A Phase 1b/2, Multicenter, Open-label, Dose Regimen Determination and Dose Expansion Trial to Evaluate the Safety, Tolerability, Anti-tumor Activity, and an Optimal Dose Regimen of Patritumab Deruxtecan (HER3-DXd) With Trastuzumab Deruxtecan (T-DXd) in Participants With Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer (HERTHENA-Breast02)

The primary purpose of the study is to assess the safety, tolerability, and anti-tumor activity of HER3-DXd and T-DXd in the combination dosing regimens in participants with hormone receptor positive, HER2-low or HER2-ultralow, unresectable, or metastatic breast cancer.

开始日期2026-08-03

申办/合作机构

Daiichi Sankyo Co., Ltd.

[+1]

NCT07286149

/ Recruiting临床1/2期

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:
* About the safety of MK-1084 and if people tolerate it when taken with other treatments
* How many people have the cancer respond (get smaller or go away) to the treatments

开始日期2026-04-30

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT07060807

/ Recruiting临床3期

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.
* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread
* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2
* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles
* Metastatic means the cancer has spread to other parts of the body
Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

开始日期2025-07-21

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

100 项与德帕瑞妥单抗相关的临床结果

登录后查看更多信息

100 项与德帕瑞妥单抗相关的转化医学

登录后查看更多信息

100 项与德帕瑞妥单抗相关的专利（医药）

登录后查看更多信息

项与德帕瑞妥单抗相关的文献（医药）

2026-07-05·BRITISH JOURNAL OF CANCER

ATR inhibition potentiates the antitumor efficacy of HER3-DXd in HER3-positive/HR-positive breast cancer by increasing DNA damage

Article

作者: Fuson, Jon A ; Gi, Young Jin ; Fukui, Jami A ; Lee, Jangsoon ; Ueno, Naoto T ; Tripathy, Debu ; Fan, Pang-Dian ; Poullikkas, Thanasis ; Xie, Xuemei

BACKGROUND:

Endocrine resistance remains a major challenge in hormone receptor-positive (HR+) breast cancer (BC), where up to 70% of tumours overexpress HER3, a receptor associated with poor prognosis and therapeutic resistance. HER3-DXd (patritumab deruxtecan) is currently under clinical investigation for HER3-expressing metastatic BC. However, strategies to further enhance its efficacy, particularly in endocrine therapy-resistant settings, are urgently needed. We hypothesised that targeting ATR, a key regulator of DNA damage repair (DDR), potentiates HER3-DXd in HER3+/HR+ BC, including tamoxifen-resistant (TMR) disease.

METHODS:

Synergistic partners for HER3-DXd were identified by whole-genome RNAi screening. Treatments' effects on cell cycle, DNA damage, and protein expression were analysed using flow cytometry, comet assay, and Western blotting, respectively. Treatments' antitumor efficacy was assessed using xenograft mouse models. TCGA and CPTAC databases were analysed for clinical relevance.

RESULTS:

HER3-DXd inhibited growth in both parental and TMR MCF7 and T47D cells. Compared to monotherapies, combining HER3-DXd with an ATR inhibitor enhanced DNA damage, sub-G1 arrest, apoptosis, downregulation of DDR and cell cycle regulatory proteins, and tumour growth inhibition. TCGA and CPTAC analyses confirmed high HER3 expression and correlation of ATR, CHEK1, and TOP1 gene expression with poor prognosis in HR+ BC.

CONCLUSION:

Combining HER3-DXd with an ATR inhibitor could benefit HER3+/HR+ BC patients with both endocrine-sensitive and -resistant diseases.

2026-06-01·CANCER

Mapping the antibody–drug‐conjugates landscape in non–small cell lung cancer: Where are we and where are we going?

