ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible/Deferred Multiple Myeloma

This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible/deferred multiple myeloma.

开始日期2026-04-15

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT07110844

/ Recruiting临床2期IIT

A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis

The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis.
The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.

开始日期2025-11-07

申办/合作机构

Janssen Pharmaceuticals, Inc.

NCT07075510

/ Recruiting临床1/2期IIT

A Phase I/II Study of Subcutaneous Daratumumab Administration in the Anterior Upper Thigh Vs Abdomen in Patients With Plasma Cell Disorders

The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Daratumumab is a monoclonal antibody that can attach itself to the CD38 protein on the surface of abnormal plasma cells. Daratumumab can kill the abnormal plasma cells and/or help your immune system find and destroy them. Due to the way daratumumab works, normal cells may also be affected. All reference to the words "study drug" in this consent form will mean Daratumumab.
Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both subcutaneous (DARZALEX FASPRO®) and intravenous (DARZALEX®) ways of being delivered. The FDA has also approved the subcutaneous administration of daratumumab combined with other standard of care drugs for patients with light chain (AL) amyloidosis. Subcutaneous means the drug is given by an injection just beneath the skin. Intravenous (IV) means the drug is given as an injection directly into a vein.
Usually when given subcutaneously, the study drug is given by an injection in the abdomen. Having the drug given by subcutaneous injection (underneath the skin of the abdomen) has lessened the IV related side effects and the drug administration by injection is quicker.
However, some patients cannot receive the study drug injections in their abdomen because they find them very painful or have other medical reasons making it difficult to get these injections. The goal of this study is to see if getting the study drug subcutaneously, injected under the skin by a needle, in the patient's upper thigh will have the same results, or better results, as getting the injection in the abdomen. This would therefore, improve patients access to the drug and provide an alternative place to receive the injection of the drug.
This study will take place at University of Maryland Medical Center and there will be about 30 people who will take place in this study here. Dr. Badros is the Sponsor-Investigator of the study. Funding to conduct the study and study drug are being provided by Johnson & Johnson Innovative Medicine (J&J IM).

开始日期2025-10-23

申办/合作机构

University of Maryland Baltimore

[+1]

100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的临床结果

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100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的转化医学

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100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的专利（医药）

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项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的文献（医药）

2025-08-03·Therapeutic Delivery

May 2025 therapeutic delivery: industry update

作者: Harris, Elaine

This month saw approvals for two products employing Halozyme's Enhanze drug delivery technology (BMS's Opdivo and Johnson and Johnson's DARZALEX FASPRO®). A number of collaborations between industry partners and charities to fight the disease, including Duchenne muscular dystrophy and Epidermolysis Bullosa, have been announced. Successful clinical trial data was disclosed for products employing a wide variety of therapeutic delivery technologies including Perfuse Therapeutics intravitreal implant for glaucoma, Aspen Neurosciences precision delivery of an autologous dopaminergic neuronal precursor cell therapy for Parkinson's disease and Resurge Therapeutics IntraProstatic Drug Elution (IPDE) therapy for prostate cancer.

2024-10-01·ANNALS OF HEMATOLOGY

The clinical efficacy of a daratumumab-based regimen in relapsed/refractory acute leukemia: a single-center experience

Article

作者: Li, Jing ; Luo, Lin ; Dai, Yi ; Luo, Jun ; Cheng, Peng ; Wei, Zhenbin

Abstract:

Relapsed/refractory acute leukemia (R/R-AL) is associated with a low remission rate, short survival rate, and poor prognosis. Treating R/R-AL remains challenging as there is no standardized effective regimen; hence, there is a need for efficient therapies. CD38 expression has been observed in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Daratumumab is a humanized anti-CD38 monoclonal antibody used to treat multiple myeloma and has been reported to treat R/R-AL safely and effectively. The clinical data of 10 adult patients with R/R-AL who were treated with a daratumumab-based salvage regimen between July 2018 and May 2023 at our center were analyzed retrospectively. Seven AML and three ALL cases were included in the analysis. Seven (70%) patients showed responses to the treatments (complete response [CR], 60%; partial response [PR], 10%). Of the seven responders, three underwent allogenic stem cell transplantation (ASCT), including one who underwent a second ASCT. Among the five patients with R/R AML who had prior exposure to venetoclax, three achieved a therapeutic response (two CR and one PR) when re-treated with venetoclax in combination with daratumumab. The median follow-up time was 6.15 months (0.9–21 months). Overall survival and event-free survival rates at 12 months were 68.6% and 40.0%, respectively. The main adverse events included grade 3 febrile neutropenia (20%) and grade 3 hematological toxicities (60%). The daratumumab-based salvage regimen offers patients with R/R-AL the opportunity of remission with acceptable tolerability, creating the possibility of bridging ASCT.

2023-06-01·Clinical pharmacokinetics

Clinical Pharmacokinetics and Pharmacodynamics of Daratumumab

Review

作者: Kim, Kyeongmin ; Phelps, Mitch A

Daratumumab is a fully human, monoclonal immunoglobulin G1 and a first-in-class CD38-targeting drug approved by the US Food and Drug Administration for the treatment of patients with relapsed/refractory and newly diagnosed multiple myeloma or newly diagnosed light-chain amyloidosis. CD38 is heavily expressed on malignant myeloma cells, and daratumumab exerts anti-myeloma activity via immune-mediated mechanisms, direct induction of apoptosis, and immunomodulation. Daratumumab is used as monotherapy or in combination with standard-of-care myeloma therapies, including proteasome inhibitors, immunomodulatory agents, DNA-alkylating agents, and corticosteroids. Following an intravenous infusion, daratumumab exhibits nonlinear pharmacokinetics (PK), as clearance decreases with higher doses and over time because of target-mediated effects. Dosing schedules vary depending on indications and co-administered drugs, but generally daratumumab is administered weekly for 6-9 weeks followed by a less frequent dosing regimen, once every 2-4 weeks. Daratumumab exposure is strongly correlated with efficacy, and the exposure-efficacy relationship follows a maximal effect model, whereas exposure is not correlated with safety endpoints. The approved dose of 16 mg/kg of daratumumab results in the saturation of 99% of the target at the end of weekly dosing in most patients, and high target saturation is maintained over time during the less frequent dosing schedule. Infusion-related reactions are frequently observed in patients given daratumumab, particularly with the first infusion, thus prompting long durations of infusion (~ 7 h) and splitting of the first dose across 2 days. This led to the development of a subcutaneous delivery formulation for daratumumab (Dara-SC). Dara-SC provides a similar efficacy and safety profile to intravenous daratumumab (Dara-IV) but has a much lower rate of infusion-related reactions and a shorter infusion time. Exposure-response relationships for efficacy and safety endpoints were similar between Dara-SC and Dara-IV, and co-administered drugs with either Dara-IV or Dara-SC do not significantly affect daratumumab PK. Except for baseline myeloma type and albumin level, none of the other investigated disease and patient characteristics (renal/hepatic function, age, sex, race, weight, Eastern Cooperative Oncology Group performance status) was identified to have clinically relevant effects on exposure to daratumumab monotherapy or combination therapy regimens. Dara-IV exposure was significantly lower in patients with immunoglobulin G myeloma compared with patients with non-immunoglobulin G myeloma (p < 0.0001) and in patients with a lower albumin level, whereas the overall response rate was similar regardless of the myeloma type and albumin level. Daratumumab dose adjustment is not currently recommended based on disease and patient characteristics.

