自阿斯特拉与捷利康之前的资产，其中最具代表性的是洛赛克，它是世界上第一款质子泵抑制剂（PPI），洛赛克在1988年上市后销量迅猛攀升，成为了人类历史上首款年销售额突破60亿美元的处方药王,这款药它不仅改变了全球胃溃疡的治疗方式，也让阿斯特拉一跃成为欧洲制药巨头。 02 2.早期核心产品：奠定行业地位的“三驾马车”（2000-2010年） Crestor（瑞舒伐他汀）：一种强效他汀类降脂药，2003年获批上市，巅峰销售额达66亿美元（2011年）。其通过抑制HMG-CoA还原酶降低胆固醇，成为心血管疾病预防的基石药物。 Nexium（埃索美拉唑）：质子泵抑制剂，2001年上市，巅峰销售额52亿美元（2005年）。作为奥美拉唑的左旋体，其抑酸效果更优，广泛用于胃溃疡、胃食管反流病等疾病。 Seroquel（喹硫平）：抗精神病药物，1997年上市，巅峰销售额58亿美元（2008年）。用于治疗精神分裂症和双相情感障碍，是当时全球最畅销的抗精神病药之一。   这三大产品的成功，让阿斯利康在2000-2010年期间保持了稳定增长，营收从150亿美元增至316亿美元（复合增长率8%） 02 3.专利悬崖后的转型：肿瘤与代谢疾病的崛起（2011-2020年） 2010年后，随着专利的陆续到期（Crestor 2016年、Nexium 2015年、Seroquel 2012年），阿斯利康面临严重的“专利悬崖”危机，营收一度下滑至202亿美元（2017年）。为应对这一挑战，公司调整战略，将研发重点转向肿瘤、代谢疾病等高增长领域。 （1）代谢疾病领域： Farxiga（达格列净）是阿斯利康在代谢疾病领域的核心产品，2014年获批上市，用于治疗2型糖尿病。其通过抑制SGLT2（钠-葡萄糖协同转运蛋白2）促进尿糖排泄，不仅降低了血糖，还具有心肾保护作用。2025年，Farxiga销售额达84.05亿美元（同比增长9%），成为阿斯利康最畅销的产品。其成功源于：①覆盖2型糖尿病、慢性肾病、心衰三大适应症，满足了患者的多重需求；②临床证据支持其心肾保护作用，符合当前“综合管理”的医疗趋势。 学子药话·用心说药 | 安达唐（达格列净）——跨界突围，心肾代谢领域的全能猛将 （2）肿瘤领域： Tagrisso（奥希替尼）：第三代EGFR-TKI，2015年上市，用于治疗EGFR突变非小细胞肺癌（NSCLC）。其巅峰销售额达72.54亿美元（2025年），成为中国EGFR突变NSCLC患者的首选药物（市场份额43.3%）。 学子药话·用心说药 | 泰瑞沙（奥希替尼）—— 狙击肺癌的“入脑”神药，改写耐药困境的王者 Imfinzi（度伐利尤单抗）：PD-L1抑制剂，2017年上市，用于治疗肺癌、膀胱癌等。2025年销售额60.63亿美元（同比增长28%），主要通过联合化疗或放疗提高患者生存率。 学子药话·用心说药 | 英飞凡(度伐利尤单抗）—— 肺癌治疗的“免疫守卫者” Enhertu（德曲妥珠单抗）：HER2 ADC（抗体偶联药物），2019年与第一三共合作上市，用于治疗HER2阳性乳腺癌。2025年销售额49.82亿美元（同比增长32.71%），其“旁观者效应”可杀伤周边癌细胞，对异质性肿瘤具有特殊优势，成为乳腺癌治疗的“变革性药物”。 学子药话·用心说药 | 优赫得（德曲妥珠单抗）—— HER2靶点的肿瘤治疗新星 02 4.未来管线：瞄准未竟需求的“下一代疗法”（2021-至今） Truqap（卡匹色替）：AKT抑制剂，2023年上市，用于治疗HR+/HER2-乳腺癌。其通过抑制PI3K/AKT/mTOR通路，解决内分泌治疗耐药问题，2025年收入3.02亿美元（同比增长2倍）。 Datroway（德达博妥单抗）：TROP2 ADC，2025年上市，用于治疗HR阳性、HER2阴性乳腺癌。其独特的“旁观者效应”对异质性肿瘤具有优势，目前正探索在三阴性乳腺癌（TNBC）中的应用。 Camizestrant（AZD9833）：新一代口服SERD（选择性雌激素受体降解剂），2025年III期研究成功，用于HR+/HER2-乳腺癌一线治疗。其通过降解雌激素受体，克服内分泌治疗耐药，预计将成为下一个“重磅炸弹”。 阿斯利康的全球市场布局：中国为何成为“增长引擎”？ 03 阿斯利康的全球市场分为美国、新兴市场（含中国）及其他地区。2025年，美国市场收入254.5亿美元（占43%），新兴市场153.03亿美元（占26%），其中中国区收入66.54亿美元（占新兴市场43.48%），连续多年位居跨国药企中国区营收榜首。  1.针对中国患者的特点，调整产品 2000年代初，阿斯利康推出了第一代EGFR抑制剂易瑞沙，针对非小细胞肺癌起初，这款药在欧美市场反响平平，并且临床效果不稳定，被批评为高价低效。但阿斯利康并未放弃。科学家们发现到在亚洲患者群体中存在特定基因突变。而易瑞沙对这类患者极其有效。于是公司改变市场，在日本与中国重新布局临床试验。这一步堪称神来之笔，易瑞沙在亚洲市场迅速爆发，成为中国第一批精准靶向治疗药物之一。又在十几年后，阿斯利康在此基础上推出了第三代hi抑制剂奥西替尼。到2019年，奥希替尼的销售额突破30亿美元，成为了公司新的增长引擎。 2.本土化生产与合作 阿斯利康在中国建立了多个生产基地（如无锡、泰州、青岛），其中无锡基地被评为“灯塔工厂”（世界经济论坛），生产效率全球领先。此外，公司与石药集团、诚益生物等本土企业合作，引进了GLP-1受体激动剂（AZD5004）、PCSK9抑制剂（YS2302018）等创新药物，丰富了产品线。 阿斯利康合作方向 04 从1999年合并，阿斯特拉与捷利康合并，成立阿斯利康，成为当时全球第三大制药巨头，在之后它不断的收购与合作将市场扩大。 2007年收购MedImmune。阿斯利康以约156亿美元收购美国生物技术公司MedImmune。此次收购标志着阿斯利康正式进军生物制药领域，为其后续在免疫疗法和疫苗（如新冠疫苗）开发方面奠定了坚实基础。 2019年与第一三共（Daiichi Sankyo）达成战略合作。阿斯利康与日本第一三共达成协议，共同开发和商业化抗体偶联药物（ADC）。这一合作使阿斯利康获得了Enhertu（德喜曲妥珠单抗）等重磅产品的权益，巩固了其在ADC领域的领先地位。 2024年3月收购Fusion Pharmaceuticals。阿斯利康宣布以24亿美元收购靶向核药公司Fusion Pharmaceuticals，彰显了其加大核药布局的决心。 2024年7月收购Amolyt Pharma。阿斯利康完成对临床阶段生物制药公司Amolyt Pharma的收购（交易金额约10.5亿美元）。此次收购获得了用于治疗甲状旁腺功能减退症的在研药物Eneboparatide，扩充了其罕见病管线。 2025年6月与石药集团达成战略合作。双方宣布建立战略研究合作，利用AI驱动的药物发现平台，共同推进新型口服候选药物的研发，重点针对免疫和慢性疾病。 2025年10月收购SixPeaks Bio AG。阿斯利康完成对瑞士生物技术公司SixPeaks Bio AG的100%控股收购，正式进军以“保留瘦肌肉”为特色的下一代体重管理治疗领域。 05 阿斯利康的发展历程，是一部“合并求生—转型创新—全球引领”的奋斗史。从1999年的合并到如今的全球第三大制药巨头，其成功源于对创新的坚持、对全球市场的精准布局及对本土化需求的满足。中国区作为阿斯利康的增长引擎，不仅为企业带来了丰厚的收入，更让其成为“在中国，为全球”的典型范例。未来，随着2030年目标的推进，阿斯利康有望继续保持增长，为全球患者带来更多创新药物，也为中国医药行业的发展提供更多可能。 药企风云 | 阿斯利康——一年在中国狂揽近500亿！阿斯利康的“钞能力”从哪来？