Review

作者: Parisi, Claudia ; Planchard, David ; Barlesi, Fabrice

Abstract:

Antibody–drug conjugates (ADCs) represent a rapidly advancing therapeutic class in the treatment of non‐small cell lung cancer (NSCLC), offering targeted delivery of cytotoxic agents to tumor cells while minimizing off‐target toxicity. In recent years, several ADCs have emerged in both early (phase 1–2) and late (phase 3) clinical development, reflecting a growing recognition of their potential to improve outcomes in defined subsets of patients with advanced NSCLC. Late‐phase ADCs include trastuzumab deruxtecan (targeting HER2 [human epidermal growth factor receptor 2]), datopotamab deruxtecan and sacituzumab govitecan (targeting TROP2 [trophoblast cell‐surface antigen 2]), patritumab deruxtecan (targeting HER3), telisotuzumab vedotin (targeting c‐MET [cellular‐mesenchymal epithelial transition factor]), and sigvotatug vedotin (targeting IB6 [integrin beta‐6]). Research efforts are ongoing to explore novel payloads, linker technologies, and targets to expand the applicability of ADCs across broader NSCLC populations, including those with limited treatment options (e.g., EGFR ‐mutant disease in the context of treatment resistance). Despite their promise, challenges remain in optimizing patient selection, overcoming resistance mechanisms, and managing unique toxicity profiles. Ongoing, biomarker‐driven trials and combination strategies with immunotherapy or tyrosine kinase inhibitors hold the potential to further enhance the efficacy of ADCs. In this review, the authors highlight the current landscape and future directions of ADCs in NSCLC, emphasizing available results for compounds in late‐stage clinical development and different disease settings.

2026-05-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Resistance mechanisms and post-trastuzumab deruxtecan (T-DXd) strategies in HER2+ and HER2-low breast cancer: From biology to clinical practice

Review

作者: Chen, Minna ; Xue, Wenwu ; Wen, Xiaofen ; Li, Xiaozhi ; Zeng, De ; Lin, Danxia ; Song, Junwei ; Wang, Wende ; Zhang, Weichun ; Shen, Jiaxin

Trastuzumab deruxtecan (T-DXd), a HER2-directed antibody-drug conjugate (ADC), has revolutionized the treatment landscape for HER2-positive and HER2-low breast cancer, offering unprecedented improvements in progression-free survival (PFS) and overall survival (OS). However, the emergence of resistance limits its long-term efficacy and highlights the need for rational post-progression strategies. This review summarizes current understanding of resistance mechanisms to T-DXd, including dynamic HER2 expression loss, dysregulation of DNA damage repair, tumor microenvironment remodeling, and immune evasion. Building upon these mechanistic insights, we explore therapeutic strategies following T-DXd resistance, including sequential ADCs with alternative targets or payloads, combinations with HER2-targeted tyrosine kinase inhibitors (TKIs), CDK4/6 or PARP inhibitors, endocrine therapy, and immunotherapy. Novel agents such as ARX788, patritumab deruxtecan, and Dato-DXd demonstrate promise in overcoming resistance through diversified mechanisms. Real-world data further support a "three-step strategy" involving ADC rechallenge after interim non-ADC therapies, offering a practical, mechanism-informed treatment model. This review provides a framework for precision-guided care in patients with advanced breast cancer and supports ongoing efforts to extend the therapeutic window beyond initial T-DXd benefit.

720

项与德帕瑞妥单抗相关的新闻（医药）

2026-07-31

·BioSpace

Datroway® Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy

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

2026-07-30

·BioEpoch

恒瑞出海：暗礁与深蓝

这个夏天，中国医药龙头恒瑞医药，再次将中国 Pharma 的野心与困局推到了聚光灯下。一边是与Elevar联合冲击美国 FDA 的重磅“双艾”疗法三度折戟，卡死在 cGMP 合规与监管沟通的铁壁前；另一边则是其自主研发的 HER3 ADC（SHR-A2009）获CDE率先受理，在第一三共与默沙东退赛后斩获冲击全球FIC的绝佳窗口。这一出充满张力的戏剧，正是中国药企从“仿制跟跑”硬闯“全球领跑”时必须经历的蜕变镇痛。1. cGMP 暗礁与监管人才短板如果说第一次被拒是意外，第二次被拒是遗憾，那么当 FDA 第三次对“双艾”方案下发完整回复函（CRL）时，市场感到的不再是震惊，而是警醒。表面上看，这是一场充满“时间差”恶意的监管误伤。 2026 年 7 月 9 日，FDA 出具 CRL，理由是负责生产阿帕替尼原料药（API）的恒瑞金桥路厂区在 4 月检查中留有未决的 Form 483 缺陷。尽管仅一周后的 7 月 15 日该厂区便拿到了 FDA 官方的自愿纠正措施（VAI）评级（确认缺陷轻微不招致惩罚），但受限于 PDUFA 审评法定期限，拒信依然被死板地签发了。然而资本市场的委屈掩盖不了更深层的合规漏洞。审评周期尾声，检查人员在负责制剂成品生产的东进路厂区扣下了第二份 Form 483，列出 9 项严厉缺陷：无菌车间清洁验证缺乏风控依据、批记录变更未经 QA 批准（甚至涉及涂改过期日期与产量），以及超出保持限度的产品在无稳定性数据支持下放行出口。路透社此前的报道揭示了中国药企更致命的隐痛：全球化监管与国际临床人才极度匮乏。数据显示，截至 2025 年，中国药企发起的临床试验中高达 88% 局限在中国本土进行。这种“本土化自嗨”导致企业在面对 FDA 的“全球多中心（MRCT）代表性数据”要求及严苛的 cGMP 现场检查时，严重缺乏熟悉欧美监管审评逻辑的高级操盘手。在国际顶尖监管语境下，惊艳的临床数据只是门票，车间批记录的合规性与国际化治理梯队才是入场硬通货。这也逼得合作伙伴 Elevar 的母公司 HLB 宣布启动“双轨制”，直接在美国寻求 CMO 备用生产基地，对本土制造合规风险进行切割。2. 慢病压舱石与肿瘤 FIC 突破正当人们以为恒瑞被海外合规监管搞得焦头烂额时，它却在本土商业化与肿瘤管线最前沿展现出令人敬畏的研发定力。 2026 年 7 月 29 日，恒瑞一天之内砸出 8.74 亿元研发成果，展现了“慢病压舱石 + 肿瘤天花板”的商业对冲逻辑：首个国产自主研发的长效胰岛素类似物（舒地胰岛素）获批上市，直接跨越外资长久垄断，面向中国 1.48 亿成人 2 型糖尿病患者提供终身用药选择，靠高黏性创新药跳出集采纯价格战泥潭，为公司锁定极其稳定的现金流。同一天，CDE 正式受理瑞康芦泽妥塔单抗（SHR-A2009）用于 EGFR-TKI 耐药晚期 NSCLC 的上市申请。如果申请顺利，恒瑞极有可能摘得全球首款上市单靶点 HER3 ADC 桂冠。HER3 因胞内激酶活性极低曾被视为不可攻克的“僵尸靶点”，但其高表达与高内吞特性使其成为 ADC 的绝佳目标。跑得最早的第一三共与默沙东（HER3-DXd）因策略激进惨烈翻车——意图靠 II 期单臂数据冲刺加速批准，却在确证性 III 期（HERTHENA-Lung02）中遭遇 OS 比对照组无获益（16.0 vs 15.9个月）的灾难性结局，最终于 2025 年 5 月撤回申请。而恒瑞的弯道超车靠的是降维打击般的临床设计：首先，避开单臂风险，直接采用 III 期 RCT 的 PFS 作为主要终点拿到入门券。但跨试验对比更关键的，是入组人群。第一三共排除化疗经治，而恒瑞 SHR-A2009-301 研究直面化疗经治与未经治的复杂人群，在包含化疗暴露的劣势下依然跑出显著 PFS 增益。在后线抢跑的同时，恒瑞已启动 SHR-A2009 联合三代 TKI 一线治疗的关键 III 期临床，将靶线前移以阻断耐药，这一前瞻布局领先第一三共 1 到 2 年。综合来看，SHR-A2009的适应症路径是：TKI后线单药（NDA已受理）→一线联合阿美替尼（III期进行中）→未来可能的泛瘤种拓展，这是一套完整的肺癌生命周期管理布局。3. 地缘博弈与创新进化恒瑞的进击与阵痛，恰好呼应了昨晚Chemical & Engineering News (C&EN) 的最新内容。恒瑞从 1970 年的仿制药厂演变为跨国巨头竞相合作的创新源头，正是中国医药 R&D 生态爆发的缩影。正如百时美施贵宝（BMS）不久前拿出 6 亿美元首付款买下恒瑞创新分子的全球权益。西方政客试图通过众议院调查、COINS 法案等强行将中国创新排除出供应链，但用封杀阻挡不了美国药企对中国创新的依赖。美方削减 NIH 预算、收紧签证导致人才流失，而中国数十年积累的研发基础设施与工程师红利已形成不可逆的势能。从 2026 年 7 月 29 日江苏恒瑞与天津恒瑞联合公开的新型 FAPα 放射性配体核药专利，到覆盖 18 款临床阶段 ADC 的全栈平台，恒瑞的迭代速度早已不是行政禁令所能阻挡的。唯一的阻碍，只剩下中国企业能否建立起吸引全球顶尖药政与临床人才的“软实力”。恒瑞在 2026 年夏天的这场剧烈颠簸，给所有出海药企上了深刻一课。中国生物医药的大航海时代已告别了依赖低成本刷数据和“88% 本土临床”的粗放期。如果说源头创新的科学突破是推着船队驶向深蓝的“风帆”，那么严苛的全球合规、cGMP 质量体系以及具备全球视野的人才，则是防范巨浪翻船的“重舱石”。中国药企既需要保持在前沿靶点上破浪前行的敏锐洞察，更须在工厂车间的每一项标准操作规范、每一份原始数据、全球监管合规以及国际化人才梯队建设中，铸就耐得住风浪的舷窗。唯有将突破与合规凝炼成底色，中国创新药才能真正穿越地缘政治的迷雾与监管的暗礁，在世界的正中央，赢得属于中国药企的尊严。 References Fierce Pharma: How 2 FDA citations trouble Hengrui, Elevar's liver cancer combo (July 28, 2026) Fierce Pharma: FDA rejects Hengrui, Elevar PD-1 liver cancer combo a 3rd time (July 10, 2026) Fierce Pharma: Behind Hengrui's surprise FDA rejection: Scathing Form 483 lists litany of shortfalls at PD-1 drug plant (July 16, 2024) Reuters: Chinese drugmakers with big ambitions struggle to recruit staff for global expansion (July 15, 2026) Chemical & Engineering News (C&EN): Editorial: How China is outpacing the US in R&D and innovation (July 29, 2026) 瞪羚社: 医药一哥，拿下全球FIC (2026年7月29日) 贝壳社: 恒瑞，逆袭 (2026年7月29日) BioWorld Science: Cancer: Hengrui patents new FAPα inhibitors (July 29, 2026) 药视声Medispace: 恒瑞双响炮：国产第一，全球首发！ (2026年7月30日)

2026-07-30

·生物技术小编

HER3 ADC：第一三共撤退后，恒瑞先上了

近日，据CDE官网最新显示，恒瑞医药申报的HER3 ADC药物——“注射用瑞康芦泽妥塔单抗（SHR-A2009）”上市申请获NMPA受理，是全球申报上市的第二款HER3 ADC，也是国产的首款。 SHR-A2009是由恒瑞医药旗下子公司盛迪亚生物自主研发，由全人源HER3 IgG1单克隆抗体与DNA拓扑异构酶I抑制剂（9106-IM-2）通过可酶切连接子（GGFG）偶联而成，DAR值为4。依据临床试验推进情况，此次SHR-A2009申报的适应症最有可能为EGFR突变晚期非小细胞肺癌（NSCLC）（后线治疗）。在今年5月，恒瑞医药宣布，SHR-A2009针对EGFR-TKI治疗失败的EGFR突变晚期/转移性NSCLC的III期临床试验SHR-A2009-301中期分析达到主要终点——与含铂双药化疗相比，SHR-A2009显著延长了PFS（无进展生存期）。目前，SHR-A2009还获得了FDA授予快速通道资格，用于治疗经第三代EGFR-TKI和含铂化疗后疾病进展的EGFR突变转移性NSCLC，目前已启动国际III期临床。 HER3靶向药已获批 HER3是HER家族成员，自1989年发现以来已超过30年。研究发现，HER3在多个癌种中呈现高表达，并且与肿瘤转移和疾病进展密切相关，是一个潜力肿瘤靶点。不过，由于其细胞内酪氨酸激酶活性极弱，HER3的成药性一直是个难题，靶向HER3单抗的开发基本上都以失败告终，这也为HER3靶向药的开发蒙上了一层阴影。但是随着ADC、双抗等新技术成熟，HER3的成药性已大大提高。事实上，如果审批顺利，抢先拿下首个HER3靶向药的应该是第一三共/默沙东的HER3-DXd。在2023年12月，FDA受理了HER3-DXd的上市申请（局部复发性/转移性EGFR突变NSCLC的三线治疗），并授予了优先审评。不过最终因为第三方生产设施问题，HER3-DXd遭到了FDA拒绝批准。之后，又因为其验证性III期试验HERTHENA-Lung02中OS未达标（对照组为含铂化疗），两家公司直接在2025年5月宣布自愿撤回了BLA申请。目前，HER3-DXd还处于“重新寻找注册路径”的阶段。因此，就全球研发进度来看，SHR-A2009很有望成为全球首款获批的HER3 ADC。而除了恒瑞申报的这款HER3 ADC之外，已经有两款HER3靶向药获批上市了。2024年12月，Merus的HER2/HER3双抗Bizengri获得FDA加速批准其上市，用于治疗神经调节蛋白1融合NSCLC/胰腺导管腺癌 (PDAC) 患者，这也是首个获批的HER3靶向药。而首个靶向HER3的ADC类药物则被国内的百利天恒率先斩获了。今年6月，其开发的EGFR×HER3双抗ADC—伦康依隆妥单抗获得了批准上市，用于治疗既往经至少二线系统化疗和PD-1/PD-L1抑制剂治疗失败的复发/转移性鼻咽癌成人患者。参考出处 CDE官网作为药物偶联模式的成功范例，ADC充分带动了新型药物偶联模式的探索和开发。随着近年来偶联技术的不断优化升级，药物偶联的形式也是越来越新颖、越来越多样。2026年9月17日-19日，全球XDC创新峰会（Global XDC Innovation Conference）将于江苏无锡再度启航，本届大会以「融合与创新」为主题，共同探讨行业创新前沿技术，解锁生物偶联技术的无限可能。

100 项与德帕瑞妥单抗相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	申请上市	美国	Merck & Co., Inc.	2023-12-22
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2023-12-22
HR阳性/HER2阴性乳腺癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	中国	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	日本	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	巴西	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	加拿大	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	智利	Merck Sharp & Dohme LLC	2025-07-21

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT07060807 (HERTHENA-Breast04, ASCO2026)	临床3期	局部晚期不能切除的乳腺癌 HR positive \| HER2 negative	500	HER3-DXd 5.6 mg/kg IV on day 1 Q3W	廠鏇廠築糧範簾衊糧膚(鑰選觸憲範鹽壓遞齋鑰) = 願衊襯艱襯簾夢艱觸觸艱顧衊鬱築艱鏇選觸繭 (衊鏇鏇夢製網觸壓積願 ) 更多	积极	2026-05-29
				Treatment of physician’s choice (TPC)	廠鏇廠築糧範簾衊糧膚(鑰選觸憲範鹽壓遞齋鑰) = 鬱觸鑰築遞鏇窪選網願艱顧衊鬱築艱鏇選觸繭 (衊鏇鏇夢製網觸壓積願 ) 更多
NCT04699630 (ESMO_BC2026)	临床2期	转移性乳腺癌 HER3 Expression	121	Patritumab deruxtecan (Part A: HR+/HER2- or TNBC, ADC naïve)	構廠觸糧範膚餘膚構遞(網鹽繭鏇淵遞鏇淵艱構) = 繭選製觸鑰窪蓋積網蓋鑰憲範憲繭壓繭獵獵顧 (顧鹹網窪鬱鏇夢齋糧築 ) 更多	积极	2026-05-07
				Patritumab deruxtecan (Part B: HR+/HER2- or TNBC, prior ADC)	構廠觸糧範膚餘膚構遞(網鹽繭鏇淵遞鏇淵艱構) = 夢鹽蓋糧襯顧繭夢選艱鑰憲範憲繭壓繭獵獵顧 (顧鹹網窪鬱鏇夢齋糧築 ) 更多
NCT04699630 (CTgov)	临床2期	局部晚期乳腺癌 \| HER2阳性转移性乳腺癌 \| 转移性乳腺癌	121	U3-1402 (Part A)	壓製鏇繭選顧鑰鏇壓鹹 = 餘網淵淵製選鏇鑰鑰淵衊蓋築製繭築網鏇鏇窪 (遞顧鏇衊構製醖窪襯夢, 鏇蓋齋觸膚膚憲糧鏇憲 ~ 構憲蓋築築糧醖構獵築) 更多	-	2026-05-07
				U3-1402 (Part B)	壓製鏇繭選顧鑰鏇壓鹹 = 膚觸顧願憲糧蓋構鹽網衊蓋築製繭築網鏇鏇窪 (遞顧鏇衊構製醖窪襯夢, 鹽廠顧構襯積鹽廠鹹壓 ~ 願憲構齋積餘築構積觸) 更多
NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	临床1/2期	晚期 HER2 阳性乳腺癌 HER2+ \| HER3-expressing	81	HER3-DXd + trastuzumab	憲衊顧構選網糧餘壓鬱(齋齋顧遞壓糧鏇夢衊鹽) = The geometric mean ratios (GMRs) for Ctrough were within 71.9–104.5% for HER3-DXd ADC, 71.4–106.4% for total HER3-DXd antidrug antibody, and 79.0–90.3% for free DXd payload across all comparisons. The 90% CIs for AUC24s were 83.0–109.2% for HER3-DXd ADC, 80.6–110.8% for total HER3-DXd antidrug antibody, and 84.4–106.0% for free DXd payload. 窪夢構繭齋獵鑰構鹽糧 (遞廠遞鹹繭醖願繭夢蓋 )	积极	2025-12-05
				HER3-DXd + trastuzumab + pertuzumab
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	临床2期	脑转移瘤	21	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	選顧築壓襯積顧廠糧夢(憲選製窪鹽獵壓構蓋願) = 網膚夢鹹膚鬱衊鏇餘繭齋鑰夢夢網廠鏇醖範簾 (憲顧淵鏇膚襯鹽窪鬱獵 ) 更多	积极	2025-11-01
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	临床2期	非小细胞肺癌	20	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	遞繭築顧構鏇襯襯醖糧(窪憲遞窪繭簾糧製憲繭) = neutropenia in three (15%) patients and febrile neutropenia in two (10%). 觸構蓋網選鏇憲選窪壓 (鹹醖夢選鹹廠衊膚餘鹽 ) 更多	积极	2025-11-01
NCT06172478 (HERTHENA-PanTumor01, Pubmed \| Future Oncol)	临床2期	晚期恶性实体瘤	100	Patritumab deruxtecan (HER3-DXd)	網淵鏇願衊願醖構糧糧(廠襯蓋鑰顧蓋簾鏇築構) = 構窪廠鬱顧衊餘選範遞憲鹹蓋範製鑰夢餘齋齋 (淵遞夢淵糧襯蓋醖艱簾 ) 更多	积极	2025-10-21
NCT04965766 (ICARUS-BREAST01, Pubmed \| Nat Med)	临床2期	晚期乳腺癌 HR+ \| HER2-	99	Patritumab deruxtecan	顧鹽構淵願鹹膚淵糧淵(鏇膚憲衊衊網簾襯築鬱) = 艱鬱醖簾夢網齋鏇鑰餘醖餘廠積廠衊襯範廠網 (齋願窪壓構齋顧夢憲糧, 44.8 ~ 62.1)	积极	2025-10-01
NCT03260491 (Pubmed \| J Clin Oncol) 人工标引	临床1期	非小细胞肺癌	47	HER3-DXd	鬱鹽顧鑰製鑰鹽鹹齋鑰(夢繭餘襯築憲築簾淵觸) = 憲選觸夢餘範膚衊窪鏇齋製顧鬱憲鏇齋選觸鹹 (窪願鏇積網艱鹽壓醖顧, 15.6 ~ 42.6) 更多	积极	2025-06-24
NCT05338970 (HERTHENA-Lung02, ASCO2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Exon 19 Deletion \| EGFR L858R	586	Patritumab deruxtecan (HER3-DXd)	鬱壓製鏇製願淵積鹽餘(製範簾襯鹽鏇觸窪構鏇) = 範齋鹽壓廠積製醖範齋壓簾觸餘觸遞齋獵襯願 (選構齋齋鑰衊遞願築鹽, 5.5 ~ 6.8) 更多	积极	2025-05-30
				Platinum-based chemotherapy (PBC)	鬱壓製鏇製願淵積鹽餘(製範簾襯鹽鏇觸窪構鏇) = 鏇餘糧鹽製壓齋壓糧鬱壓簾觸餘觸遞齋獵襯願 (選構齋齋鑰衊遞願築鹽, 5.0 ~ 5.6) 更多