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项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的新闻（医药）

2026-01-08

·素舸科技

全球医药单品收入50强分析：特点、趋势及启示

一、全球医药单品收入50强产品特点分析1. 市场集中度高，“超级重磅炸弹”效应显著从近10年收入数据来看，排名前10的产品合计收入占比超过50强总收入的50%以上，呈现明显的头部集中效应。Humira（阿达木单抗）以1,728亿美元的十年总收入高居榜首，创造了“药王”神话；Keytruda（帕博利珠单抗）虽然上市时间相对较晚，但凭借惊人的增长势头，五年收入已达1,070亿美元，十年收入1,310亿美元，成为新一代重磅炸弹的典范。这种“超级重磅炸弹”现象反映出全球医药市场的高度聚焦特征：少数几个创新性强、临床价值高的产品能够占据极大的市场份额，为企业带来持续巨额回报。这些产品通常具备以下共性：针对重大疾病领域、具有突破性疗效、形成专利壁垒和先发优势、拥有强大的商业化团队支持。对于制药企业而言，打造一个“超级重磅炸弹”往往意味着十年以上的市场独占期和数百亿美元的现金流，这足以支撑企业后续研发管线布局和长期发展战略。2. 治疗领域分布呈现“三足鼎立”格局分析50强产品的治疗领域分布，可以清晰看出肿瘤、自身免疫性疾病和代谢性疾病（以糖尿病为主）构成三大支柱领域。肿瘤领域产品数量最多、收入规模最大，包括Keytruda、Opdivo、Imbruvica、Darzalex等多款产品，反映了全球癌症发病率的持续上升和肿瘤免疫治疗的革命性突破。自身免疫性疾病领域以Humira为标杆，Stelara、Enbrel、Cosentyx、Skyrizi等后续产品接力，显示出该领域持续的产品迭代和市场需求。代谢性疾病领域虽然单品收入规模相对较小，但司美格鲁肽的爆发式增长（从2020年35亿美元飙升至2024年293亿美元）以及Jardiance、Trulicity等产品的稳步增长，预示着GLP-1受体激动剂等新机制药物正在重塑糖尿病治疗格局。此外，抗凝血药（Eliquis、Xarelto）、疫苗（Prevnar、Gardasil）、HIV治疗（Biktarvy）、眼科疾病（Eylea）等专科领域也各有代表性产品上榜，形成多元但相对集中的治疗领域分布特征。3. 产品生命周期呈现差异化演进路径对比各产品的年度收入变化曲线，可以发现明显的生命周期差异。传统“重磅炸弹”如Humira、Enbrel、Avastin、Herceptin等，在经历峰值后因专利到期和生物类似药竞争而出现显著下滑，Humira在2023-2024年收入从212亿美元骤降至90亿美元，是典型的专利悬崖效应。而新一代创新药则展现出更强的生命周期管理能力：Keytruda通过持续拓展适应症（从黑色素瘤扩展到非小细胞肺癌、头颈癌等十多个癌种）实现收入线性增长；司美格鲁肽凭借减肥适应症的批准实现指数级增长；Dupixent通过新增哮喘、特应性皮炎等适应症保持强劲增长。更有一些产品如Eliquis、Eylea等通过长期临床数据积累和剂型优化，维持了平稳增长或缓慢下降的态势。这种差异化演进路径表明，现代医药产品的生命周期不仅取决于专利期限，更与企业的临床开发策略、适应症拓展能力、市场准入水平和差异化竞争策略密切相关。4. 企业竞争格局呈现“巨头主导、新锐突破”的双层结构从产品所属企业分析，跨国制药巨头仍然主导全球药品市场。艾伯维（Humira、Skyrizi）、默沙东（Keytruda、Gardasil）、BMS（Eliquis、Opdivo、Revlimid）、强生（Stelara、Darzalex）、罗氏（Avastin、Herceptin、Perjeta）等前十大药企拥有榜单中超过70%的产品。这些企业凭借强大的研发体系、全球商业化网络和资源整合能力，持续推出重磅产品并实现最大化价值。与此同时，一些中小型生物技术公司也展现出突破性创新能力：诺和诺德的司美格鲁肽颠覆了糖尿病和肥胖症治疗格局；Vertex的囊性纤维化三联疗法Trikafta在罕见病领域创造了年销售超百亿美元的奇迹；再生元的Eylea在眼科领域与巨头分庭抗礼。这种“巨头主导、新锐突破”的竞争结构既保证了医药创新的系统性推进，也为颠覆性技术的出现提供了空间。值得注意的是，license-in/out合作模式日益普遍，如BMS/辉瑞共同推广Eliquis、艾伯维/强生合作开发Imbruvica，显示出行业生态的协作化特征。5. 技术创新驱动产品价值层级分化 50强产品清单清晰地反映了不同技术平台的价值创造能力。第一梯队是单克隆抗体（尤其是PD-1/L1抑制剂、TNF-α抑制剂、IL类抑制剂），占据榜单近半数席位，证明了抗体药物在特异性、疗效和商业化方面的综合优势。第二梯队是小分子靶向药（如BTK抑制剂Imbruvica、CDK4/6抑制剂Ibrance、EGFR抑制剂Tagrisso），在肿瘤等疾病领域仍保持重要地位。第三梯队是新兴技术平台产品，如GLP-1受体激动剂（司美格鲁肽）、双特异性抗体（Hemlibra）、ADC药物（虽然未进入前50但增长迅速）、基因疗法等，这些产品虽然当前收入规模有限，但增长速度和临床价值备受瞩目。值得注意的是，同一技术平台内部也出现明显分化：在PD-1抑制剂中，Keytruda凭借更广泛的适应症布局和更优的临床数据，收入规模是Opdivo的近三倍；在GLP-1激动剂中，司美格鲁肽凭借减重适应症的巨大市场空间，迅速超越度拉糖肽等前辈。这种分化表明，技术平台只是基础，具体的分子特性、临床开发策略和商业化执行才是决定产品成败的关键。6. 地域市场与定价策略影响收入格局虽然表格未明确列出地域分布数据，但结合行业知识可知，美国市场贡献了50强产品的大部分收入（通常占50-70%），这得益于美国较高的药品定价、宽松的医保支付体系和强大的患者支付能力。欧洲市场虽然规模较大，但价格控制严格，单品收入贡献相对有限。新兴市场（尤其是中国）虽然增长迅速，但受制于医保谈判和集采政策，对全球收入的贡献比例仍较低。不同产品的定价策略也显著影响其收入表现：罕见病药物如Soliris、Trikafta凭借极高的年治疗费用（通常10-50万美元）实现可观收入；而慢性病药物如胰岛素、降压药虽然患者基数巨大，但单价较低，需要依靠规模效应。近年来，全球范围内医保控费压力增大，美国IRA（通胀削减法案）允许医保对上市9年后的药物进行价格谈判，这将重塑未来的药品定价模式和收入预期。企业需要更加精细化的市场准入策略和生命周期管理能力来应对这一挑战。二、全球医药单品发展趋势分析1. 免疫治疗从肿瘤向自身免疫性疾病等多领域扩展 PD-1/PD-L1抑制剂开启了肿瘤免疫治疗时代，Keytruda和Opdivo的成功证明了免疫调节在癌症治疗中的巨大潜力。当前这一趋势正在向更多疾病领域扩展：在自身免疫性疾病领域，新一代IL-23抑制剂（如Skyrizi、Cosentyx）正在挑战TNF-α抑制剂的传统地位；JAK抑制剂（如Rinvoq、Xeljanz）为类风湿关节炎等疾病提供了口服便捷选择；在皮肤病领域，度普利尤单抗（Dupixent）通过靶向IL-4/IL-13通路，在特应性皮炎和哮喘治疗中取得突破。未来，免疫治疗将进一步细分，针对特定免疫细胞亚群（如Treg、B细胞、巨噬细胞）、免疫检查点（如LAG-3、TIGIT、TIM-3）和细胞因子通路的药物将不断涌现。