A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol

BLOOD-dose is a multicentre, adaptive, randomized, multidomain platform trial designed to optimize treatment dosing strategies in adult patients with haematological diseases.
The BLOOD-dose core protocol outlines the overall clinical trial design that applies to all included interventions, while domain-specific appendices (DSA) detail the unique characteristics of each domain and specify domain-specific interventions.
New domains will be incorporated over time to address distinct dose-optimization research questions across different haematological conditions and interventions.

开始日期2027-03-01

申办/合作机构

Rigshospitalet

NCT07720843

/ Not yet recruiting临床1期IIT

TAlquetamab and BeLantamab Mafodotin in Relapsed/Refractory Multiple Myeloma (TaBleMM)

This is a Phase 1, open-label dose escalation study evaluating the safety and clinical efficacy of Talquetamab in combination with Belantamab mafodotin for a time-limited interval followed by Belantamab mafodotin and Pomalidomide maintenance.
The study will enroll subjects with Multiple Myeloma that have previously been treated with at least one prior line of therapy and have been treated with IMiDs, proteasome inhibitors, and anti-CD38 therapies either in combination or as single agent and are relapsed or are refractory to, or intolerant of, established therapies with clinical benefit in Multiple Myeloma.
Talquetamab will be administered with step up dosing on day 1, 3, 5 with or without day 7 pending target dose (TD1) of Talquetamab (Tal) in dose level. Two weeks after TD1, patients will enroll on C1D1 of Tal (TD2) with Belantamab (Bela). Tal will subsequently be dosed every two weeks. Bela will be administered every 8 weeks on D1 of odd numbered cycles or until resolution of any ocular toxicities to grade 1 or better. After 6 cycles of induction, patients may transition to Bela/Pom maintenance.

开始日期2026-09-01

申办/合作机构

Montefiore Medical Center

[+1]

NCT07657312

/ Recruiting临床2期IIT

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma

This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CRS and neurologic toxicity (damage to the nervous system which includes the brain, spinal cord, and nerves) are potential risks of treatment with talquetamab and teclistamab. CRS involves a release of a large amount of proteins into the bloodstream causing inflammation. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or affect the lung/liver/kidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function (possible paralysis and/or coma). Infliximab is a drug that prevents the tumor necrosis factor-alpha (TNF-α) from working. TNF-α is a cytokine, or chemical messenger, that helps your immune system produce inflammation. Giving infliximab may work well for the prevention of cytokine release syndrome during treatment with teclistamab or talquetamab in patients with relapsed or refractory multiple myeloma.

开始日期2026-08-01

申办/合作机构

Ohio State University Comprehensive Cancer Center

[+2]

100 项与塔奎妥单抗相关的临床结果

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100 项与塔奎妥单抗相关的转化医学

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100 项与塔奎妥单抗相关的专利（医药）

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140

项与塔奎妥单抗相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Costs per responder for patients with relapsed or refractory multiple myeloma treated with Talquetamab compared with usual care

Article

作者: Mu, Fan ; Patel, Neel ; Yang, Chelsey ; Jiao, Tianze ; Liu, Yi-Hsuan ; Wang, Jiamin ; Grajales-Cruz, Ariel F. ; Zhang, Xinke ; Lee, Hans C. ; Goble, Joseph

AIMS:

To evaluate costs per responder for patients with triple-class exposed (TCE) relapsed or refractory multiple myeloma (RRMM) receiving talquetamab (Tal) on weekly (QW) and biweekly (Q2W) dosing schedules, compared with usual care from a United States commercial payer's perspective.

METHODS:

A cost per responder model was developed over a 6-month time horizon, incorporating pre-progression and post-progression costs. For Tal QW and Tal Q2W, pre-progression costs included costs of drug acquisition, inpatient step-up doses (hospitalization, pre-medication, and tocilizumab), outpatient visits, and monitoring. Pre-progression costs for usual care were estimated based on a weighted average of the 10 most used regimens in a real-world LocoMMotion/MoMMent study, including costs of acquisition, administration, co-medication, and monitoring. Post-progression costs included subsequent treatment for a subset of patients and terminal care costs prior to death. All costs were reported in 2025 United States Dollars. Clinical data of overall response rate (ORR), progression-free survival, and overall survival were obtained from an indirect treatment comparison using MonumenTAL-1 (September 2024 data cut) and LocoMMotion/MoMMent (October 2022 and August 2023 data cuts) as data sources. Deterministic sensitivity analyses and scenario analyses were conducted to assess the robustness of model results.

RESULTS:

Over the 6-month period, the total cost of care was $179,556 for usual care, $295,993 for Tal QW, and $315,135 for Tal Q2W. Despite higher costs, Tal demonstrated superior ORR, resulting in lower cost per responder: $575,962 for usual care, $405,470 for Tal QW, and $443,165 for Tal Q2W, representing a 23-30% reduction in cost per responder with Tal. Sensitivity and scenario analyses showed consistent findings.

