Raludotatug deruxtecan

药品注册审批月报（2026年7月） 统计周期：2026年7月1日—7月31日 查询时间：2026年8月1日。数据可能动态更新，请以官方最新公示为准。 本月CDE受理2188个受理号，化药占比49.7%，1类创新药195个（化药）；NMPA批准上市395个（化药新药1个、生物类似药2个、中药新药1个）。一、受理概况 药品类型 受理号数 占比 化药 1,087 49.7% 中药 732 33.5% 生物制品 369 16.9% 合计 2,188 100% *注：生物制品含治疗用344个、预防用20个、未细分5个。二、化药受理 2.1 按申请类型分布 2.2 按注册分类分布（仅新药+进口+仿制，共601个） *注：2.2,2.4（4个）和2.22.4（2个）已合并计入对应类别。 2.3 化药1类创新药（新药+进口，部分代表性品种） 药品名称 申请类型 企业名称 承办日期 YF550片 新药 益祺生物 07-01 HS-10582片 新药 翰森/豪森 07-01 注射用PTT-121 新药 北京炎明生物 07-01 AHB-137注射液 新药 杭州浩博 07-01 MDR-001片 新药 杭州德睿智药 07-02 QLS1510片 新药 齐鲁制药 07-02 注射用JY1001 新药 浙江杭煜 07-02 AZD6234注射液 进口 阿斯利康 07-03 PF-08653944注射液 进口 辉瑞 07-03 AZD5305 进口 阿斯利康 07-03 SYH2083滴眼液 新药 上海翊石 07-03 VV147片 新药 旺山旺水 07-06 FXS5626片 新药 复星医药 07-06 Rinzimetostat 进口 ORIC Pharma 07-02 *化药1类（含新药+进口）共195个受理号，上表为部分代表性品种。 2.4 重点品种 HS-10582片（翰森制药/豪森药业） - 化药1类新药，具体靶点与适应症待后续披露。本品为翰森自主研发的小分子创新药，7月1日首次提交IND申请。 - 翰森是国内头部创新药企，管线覆盖肿瘤、自免、代谢等领域，2026年以来已有多款1类新药进入临床。 - 本次承办日期：2026-07-01，申请类型：新药IND。 AZD6234注射液（阿斯利康） - 化药1类进口药，为阿斯利康全球在研的长效Amylin类似物，拟用于肥胖/超重适应症。AZD6234作为单药或联合疗法在海外已推进至II期临床。 - 2026年7月3日，阿斯利康在中国一次性提交12个规格的IND申请，涵盖不同剂量组，显示其在中国临床开发力度。 - 本次承办日期：2026-07-03，申请类型：进口IND。三、生物制品受理 本月生物制品受理369个，治疗用344个，预防用20个，一次性进口5个。 3.1 治疗用生物制品1类新药（部分代表性品种） 药品名称 类别 注册分类 企业名称 承办日期 注射用VDJ010 治疗用 1 北京伟德杰 07-01 NW-301V注射液 治疗用 1 新景智源 07-01 乐德奇拜单抗注射液 治疗用 1 先声药业 07-02 CM313(SC)注射液 治疗用 1 康诺亚 07-03 CM336注射液 治疗用 1 康诺亚 07-03 CM529D1 治疗用 1 康诺亚 07-06 DS-6000a 治疗用 1(进口) 第一三共 07-03 DS-1103a 治疗用 1(进口) 第一三共 07-08 DS-3939a 治疗用 1(进口) 第一三共 07-08 Telisotuzumab Adizutecan 治疗用 1(进口) AbbVie 07-08 注射用HS-20197 治疗用 1 翰森/常州恒邦 07-09 GenSci148注射液 治疗用 1 长春金赛 07-07 BA1203注射液 治疗用 1 山东博安 07-08 AZD7003 治疗用 1 阿斯利康 07-08 LBL-034注射液 治疗用 1 南京维立志博 07-08 SYS6043 治疗用 1 石药巨石 07-08 注射用SHR-4595 治疗用 1 苏州盛迪亚 07-07 *1类生物制品（新药+进口）共约174个受理号，康诺亚、第一三共、翰森等企业密集申报。 3.2 进口生物制品上市申请（NDA/BLA） 药品名称 注册分类 企业名称 承办日期 帕博利珠单抗注射液 2.2 MSD(默沙东) 07-01 注射用维恩妥尤单抗 2.2 Astellas(安斯泰来) 07-06 纳武利尤单抗注射液 3.1 BMS(百时美施贵宝) 07-09 3.3 重点品种：乐德奇拜单抗注射液（先声药业） - 治疗用生物制品1类新药，为先声药业自主研发的单克隆抗体，靶向IL-4Rα（推测），拟用于特应性皮炎等自免疾病。本品于2026年7月2日提交IND申请（2个规格）。 - 先声药业近年来在自免领域持续投入，此前已有多个生物创新药进入临床阶段。 - 本次承办日期：2026-07-02，申请类型：新药临床申请。四、中药受理 中药受理732个，补充申请710个，新药18个（IND 12个、NDA 6个），一次性进口4个，仿制药0个。 4.1 中药新药列表 药品名称 申请类型 注册分类 企业名称 承办日期 柴芍肠宁颗粒 IND 1.1 玉森(佛山) 07-02 糖宁通络乳膏 IND 1.1 百灵毓秀 07-13 ZYY-757颗粒 IND 1.1 扬子江龙凤堂 07-15 CHA756丸 IND 1.1 诺贝生物 07-23 TDX105颗粒 IND 1.1 天士力 07-27 藿连消滞颗粒 IND 1.1 和光中药 07-31 复方野菊花颗粒 IND 1.1 浙江中医药大学 07-31 塞络通胶囊 NDA 1.1 神威药业 07-30 注射用和厚朴酚脂质体冻干粉 IND 1.2 北京金瑞基业 07-08 骨龙胶囊 IND 2.3 东阿阿胶 07-01 季德胜蛇药片 IND 2.3 精华制药 07-17 舒筋健腰丸 IND 2.3 白云山陈李济 07-23 银杏二萜内酯滴丸 IND 2.12.22.3 江苏康缘 07-23 桃红四物汤颗粒 NDA 3.1 株洲千金 07-02 当归饮子颗粒 NDA 3.1 海南斯达 07-13 温经汤颗粒 NDA 3.1 山东齐都 07-21 当归四逆汤颗粒 NDA 3.1 广东经典名方 07-28 桃红四物颗粒 NDA 3.1 国药广东环球 07-28 *亮点：塞络通胶囊（神威药业，1.1类NDA）为中药创新药直接申报上市；古代经典名方3.1类集中申报5个品种（桃红四物汤、当归饮子、温经汤、当归四逆汤、桃红四物），显示经典名方研发热度持续。 本月无中药仿制药。五、药品上市 NMPA批准上市药品395个（批准文号/受理号计），化药约390个（新药1个、仿制药约385个、进口1个），生物制品2个，中药1个。 5.1 重点获批品种 药品名称 注册分类 企业名称 批准日期 左乙拉西坦缓释颗粒 2.2(化药新药) 浙江赛默 07-14 利拉鲁肽注射液 3.3(生物类似药) 重庆宸安 07-08 注射用奥马珠单抗 3.3(生物类似药) 远大蜀阳 07-28 五味消毒饮颗粒 3.1(中药经典名方) 瑞阳制药 07-21 他达拉非片 5.2(进口仿制) Sawai(日本) 07-08 5.2 重点品种详情 左乙拉西坦缓释颗粒（浙江赛默制药，化药2.2类改良型新药） - 企业：浙江赛默制药有限公司。