此外，免疫治疗与其它疗法的联合应用（如免疫+化疗、免疫+靶向、免疫+放疗）将成为标准治疗模式的组成部分，这不仅拓展了现有产品的生命周期，也为新药开发提供了更多可能性。2. 代谢性疾病药物从血糖控制向多适应症拓展以GLP-1受体激动剂为代表的代谢性疾病药物正在经历范式转变。以司美格鲁肽为例，其成功不仅源于优异的降糖效果，更得益于在减重、心血管获益、非酒精性脂肪性肝炎（NASH）、慢性肾病等多适应症中展现的治疗潜力。诺和诺德的SELECT试验证明司美格鲁肽可将心血管事件风险降低20%，这一数据可能使其成为数亿心血管高危患者的基础用药。礼来的替尔泊肽（Mounjaro）在头对头临床试验中显示出优于司美格鲁肽的减重效果，预示着GLP-1/GIP双靶点激动剂可能成为新一代标准。未来代谢性疾病药物的竞争将不再局限于血糖控制，而是扩展到体重管理、心血管保护、器官纤维化改善等多维度临床终点。这种“一药多能”的开发策略不仅扩大了目标患者群体，也提高了产品的临床价值和支付意愿，可能催生比当前肿瘤药物规模更大的超级重磅炸弹。3. 生物制剂持续升级迭代，双抗/ADC等新型抗体药物崛起单克隆抗体作为过去20年最成功的生物药形式，正经历新一轮技术升级。双特异性抗体通过同时结合两个靶点，实现了传统单抗无法达到的治疗效果：罗氏的Hemlibra（艾美赛珠单抗）通过模拟FVIII功能，为血友病A患者提供了首个无需频繁注射的预防治疗选择；强生的Darzalex Faspro（CD38xCD3双抗）在多发性骨髓瘤中显示出深度缓解。抗体偶联药物（ADC）通过“精准化疗”理念，将细胞毒性药物靶向递送至肿瘤细胞，Enhertu（DS-8201）在HER2低表达乳腺癌中的突破性疗效，重新定义了乳腺癌分型和治疗标准。此外，Fc工程化抗体（延长半衰期、增强效应功能）、抗体-细胞因子融合蛋白、PROTAC技术等创新平台也在快速发展。这些新一代生物制剂的共同特点是更高的靶向性、更强的疗效和更好的安全性，但同时也面临更复杂的生产工艺、更高的开发成本和更严格的质量控制要求。4. 慢病管理从治疗向预防和功能改善延伸随着全球人口老龄化和疾病谱变化，慢性疾病管理正从传统的“症状控制”向“预防发病”和“功能改善”延伸。在心血管领域，PCSK9抑制剂（如Repatha、Praluent）通过强效降脂预防心血管事件；SGLT2抑制剂（如Jardiance、Farxiga）在降糖之外展现出明确的心肾保护作用，被多个指南推荐用于心衰和慢性肾病治疗。在神经退行性疾病领域，阿尔茨海默病药物（如Lecanemab）虽然疗效有限，但证明了疾病修饰疗法的可能性；多发性硬化症药物（如Ocrevus）正在从减少复发向促进神经修复探索。在骨质疏松领域，地舒单抗（Prolia）和romosozumab通过不同机制增加骨密度、降低骨折风险。这种转变要求制药企业重新定义临床开发终点：不仅关注传统的生化指标（如血糖、血脂），更要评估长期临床结局（如心血管死亡、终末期肾病、残疾进展）、患者报告结局（生活质量、功能状态）和卫生经济学指标（减少住院、降低护理负担）。5. 数字化和真实世界证据重塑药品开发与商业化模式数字健康技术正在深度融入医药产品生命周期。在研发阶段，人工智能加速靶点发现、化合物筛选和临床试验设计；可穿戴设备连续收集生理数据，为疗效评估提供更敏感的终点指标。在监管审批阶段，真实世界证据（RWE）作为随机对照试验的补充，帮助加速罕见病和突破性疗法的批准；FDA的Real-World Evidence Program已接受RWE用于支持新适应症批准和标签更新。在商业化阶段，数字疗法（DTx）与药物联合使用提高患者依从性和疗效；基于大数据的精准营销帮助识别最有需求的患者群体。以司美格鲁肽为例，其配套的数字健康工具（如诺和诺德的APP）帮助患者记录饮食、运动和用药情况，形成“药物+服务”的完整解决方案。未来，医药企业需要建立数字化能力，将传统制药与数字健康融合，创造更具个性化的疾病管理方案。这不仅会改变产品形态（从单一分子到组合解决方案），也会改变商业模式（从销售药品到提供健康结果）。6. 全球化与本土化并存，新兴市场重要性提升虽然美国仍将是全球最大的药品市场，但新兴市场（尤其是中国）的增长速度和战略重要性显著提升。中国药品市场规模已位居全球第二，并且以每年5-10%的速度增长。这种变化带来双重影响：一方面，跨国药企加速将创新药引入中国市场，从以往滞后5-10年上市缩短至与全球同步（如PD-1抑制剂、奥希替尼等）；另一方面，中国本土生物医药企业快速崛起，通过license-out将创新产品授权给跨国企业（如传奇生物的CAR-T、百济神州的泽布替尼），实现“出海”突破。全球医药市场正在形成“美国主导创新、欧洲贡献科学、中国提供增长和部分创新”的新格局。然而，不同市场的支付能力、监管要求和临床实践差异巨大，企业需要制定差异化的市场准入策略：在发达国家市场追求高价和高价值，在中等收入国家探索分级定价，在低收入国家寻求人道主义访问计划。这种复杂的全球化运营能力将成为制药企业的核心竞争力之一。三、对中国生物医药企业的启示1. 构建差异化创新管线，避免同质化竞争中国生物医药行业在过去十年经历了快速发展，但也暴露出严重的同质化问题。以PD-1抑制剂为例，国内已有十余个产品上市，虽然满足了临床可及性需求，但多数产品缺乏显著差异化，导致激烈的价格竞争和有限的市场回报。从全球50强产品的发展经验看，真正的重磅炸弹都具备明确的差异化优势：或针对未满足的临床需求（如囊性纤维化、血友病），或具有显著的疗效优势（如Keytruda在多个癌种的一线治疗地位），或提供独特的给药便利性（如长效制剂、口服剂型）。中国药企应深入分析疾病生物学、患者细分需求和治疗模式演进，寻找差异化的创新机会。例如，在肿瘤领域，除了热门的PD-1/L1靶点，可关注肿瘤微环境调节、癌症代谢、表观遗传调控等新兴方向；在自免疾病领域，可开发更精准的免疫调节剂，减少感染风险；在慢病领域，可结合中国人群遗传和疾病特征，开发适合国人的治疗方案。差异化不仅体现在靶点选择，也体现在分子设计（如双抗、ADC、PROTAC等新形式）、适应症策略（聚焦特定患者亚群）和临床开发计划（采用创新终点、富集人群设计）。2. 建立科学驱动的临床开发能力，提高研发成功率全球创新药的研发成功率仅为10%左右，而中国药企的研发效率更低。提高研发成功率需要建立科学驱动的临床开发体系。首先，加强转化医学研究，深入理解疾病生物学和药物作用机制，利用生物标志物筛选最可能获益的患者群体。Keytruda的成功很大程度上归功于PD-L1表达、TMB等生物标志物的应用，实现了精准的患者分层。其次，优化临床试验设计，采用适应性设计、篮子试验、伞式试验等创新方法，提高开发效率。再生元的Eylea通过精心的临床试验计划，在湿性AMD、糖尿病黄斑水肿、视网膜静脉阻塞等多个适应症中获批，最大化产品价值。第三，注重早期临床数据质量，建立严格的临床药理学研究（PK/PD、剂量探索），为后期试验奠定基础。中国药企在临床开发上常犯的错误包括：剂量选择缺乏科学依据、患者入组标准过于宽泛、终点指标选择不合理、对照组设置不恰当等。这些缺陷导致临床试验结果难以支持监管批准和市场成功。建立内部临床开发专家团队，与顶尖学术机构合作，利用真实世界数据指导开发决策，是提升临床开发能力的关键。3. 加强全球知识产权布局和生命周期管理医药创新是高投入、高风险、长周期的活动，知识产权保护是保障投资回报的核心机制。