CONCLUSION:

Although Tal QW and Q2W are associated with higher total per-patient costs compared with usual care, they offer improved clinical effectiveness, resulting in lower cost per responder. These findings suggest greater economic value for Tal in the treatment of TCE RRMM.

2026-07-01·BRITISH JOURNAL OF HAEMATOLOGY

Retreatment with talquetamab and pomalidomide in triple‐class– BCMA – GPRC5D refractory myeloma

Article

作者: Galarza Fortuna, Gliceida M. ; Baljevic, Muhamed ; Rahbari, Kian J. ; Dholaria, Bhagirathbhai ; Sborov, Douglas W.

2026-06-01·JCO Oncology Practice

Defining the Rates of Cytokine Release Syndrome Associated With Talquetamab Step-up Doses

Article

作者: Giralt, Sergio ; Mailankody, Sham ; Shah, Gunjan L. ; Mitchell, Aaron ; Modelevsky, Lisa ; Landau, Heather J. ; Tan, Carlyn R. ; Patel, Dhwani ; Korde, Neha ; Firestone, Ross S. ; Hashmi, Hamza ; Hultcrantz, Malin L. ; Chan, Amelia ; Hamadeh, Issam S. ; Scordo, Michael ; Rajeeve, Sridevi ; Wang, Alice X. ; Hassoun, Hani ; Shekarkhand, Tala ; Lesokhin, Alexander M. ; Shah, Urvi A. ; Usmani, Saad Z. ; Maclachlan, Kylee

PURPOSE:

Talquetamab is a G protein–coupled receptor class C group 5 member D T-cell–engaging antibody, approved for relapsed/refractory multiple myeloma (RRMM). In the MonumenTAL-1 clinical trial, cytokine release syndrome (CRS) occurred at a frequency of 77%; however, there was no assessment of CRS rates by step-up dose. The primary objective of this study was to characterize CRS rates after each talquetamab step-up dose in a real-world setting.

METHODS:

Patients with RRMM who completed the talquetamab once a week or once every 2 weeks step-up dosing schedule between September 2023 and November 2024 were identified via the institutional database. CRS rate after each talquetamab step-up dose was compared using the chi-square/Fisher’s exact test. The Kruskal-Wallis test was used to compare difference in median time to the CRS onset. Multivariate logistic regression analysis was performed to identify predictors of CRS.

RESULTS:

Fifty patients completed the talquetamab step-up dosing phase during the study period; CRS occurred at a rate of 80%. Pairwise comparisons revealed significant differences in CRS rates between the fourth dose (4%) and each of step-up dose 1 (28%, P = .014) and 2 (34%, P = .003). The only CRS event with fourth dose was grade 1. The median time to onset of first CRS did not differ significantly between step-up doses ( P = .441). Previous exposure to T-cell–redirecting therapy had no impact on CRS incidence (odds ratio: 0.20 [95% CI, 0.03 to 1.10]).

CONCLUSION:

Our findings suggested that the fourth talquetamab dose could be administered in outpatient settings given its high tolerability. The reduced hospitalization period for talquetamab step-up dosing could reduce health care expenses.