左乙拉西坦为第二代广谱抗癫痫药物，缓释颗粒剂型可改善儿童及吞咽困难患者的服药依从性，属改良型新药（2.2类）。 - 本品于2024年8月23日承办（CXHS2400081），以NDA路径申报，2026年7月14日获批生产，审评周期约23个月。 - 左乙拉西坦国内已有片剂、口服溶液、注射剂等多种剂型，缓释颗粒为首家获批，差异化优势明显。 利拉鲁肽注射液（重庆宸安生物制药，3.3类生物类似药） - 企业：重庆宸安生物制药有限公司。利拉鲁肽为GLP-1受体激动剂，原研诺和诺德，适应症为2型糖尿病及肥胖。本品为生物类似药（3.3类）。 - 2024年12月3日承办（CXSS2400132），以"上市"通道申报，2026年7月8日获批生产，审评周期约19个月。 - GLP-1赛道国内竞争激烈，利拉鲁肽生物类似药已有华东医药、通化东宝等获批，重庆宸安为又一家获批企业。 注射用奥马珠单抗（远大蜀阳生命科学，3.3类生物类似药） - 企业：远大蜀阳生命科学（成都）有限公司，委托澳斯康生物（南通）生产。奥马珠单抗为抗IgE单克隆抗体，原研诺华/罗氏，用于中重度过敏性哮喘及慢性自发性荨麻疹。 - 2024年12月31日承办（CXSS2400143），2026年7月28日获批生产，审评周期约19个月。 - 国内奥马珠单抗生物类似药此前已有石药集团巨石生物获批，远大蜀阳为第二家。六、CDE文件/公告/新闻（7月） 1. 《药品审评书面发补标准》征求意见（07-24） CDE发布征求意见稿，统一发补要求，规定14种允许发补情形，旨在严控发补次数、提高审评效率。 https://www.cde.org.cn 2. 《原发免疫性血小板减少症创新药临床研发技术指导原则》征求意见（07-24） CDE公开征求ITP创新药临床研发技术指导原则意见，推动罕见血液病药物研发规范化。 https://www.cde.org.cn 3. CDE"先锋计划"征求意见：推进NAMs研究和应用（07-07） 就"推进新方法（NAMs）研究和应用试点计划"公开征求意见，类器官和器官芯片正式进入监管审评通道，标志中国药物非临床评价迈向"去动物化"。 https://www.cde.org.cn 4. 国家药监局发布CGT审评审批优化公告征求意见（07-03） 拟将细胞与基因治疗药品纳入30日审评通道，政策红利从"沟通环节"延伸至"审评审批全链条"。 https://www.nmpa.gov.cn 5. 药审中心召开鼓励和促进抗结核创新药物临床研发技术研讨会（07-15） 聚焦抗结核新药研发难点，推动该领域创新药的临床开发。 https://www.cde.org.cn 想查更多？药达·isearch 免费体验 文末「阅读原文」直达 戊戌数据 · 注册报告 数据来源：药达isearch（https://isearch.wuxuwang.com） 戊戌数据（www.wuxuwang.com） 内容仅供参考，不构成投资或用药建议 END ★ 点击下方卡片，发现更多精彩

Approval based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival Datroway now approved for two breast cancer indications in the EU TOKYO--(BUSINESS WIRE)--Datroway ® (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-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. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast02 phase 3 trial, which were presented at the 2025 European Society for Medical Oncology Congress and subsequently published in Annals of Oncology . In TROPION-Breast02, which included patients with metastatic TNBC who experienced early relapse following prior treatment, Datroway demonstrated a statistically significant and clinically meaningful 5.0 month improvement in median overall survival (OS) versus investigator’s choice of chemotherapy (hazard ratio [HR]=0.79; 95% confidence interval [CI]: 0.64-0.98; p=0.0291). 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). Median progression-free survival (PFS) was 10.8 months for patients treated with Datroway versus 5.6 months for those treated with chemotherapy in patients with metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway also was associated with more robust treatment responses compared to chemotherapy, with an objective response rate (ORR) of 62.5% versus 29.3% for those treated with chemotherapy. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “For people living with metastatic triple negative breast cancer, every new treatment option matters. Despite recent advances, more than two thirds of patients are not candidates for immunotherapy and have had limited options beyond chemotherapy,” said Giuseppe Curigliano, MD, PhD, Director of the Early Drug Development Division, European Institute of Oncology, Professor of Medical Oncology, University of Milan, Italy