全球50强产品都建立了严密的知识产权壁垒，包括化合物专利、制剂专利、使用方法专利、生产工艺专利等，形成多层次的保护网。中国药企在知识产权方面存在明显短板：一方面，原始创新能力不足，多数创新属于跟随式创新（fast-follower），专利质量不高，国际布局有限；另一方面，知识产权保护意识薄弱，商业秘密泄露、专利无效风险较高。未来，中国药企应从研发早期就进行全球专利布局，不仅要申请中国专利，更要覆盖美国、欧洲、日本等主要市场。在专利撰写时，要考虑尽可能宽的保护范围，同时避免被无效的风险。除了专利保护，还应综合运用数据独占期、市场独占期、孤儿药认定、突破性疗法认定等监管保护措施。在生命周期管理上，应提前规划适应症拓展、剂型改进、组合疗法、生物类似药应对等策略。以Humira为例，虽然最终面临专利悬崖，但艾伯维通过剂型改进（ citrate-free formulation）、新适应症拓展、直接与生物类似药签订市场协议等方式，将产品峰值延长了多年，为公司下一代产品（Skyrizi、Rinvoq）的成长赢得了宝贵时间。4. 建立国际化商业化能力，拓展全球市场中国药品市场规模虽大，但仅占全球的约10-15%，且面临医保控费和集采压力。要实现创新药的价值最大化，必须走向国际市场。全球50强产品的收入绝大部分来自海外市场，尤其是美国、欧洲和日本。中国药企的国际化可采取渐进式路径：首先，通过license-out将产品授权给跨国药企，借助合作伙伴的全球网络实现商业化（如百济神州与诺华合作推广替雷利珠单抗）。这种模式可降低自身风险，快速获得现金流，但价值分享有限。其次，在重点市场建立自营团队，如在美国、欧洲设立子公司，直接负责产品注册和商业化（如传奇生物的CAR-T产品由强生合作推广，但公司积极参与）。这种模式需要大量资金投入和国际化人才，但长期回报更高。第三，针对不同市场特点制定差异化策略：在美国市场注重临床价值和价格博弈，在欧洲市场关注卫生经济学和医保谈判，在新兴市场探索可及性创新和本地化生产。无论选择哪种路径，都需要建立国际化的专业团队，包括注册事务、市场准入、医学事务、市场营销、渠道管理等职能。同时，要深入了解当地法规环境、医疗体系、竞争格局和患者需求，避免简单复制中国经验。5. 探索多元合作模式，构建开放创新生态现代医药创新越来越依赖于多元化的合作网络。全球50强产品中，超过三分之一是通过合作开发或授权引进方式诞生的，如Eliquis（BMS/辉瑞合作）、Imbruvica（Pharmacyclics开发，艾伯维/强生商业化）、Eylea（再生元研发，拜耳商业化）等。中国生物医药产业处于发展初期，更应积极构建开放创新生态。首先，加强与学术机构的基础研究合作，早期介入有潜力的科学发现。中国拥有众多高水平科研院所和临床中心，但在成果转化效率上仍有提升空间。药企可通过设立联合实验室、博士后项目、研究基金等方式，深度绑定学术资源。其次，与生物技术公司建立灵活的合作伙伴关系，通过license-in引进早期或临床阶段产品，补充自身管线。再鼎医药的成功证明了license-in模式在中国市场的可行性，但需要专业的评估能力和交易执行能力。第三，与跨国药企开展对等合作，不仅作为技术输出方，也可作为技术引进方。例如，中国药企在某些领域（如细胞治疗、基因编辑、ADC技术）已具备全球竞争力，可通过技术授权或共同开发方式与跨国公司合作。第四，与供应链伙伴、数字化企业、医疗服务机构等形成产业联盟，共同构建疾病管理解决方案。在资本层面，可通过产业基金投资早期创新项目，既获得财务回报，也保持技术前瞻性。6. 关注卫生经济学和价值医疗，重塑市场准入策略随着全球医保支付压力增大，药品的市场成功不再仅仅取决于临床疗效，更取决于其卫生经济学价值。美国虽然药品价格较高，但保险公司和PBM（药品福利管理公司）日益注重成本效益分析；欧洲则一直实行严格的卫生技术评估（HTA）；中国的医保谈判和集采更是将价格压力推到极致。中国药企在创新药定价和市场准入上面临双重挑战：一方面，研发成本高昂，需要合理价格回收投资；另一方面，医保基金有限，需要证明产品的“性价比”。解决这一矛盾需要重塑市场准入策略：首先，从研发早期就引入卫生经济学考量，在临床试验中收集生活质量、医疗资源利用等数据，为后续的价格谈判提供证据。其次，开发差异化的价值主张，不仅证明临床疗效优于现有疗法，更要展示其在减少住院、提高生产力、改善长期预后等方面的综合价值。第三，探索基于风险分担的创新支付模式，如按疗效付费、分期付款、年度预算封顶等，减轻医保短期支付压力。第四，建立多元支付体系，在基本医保之外，探索商业健康险、城市定制型商业保险、患者援助计划等补充支付渠道。以司美格鲁肽为例，虽然价格昂贵，但通过证明其降低心血管事件和减重带来的长期健康获益，获得了广泛的医保覆盖和商业保险报销。中国药企需要培养专业的卫生经济学团队和市场准入团队，将价值证明贯穿于产品全生命周期。7. 拥抱数字化转型，提升研发效率和患者服务能力数字技术正在深刻改变医药行业的每一个环节。在研发环节，人工智能可加速靶点识别、分子设计和临床试验患者匹配。英矽智能（Insilico Medicine）等中国AI制药公司已证明，AI可将新药发现时间从4-5年缩短至1-2年。中国药企应积极与AI公司合作，或将AI工具整合到内部研发流程中。在临床开发环节，电子数据采集（EDC）、远程监查、电子患者报告结局（ePRO）等技术可提高试验效率和质量；真实世界数据（RWD）平台可帮助识别临床试验中心、优化入组标准、探索新适应症。在商业化环节，数字化营销工具可帮助精准触达医生和患者，提高营销投入产出比；数字疗法（DTx）与药物联合使用可提高患者依从性和治疗效果。例如，在糖尿病管理中，药物+连续血糖监测+AI决策支持系统的组合方案正在成为新标准。在供应链环节，区块链技术可提高药品追溯能力，防止假药流通；物联网设备可实时监控药品运输条件。中国在数字技术应用方面具有独特优势：庞大的患者群体、丰富的医疗数据、发达的互联网基础设施、活跃的数字化创新生态。药企应积极拥抱这些优势，将数字化能力建设为企业核心竞争力之一。这需要企业进行组织变革，培养兼具医药知识和数字技能的人才，建立数据驱动的决策文化，与科技公司形成战略合作。结论全球医药单品收入50强榜单是一面镜子，既反映了过去十年医药创新的辉煌成就，也揭示了行业发展的内在规律和未来趋势。从这些顶尖产品的成功经验中，中国生物医药企业可以汲取宝贵启示：创新需要差异化，研发需要科学驱动，国际化需要战略耐心，商业化需要价值证明，合作需要开放心态，发展需要数字赋能。当前，中国生物医药产业正处于从“跟随创新”向“源头创新”转型的关键时期。一方面，国内市场竞争加剧，医保控费压力增大，同质化产品面临生存挑战；另一方面，全球医药创新格局正在重构，新技术平台不断涌现，为中国企业提供了弯道超车的机会窗口。那些能够立足中国患者需求、放眼全球市场机遇、坚持科学驱动创新、构建生态合作网络的企业，有望在全球医药创新版图中占据一席之地。展望未来十年，随着中国人口老龄化加速、疾病谱变化、医疗需求升级，医药市场仍将保持增长态势。同时，国家政策持续鼓励创新，资本市场逐步回归理性，产业生态日益完善，为真正具有创新能力的生物医药企业提供了良好发展环境。中国药企应把握历史机遇，借鉴全球经验，结合本土优势，走出一条具有中国特色的医药创新之路，为全球患者贡献更多“中国智慧”和“中国方案”。这不仅关乎企业自身的发展，更关乎健康中国战略的实施和人类健康福祉的提升。文中涉及资料数据均为网上公开信息，如有侵权，请及时联系我们删除。欢迎关注“素舸科技”！