672

项与塔奎妥单抗相关的新闻（医药）

23 小时之前

·BiG生物创新社

MNC的AB面：砍掉不确定，买入确定性

7月中下旬，诺华、阿斯利康、强生和勃林格殷格翰（BI）等八家MNC陆续披露半年报。整体来看，全球医药市场仍由创新药大单品放量和中后期管线接续支撑，但不同企业的增长质量与业绩预期进一步分化，资本市场反馈也随之拉开差距。更值得关注的是，MNC的研发与资本配置逻辑正在从“以管线数量分散风险”转向“以资本回报筛选资产”。专利悬崖与内部研发效率下降共同放大了增长压力，也使临床确定性和商业兑现能力成为资产定价的核心。 01 低质量研发扩张周期结束 2026年，延续近三十年的全球药物研发管线扩张周期出现了拐点。据Citeline发布的《2026年医药研发年度回顾》显示，截至2026年1月，全球在研药物数量由上一年的23,875个下降至22,940个，降幅为3.9%。这是近三十年来全球研发管线规模首次收缩。过去，MNC习惯通过庞大的项目数量分散风险。只要候选药物足够多，即便单个项目成功率不高，最终也可能跑出几个重磅产品。然而，在当前研发成本持续攀升的背景下，行业已不再愿意为低确定性项目买单。越来越多企业选择及时止损，避免后期更高昂的失败成本。表1.2026上半年8大MNC削减管线情况数据来源：公开资料整理阿斯利康是其中的典型代表。2026年上半年，公司共终止13条管线，覆盖肿瘤、自免、心血管等多个治疗领域，且涉及从Ⅰ期到Ⅲ期的不同开发阶段（表1）。值得注意的是，同一天阿斯利康移除了两款自研ADC管线：EGFR/cMET双特异性ADC AZD9592和CLDN18.2 ADC AZD4360分别因为PK/PD不佳、疗效不足被终止。而从中国引进的CLDN18.2 ADC CMG901的III期达到双主要终点，管理层给出峰值销售30至50亿美元的预期。自研CLDN18.2 ADC AZD4360因疗效终止，同一天中国引进的同靶点ADC CMG901拿到了III期阳性。这说明在ADC这个高度依赖工程经验的领域，外部采购已成为阿斯利康填补管线的既定策略。罗氏的调整同样集中在缺乏足够验证的项目。据罗氏2026H1财报显示，其共有七款新药被移出管线。仅7月9日，罗氏便终止两款亨廷顿病反义寡核苷酸候选药物的临床开发。其中，与Ionis合作开发的tominersen在II期GENERATION HD2试验中，虽达到安全性和生物标志物终点，但经过16个月治疗，患者的功能、认知和运动能力均未获得实质改善。另一款候选药物RG6496则因动物模型提示长期重复给药可能存在安全隐患，在Ⅰ期首次人体试验阶段即被叫停。对罗氏而言，及时砍掉长期投入却缺乏临床兑现能力的低效管线是主动止损。面对神经退行性疾病高投入、高失败率的现实，能够动态调整赛道、集中资源于优势领域，正是其穿越周期的核心能力。除此之外，GSK、BMS和强生等MNC也作出了类似的战略取舍（表1）。因此，MNC所谓的研发降本是重新计算项目的预期回报。当一项资产的成功概率、商业价值和剩余开发成本不再匹配时，继续推进本身就是一种低效率的资本配置。从这个角度看，全球管线数量的首次收缩是低质量研发扩张周期的结束，MNC的研发模式将由“拼管线数量”转向“重资产质量”。 02 资源向确定性资产集中在清理低潜力项目的同时，MNC正在将资源集中到能够支撑当期业绩、同时具备适应症拓展或全球放量空间的大单品上（表2）。表2. 2026H1年MNC制药收入排名数据来源：官网信息整理 2026 H1，诺华净销售额为275.21亿美元，同比下降2%，核心营业收入下降7%。但肿瘤业务收入达到85.36亿美元，同比增长34%，成为表现最强的业务板块。其中，Kisqali上半年销售额达到32.11亿美元，同比增长48%，并在第一季度超过礼来阿贝西利，成为全球销售额最高的CDK4/6抑制剂。早期乳腺癌和转移性乳腺癌两大市场共同推动放量。其临床基础也为增长提供支撑。紧随其后接力的是放射配体疗法Pluvicto，该产品上半年销售额12.93亿美元，同比增长55%，主要由转移性去势抵抗性前列腺癌市场需求推动。也是在通过技术平台、生产供应链和临床开发能力，提高后来者复制与追赶的难度。与此同时，Kesimpta、Cosentyx和Leqvio等产品在不同治疗领域形成接力。在多款大单品的共同驱动下，诺华在Q2单季销售额达到144.08亿美元，同比增长1%，成功扭转一季度颓势。 BI的增长确定性更为直观。2026 H1，公司总营收达到183.49亿美元，同比增长16.2%；人用药品业务收入153.1亿美元，同比增长20.1%。其中，仅Jardiance（恩格列净）一款产品便贡献66亿美元收入，仍是公司最主要的增长动力。但BI并非只依赖一款成熟产品。2025年获批的肺纤维化药物Jascayd（那米司特）和HER2突变非小细胞肺癌药物Hernexeos（宗艾替尼）已经开始商业化。与此同时，GLP-1R/GCGR双激动剂Survodutide进入Ⅲ期并取得积极数据，公司还启动了三项肿瘤Ⅲ期研究。从Jardiance的持续放量到Jascayd和Hernexeos两款新药进入商业化，再到多项Ⅲ期资产推进，BI正在将单一产品的增长优势转化为更具延续性的业绩支撑。强生也不例外，2026年上半年，强生创新制药业务收入318.10亿美元，同比增长9.4%，其中肿瘤业务增长19.9%。Darzalex收入达到81.71亿美元，增长20.6%；Carvykti增长55.1%至12.54亿美元；Tecvayli、Talvey和Rybrevant三款双抗合计收入13.34亿美元。自身免疫领域的Tremfya增长70.6%，神经科学产品Spravato增长43.2%。尽管这些产品覆盖不同技术平台，但它们都已经越过早期概念验证，进入适应症拓展和商业放量阶段。正是由于核心产品增长具备较高可见度，强生将全年营收指引从1003亿至1013亿美元上调至1008亿至1014亿美元。赛诺菲、罗氏和GSK财报中也能看到类似的资源集中趋势（表2）。由此来看，MNC正在形成清晰的三层增长结构，最上层是当期贡献现金流的大单品，中层是刚上市或正在拓展适应症的新产品，底层则是距离注册较近的Ⅲ期资产。对于无法进入这三层结构、又缺乏明显技术差异化的项目，其继续留在管线中的价值正在迅速下降。 03 研发竞争资本化管线收缩和资产聚焦的背后，是日益迫近的专利悬崖。据Evaluate Pharma数据显示，2027年至2028年间，预计将有年销售额超过1800亿美元的药物失去专利保护，约占全球药品市场的12%。这意味着，MNC需要在非常有限的时间窗口内，找到足以填补千亿美元收入缺口的新产品。压力已经反映在财报中。强生的Stelara在2025年迎来生物类似药竞争后，国际市场销售额在2025年一年内下降近33%。另一款自免产品Simponi的美国化合物专利已经于2024年到期，目前也有生物类似药处于开发阶段。诺华的Entresto已经失去美国市场独占权，多家仿制药获得FDA批准；该产品同时进入美国首轮医保谈判，谈判价格降幅达到53%，并于今年生效。对诺华而言，即使Kisqali、Kesimpta和Pluvicto仍在高速增长，也必须尽快完成新旧产品切换。罗氏面对的是更长周期的HER2产品迭代压力。Herceptin之后，Perjeta和Kadcyla接过了收入贡献，但Kadcyla的核心专利已在欧美部分地区到期，同时受到Enhertu扩张的挤压。2026年上半年，Kadcyla销售额同比下降6%。Perjeta也进入生物类似药竞争窗口，罗氏因此通过固定剂量皮下注射制剂Phesgo改善给药便利性，试图延长产品生命周期。 GSK的核心HIV产品Dovato将在2028年面临专利到期。公司一方面要从2024年314亿英镑收入增长至2031年超过400亿英镑，另一方面必须在Dovato收入承压前建立新的增长支柱。对GSK而言，这是一场产品周期与研发周期之间的赛跑。然而，专利悬崖压力之外，MNC内部研发管线收益率持续走低，据摩根士丹利报告显示，MNC内部研发管线收益率不足5%，难以支撑公司市值和净资产收益率，相比之下，MNC通过BD与并购合作快速填补产品线缺口，这种“借力”策略比完全自主研发更加高效和经济。以GSK为例。2026年上半年，GSK研发投入为51.58亿英镑（约69.38亿美元），同时启动“Accelerate Growth”成本节约计划，目标到2029年实现每年19亿英镑（约25.56亿美元）节约。节省下来的资源将用于后期管线，公司预计2026年启动超过20项Ⅲ期研究。与此同时，GSK以约106亿美元完成对Nuvalent的收购，获得zidesamtinib和neladalkib等晚期肺癌资产。这一系列动作并非简单削减研发，而是通过压缩低回报成本，将更多资金投向成功概率更高项目上。由此，MNC的研发竞争开始呈现明显的资本化特征。研发预算的边际增量越来越多地流向BD和并购。面对专利悬崖与内部研发效率下降的双重压力，MNC愿意为更高的临床确定性和更清晰的商业前景的资产支付溢价。写在最后 2026年上半年的MNC的财报折射出全球药企资本配置方式的深刻变化：高质量资产因临床确定性与时间价值而愈发昂贵，缺乏差异化的普通项目则可能同时失去融资和交易机会。增长焦虑并未削弱MNC的下注意愿，反而推动资本加速向确定性资产集中，并由此催生出越来越显著的“确定性溢价”。参考资料 [1]https://www.citeline.com/en/rd26 [2]国信证券、中信建投、东吴证券研报 [3]各企业财报，各种公开资料等近期活动第12届 BiG IMPACT年会10月23-24日将在上海张江正式启幕，本次年会汇聚哈佛院士、RA Capital等全球顶级产学研投力量，打造中国创新对话世界的稀缺跨境平台；早鸟6折优惠截至8月31日，点击报名锁定国际前沿盛宴！时间及地点：10月23-24日（周五-周六）上海-张江希尔顿；规模：800-1000人报名入口 ▼ 参会通道 VIP 门票：3000 元 / 人；含：全部论坛 + 闭门会 + 23 日晚宴 + 24 日午餐会议门票：1000元/人；含：10月23-24日公开会议 * 以上付费门票 8月31日前可享早鸟价 6折优惠会员 / 特邀通道：免费；审核制（限 BiG 会员 / 特邀 / 往届 speaker），权益同VIP门票院校 / 临床通道：免费；审核制（仅含10月23-24公开会议，不含午餐及晚宴）共建Biomedical创新生态圈！如何加入BiG会员？

财报临床3期

2026-07-31

·Healthcare Digital

Johnson & Johnson and Firefly: Targeting KRAS-Driven Cancers

Johnson & Johnson has built one of the industry's most diversified oncology portfolios. Credit: National Cancer Institute / Unsplash Johnson & Johnson is hoping it can improve treatment outcomes for one of oncology’s toughest challenges after confirming the acquisition of Firefly Bio KRAS mutations occur in roughly one in five human cancers , making them among the most common oncogenic drivers. The mutations multiply rapidly, making them challenging to treat, and are particularly common in pancreatic cancer sufferers, where the vast majority of tumours contain a KRAS mutation. After completing its acquisition of Firefly Bio, a preclinical biotechnology company developing targeted protein degradation cancer therapies, Johnson & Johnson is hoping Firefly's degrader antibody conjugate (DAC) technology can improve treatment outcomes for one of oncology's most difficult molecular targets. Using its proprietary FireLink DAC platform, Firefly aims to selectively deliver protein degraders to cancer cells, initially targeting KRAS-driven solid tumours. A new approach to KRAS treatment John Reed, Executive Vice President of Pharmaceuticals and R&D at Johnson & Johnson Innovative Medicine, believes the acquisition will deliver more meaningful and lasting treatment options for patients battling KRAS-driven cancer. On LinkedIn following the acquisition’s confirmation, he writes, “Despite recent advances, improvements in treatments for KRAS-driven cancers are still needed, with the aim of reducing toxicities and prolonging the durability of responses. John Reed, Executive Vice President of Pharmaceuticals and R&D at Johnson & Johnson Innovative Medicine. Credit: Johnson & Johnson By delivering a highly selective KRAS protein degrader directly into tumour cells, the DAC platform is designed to target degrader molecules where they are needed, while preserving healthy tissues – potentially overcoming key limitations associated with existing untargeted approaches.” Why are KRAS-driven cancers so difficult to treat? For decades, KRAS was considered "undruggable" because: The protein has a very smooth surface with few places for drugs to bind. It binds its natural fuel molecule (GTP) extremely tightly. It naturally cycles rapidly between active and inactive states, making it difficult for drugs to bind effectively. Until recently, treatment options have largely been limited to chemotherapy, immunotherapy and therapies targeting pathways downstream of KRAS. A diverse oncology portfolio Johnson & Johnson has built one of the industry's most diversified oncology portfolios, spanning conventional biologics, cell therapies and next-generation targeted treatment platforms. It includes established multiple myeloma treatments Darzalex and Carvykti, alongside newer medicines such as Rybrevant, Talvey and Tecvayli. Firefly marks the company's latest investment in next-generation oncology technologies. Prior to the Firefly acquisition, Johnson & Johnson’s most recent oncology deal was the US$3.05bn purchase of clinical-stage biotech firm Halda Therapeutics in December 2025, which expanded its presence in solid tumours through Halda's RIPTAC platform. Jennifer Taubert, Executive Vice President and Worldwide Chairman of Johnson & Johnson Innovative Medicine. Credit: Johnson & Johnson. Speaking at the time of the Halda Therapeutics acquisition, Jennifer Taubert, Executive Vice President and Worldwide Chairman at Johnson & Johnson Innovative Medicine, says, “This strategic milestone underscores our commitment to redefining cancer treatment with breakthrough science and transformative medicines. “We are excited to formally welcome the talented Halda team to Johnson & Johnson and look forward to working together to achieve our shared goal of eliminating cancer.” Acquiring biotech firms before clinical maturity Firefly Bio is the latest example of a growing trend in pharmaceutical M&A, with major drugmakers increasingly acquiring early-stage platform companies to secure access to emerging modalities such as protein degradation, antibody-drug conjugates and radiopharmaceuticals that could underpin the next generation of precision oncology treatments. Given the high costs associated with clinical-stage, low-risk oncology assets, such as GSK’s US$10.6bn acquisition of Nuvalent , purchasing a comparatively inexpensive early-stage platform capable of generating multiple future therapies represents an attractive long-term investment for healthcare’s biggest players. Company portals Johnson & Johnson Executives Jennifer Taubert Executive Vice President, Worldwide Chairman and Innovative Medicine John Reed Executive Vice President, Innovative Medicine, Research & Development

并购免疫疗法

2026-07-30

·管线研发速递

新药速递｜7.23-7.30：全球扎堆获批、重磅临床接连出炉，中国创新药驶入出海快车道

医药研发圈本周热度拉满！欧美药监集中放行多款First-in-class新药，国内NMPA接连落地全球首创品种；CLDN18.2 ADC、双抗联合疗法交出里程碑III期数据；百亿级药企并购轮番上演，叠加工信部发布上半年创新药全景成绩单，全球生物医药产业迎来密集兑现期。本文将从全球新药获批、重磅临床突破、药企资本交易、国内创新产业盘点四大维度，完整梳理本周核心行业动态。一、全球三地药监密集放行，多款全球首创新药落地（一）美国FDA：本月多款新分子实体获批，慢病、肿瘤、神经领域全面开花获批日期药物通用名（商品名）研发企业核心适应症 7.24 Bevacizumab-vikg（Lytenava） Outlook Therapeutics Inc 用于治疗新生血管（湿性）年龄相关性黄斑变性患者 7.24 Centanafadine（Simtriyo）大冢制药用于治疗注意力缺陷多动障碍 7.22 Zidesamtinib（Jideytro） Nuvalent Inc 用于治疗接受过ROS1激酶抑制剂治疗后，局部晚期或转移性ROS1阳性非小细胞肺癌的成人患者 7.15 Enlicitide（Lipfendra）默沙东降低低密度脂蛋白胆固醇，全球首款口服PCSK9抑制剂，每日口服片剂强效降低LDL-C，打破PCSK9靶点只能皮下注射的局限 7.14 Gedatolisib（Revtorpyk）惠氏联合氟维司群，用于治疗激素受体阳性、人表皮生长因子受体2阴性、局部晚期或转移性乳腺癌，且在转移性阶段接受至少一线内分泌治疗进展后未检测到PIK3CA突变 7.7 Atacicept（Trutakna） Vera Therapeutics 旨在减少有疾病进展风险的原发性免疫球蛋白A肾病成人患者的蛋白尿数据来源：FDA Novel Drug Approvals 2026 （二）中国NMPA：国产原研持续突围，多项疗法实现全球率先上市本周国内创新药审批迎来爆发，多款First-in-class、国产首创品种集中获批，抗感染、自身免疫、糖尿病、肿瘤、嗜睡症赛道多点突破：获批日期药品名称申报企业核心价值解读 7.29 盐酸伊司特韦片西湖制药用于治疗成人轻型、中型新型冠状病毒感染（COVID-19） 7.29 瑞西奇拜单抗注射液（商品名：华亦净）上海华奥泰治疗成人(体重≥40kg)泛发性脓疱型银屑病发作 7.29 舒地胰岛素注射液恒瑞医药中国首个自主研发长效胰岛素类似物，，打破海外药企长效胰岛素长期垄断格局 7.23 琥珀酸思普可泮片海思科全球首款每日1次口服补体B因子抑制剂，用于阵发性睡眠性血红蛋白尿症（PNH）；III期临床血红蛋白达标率59.5%，远高于经典注射药物依库珠单抗8.3%，口服剂型彻底改写罕见血液病治疗范式 7.23 苹果酸法米替尼胶囊恒瑞医药新增适应症联合注射用卡瑞利珠单抗（艾瑞卡 ®）用于复发或转移性宫颈癌成人患者的一线治疗。这是国内首个获批用于宫颈癌一线治疗的国产PD-1联合抗血管靶向去化疗方案，标志晚期宫颈癌正式迎来不含化疗的一线靶免新选择 7.21 奥博雷通片（奥泽悦）武田用于16岁及以上青少年和成人1型发作性睡病患者。全球首个口服OX2R食欲素受体激动剂，中国为全球首个上市国家，用于1型发作性睡病；超85%患者日间嗜睡症状恢复至正常水平，告别中枢兴奋剂依赖数据来源：NMPA、CDE、行业医药资讯平台（三）欧盟EMA：CHMP月度会议释放12项积极意见，降脂赛道迎来多款新品 7月下旬欧洲人用医药产品委员会（CHMP）月度评审收官，共计推荐12款新药获批，降脂领域成果最为突出：Obicetrapib（Ubeslo/Evlarco）：新一代CETP胆固醇通路抑制剂，单药LDL-C降幅40%，联合依折麦布降脂可达50%，专为他汀不耐受高血脂人群打造；Lyrokaul（lerodalcibep）：每月1次皮下注射降脂药，可居家自行给药。二、重磅III期临床数据集中公布，多个靶点迎来历史性突破本周全球各大药企密集披露关键注册临床顶线结果，ADC、双抗、肺癌、代谢四大赛道改写治疗格局，国产创新药临床实力备受全球瞩目： 1.全球首个CLDN18.2 ADC III期总生存期获益敲定：阿斯利康Sone-Ve登顶胃癌靶向治疗 7月27日，阿斯利康宣布Sonesitatug vedotin（Sone-Ve，AZD0901/CMG901）治疗胃癌的III期CLARITY-Gastric01研究取得了积极结果。这是Sone-Ve披露的第一个III期研究结果。该药物最早由康诺亚+乐普生物研发，2023年以6300万美元首付款+最高11.6亿美元里程碑授权给阿斯利康，是中国ADC出海里程碑项目；虽无进展生存期统计学获益，但总生存期作为注册核心终点完全达标，即将递交全球多国上市申请。 2.强生双抗组合疗效比肩CAR-T，多发性骨髓瘤后线治疗再添优选方案 Tecvayli联合Talvey两款双特异性抗体III期MonumenTAL-6数据出炉：疾病进展或死亡风险分别降低了73%（HR=0.27）和89%（HR=0.11）。此外，Tal-Tec方案组的死亡风险较PVd方案组降低了62%（HR=0.38）。 3.国产三项肺癌III期数据出炉，重塑非小细胞肺癌一线治疗体系国内药企集中交出肺癌重磅临床成果，三条主流赛道全线突破：①依沃西单抗（PD-1/VEGF双抗）+化疗一线肺鳞癌：头对头优于替雷利珠单抗联合化疗，康方生物自主研发的First-in-Class的双特异性抗体依沃西单抗（Ivonescimab）联合化疗将患者的死亡风险降低 34%（中位总生存期分别为27.9个月vs 23.7个月），依沃西单抗也因此成为全球首个在头对头III期临床试验中正面击败抗PD-1单抗并实现总生存期和无进展生存期双显著阳性的PD-1×VEGF双特异性抗体。刊发于《柳叶刀》；②国产TROP2 ADC +帕博利珠单抗一线PD-L1阳性NSCLC：PFS显著延长，全球首个证实ADC+IO优于免疫+化疗的III期证据；③奥希替尼联合化疗一线EGFR突变肺癌：PFS大幅延长，疾病进展风险降56%。 4.恒瑞GLP-1/GIP双靶减重降糖III期登顶，国产多肽追赶海外第一梯队恒瑞瑞普泊肽（HRS9531）III期顶线数据积极：36周治疗后，4mg剂量组糖化血红蛋白降幅高达2.67%，血糖达标率94.5%；减重适应症国内上市申请已于2025年递交，降糖适应症近期即将申报，国产长效GLP-1赛道竞争进入白热化阶段。三、百亿级并购频繁落地，全球药企管线洗牌加速本周医药资本市场交易活跃度居高不下，迷幻药、肿瘤、CDMO、AI基因组学赛道大额并购接连落地：收购事件交易总金额战略布局意义礼来收购AtaiBeckley 最高38亿美元拿下迷幻类抗抑郁新药BPL-003，布局难治性抑郁症赛道，精神神经疾病成为巨头必争领域 GSK收购Nuvalent 106亿美元 2026年度全球第二大医药并购，全盘吸纳ROS1/TRK肺癌靶向管线，夯实肿瘤核心板块阿斯利康×正大天晴 2亿美元 COPD呼吸管线项目海外授权，深化国内药企与跨国巨头双向合作阿斯利康×迪哲医药 15亿美元肺癌靶向药物全球权益授权，国产小分子靶向药持续出海变现 Samsung Biologics收购PolyPeptide 18.1亿美元扩充多肽原料药与CDMO产能，抢占全球多肽药物生产供应链 Tempus AI收购 Personalis 15亿美元 AI+基因组技术深度整合，精准医疗数字化进程提速 Incyte收购Vega Therapeutics 约20亿美元布局罕见血液病资产，补齐自身炎症血液管线短板数据来源：BioSpace、EMJ Reviews 行业综述四、工信部发布上半年创新药成绩单：国产创新驶入黄金发展期 7月20日工信部官方发布2026上半年中国生物医药产业核心数据，全方位展现国内创新药硬核实力：①新药获批数量：上半年共计38款创新药获批上市，其中国产创新药31款，占比超过80%。且据国家药监局披露，这31款国产创新药中有11个属于全新靶点、全新机制的药物，且全部为自主研发的国产创新药；②创新出海成果：81笔国产新药对外授权（License-out）交易落地，交易总额约1100亿美元，已达到2025年全年总额的80%，合作覆盖全球20余个国家；③产业业绩向好：超38家创新药企预告上半年净利润实现正向增长；④里程碑成果密集兑现：全球首个双特异性ADC、实体瘤CAR-T疗法、乙肝/丁肝靶向单抗、国产首创放射性新药均于上半年陆续获批上市。从跟随仿制到源头创新、从国内临床走向全球商业化，中国生物医药产业已经完成阶段性跨越。结语全球药监审批、关键临床、大额资本交易轮番落地，肿瘤、代谢、罕见病、神经精神领域创新持续迭代；一边是跨国药企重金并购补齐管线，另一边是中国创新药以First-in-class产品、大额海外授权站稳全球舞台。后续随着多款III期数据持续读出、新药商业化铺开，生物医药行业创新红利还将持续释放。

100 项与塔奎妥单抗相关的药物交易

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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
难治性多发性骨髓瘤	日本	Janssen Pharmaceutical KK	2025-06-24
复发性多发性骨髓瘤	日本	Janssen Pharmaceutical KK	2025-06-24
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2023-08-09

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
残留肿瘤	临床3期	-	Johnson & Johnson	2026-09-01
复发性浆细胞骨髓瘤	临床2期	美国	Johnson & Johnson Pharmaceutical Research & Development LLC	2026-08-01
复发性浆细胞骨髓瘤	临床2期	美国	Janssen Research & Development LLC	2026-08-01
外周干细胞移植	临床2期	美国	Janssen Scientific Affairs LLC	2025-06-05
阴燃多发性骨髓瘤	临床2期	美国	Janssen Scientific Affairs LLC	2023-12-04
多发性骨髓瘤的髓外病变	临床2期	西班牙	Janssen Pharmaceutica NV	2023-09-21
血液肿瘤	临床1期	美国	Janssen Research & Development LLC	2017-12-16
血液肿瘤	临床1期	比利时	Janssen Research & Development LLC	2017-12-16
血液肿瘤	临床1期	荷兰	Janssen Research & Development LLC	2017-12-16
血液肿瘤	临床1期	西班牙	Janssen Research & Development LLC	2017-12-16

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临床结果

适应症

分期

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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


