Fam-trastuzumab deruxtecan-NXKI

精彩内容近日，CDE官网显示，中美华东申报的全球首创1类新药注射用HDM2012获得临床试验默示许可，拟用于治疗晚期实体瘤。米内网数据显示，2024年中国三大终端六大市场（统计范围详见本文末）抗肿瘤药（化药+生物药）销售额超过1500亿元。注射用HDM2012是中美华东自主研发的一款靶向人粘蛋白-17(MUC-17)的新型抗体药物偶联物(ADC)，属于全球首创的1类生物制品。据悉，该项目于2025年5月被纳入《优化创新药临床试验审评审批试点工作方案》试点项目；同年6月，中美华东递交注射用HDM2012临床申请获受理，25个工作日后完成了审评审批，极大地缩短了IND审评时限。今年以来，中美华东有5款1类新药获批临床，注射用HDM2012、注射用HDM2020、注射用HDM2005均为抗肿瘤药，其中注射用HDM2005已在开展弥漫性大B细胞淋巴瘤适应症的Ib/II期临床。米内网数据显示，2023年以来中国三大终端六大市场抗肿瘤药（化药+生物药）销售额呈逐年上涨态势，2024年超过1500亿元，2025年第一季度超过400亿元。从治疗小类看，抗体药物领跑，近年来占比均超过40%。近年来中国三大终端六大市场抗肿瘤药（化药+生物药）销售情况（单位：万元）来源：米内网格局数据库在抗肿瘤新药方面，中美华东与ImmunoGen（已被AbbVie收购）合作开发的索米妥昔单抗注射液于2024年11月在国内获批上市，为全球首个也是目前唯一一个批准用于治疗铂类耐药卵巢癌(PROC)的靶向叶酸受体α(FRα)的ADC药物。此外，据不完全统计，中美华东有5款抗肿瘤1类新药在国内处于获批临床及以上阶段。从研发进展看，EGFR/HER2小分子抑制剂迈华替尼片已于2024年5月提交NDA，用于治疗局部晚期或转移性非鳞非小细胞肺癌。中美华东国内部分在研抗肿瘤1类新药来源：米内网综合数据库从作用机制看，有3款为ADC药物，目前全球均无同类产品获批，分别为靶向受体酪氨酸激酶样孤儿受体1(ROR1)的ADC药物注射用HDM2005、靶向成纤维细胞生长因子受体2b(FGFR2b)的ADC药物注射用HDM2020、靶向人粘蛋白-17(MUC-17)的ADC药物注射用HDM2012。目前全球有10多款ADC药物获批上市，主要靶向TROP2、HER2、EGFR、CD19、c-Met、CD22等靶点。2024年全球ADC药物市场规模约达130亿美元，其中有6款销售额超过10亿美元，包括第一三共/阿斯利康的德曲妥珠单抗、罗氏的恩美曲妥珠单抗、武田/辉瑞的维布妥昔单抗等。全球已获批上市的ADC药物注：不含生物类似药来源：米内网全球新药研发数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月21日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

Positive high-level results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to Tagrisso monotherapy for patients with 1st-line locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).​ The final OS analysis demonstrates consistent survival benefit as previously reported in the interim OS results, and builds on the previously presented primary endpoint data, which demonstrated the longest-reported median progression-free survival (PFS) in this setting. Pasi A. Jänne, MD, PhD, Senior Vice President for Translational Medicine and thoracic medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said: “When treating lung cancer, the aim is to both prolong survival and improve the patient experience, especially in 1st-line where treatment duration can be long and many patients remain active. These positive results support osimertinib, either as monotherapy or in combination with chemotherapy, as standard of care for patients with 1st-line advanced EGFR-mutated lung cancer and reinforce the meaningful benefit of the combination in the current clinical setting. The observed survival benefit is particularly impressive given that FLAURA2 did not impose any restrictions on the choice of subsequent treatment after disease progression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “These exciting overall survival results add to the extensive evidence supporting Tagrisso as the backbone therapy in EGFR-mutated lung cancer, demonstrating that Tagrisso plus chemotherapy can significantly extend survival in the 1st-line advanced setting, in addition to prior trials showing survival benefits as monotherapy in both early stage and advanced disease. With its strong survival benefit and tolerable safety profile, this combination has the potential to help patients live longer while maintaining their quality of life on treatment.” With longer follow up, the safety profile of Tagrisso plus chemotherapy continues to be manageable and consistent with the established profiles of the individual medicines. Adverse event (AE) rates were higher in the Tagrisso plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs. Discontinuation rates due to AEs and on-target toxicities were low in both arms of the trial. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Tagrisso plus chemotherapy is approved in more than 80 countries, including the US, EU, China and Japan, based on the FLAURA2 Phase III trial. Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.1-2 Approximately 75% of people are diagnosed with advanced NSCLC.3 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.4-6 While EGFR-tyrosine kinase inhibitors (TKI) have significantly improved outcomes in the 1st-line setting, mechanisms of resistance and disease progression are extremely common, and a significant unmet need exists in later-line settings for effective and well-tolerated treatment options.7-10 FLAURA2 FLAURA2 is a randomised, open-label, multi-centre, global Phase III trial in the 1st-line treatment of patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Patients were treated with Tagrisso 80mg QD oral tablets with the addition of chemotherapy (pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5) every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks. The trial enrolled 557 patients in more than 150 centres across more than 20 countries, including in the US, Europe, South America and Asia. The primary endpoint is PFS with OS as the key secondary endpoint. Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Tagrisso (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC. Tagrisso is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy (CRT). Tagrisso plus chemotherapy is approved in more than 80 countries, including the US, EU, China and Japan, for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC. There is an extensive body of evidence supporting the use of Tagrisso in EGFRm NSCLC. Tagrisso is the only targeted therapy shown to improve patient outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials, locally advanced stages in the LAURA Phase III trial and late-stage disease in the FLAURA and FLAURA2 Phase III trials. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. 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/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. 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 1. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed July 2025. 2. American Cancer Society. What Is Lung Cancer?. https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed July 2025. 3. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. 4. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. 5. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. 6. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. 7. Chen R, et al. Emerging therapeutic agents for advanced non-small cell lung cancer. J Hematol Oncol. 2020;13(1):58. 8. Majeed U, et al. Targeted therapy in advanced non-small cell lung cancer: current advances and future trends. J Hematol Oncol. 2021;14(1):108. 9. Morgillo F, et al. Mechanisms of resistance to EGFR-targeted drugs: lung cancer. ESMO Open. 2016;1(3):e000060. 10. Han B, et al. Efficacy of pemetrexed-based regimens in advanced non-small cell lung cancer patients with activating epidermal growth factor receptor mutations after tyrosine kinase inhibitor failure: a systematic review. Onco Targets Ther. 2018;11:2121-2129. Oncology Corporate and financial