2026-01-07

·bioSeedin柏思荟

平台合作 | 重组人透明质酸酶rHuPH20，“皮下制剂”的开发伴侣

2017年罗氏利妥昔单抗皮下注射剂获FDA批准上市，成为了首款获批上市的用于治疗恶性肿瘤的皮下注射抗体药物。2021年，康宁杰瑞皮下给药的恩沃利单抗获批上市，用于晚期实体瘤成人患者治疗。2025年，第一三共注册了皮下注射的DS-8201治疗转移性实体瘤的一期临床试验。项目推荐重组人透明质酸酶PH20 (rHuPH20) 是一种高度纯化的重组人PH20酶，其氨基酸序列为人类而非动物来源，从而最大限度地降低了动物制剂相关的致敏风险。皮下透明质酸的降解使得单次输注剂量可达 600 mL，从而能够增加皮下给药治疗药物的分散和吸收。本项目在天然序列的基础上完善了糖型调控，开发了标准的生产工艺。相关技术指标达到同行标准，并且在药典法酶活、不同缓冲体系下的中性酶活、以及产物的氨基酸序列完整性等方面具有一定的优势。本项目rHuPH20展现了卓越的序列完整性。质谱对比显示，其主峰纯净，无其他厂商产品中出现的降解或截断现象（C末端-IFY和-FY）；优化工艺获得的rHuPH20唾液酸化程度较竞品低7.9%、半乳糖化程度低5.0%；产品在制剂处方在4℃、 -20 ℃ 、 -80 ℃都能稳定保存，展现了较好的稳定性；通过糖型调控技术和酶活抗干扰筛选方法的协同创新，筛选出同时具备高表达量、优质糖型以及强抗干扰能力rHuPH20的优质细胞株，并配套开发了适配的高效上下游生产工艺。皮下注射传统抗体药物主要通过静脉注射 (IV) 给药，这一方式虽然能够实现药物的快速起效，但存在诸多局限性。静脉注射通常需要 30-60 分钟完成给药，患者需要前往医疗机构接受治疗，增加了就医负担和感染风险。更为重要的是，静脉注射可能导致严重的输注反应，如过敏、低血压、支气管痉挛等，这些不良反应的发生率在某些抗体药物中高达 40% 以上。皮下注射（SC）在多种治疗领域中应用广泛，在糖尿病领域，胰岛素皮下注射已应用超过50年。在抗体药领域作为一种替代给药方式，正经历着从 "辅助选择" 到 "主流趋势" 的根本性转变。皮下注射的优势在于能够显著改善患者体验，给药时间从数小时缩短至 5-10 分钟，患者可以在医生指导下进行自我给药，大大提高了治疗的便利性和依从性。以曲妥珠抗单抗为例，乳腺癌患者接受传统静脉输注剂型需要每3周到医院治疗1次，每次给药30~90分钟，而其皮下注射剂只需2~5分钟就可以完成治疗。用于治疗血液瘤和自免疾病的CD20抗体利妥昔单抗静脉注射的输注时间长达2.5小时，而其皮下注射剂仅需5分钟就能完成给药。皮下注射抗体部分统计另外皮下注射吸收缓慢，血药浓度峰值较低，可降低与输注相关的全身性不良反应（如细胞因子释放综合征、过敏样反应）的发生率和严重程度。最常见的不良反应是注射部位反应（如红肿、疼痛、瘙痒），这些反应通常是轻度、短暂的，易于管理。另外皮下注射能提供更持久、更平稳的血药浓度，减少峰谷波动，可能对维持疗效有积极意义。从数据上看，自2014年以来，随着FDA批准抗体药物数量的增加，抗体药皮下制剂的数量也显著增加。截至2024年，FDA批准上市抗体药的给药方式中，皮下注射（SC）是静脉注射（IV）后第二大给药方式，占比超30%（27款）。在FDA批准的超过34种高浓度抗体药物中，皮下注射剂型占比最多（约占76%）。随着抗体药物研发的成熟，部分成熟的治疗药物正从“疗效”开始兼顾“简单”治疗。有皮下注射版本的药物相对同样的静脉注射项目其销售开始超越静脉注射成为患者的主流选择。参考DARZALEX的皮下注射版（SC），其占总销售（SC+静脉注射IV）的比例从2020年Q4的 45% 飙升至2024年的 94% ，2023年已达 90% ，皮下注射已成为该药物的主流给药方式。IV剂型：年销售额不足20亿美元，SC剂型上市后第一季度销售额突破25亿美元。拉开了使用透明质酸酶皮下注射(SC)形式“黄金标准”的序幕。 Phesgo的皮下注射转换率从2020年的0%持续提升至2024年上半年（H1）的 41% ，反映皮下注射版本在全球范围内的接受度逐年递增。皮下制剂通常皮下给药最大注射量约为1-2 mL，超过2毫升的剂量会导致组织变形和疼痛。同时由于SC的生物利用度小于静脉（IV）给药，要想达到和静脉注射制剂相同的疗效，抗体药物皮下注射往往需要更大的给药量。但受限于单次皮下注射量，常规采用多次注射的方式，但多次皮下注射的替代方案相应的更加耗时，对患者和医疗保健提供者来说都不方便，对患者来说可能更加痛苦，并且会降低不同给药时治疗血清水平的可重复性。因此皮下注射大多需要制备高浓度的蛋白制剂，而高浓度蛋白溶液则往往会带来稳定性差、高粘度、蛋白溶解度、蛋白降解和聚集等问题。对于部分制备高浓度制剂比较困难的药物还可以通过扩大给药量的方式，例如使用重组人透明质酸酶制备复合制剂，来增加组织渗透和吸收，增大单次注射量，并适配更多类型的抗体药物的皮下制剂开发。采用rHuPH20的部分皮下制剂透明质酸与透明质酸酶透明质酸（HA）是由N-乙酰葡糖胺和D-葡萄糖醛酸组成的双糖单位糖胺聚糖，存在于脊椎动物的大多数组织和体液中，在结缔组织的细胞外基质中含量最多。在皮肤组织中，HA填充了胶原基质内的间质空间，并作为一个物理屏障，阻止大量液体在皮下空间流动，具有较高的液体排除容积。透明质酸会随着正常的生理功能被分解和补充，半衰期为15-20小时。在常规皮下注射给药时限制了大容量SC给药、分散和吸收，因此可以暂时破坏其结构以优化皮下药物递送。透明质酸酶（rHuPH20）是一种能够降解透明质酸的酶，通过降解透明质酸来降低细胞间质的粘性和阻力，促进药物的快速扩散和吸收，突破在皮下2 mL给药量的限制，显著增加皮下给药的最大注射量（如10-15 mL）。这不仅使得抗体相关药物可以通过皮下注射的方式快速进入体内，大大缩短给药时间，同时还可降低给药频率。 rHuPH20作用机理利妥昔单抗皮下注射液（不含rHuPH20，左图；含rHuPH20，右图）在人微血管内皮细胞培养中，rHuPH20不会引起炎症反应。动物研究表明，重复给药后未出现局部不良反应或心电图、血流动力学、临床或解剖学改变。此外，rHuPH20诱导的细胞外基质变化是局部的、可逆的和短暂的。酶解产生的透明质酸片段会被组织中的其他酶进一步代谢，同时机体也会合成新的透明质酸来修复被降解的部分，通常在24-48小时即可在皮肤下恢复。使用透明质酸酶的皮下给药也能够实现与静脉给药相当的药物暴露水平。在纳武利尤单抗的 CheckMate-67T 研究中，皮下给药组的药代动力学参数不仅达到了非劣效性标准，在某些指标上甚至表现出更好的稳定性。阿替利珠单抗的 IMscin001 研究提供了更详细的药代动力学数据。皮下制剂 (1875mg) 的首周期血药浓度达到 89mg/mL，而静脉制剂 (1200mg) 为 85mg/mL，显示出良好的暴露水平。这种剂量差异的设计是为了补偿皮下给药可能存在的生物利用度差异，确保两种给药方式能够达到相似的治疗效果。