AstraZeneca and Daiichi Sankyo’sDatroway (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02 Phase III trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “As one of the hardest cancers to treat, today only 15% of patients with metastatic triple-negative breast cancer survive beyond five years. This positive opinion from the CHMP marks an important step forward in bringing the potential of Datroway to transform outcomes for patients with this type of cancer in the EU.” John Tsai, MD, Global Head, R&D, Daiichi Sankyo, said: “Triple-negative breast cancer remains one of the most aggressive types of breast cancer, with limited treatment options for patients with metastatic disease who are not candidates for immunotherapy and are currently treated with traditional chemotherapy. This positive recommendation by the CHMP underscores the potential for Datroway to replace traditional chemotherapy in this setting and we look forward to working closely with the EMA to bring this new indication to patients in the EU.” In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) compared to chemotherapy as 1st-line treatment in this patient population. 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). Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 62.5% compared to an ORR of 29.3% with chemotherapy.1 The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer. Datroway was approved in the US in May 2026 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 China and Japan, as well as Australia, Canada, Singapore and Switzerland as part of Project Orbis. Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Notes Triple-negative breast cancer TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.2,3 In Europe, there are an estimated 83,000 diagnoses of TNBC each year.2,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5-7 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.5,8,9 While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.5 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.5 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.10,11However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, prior to the approval of Datroway, chemotherapy was the standard 1st-line treatment.12 TROP2 is a protein broadly expressed in several solid tumours, including TNBC.13 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.14,15 TROPION-Breast02 TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III 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 tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment 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 progression-free survival (PFS) as assessed by blinded independent central review. 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. Datroway Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised 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 is also approved in more than 40 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 results from the TROPION-Breast01 trial. Datroway is approved in the US 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 is available in the US under accelerated approval 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 results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway clinical development programme A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu (trastuzumab deruxtecan) 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. AstraZeneca in breast cancer 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. 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. 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 expanding its potential in earlier lines of treatment and in new breast cancer settings. 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 TROP2-directed ADC, Datroway, and next-generation oral SERD, Etcamah. 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. 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).  AstraZeneca in oncology 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. 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. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca 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 Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. 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. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial