A Prospective, Single-arm, Multicenter, Open-label , Phase 2 Study to Evaluate Efficacy and Safety of the Daratumumab in T Cell Acute Lymphoblastic Leukemia With Minimal Residual-Positive After Standard Chemotherapy

T-ALL accounts for about 15%-25% of Ph-negative ALL, and its clinical prognosis is worse than B-ALL. The successful application of immunotherapy has brought revolutionary progress to the treatment of ALL. But progress in the treatment of T-ALL has been relatively slow. Minimal residual disease (MRD) is a strong prognostic indicator for ALL patients. MRD-positive after induction therapy predicts a high risk of relapse. The National Comprehensive Cancer Network (NCCN) considers MRD-positive ALL patients to be at high risk. Research in the B-ALL field has demonstrated that immunotherapy has the potential to further clear MRD, which in turn translates into survival benefits. Daratumumab is a humanized, anti-CD38 IgG1 monoclonal antibody that binds to CD38 expressed by tumor cells. Apoptosis of tumor cells is induced through a variety of immune-related mechanisms such as complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cytophagocytosis (ADCP), and FCγ receptors, which are currently mainly used in the treatment of multiple myeloma. CD38 is highly and stably expressed on the surface of T-ALL cells, and its expression was less influenced by the previous treatment. Preliminary data from the clinical study of daratumumab combined with BFM bone frame prescription for the treatment of recurrent refractory T ALL(NCT03384654) showed that the effectiveness rate (ORR) was 83.3% in children and 60% in young adults. Compared with the previous historical data, the safety and tolerability were significantly improved. For T-ALL patients who relapse after allogeneic transplantation and achieve CR with intense chemotherapy but continue to have MRD-positive flow rate, daratumumab monotherapy can further clear MRD and achieve the purpose of sustaining CR. These studies all demonstrate the potential role of daratumumab in the treatment of T-ALL. Based on the current difficulties in the treatment of T-ALL and existing research data, we plan to conduct a prospective, single-arm, open-label phase II clinical study to explore the efficacy and safety of daratumumab for flow minimal residual disease positive T-ALL after standard chemotherapy.

开始日期2025-12-01

申办/合作机构

中国医学科学院血液病医院

NCT06948084

/ Not yet recruiting临床2期IIT

A Randomized Phase II Trial for High-Risk Multiple Myeloma That is Refractory or in First Relapse With Daratumumab, Teclistamab (DT) Versus Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Carfilzomib, Dexamethasone (DKd)

This phase II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen, a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Carfilzomib, a type of proteasome inhibitor, blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. Giving daratumumab and teclistamab may be more effective than the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in reducing myeloma cells to undetectable levels in patients with relapsed or refractory multiple myeloma.

开始日期2025-10-31

申办/合作机构

National Cancer Institute

NCT06932562

/ Not yet recruiting临床3期IIT

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

开始日期2025-09-01

申办/合作机构

European Myeloma Network

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2,068

项与达雷妥尤单抗相关的文献（医药）

2026-01-01·BIOMATERIALS

CD38-targeted antibody-polymer drug conjugates for enhanced treatment of multiple myeloma

Article

作者: Li, Shannuo ; Al Faruque, Hasan ; Yang, Jiyuan ; Li, Jiahui ; Kopeček, Jindřich ; Sborov, Douglas W

Multiple myeloma (MM) remains a formidable disease, especially in relapsed or refractory cases when there are limited treatment options. In this study, we introduce two polymer-antibody drug conjugates (pADCs), ISA-P-EPI (U6244-021) and DARA-P-EPI (U6244-031), which contain semitelechelic N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-epirubicin (EPI) conjugate attached to CD38-targeting antibodies Isatuximab (ISA) and Daratumumab (DARA). These pADCs enhance therapeutic efficacy by combining the specificity of ISA and DARA with the cytotoxic potency of EPI while preserving antibody function. The EPI is linked to the HPMA polymer backbone via a tetrapeptide spacer cleavable by lysosomal enzymes, enabling drug release upon endocytosis within tumor cells. This design achieves a higher drug-to-antibody ratio than conventional ADCs for safer delivery of drug payload. In vitro studies demonstrate efficient binding, internalization, and cytotoxic efficacy of these pADCs in MM cell lines. Mechanistic investigations revealed significant therapeutic effects, including cell cycle arrest, immunogenic cell death, and preserved antibody-dependent cellular cytotoxicity (ADCC). In addition, pADCs were effective in 5 out of 8 primary samples, with their efficacy closely correlating with CD38 surface expression levels. To enhance therapeutic outcomes, we employed panobinostat to upregulate CD38 expression, which further improved pADC efficacy. In a preclinical NRG mouse model inoculated with MM.1S-luc cells, pADC treatment significantly delayed tumor progression and prolonged survival, with all treated mice remaining alive at the 100-day endpoint. These findings underscore the potential of CD38-targeted pADCs as a novel approach to combining chemotherapy with immunotherapy for MM treatment, warranting further investigation into their optimization and clinical application.

2025-12-31·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

作者: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

2025-12-31·ANNALS OF MEDICINE

Clinical outcome of ≥2% circulating tumor cells in newly diagnosed multiple myeloma: insights from a multicenter study

Article

作者: Liang, Dong ; Wang, Hua ; Xia, Zhongjun ; Feng, Yuan ; Yan, Yurong ; Jin, Fengyan ; Chen, Xiaoqin ; Nie, Xiaomiao ; Zeng, Min ; Bu, Yuying ; Bai, Shenrui ; Liang, Yang ; Wang, Qiaoli ; Xu, Weiling ; Feng, Demei

PURPOSE:

Previous studies have shown that ≥2% circulating tumor cells (CTCs) in multiple myeloma are associated with a prognosis similar to primary plasma cell leukemia. This study aims to examine this ultra-high-risk patient subset and evaluate their clinical outcomes in a real-world clinical setting.

METHODS:

We included 1,056 newly diagnosed multiple myeloma patients treated with novel agents. CTCs levels were determined via morphological assessment on peripheral blood smears, using a 2% cutoff to stratify patients into <2% and ≥2% CTCs groups. We then evaluated clinical outcomes across these groups.

RESULTS:

Patients with ≥2% CTCs constitute an ultra-high-risk subgroup, with outcomes resembling those of primary plasma cell leukemia. Survival outcomes improved for patients receiving daratumumab-based quadruplet therapy. Single autologous stem cell transplantation (ASCT) partially improved outcomes for patients with ≥2% CTCs. Achieving complete remission (CR) after induction treatment did not confer a better prognosis for this population. Furthermore, one high-risk cytogenetic abnormality (HRA) worsened outcomes in the <2% CTC group, while ≥2 HRA were associated with poorer outcomes in the ≥2% CTC group. Concurrent 1q21+ and other HRA further conferred a worse prognosis. In de novo extramedullary extraosseous (EME) multiple myeloma, defined as patients presenting with soft tissue or visceral plasmacytomas not connected to bone at initial diagnosis, ≥2% CTCs remained a strong predictor of poor prognosis.

CONCLUSION:

Our study suggests that patients with ≥2% CTCs represent a distinct ultra-high-risk subgroup in multiple myeloma and warrant separate consideration. VRD, IRD, DVRD, and DRD were reliable choices as frontline therapies for patients with <2% CTCs. Daratumumab-based quadruplet therapy may be a promising option for patients with ≥2% CTCs. Further research should continue to explore this specific aspect in greater depth.

1,028

项与达雷妥尤单抗相关的新闻（医药）

2025-07-08

·CPHI制药在线

自我给药的抗癌药物：一场便利性与价值体系的对话

关注并星标CPHI制药在线在肿瘤药物开发的竞速赛道上，"疗效"不再是唯一的衡量标准。如今，给药途径正在成为制药公司新的战略焦点。近年来，"自我给药"（self administered）的抗癌药物逐渐成为了传统肿瘤学疗法开发之外的新兴热点。这些药物多为口服或皮下注射形式，患者可以在家中自行完成用药，摆脱了静脉输注的种种束缚。1自我给药浪潮：从口服制剂到皮下注射的系统进化最具代表性的，是全球畅销处方药 Keytruda（帕博利珠单抗）。2024年9月，美国FDA正式批准其皮下注射版本，相比静脉输注大幅缩短了给药时间，从30分钟降至仅2分钟。默沙东表示，该剂型将于2025年10月1日开始在美国市场供应，并预计未来两年内，皮下注射版本将占Keytruda整体用药人群的30%至40%。据默沙东高管介绍，皮下剂型将优先推广给使用Keytruda单药治疗、联合口服治疗、以及早期癌症患者，以提升治疗便捷性、减少患者往返医院的时间成本。这一版本还可能在未来为Keytruda构建新的专利保护层，在2028年核心专利到期前争取更长的生命周期。除了Keytruda，BMS 的 Opdivo（纳武利尤单抗）和强生的 Darzalex（达雷妥尤单抗）也纷纷推出皮下注射剂型，部分产品已获批上市。例如 Darzalex Faspro 就成功取代了静脉剂型，成为多发性骨髓瘤治疗中的主流方案。此外，罗氏、阿斯利康等公司也在尝试将抗体药物偶联物（ADC）等大分子制剂转为皮下注射，甚至开发自动注射装置与皮下植入泵，试图将"抗癌治疗"彻底带出医院场景。这一趋势背后，反映的不仅是制药工艺的突破，更是一种临床逻辑的转变：将抗癌治疗"脱嵌"于医院体系，融入患者的日常生活场景，推动癌症管理"慢病化"与"家庭化"。这一趋势的核心逻辑是显而易见的：延续药物疗效的同时，最大程度减少患者与医疗体系的"物理依赖"，降低治疗负担，提高生活质量，进而推动抗癌治疗的"慢病化"管理转型。从患者视角来看，自我给药带来了切实改变。它意味着不再频繁往返医院；用药行为融入日常生活；对治疗过程拥有更多自主权。对于晚期或慢病管理阶段的肿瘤患者来说，这种"轻装上阵"的治疗方式甚至决定了是否能够坚持长期用药。皮下注射有着吸收可控、适配大分子的优势，且能通过自动注射器等装置支持患者自用，形成与口服药互补而非竞争的自我给药版图。从药企视角来看，自我给药也创造了新的商业逻辑：加速获批：自服口服药或皮下注射常常比复杂的输注产品更快设计临床方案；降低操作门槛：避免了输液中心等重成本环节；增加市场渗透率：患者更容易接受，也能扩展到社区或家庭场景。这类药物的开发不仅是技术平台的演进，更反映了肿瘤治疗从"高干预医疗模式"转向"以患者为中心管理"的趋势。2 自我给药的肿瘤药物价格成为关注点但在皮下注射抗体药物逐渐兴起的同时，来自《JAMA》的一项最新研究却发出预警：被收入Medicare D部分的肿瘤学产品（通常是可以实现自我给药的处方药物，大多数为口服药）的上市价格正在快速上涨，涨幅远超通货膨胀，甚至高达200%以上。这背后既反映出医保制度的结构性空档，也暴露出当前价值评估体系的局限。图1. Medicare D 部分承保的抗癌药物上市月平均价格。（图片来源：JAMA）一项由美国Vanderbilt大学和哈佛大学团队联合开展的研究，最新发表于2025年5月的《JAMA》。研究聚焦于2010-2024年间纳入Medicare Part D的自我给药抗癌药，涵盖86款产品（详情见附表）。该项研究的主要发现如下（图1）：2012-2014年间上市的自我给药抗癌药物，每月平均价格为 10954美元；2023-2025年间新上市的自我给药抗癌药物，每月平均已达 27891美元；即便调整通货膨胀后，自我给药抗癌药物的上市价格仍以每年1694美元的速度上升（P<0.001）；实际2025年价格比理论通胀调整值高出14.8%-200.9%不等。换言之，这些药物的定价增长已严重偏离经济基本面，成为医保开支的不可忽视负担。3为何自我给药更容易"高价上市"？自我给药高药价的背后，是制度逻辑与市场激励结构的共同作用：医保报销机制"先保后谈"许多自我给药的抗癌药被纳入Medicare Part D的"受保护类别"，医保必须覆盖，但缺乏与药企的有效议价机制。这等于给予药企在定价初期更大的自由。IRA法规规避效应2022年出台的《通胀削减法案》（IRA）限制的是"上市后涨价幅度"，但不限制首次上市价格。于是，药企有动机在上市阶段就设定更高价格，以对冲后期涨价受限带来的风险。自我给药产品可塑性强，便于做出高价值叙事除了疗效本身，药企还可以强调"便利性"、"生活质量提升"、"依从性改善"等非临床因素，构成价格溢价的合理性包装。4该如何衡量自我给药的真实价值？面对自我给药的浪潮与价格不断攀升的趋势，问题的核心早已不是"要不要推广"这种治疗方式，而是如何科学、系统地评估其价值。如果我们无法正确定义价值，就无法理性判断价格，也无法为医保支付与商业模式提供清晰方向。当前，肿瘤药物的定价体系主要仍建立在两个维度之上：临床疗效（如PFS、OS等）市场对标（即与已上市药物对比）这套逻辑在评价传统治疗时尚可适用，但对于"自我给药"药物而言，显然过于狭窄。因为它们的价值，往往并不只体现在肿瘤缩小或生存期延长上，而更体现在对患者生活方式的重构能力上。在评估缓解中，容易被忽视的几个关键维度包括：✓ 患者生活质量（QoL）的显著改善从每日输液到每周注射、从医院排队到家中服药，许多患者在自我给药模式中真正获得了"生活权"。尤其是在长期维持治疗或复发高风险人群中，这种便利性直接改善了睡眠、营养、心理状态等QoL指标，而这些目前尚未成为定价评估中的显性权重。✓ 提升依从性所带来的治疗连续性和远期获益研究显示，给药频率越低、操作越简便，患者依从性越高。对于免疫治疗或靶向治疗等需长期服药的方案来说，依从性直接关系到疗效持续性与疾病控制率。自我给药方式提升的不仅是用药的便利性，更是治疗的"完整度"，这在慢病化管理中尤为关键。✓ 对卫生系统资源的节约与再分配价值自我给药不仅让患者受益，也间接减轻了卫生系统压力。医院资源（如输液椅位、护理人力、药房窗口）得以释放，使医疗体系更专注于重症、急性和复杂病例的处理。但目前，这类"系统性支出节约"在医保经济模型中鲜有计入，导致制度层面对这类药物的支付激励依然不足。如果这些维度始终未能纳入医保支付机制与价值评估模型中，那自我给药所创造的真实社会价值就只能停留在药企定价逻辑内部，成为它们塑造"溢价叙事"的工具，而无法转化为医患双方乃至整个系统的"共赢成果"。反之，若能通过健康技术评估（HTA）、患者报告结局（PRO）、医保谈判机制等手段将这些"非临床"但"高相关"的价值显性化，我们或许能够迎来一个更理性、可持续的自我给药时代。5皮下注射抗体药物具有价格优势不过，在讨论价格趋势的同时，我们也需要区分不同层面的"价格"含义，避免视角混淆。《JAMA》研究所揭示的"价格上涨"趋势，指的是近年来新上市的自我给药抗癌药物整体的月度价格中位数不断上升，反映的是一种横向的时间趋势。从同一产品的静脉注射版本与皮下注射版本的对比来看，则观察到相反的现象：在多个典型案例中，SC版本的价格往往低于传统IV版本。例如，Darzalex Faspro 的定价显著低于静脉注射版 Darzalex，Herceptin SC、Rituxan Hycela 也分别低于其对应的IV剂型（图2）。图2. 肿瘤学产品静脉注射与皮下注射制剂全年成本对比图。这背后体现的，是抗体药物"皮下注射化"趋势所带来的多重变革（表1）。传统上，单克隆抗体因分子量大、吸收慢，长期依赖静脉给药。近年来，随着透明质酸酶（如recombinant human hyaluronidase）技术的发展，皮下注射吸收效率显著提升，使得大分子抗体得以实现快速、有效的皮下注射适配。比如Darzalex Faspro、Herceptin SC与Rituxan Hycela等产品，均采用了这一酶促辅助技术，极大缩短了给药时间（从数小时缩至5分钟以内），并实现在家用药的可能。表1. 上市肿瘤学产品IV与SC制剂对比值得强调的是，这些SC剂型在价格上的"下探"，并不意味着药企放弃利润空间，反而是一种更具战略性的"生命周期延展"方案：通过剂型革新避开专利悬崖、构建新知识产权屏障，同时也能通过更友好的用药体验带来市场扩张效应。此外，从医保角度看，SC剂型的推广可显著降低住院输注成本与人力消耗，逐步转化为整个系统层面的节支工具。因此，虽然"自我给药药物整体价格趋高"这一趋势成立，但"SC版本价格低于IV版本"亦可视作行业在"疗效-便利-可负担"三角关系中，寻求再平衡的现实路径。6离开医院的药物，不能也离开价值体系的衡量自我给药的兴起，并不只是一次给药形式的革新，更是一种价值体系的重新审视。越来越多的抗肿瘤药物正从医院走向家庭，从静脉滴注走向口服与皮下注射，每一次剂型的改变背后，都是对治疗可及性、患者体验与系统成本的重新权衡。尤其是以 Darzalex Faspro、Herceptin SC、Rituxan Hycela 为代表的抗体类药物，通过酶辅助吸收技术实现大分子皮下注射，从根本上打破了"抗体只能输注"的技术桎梏，也为"在家治疗"打开了新的空间。在这些产品中，我们不仅看到了疗效的持续，更看到了给药便利性带来的患者依从性提升、输注资源的系统节约与医保结构性降压的潜力。因此，真正的问题已不再是"是否应该推广自我给药"，而是能否用一套更完整、更动态的价值衡量体系，去捕捉它带来的真实效益？这套体系应当不仅包括生存期（OS）、无进展生存期（PFS）等传统指标，也应涵盖生活质量（QoL）、治疗连续性、患者负担、护理转移与医保节支等长期价值。如果仍以旧有的药物评价范式去判断新剂型、新场景的临床价值，那么"自我给药"可能更多服务于企业的定价策略，而难以成为真正推动医疗系统进步的力量。而一旦医保、监管与产业共同重塑出一套更全面的评估逻辑，将"疗效"与"便利性"纳入同一价值衡量框架，自我给药就不仅是一种药物形式，更是一种可持续的制度创新。正如Keytruda皮下注射版本的推出所标志的那样，"如何给药"正日益成为治疗策略中不可忽视的一环。而"如何衡量这种改变带来的真实价值"，将决定这场以便利为表、以共赢为核的变革，能走多远。附表：自我给药的肿瘤学产品Ref.Erman, M. Merck plans to launch US subcutaneous version of Keytruda on October 1. Reuters. 28. 03. 2025.Dusetzina, S. B.; Jazowski, S. A.; Nayak, R. K.; Huskamp, H. A.; Keating, N. L. Trends in Launch Prices and Price Increases for Self-Administered Anticancer Drugs in Medicare. JAMA. Published online May 15, 2025. doi:10.1001/jama.2025.6366END智药研习社近期直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

专利到期抗体药物偶联物上市批准

2025-07-06

·药时空

预测：2030年畅销药和世界药企排名

根据Evaluate的一份新报告，到2030 年，处方药总销售额预计将增长到 1.75 万亿美元，预计GLP-1将在 2024 年至 2030年期间增长 20%销售额。届时GLP-1 疗法将占总药物的 9%。以下是Evaluate 预测的2030年畅销药物排行榜。1.药物名称：Mounjaro 企业名称：礼来2024年销售额：115亿美元2030年销售额预测：362亿美元排在榜首的为礼来的Mounjaro，2022年5月13日，美国食品药品监督管理局(FDA)批准礼来公司（Eli Lilly）每周一次的双重GIP和GLP-1受体激动剂Mounjaro(Tirzepatide，替尔泊肽)注射液，作为饮食和运动的辅助疗法，以改善二型糖尿病成人的血糖控制。2.药物名称：Skyrizi企业名称：AbbVie2024年销售额：117亿美元2030年销售额预测：266亿美元截至2024年6月，Skyrizi已斩获含斑块状银屑病、银屑病关节炎、克罗恩病等在内的7项适应症。Skyrizi成为艾伯维继Humira之后的下一个百亿大单品。凭借在炎症性肠病和皮肤病治疗等领域广泛的应用前景，该产品被《Nature》预测将进入2025年全球畅销榜前五名。目前，艾伯维仍在积极推进Skyrizi在幼年银屑病关节炎、强直性脊柱炎、化脓性汗腺炎等多项适应症中的临床研究。3.药物名称：Zepbound企业名称： Eli Lilly2024年销售额：49亿美元2030年销售额预测：255亿美元Mounjaro（替尔泊肽，2型糖尿病）和 Zepbound（替尔泊肽，减重）是礼来产品阵容中最耀眼的明星。Mounjaro2024年销售额115.4亿美元美元，同比增长124%；Zepbound2024年销售额49.26亿美元，在2024年合计贡献了164.66亿美元的销售收入。2024年12月，美国FDA批准Zepbound用于新的适应症，这是首个也是唯一一个治疗中重度肥胖症成人阻塞性睡眠呼吸暂停 (OSA) 的处方药。根据预测，礼来的Mounjaro和 Zepbound，预计到 2030 年将赚取 620 亿美元。这一估值将比艾伯维（AbbVie）的重磅炸弹修美乐（Humira）——长期以来被认为是世界上最畅销的药物——所达到的估值高出三倍。是默克 Keytruda 2024 年销售额的两倍。4.药物名称： Dupixent企业名称： Sanofi/Regeneron2024年销售额：141亿美元2030年销售额预测：251亿美元Dupixent是一种全人源化单克隆抗体，能够抑制白细胞介素4（IL-4）和白细胞介素13（IL-13）信号通路。它已在全球60多个国家和地区获得一种或多种适应症的监管批准，包括特应性皮炎、哮喘、伴鼻息肉的慢性鼻窦炎、嗜酸性食管炎、结节性瘙痒症、慢性自发性荨麻疹及慢性阻塞性肺病。全球有超过100万名患者正在接受Dupixent治疗。2025年6月21日， Dupixent获美国FDA批准，用于治疗大疱性类天疱疮（BP）成人患者。根据新闻稿，Dupixent是获美国FDA批准的首款BP疗法。5.药物名称： Ozempic企业名称：Novo Nordisk2024年销售额：175亿美元2030年销售额预测：244亿美元6.药物名称： Wegovy企业名称：Novo Nordisk2024年销售额：84亿美元2030年销售额预测：181亿美元礼来的主要竞争对手是诺和诺德，其 semaglutide 以 Wegovy（糖尿病）和 Ozempic（减肥）销售。根据诺和诺德此前公布的财报，Ozempic、 Wegovy销司美格鲁肽降糖口服版（Rybelsus）三种制剂合计销售额约293.0亿美元，占超诺和诺德总营收的三分之二。7.药物名称： Keytruda企业名称：Merck2024年销售额：295亿美元2030年销售额预测：169亿美元默克公司的重磅 PD-1 抑制剂 Keytruda 2024年位居制药公司最畅销产品榜首。但Keytruda的关键专利将于 2028 年到期，这将使其面临生物仿制药竞争，进而瓜分销售额。使其成为唯一一家出现负增长的前十名药物。8.药物名称： Darzalex企业名称：J&J/Genmab2024年销售额：117亿美元2030年销售额预测：166亿美元Darzalex为抗CD38单抗用于多发性骨髓瘤治疗，2024年销售额首次突破百亿美元，Darzalex也成为强生最畅销药物。但Darzalex在美国、欧洲和日本的组合物专利将于2026年3月到期。目前，该产品还在开展多项3期试验，拟拓展适应症，包括一线治疗符合及不符合自体干细胞移植的新诊断MM、郁积多发性骨髓瘤或冒烟型多发性骨髓瘤等。以积极应对仿制药瓜分销售额。9.药物名称： Biktarvy企业名称： Gilead2024年销售额：135亿美元2030年销售额预测：157亿美元在HIV领域，吉利德凭借多款产品保持着市场领先地位。其中，核心产品Biktarvy（比克替拉韦+恩曲他滨+丙酚替诺福韦）自2018年上市以来，销售额连年攀升，在2022年突破了100亿美元。2024年，该产品的销售额达135亿美元。Biktarvy在不久的将来没有明显的阻力。该药物的关键专利保护将在未来几年保持不变，并将在 2033 年之前使仿制药竞争对手无法进入市场。10.药物名称： Cagriema企业名称： Novo Nordisk2024年销售额：0亿美元2030年销售额预测：152亿美元CagriSema 是由诺和诺德开发的一种双靶点联合注射制剂，由两种成分组成：Cagrilintide（卡格列肽）和司美格鲁肽，主要用于体重管理（肥胖/超重）与 2 型糖尿病治疗。诺和诺德表示，将在 2026 年初向 FDA 提交CagriSema 的上市申请，预计有望于 2027 年初上市。该药是目前研发中最有前途的资产，预计峰值销售额为800亿美元。11. 药物名称： Enhertu企业名称：AstraZeneca/Daiichi Sankyo2024年销售额：42亿美元2030年销售额预测：152亿美元ENHERTU自2019年获批以来，累计被纳入19项美国国立综合癌症网络（NCCN）指南，其适应症范围从后线治疗逐步扩展至一线应用截至2025年初，ENHERTU已在全球60多个国家获批乳腺癌、胃癌等适应症，累计销售额达73.7亿美元，2024年单年销售额稳居全球ADC药物榜首。随着药物排名的变化，各大药企排名也将重新洗牌，Evaluate预测2030年，凭借GLP-1领域的强劲增长趋势，礼来和诺和诺德将迅速超越2024年处方药销售领域的行业领先者。2030年十大药企排行榜预测如下：参考文献：1.https://www.biospace.com/business/prescription-drug-sales-will-hit-1-75t-by-2030-thanks-to-glp-1s-evaluate识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

申请上市

2025-07-04

·Pharmaceutical Technology

Big pharma braces for revenue headwinds as patent expiries loom

Only 4% of global drugs sales in 2030 will have patent protection. LanKS via Shutterstock. One of the biggest patent cliffs is set to hit the pharmaceutical industry this decade, with major players bracing for a blow to their revenue streams, according to market analysis. A recent report by GlobalData projects that the share of global drug sales under patent protection will decline by 2030. Only 4% of global drugs sales will have patent protection, compared to 12% and 6% in 2022 and 2024. Historically, the loss of patent exclusivity can have big bearings on a company’s financial prospects. Biosimilars and generics flood the market upon patent loss, which exerts pricing pressure on the branded product. There has been a push by the Trump administration to increase biosimilar and generic drug use in the US. In May 2025, the US president signed an executive order that overhauled pharmaceutical pricing in the country. According to a Reuters article, pharma companies launched new US drugs at prices 35% higher in 2023, compared to those launched in 2022. Biosimilars and generics can be as much as 80% cheaper than branded alternatives. For example, AbbVie’s anti-inflammatory blockbuster Humira (adalimumab) used to be one of the top-selling drugs world, with the drug generating $21.2bn in sales in its last year of market exclusivity. Whilst still a heavyweight in the monoclonal antibody arena, revenue is forecast to slump to $2.6bn by 2030, as per a separate analysis by GlobalData. Other drugs are set to face competition too, with both MSD’s Keytruda (pembrolizumab) and Johnson & Johnson’s (J&J) Darzalex/Faspro (daratumumab and hyaluronidase-fihj) losing US exclusivity by 2029, representing a particular headwind in oncology . Keytruda, approved to treat a range of solid tumours, was the top selling drug in the world in 2024, netting over $29bn in annual sales. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Revenue loss for MSD and J&J’s products will contribute to a US drug market that is set to lose over $230bn between this year and 2030. Bristol Myers Squibb (BMS) is forecast to be most affected by the patent cliff. Anticoagulant Eliquis (apixaban) and immunotherapy Opdivo (nivolumab), two of BMS’s blockbuster drugs, account for a significant portion of company’s annual revenue. They are both set to lose exclusivity over the next few years, with GlobalData analysts forecasting a dent to BMS’s financial outlook. George El-Helou, strategic intelligence analyst at GlobalData, comments: “More than half of the top 15 pharma companies are expected to face challenges in managing the impact of the upcoming patent cliff. However, some companies have pipeline drugs forecast to offset part of these losses.” A company expected to fare well during this time is Eli Lilly, with revenue forecast to improve by 165% in 2030. This will largely be driven by the company’s glucagon like peptide-1 receptor agonist (GLP-1RA) tirzepatide, sold under the brand names Mounjaro and Zepbound for weight loss and type 2 diabetes respectively. El-Helou noted that pharma companies could strengthen their pipelines by acquiring early-stage biotechs developing promising therapies, increasing investment in R&D, and targeting diseases with high unmet needs. Hannah Hans, head of pharma strategic intelligence at GlobalData, says: “It is critical to plan from both a patent and regulatory perspective, while also embedding lifecycle management strategies early on in development. This integrated approach will help optimise long term value. The current patent cliff implications on pharma companies include loss of revenue and pricing pressures, however there are several opportunities for companies to focus on innovative therapies and re-defining their portfolio.” Hans concludes: “This opens up a significant opportunity for biotech companies to partner with pharma on next generation therapies, novel delivery platforms and differentiated formulations as companies look to strengthen their pipeline.” Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

100 项与达雷妥尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10777	达雷妥尤单抗	L01XC24	DB09331

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
免疫球蛋白轻链淀粉样变性	欧盟	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	冰岛	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	列支敦士登	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	挪威	Janssen-Cilag International NV	2016-05-20
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2015-11-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
阴燃多发性骨髓瘤	申请上市	欧盟	Johnson & Johnson	2024-11-08
残留肿瘤	临床3期	美国	Janssen Research & Development LLC	2019-04-26
残留肿瘤	临床3期	加拿大	Janssen Research & Development LLC	2019-04-26
淀粉样变性	临床3期	美国	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	美国	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	日本	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	日本	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	澳大利亚	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	澳大利亚	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	比利时	Janssen Research & Development LLC	2017-10-10

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03012880 (CTgov)	临床2期	多发性骨髓瘤	80	lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort A)	壓鏇網窪獵膚夢構選繭 = 淵鹽築糧鹹齋選獵鏇鹽襯艱窪範願淵鏇積膚憲 (淵齋膚憲襯餘蓋鬱鏇構, 獵蓋遞獵窪築廠製鹽範 ~ 鹽膚製膚醖醖網廠憲築) 更多	-	2025-06-04
				lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort B)	壓鏇網窪獵膚夢構選繭 = 餘蓋範構範餘簾鏇廠願襯艱窪範願淵鏇積膚憲 (淵齋膚憲襯餘蓋鬱鏇構, 鑰餘窪壓衊鏇鑰窪壓積 ~ 廠壓憲積範艱夢襯簾鹹) 更多
ASCO2025	N/A	多发性骨髓瘤	804	Daratumumab	獵遞顧壓憲簾壓積憲窪(淵構鹽蓋壓製築蓋醖襯) = 餘觸艱夢鏇艱淵淵顧鬱選鹽醖窪憲鏇遞夢襯夢 (夢衊繭蓋糧憲鏇獵淵鏇 ) 更多	积极	2025-05-30
				Lenalidomide	獵遞顧壓憲簾壓積憲窪(淵構鹽蓋壓製築蓋醖襯) = 網顧鬱窪壓觸廠積鏇醖選鹽醖窪憲鏇遞夢襯夢 (夢衊繭蓋糧憲鏇獵淵鏇 ) 更多
NCT04661137 (phase 2b study of selinexor, ASCO2025)	临床2期	多发性骨髓瘤	28	Selinexor 80 mg + Carfilzomib 20 mg/m2 + Dexamethasone	獵齋衊遞廠夢窪壓餘範(構顧艱糧鬱積艱餘夢鹽) = 觸壓獵積構艱齋衊範蓋廠壓顧鹽鬱糧範襯築簾 (遞齋製鹽範壓鑰範餘憲 ) 更多	积极	2025-05-30
				Selinexor 60 mg + Pomalidomide 4 mg + Dexamethasone	獵齋衊遞廠夢窪壓餘範(構顧艱糧鬱積艱餘夢鹽) = 衊淵蓋艱觸鑰選壓憲網廠壓顧鹽鬱糧範襯築簾 (遞齋製鹽範壓鑰範餘憲 )
NCT04181827 (CARTITUDE-4, CTgov)	临床3期	复发性多发性骨髓瘤 \| 多发性骨髓瘤	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	製襯築網獵齋蓋淵製構(築積衊衊衊鑰繭壓鑰鏇) = 艱醖願繭憲顧襯膚簾鑰積淵顧獵簾壓餘遞壓觸 (膚夢獵膚蓋鏇遞構製蓋, 憲艱壓顧網顧鑰淵遞淵 ~ 窪鑰鑰製鑰鹹壓齋鬱壓) 更多	-	2025-05-20
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	製襯築網獵齋蓋淵製構(築積衊衊衊鑰繭壓鑰鏇) = 餘衊艱窪願觸觸獵窪醖積淵顧獵簾壓餘遞壓觸 (膚夢獵膚蓋鏇遞構製蓋, 選醖廠夢獵鹹糧選襯夢 ~ 淵遞衊願獵壓願遞觸醖) 更多
PS1792 (EHA2025)	临床3期	免疫球蛋白轻链淀粉样变性一线 CD38	24	Daratumumab-based regimens	製齋鬱衊築壓獵鹹顧蓋(壓積鑰築鏇廠鬱選膚衊) = Lymphopenia was the most common hematologic adverse reaction of ≥grade 3 鏇繭鹹繭遞淵窪艱鹽簾 (鬱鬱憲選夢網蓋鹽製蓋 )	积极	2025-05-14
				VCD (bortezomib, cyclophosphamide, and dexamethasone)
PB3609 (EHA2025)	N/A	感染二线 CD38	55	Daratumumab	觸願鬱願範糧壓簾觸糧(艱網鑰齋製夢選製獵鏇) = Fatal outcomes have been reported in studies, only one patient died in our experience 鑰窪選艱夢鏇壓憲選簾 (遞選願醖願獵簾艱淵憲 ) 更多	积极	2025-05-14
PB2995 (EHA2025)	临床2期	多发性骨髓瘤维持	22	Daratumumab	醖簾顧窪鏇觸簾衊製夢(餘醖齋憲餘繭膚齋簾範) = 鹹壓構醖鹽願衊衊鏇蓋選衊獵顧糧範鏇鏇艱餘 (鹹鏇鏇夢餘願範鬱範觸 ) 更多	积极	2025-05-14
				Bortezomib	醖簾顧窪鏇觸簾衊製夢(餘醖齋憲餘繭膚齋簾範) = 網淵膚壓衊齋繭膚膚網選衊獵顧糧範鏇鏇艱餘 (鹹鏇鏇夢餘願範鬱範觸 )
NCT04703621 (THE DART STUDY, EHA2025)	临床2期	免疫性血小板减少症二线	21	Daratumumab	廠觸願窪膚簾窪襯網淵(淵鬱衊獵簾網糧齋製糧) = Infections were the most common treatment-emergent adverse events (38%) 壓鑰鹽獵鹽餘範夢網鏇 (築積鏇鹽製網獵築築鏇 ) 更多	积极	2025-05-14
PB3012 (EHA2025)	N/A	多发性骨髓瘤一线 \| 二线 \| 三线 CD38	133	Daratumumab (1L group)	範簾壓繭憲壓範醖築艱(獵夢糧鹹顧顧鏇壓糧製) = 齋獵築願選膚餘願廠鹽壓積淵範築網繭齋鹹顧 (選簾選鹽顧鏇顧鹽餘衊 ) 更多	积极	2025-05-14
				Daratumumab (2L group)	範簾壓繭憲壓範醖築艱(獵夢糧鹹顧顧鏇壓糧製) = 範鹽構願糧鬱糧構餘憲壓積淵範築網繭齋鹹顧 (選簾選鹽顧鏇顧鹽餘衊 ) 更多
NCT03697655 (PREDATOR-MRD, EHA2025)	临床2期	多发性骨髓瘤 MRD-negative complete response	71	Daratumumab	夢築鏇鏇廠淵願鹽鏇簾(淵觸艱夢夢遞積製淵鹹) = 鏇艱範餘製鹽夢齋鬱繭觸網範觸構夢構壓鬱網 (窪顧範鬱構網膚遞壓顧, not reached ~ not reached) 更多	积极	2025-05-14
				Daratumumab (Observation)	夢築鏇鏇廠淵願鹽鏇簾(淵觸艱夢夢遞積製淵鹹) = 餘膚蓋鏇壓鏇願構膚製觸網範觸構夢構壓鬱網 (窪顧範鬱構網膚遞壓顧, 5.0 ~ not reached) 更多