临床参考皮下利妥昔单抗利妥昔单抗为罗氏与渤健合作开发的一款 CD 20 单克隆抗体，其静脉注射剂型于 1997 年 11 月在美国获批上市，商品名为 MabThera，用于治疗弥漫性大 B 细胞淋巴瘤（DLBCL）。该剂型于 2000 年在中国获批上市。利妥昔单抗「皮下注射液」是罗氏利用 Halozyme Therapeutics 的 Enhanze 技术开发的一款剂型创新产品，于 2014 年 3 月在欧盟首次获批上市，商品名为 MabThera sc。除了 MabThera sc 以外，罗氏还利用 Enhanze 技术（Halozyme 基于重组人透明质酸酶 PH 20（rHuPH 20）开发的药物递送技术平台）开发了曲妥珠单抗和帕妥珠单抗/曲妥珠单抗复方的皮下注射制剂，前者（Herceptin SC）于 2013 年 9 月在欧盟首次上市，后者（Phesgo）于 2020 年 6 月在美国首次上市。滤泡性淋巴瘤（FL）的III期研究 —— SABRINA研究设计：初治FL患者，接受R-CHOP方案（利妥昔单抗+化疗）诱导治疗。患者被随机分到皮下注射组（固定剂量1400mg）或静脉输注组（按体表面积375 mg/m²）。达到缓解的患者继续接受相同方案的利妥昔单抗维持治疗。 CR率：皮下组为 45.7%，静脉组为 48.6%。统计学证实皮下注射非劣效于静脉输注。客观缓解率（ORR）：两组相似（皮下 81.3% vs. 静脉 84.6%）。药代动力学：皮下组的血清谷浓度在整个诱导和维持治疗期间均不低于静脉组，为疗效等效提供了药学基础。长期随访（PFS）：两组的无进展生存期曲线高度重叠，长期疗效无差异。弥漫大B细胞淋巴瘤（DLBCL）的III期研究 —— MabEase研究设计：初治DLBCL患者，接受R-CHOP方案。主要终点：治疗结束时的总缓解率（ORR），皮下组与静脉组无显著差异。长期生存：两组的2年无进展生存率（PFS）和总生存率（OS）均无统计学差异，再次证实了在侵袭性淋巴瘤中的疗效等效性。皮下与静脉剂型的总体不良事件发生率、严重不良事件发生率和3-5级不良事件发生率均相似。差异主要体现在给药途径相关反应上。相似的安全性问题（与药物作用机制相关）血液学毒性：如中性粒细胞减少、血小板减少、贫血的发生率相似（主要由联合的化疗引起）。感染：两组发生率无显著差异。心脏事件、乙型肝炎再激活等已知风险的发生率相近。不同的安全性特征静脉输注组更常见：输注相关反应：尤其是在首次输注时。这是利妥昔单抗静脉给药最典型的不良反应，包括发热、寒战、恶心、呼吸困难等。静脉组的发生率显著高于皮下组。皮下注射组更常见：注射部位反应：这是皮下给药最主要的不良反应，包括疼痛、红斑、硬结、瘙痒。发生特点：绝大多数为轻度至中度（1-2级），持续时间短（通常数分钟至数天），随着治疗次数增加，发生率会下降。严重反应罕见。全身性给药相关反应：尽管总发生率低于静脉组，但皮下给药后也可能发生轻至中度的全身性反应（如疲劳、皮疹、咽喉刺激等），通常可控。皮下曲妥珠单抗皮下曲妥珠单抗最早于2013年获欧盟获批上市，2019年获美国FDA批准，2022年获中国NMPA批准。 HannaH研究（III期）设计：新辅助（术前）治疗+辅助（术后）治疗。患者被随机分为两组：一组接受固定剂量（600mg）皮下注射，另一组接受按体重（8mg/kg负荷量→6mg/kg维持）静脉输注。两组均联合化疗。主要终点：病理完全缓解率（pCR）。结果： pCR率：皮下组为 45.4%，静脉组为 40.7%。统计学结论：皮下注射的疗效非劣效于静脉输注。长期随访（5年无病生存期DFS和总生存期OS）：两组无显著差异，进一步证实了长期疗效的等效性。 PrefHer研究（患者偏好研究）及后续分析设计：主要评估患者偏好。患者在辅助治疗阶段交叉接受皮下和静脉注射，然后表达偏好。疗效结果：两组的3年无病生存率（DFS）高度相似（皮下 vs. 静脉：90.3% vs. 88.8%），再次支持疗效等效。行业进展 Halozyme Therapeutics 在透明质酸酶市场中占据绝对主导地位，这种优势地位建立在其强大的技术平台和广泛的合作伙伴网络之上。公司的 Enhanze 技术平台已经成功应用于 7 种单克隆抗体的皮下制剂开发，包括罗氏的 Tecentriq、强生的 Darzalex Faspro、罗氏的 Phesgo 等重磅产品。 Halozyme 的商业模式独具特色，公司本身并不直接生产和销售最终的药物产品，而是通过向制药企业授权 Enhanze 技术来获取收入。这种轻资产模式使得公司能够专注于技术创新，同时通过与多家大型制药企业的合作实现风险分散。目前，Halozyme 已经与罗氏、辉瑞、强生、艾伯维、礼来、阿斯利康、BMS、Alexion 和 Argenx 等全球领先制药企业建立了合作关系。财务表现方面，Halozyme 展现出强劲的增长势头。2024 年第四季度，公司收入达到 2.98 亿美元，相比 2023 年同期的 2.30 亿美元增长了 29.6%。公司预计 2025 年的特许权使用费收入将继续增长，并预测到 2027 年总特许权使用费收入将达到 10 亿美元。目前Halozyme最主要的问题就是其专利到期问题，公司的核心 Enhanze 专利将于 2027 年在美国到期，2029 年在欧洲到期。总结从临床证据看，已上市的含透明质酸酶皮下制剂在多个治疗领域都显示出与静脉制剂相当的疗效，同时在安全性和患者体验方面有显著改善。特别是在降低输注反应、提高治疗依从性、改善生活质量等方面，皮下给药展现出独特优势。患者偏好研究显示，超过 90% 的患者更愿意选择皮下给药。单看利妥昔单抗和曲妥珠单抗的患者用药偏好性调查结果显示，超75%的患者在静注给药和皮下给药中选择了皮下给药的方式，理由均为更短的给药时间。从市场规模来看，该领域的增长前景十分乐观。根据多家机构的预测，全球透明质酸酶市场将在未来 5-7 年内保持 10% 以上的年复合增长率。特别是在肿瘤免疫治疗和 ADC 药物领域，随着更多产品的获批上市，市场需求将呈现爆发式增长。中国市场的增长潜力尤为突出，预计将成为全球增长最快的市场之一。根据市场预测，中国透明质酸酶市场规模将从 2025 年的 78.6 亿元人民币增长到 2030 年的 145.3 亿元，年复合增长率达到 13.1%。同时，在已上市注射剂的基础上，进一步开发皮下给药剂型也可以帮助企业通过对新剂型专利的保护进一步延长药物的生命周期。注：资料转载自各大公司官网、公开信息源。版权归原作者所有，仅供读者学习、研究或者欣赏，不得用于商业用途，如涉及作品内容、版权和其他问题，请在30日内联系删除；本公众号对转载、分享的内容、陈述、观点判断保持中立，不对所包含内容的真实可靠性或完善性提供任何明示或暗示的保证，仅供读者学习、参考。本文仅为行业分析，不构成投资建议。股市有风险，投资需谨慎。欢迎BD、研发小伙伴添加小助手进交流群（请注明姓名+公司） ▲扫描小程序码报名观看 ▲点击图片链接查看详情 ▲点击图片链接查看详情 ↑点击图片长按识别二维码跳转相关链接