and investigator for the TROPION-Breast02 trial. “In my practice, I see firsthand the devastating impact this aggressive disease has on patients and their families. This approval of datopotamab deruxtecan provides a new treatment option for eligible patients and represents meaningful progress.” The safety pro Datroway (6 mg/kg) was evaluated in 319 patients with TNBC who received Datroway in TROPION-Breast02. The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, decreased white blood cells, constipation, decreased calcium, decreased lymphocytes, fatigue, decreased neutrophils, increased alanine aminotransferase, increased aspartate aminotransferase, dry eye, keratitis, decreased albumin, vomiting, musculoskeletal pain, decreased sodium and increased blood alkaline phosphatase. Serious adverse reactions occurred in 17% of patients who received Datroway. Serious adverse reactions in more than 1% of patients who received Datroway included pneumonia, vomiting, COVID-19 and anemia. One patient fatality was attributed to interstitial lung disease/pneumonitis. “With this approval, Datroway is the only TROP2 directed antibody drug conjugate approved in the EU that has demonstrated an overall survival benefit in the first-line setting, representing a meaningful advance for the treatment of patients with metastatic triple negative breast cancer,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “We look forward to bringing Datroway to patients in the EU as an additional treatment option with the potential to extend survival, reflecting our commitment to advancing innovative medicines that address unmet needs for people living with cancer.” “Every year, more than 80,000 people in Europe are diagnosed with triple negative breast cancer, a disease that often affects younger women and has limited treatment options in the metastatic setting,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “Today’s approval of Datroway brings an antibody drug conjugate with a differentiated clinical pro by a strong survival benefit to people with this aggressive disease.” Based on the results of TROPION-Breast02, Datroway has been included in the ESMO Clinical Practice Guidelines as a Category IA first-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy, and it is the preferred option for patients who have relapsed within six months of completing adjuvant therapy. 1 Datroway also received a score of four out of five on the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), recognizing the clinically meaningful benefit demonstrated in TROPION-Breast02. 2 Datroway (6 mg/kg) was approved in the U.S. 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. About TROPION-Breast02 TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 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 tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment 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 PFS as assessed by BICR. 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 . About Triple Negative Breast Cancer TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 365,000 diagnoses globally each year. 3,4 In Europe, there are an estimated 81,000 diagnoses of TNBC each year. 3,5 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women. 6,7,8 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. 6,9,10 While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three. 6 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat. 6 For patients with metastatic disease with PD-L1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the first-line setting. 11,12 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy was the standard first-line treatment. 13 TROP2 is a protein broadly expressed in several solid tumors, including TNBC. 14 TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer. 15,16 About Datroway Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. 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 programs in AstraZeneca’s ADC scientific platform. Datroway 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. Datroway (6 mg/kg) is approved in more than 30 countries/regions worldwide 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 (6 mg/kg) is approved in more than 45 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 the results from the TROPION-Breast01 trial. Datroway (6 mg/kg) is approved in Brazil, Russia, Singapore and the U.S. 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 the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the Datroway Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program includes eight phase 3 trials in lung cancer, five phase 3 trials in breast cancer, and one phase 2/3 trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu ® 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. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . ____________________ REFERENCES: 1 de Azambuja E, et al., Annals of Oncology . 2026 2 ESMO. ESMO-MCBS Scorecard: Datopotamab deruxtecan . Accessed July 2026 3 O’Reilly D, et al. World J Clin Oncol . 2021;12(3):164-182. 4 World Health Organization. Global Status Report on Cancer 2026 . Accessed July 2026. 5 World Health Organization. Global Cancer Observatory: Europe . Accessed July 2026. 6 American Cancer Society. Triple-Negative Breast Cancer . Accessed July 2026. 7 Martinez M, et al. Breast Cancer Res Treat . 2017;166(1):185-193. 8 Vargas L, et al. Cancer Epidemiol Biomarkers Prev . 2019;28(11):1771-1783. 9 National Cancer Institute . SEER Cancer Stat Facts: Female Breast Cancer Subtypes . Accessed July 2026. 10 Huppert L, et al. Ther Adv Med Oncol . 2022;14:1-25. 11 Cortes J, et al. N Engl J Med . 2022;387:217-226. 12 Geurts V, et al. Curr Treat Options Oncol . 2023;24:628-643. 13 Punie K, et al. Oncologist . 2025;30(3):oyaf034. 14 Rossi V, et al. Front Immunol . 2024;15:1447280. 15 Lin H, et al. Exp Mol Pathol . 2013:94(1):73-78. 16 Goldenberg D, et al. Oncotarget . 2018;9(48):28989-29006. Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) EU: Simone Jendsch-Dowé simone.jendsch-dowe@daiichisankyo.com +49 (89) 78080 (office) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com