上市批准

2026-01-06

·BioSpace

Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma

Novel immunotherapy combination regimen brings together two complementary therapies to improve outcomes for people living with multiple myeloma as early as second line 1 The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement in progression-free and overall survival compared to standard treatment 1 Beerse, Belgium, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI ® ▼(teclistamab) in combination with DARZALEX ® subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. The combination of teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38 to prime and activate the immune system, supporting the potential to improve patient outcomes by enhancing immune-mediated response earlier in the treatment journey. 1 “There remains a critical need for off-the-shelf treatment options that can achieve deep and durable responses at second line, when immune function is better preserved,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson Innovative Medicine. “Teclistamab and daratumumab SC is the first off-the-shelf immunotherapy combination to demonstrate significant improvements in progression-free and overall survival in relapsed/refractory multiple myeloma as early as second-line treatment, compared to current standards of care.” The submission is supported by data from the Phase 3 MajesTEC-3 study. The study enrolled 587 patients across two treatment arms: teclistamab and daratumumab SC versus daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd). 1 Results show an 83.4 percent reduction in the risk of disease progression or death compared to standard regimens at nearly three years follow-up (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P <0.0001). 1 ,2 More than 90 percent of patients who remained progression-free at six months (n=249) remained progression-free at three years. 1 In the study, teclistamab plus daratumumab SC and standard of care comparators had similar rates of Grade 3/4 treatment-emergent adverse events (TEAE) (95.1 percent vs. 96.6 percent). 1 Most common Grade 3/4 events were cytopenia and infection. 1 Infections were observed with teclistamab and daratumumab SC (any grade, 96.5 percent; Grade 3/4, 54.1 percent) and DPd/DVd comparator (any grade, 84.1 percent; Grade 3/4, 43.4 percent). 1 Based on the statistical significance of the results, the Independent Data Monitoring Committee (IDMC) recommended unblinding of the study. 3 Data from the MajesTEC-3 study were recently presented as a late-breaking oral presentation at the 2025 American Society of Hematology (ASH) Annual Meeting, with simultaneous publication in The New England Journal of Medicine . 1,2 Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) for the use of teclistamab and daratumumab SC in combination as a treatment for RRMM to the U.S. Food and Drug Administration (FDA). The FDA has granted Breakthrough Therapy Designation for the combination regimen, which allows for expediting the development and regulatory review of a medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement over available therapies on a clinically significant endpoint(s). “Johnson & Johnson is committed to redefining what’s possible in multiple myeloma. An integral part of this strategy involves using the right medicines as early as possible and combining and sequencing them to achieve the best outcomes,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “Today’s submission to the EMA reinforces this approach. Daratumumab has become a cornerstone of care for patients with newly diagnosed multiple myeloma, and by combining it with teclistamab, we see the potential to advance outcomes for relapsed patients as early as second line.” About the MajesTEC-3 Study MajesTEC-3 ( NCT05083169 ) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab subcutaneous (SC) and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy. 1,4 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety. 4 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 4 About Teclistamab Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. 5 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 6 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 7 ,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. Teclistamab is currently being evaluated in several combination studies. 4,7,9,10,11 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: .▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. 7 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide. 12 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 13 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 13 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 13 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 13 Daratumumab may also have an effect on normal cells. 13 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 14,15,16,17,18,19,20,21,22,23 For further information on daratumumab, please see the Summary of Product Characteristics at: About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 24 ,25 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 24,25 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died. 26 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 27,28,29 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 30 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Key Search Terms MajesTEC-3 Phase 3 clinical trial TECVAYLI Teclistamab DARZALEX Daratumumab Teclistamab and daratumumab combination TECVAYLI and DARZALEX combination Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second-line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy CD38-targeted therapy BCMA-targeted bispecific therapy Combination immunotherapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment [1] Mateos M-V, et al. Phase 3 Randomized Study of Teclistamab plus Daratumumab Versus Investigator’s Choice of Daratumumab and Dexamethasone with either Pomalidomide or Bortezomib (DPd/DVd) in patients (pts) with Relapsed Refractory Multiple Myeloma (RRMM): Results of the MajesTEC-3 Study. Oral Presentation #06. American Society of Hematology (ASH) Annual Meeting; 06-09 December, 2025. [2] Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine. 2025; Full article and supplementary material. Available at: . Last accessed: January 2026. [3] Johnson&Johnson.com. TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care. Available at: . Last accessed: January 2026. [4] ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: January 2026. [5] Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: . Last accessed: January 2026. [6] Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: . Last accessed: January 2026. [7] European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: January 2026. [8] Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022;287(6):494-505. [9] ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: January 2026. [10] ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: January 2026. [11] ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: . Last accessed: January 2026. [12] J&J Data on File (RF-452129). Number of Patients Treated with DARZALEX Worldwide as of December 2024. [13] Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: January 2026. [14] Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. [15] Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115. [16] Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. [17] Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. [18] Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. [19] Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. [20] Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. [21] Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. [22] Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. [23] Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313. [24] Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. [25] American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: . Last accessed: January 2026. [26] ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: $0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27 . Last accessed: January 2026. [27] Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. [28] Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. [29] Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. [30] American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: January 2026. CP-553511 December 2025 CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@its.jnj.com

临床3期临床结果上市批准突破性疗法引进/卖出

100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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
阴燃多发性骨髓瘤	美国	Johnson & Johnson	2025-11-06
阴燃多发性骨髓瘤	美国	Janssen Biotech, Inc.	2025-11-06
免疫球蛋白轻链淀粉样变性	美国	Janssen Biotech, Inc.	2021-01-15
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2020-05-01
难治性多发性骨髓瘤	澳大利亚	Janssen-Cilag Pty Ltd.	2017-07-17
复发性多发性骨髓瘤	澳大利亚	Janssen-Cilag Pty Ltd.	2017-07-17

未上市

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适应症	最高研发状态	国家/地区	公司	日期
意义不明的单克隆丙种球蛋白病	临床2期	美国	Janssen LP	2025-09-26
前体T淋巴细胞白血病淋巴瘤	临床2期	美国	Janssen LP	2023-05-25
残留肿瘤	临床2期	美国	Janssen LP	2023-05-25
急性髓性白血病	临床1期	美国	Janssen Research & Development LLC	2024-09-19
成人急性淋巴细胞白血病	临床1期	美国	Janssen Research & Development LLC	2024-09-19
再生障碍性贫血	临床1期	美国	Janssen Research & Development LLC	2024-09-19
骨髓移植排斥反应	临床1期	美国	Janssen Research & Development LLC	2024-09-19
慢性粒细胞性白血病	临床1期	美国	Janssen Research & Development LLC	2024-09-19
霍奇金淋巴瘤	临床1期	美国	Janssen Research & Development LLC	2024-09-19
骨髓增生异常综合征	临床1期	美国	Janssen Research & Development LLC	2024-09-19

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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


NCT05083169 (MajesTEC-3, ASH2025) 人工标引	临床3期	难治性多发性骨髓瘤	587	Teclistamab + Daratumumab	構觸製蓋壓廠築窪鑰襯(網築鹹憲壓繭繭觸夢鑰) = 憲觸製獵鏇顧憲鹽膚鏇夢選鹽鏇憲構觸醖憲獵 (築構艱獵醖餘網鏇餘鏇 ) 更多	积极	2025-12-09
				Daratumumab + Dexamethasone + either Pomalidomide or Bortezomib	構觸製蓋壓廠築窪鑰襯(網築鹹憲壓繭繭觸夢鑰) = 襯窪餘醖網遞憲遞餘壓夢選鹽鏇憲構觸醖憲獵 (築構艱獵醖餘網鏇餘鏇 ) 更多
NCT05511428 (CTgov)	临床4期	多发性骨髓瘤	20	Interview+Daratumumab and Hyaluronidase-fihj	糧簾壓壓襯艱繭選願築(廠選製製範艱醖壓鏇選) = 衊簾憲淵齋鑰顧積醖遞鏇廠製淵壓鑰餘鹹窪積 (鏇築顧願鬱鬱廠簾繭鑰, 10.5) 更多	-	2025-11-21
NCT05083169 (MajesTEC-3, Company_Website) 人工标引	临床3期	多发性骨髓瘤二线 \| 末线 \| 三线	-	Daratumumab Injection（Subcutaneous Injection）+Teclistamab	衊鬱齋壓憲鏇蓋醖餘齋(觸醖簾顧壓簾衊觸鏇範) = Reaching the endpoint 鑰憲壓製製夢鑰窪蓋膚 (願鹹醖壓範鏇製觸築憲 ) 达到更多	积极	2025-10-16
				standard of care
NCT03652064 (CEPHEUS, ASCO2025) 人工标引	临床3期	多发性骨髓瘤一线 HRCA del(17p) \| HRCA t(4;14) \| HRCA t(14;16) ... 更多	395	Daratumumab + bortezomib + lenalidomide + dexamethasone (HiR)	淵壓鹽繭築衊鹹鹹艱繭(觸獵窪齋願窪蓋簾糧淵) = 積範選廠齋範鹹獵選顧鹹網淵廠衊蓋壓餘夢鏇 (夢範遞積鏇繭餘艱繭艱 ) 更多	积极	2025-05-30
				Bortezomib + lenalidomide + dexamethasone (HiR)	淵壓鹽繭築衊鹹鹹艱繭(觸獵窪齋願窪蓋簾糧淵) = 蓋窪選繭憲簾艱願膚繭鹹網淵廠衊蓋壓餘夢鏇 (夢範遞積鏇繭餘艱繭艱 ) 更多
NCT03710603 (PERSEUS, ASCO2025 \| PRNewswire) 人工标引	临床3期	多发性骨髓瘤一线	709	daratumumab+bortezomib+lenalidomide+dexamethasone (Achieved sustained (≥12 mo) MRD neg (10^-5))	壓獵壓製窪壓製製觸遞(餘艱網選網積簾廠鬱夢) = 艱願鹹艱蓋膚鏇艱鬱範膚襯製鑰選憲構衊網鏇 (選鬱夢簾範膚遞遞齋淵, NE ~ NE) 更多	积极	2025-05-30
				bortezomib+lenalidomide+dexamethasone (Achieved sustained (≥12 mo) MRD neg (10^5))	壓獵壓製窪壓製製觸遞(餘艱網選網積簾廠鬱夢) = 窪衊夢觸淵鏇築膚餘範膚襯製鑰選憲構衊網鏇 (選鬱夢簾範膚遞遞齋淵, NE ~ NE) 更多
NCT03710603 (PERSEUS, CTgov)	临床3期	多发性骨髓瘤	709	Lenalidomide+VELCADE+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	遞憲觸網鬱觸簾艱觸積 = 壓網鬱築鹽選顧範網鏇襯觸醖蓋積遞襯壓糧觸 (醖構網鬱簾糧築衊衊鹽, 夢憲簾淵製繭遞網鏇願 ~ 遞糧窪範範艱廠簾遞遞) 更多	-	2024-12-24
				Lenalidomide+Daratumumab+VELCADE+dexamethasone (Daratumumab + VRd (D-VRd))	遞憲觸網鬱觸簾艱觸積 = 範蓋夢壓醖鏇選齋鬱壓襯觸醖蓋積遞襯壓糧觸 (醖構網鬱簾糧築衊衊鹽, 齋艱醖膚網製憲鑰鹹製 ~ 範夢窪鑰襯遞膚餘簾窪) 更多
NCT03201965 (Andromeda, ASH2024 \| EINPresswire) 人工标引	临床3期	免疫球蛋白轻链淀粉样变性一线	388	Daratumumab (DARA) + BortezomibBortezomib, CyclophosphamideCyclophosphamide+Dexamethasone (VCd)	窪蓋廠襯構願壓製夢蓋(艱鹽壓蓋網廠範窪淵鑰) = 願襯餘糧簾築鬱鏇衊淵齋糧窪壓願獵醖範衊範 (窪蓋繭壓膚築觸範積顧 ) 更多	积极	2024-12-09
				Bortezomib+Cyclophosphamide+Dexamethasone (VCd)	窪蓋廠襯構願壓製夢蓋(艱鹽壓蓋網廠範窪淵鑰) = 艱鹹繭觸夢鹹選願繭鹽齋糧窪壓願獵醖範衊範 (窪蓋繭壓膚築觸範積顧 ) 更多
NCT03652064 (CEPHEUS, PRNewswire) 人工标引	临床3期	多发性骨髓瘤一线	396	DARZALEX FASPRODARZALEX FASPRO® + bortezomib, lenalidomidebortezomib, lenalidomide and dexamethasonedexamethasone (D-VRd)	鏇鹹蓋鹹築網遞製衊願(積壓鹹簾壓遞鹽範顧餘) = 憲蓋醖鹹夢鑰構獵鏇廠餘構鏇簾糧獵窪鏇築觸 (鹹築網鹹廠製鬱鹹遞憲 ) 更多	积极	2024-09-30
				bortezomib, lenalidomidebortezomib, lenalidomide and dexamethasone (VRd)	鏇鹹蓋鹹築網遞製衊願(積壓鹹簾壓遞鹽範顧餘) = 築遞鏇鏇糧餘壓衊夢顧餘構鏇簾糧獵窪鏇築觸 (鹹築網鹹廠製鬱鹹遞憲 ) 更多
NCT03652064 (CEPHEUS, Company_Website) 人工标引	临床3期	多发性骨髓瘤一线	396	DARZALEX FASPRO+bortezomib+ lenalidomide + dexamethasone	製齋餘鹽窪製窪簾餘夢(鏇簾遞醖壓積餘糧餘觸) = 網廠淵淵襯願製憲簾鏇憲鏇窪鹹糧衊鑰齋願鹽 (窪廠網網憲襯繭選廠網 ) 更多	积极	2024-09-27
				Bortezomib+ Lenalidomide+ Dexamethasone	製齋餘鹽窪製窪簾餘夢(鏇簾遞醖壓積餘糧餘觸) = 餘鹹壓憲製糧襯夢齋蓋憲鏇窪鹹糧衊鑰齋願鹽 (窪廠網網憲襯繭選廠網 ) 更多
NCT03412565 (PLEIADES, FDA_CDER) 人工标引	临床2期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	66	DARZALEX FASPRO-Kd	壓衊積餘鹽艱願艱膚簾(齋簾觸齋鹽築鏇構醖襯) = 齋糧網顧鑰築積顧網鑰廠鑰艱廠蓋糧憲獵築壓 (廠餘夢簾醖顧膚廠膚艱, 73.9 ~ 92.5) 更多	积极	2024-07-30