NCT05455320 (MonumenTAL-3, Pubmed \| N Engl J Med)	临床3期	-	864	Talquetamab-Daratumumab-Pomalidomide	繭蓋簾構夢壓鬱衊窪簾(築鏇鹽艱願窪餘構淵構) = 窪觸憲範遞齋鏇鹽淵憲製憲網膚憲構製築衊夢 (衊鬱艱鏇壓衊獵鬱憲餘 ) 更多	积极	2026-06-13
				Talquetamab-Daratumumab	繭蓋簾構夢壓鬱衊窪簾(築鏇鹽艱願窪餘構淵構) = 獵膚鬱製積鑰夢齋鏇憲製憲網膚憲構製築衊夢 (衊鬱艱鏇壓衊獵鬱憲餘 ) 更多
ASCO2026	N/A	难治性多发性骨髓瘤	1,941	Talquetamab	艱醖膚糧膚艱糧鹽齋窪(鹹獵顧齋齋鹹網糧鏇醖) = TQ group had higher risk for developing CRS (RR 1.91 (1.34, 2.72), p<0.0001) 鹹餘鬱壓蓋觸醖淵壓鬱 (膚齋壓襯淵遞膚醖鏇構 ) 更多	积极	2026-05-29
				Teclistamab
ASCO2026	N/A	复发性多发性骨髓瘤	590	Talquetamab	選製夢憲鬱憲鹽憲構鬱(觸鏇醖窪鹽衊廠窪廠願) = ER visits (HR = 0.716), anemia (HR = 0.915), sepsis (HR = 0.803), and pneumonia (HR = 0.641) were numerically lower in the talquetamab group but were not statistically significant (p > 0.05). Neutropenia (HR = 1.082), thrombocytopenia (HR = 1.301), and CRS (HR = 1.617) did not differ significantly (p > 0.05). Hospitalization, MM relapse, and neurotoxicity were not analyzable due to low events. 積鏇壓憲鏇蓋築夢廠遞 (積鏇憲齋網蓋淵齋廠選 ) 更多	积极	2026-05-29
				Sequential BDT
ASCO2026	N/A	多发性骨髓瘤	542	Talquetamab+IVIG	製鬱憲淵廠網築憲網構(衊遞範憲觸膚願簾顧艱) = 獵淵餘壓衊襯網鏇壓獵簾壓憲製獵鑰醖憲淵壓 (遞簾鑰膚積壓鹹齋襯憲 ) 更多	积极	2026-05-29
				Talquetamab	製鬱憲淵廠網築憲網構(衊遞範憲觸膚願簾顧艱) = 壓繭艱製觸繭齋選壓製簾壓憲製獵鑰醖憲淵壓 (遞簾鑰膚積壓鹹齋襯憲 ) 更多
ASCO2026	N/A	难治性多发性骨髓瘤	78	Talquetamab	網醖積構願鹽壓顧範齋(鹹鬱淵製獵蓋衊簾糧鹽) = 製繭築艱餘鏇糧繭願鬱夢網製艱鏇築鑰衊簾製 (齋顧餘選觸淵築艱憲獵, 0.27 ~ 0.4) 更多	积极	2026-05-29
				Elranatamab	網醖積構願鹽壓顧範齋(鹹鬱淵製獵蓋衊簾糧鹽) = 選廠廠衊齋選製製窪願夢網製艱鏇築鑰衊簾製 (齋顧餘選觸淵築艱憲獵, 0.19 ~ 0.49) 更多
ASCO2026	N/A	多发性骨髓瘤 BCMA	7,280	Ide-cel	鑰齋衊衊積鹽膚窪壓壓(糧齋鹽餘選夢餘構獵襯) = 顧膚範鬱憲衊膚衊齋淵積鏇鏇簾願遞築製衊鏇 (鑰餘簾衊願鑰鬱壓壓餘 ) 更多	不佳	2026-05-29
				Cilta-cel	鑰齋衊衊積鹽膚窪壓壓(糧齋鹽餘選夢餘構獵襯) = 獵艱淵鹽簾襯鑰醖簾壓積鏇鏇簾願遞築製衊鏇 (鑰餘簾衊願鑰鬱壓壓餘 ) 更多
NCT04586426 (RedirecTT-1, ASCO2026)	临床1/2期	复发性多发性骨髓瘤	114	Talquetamab 0.8 mg/kg + Teclistamab 1.5 mg/kg Q2W	網製廠簾糧淵鹹醖積鹽(簾蓋壓範鬱鏇憲繭鹹願) = 製窪鑰願餘衊積襯繭夢簾淵憲蓋淵簾壓顧廠製 (衊糧範簾蓋構醖廠夢鹽 ) 更多	积极	2026-05-29
				Talquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kg	網製廠簾糧淵鹹醖積鹽(簾蓋壓範鬱鏇憲繭鹹願) = 糧齋築遞簾窪壓網選範簾淵憲蓋淵簾壓顧廠製 (衊糧範簾蓋構醖廠夢鹽 ) 更多
ASCO2026	N/A	复发性多发性骨髓瘤	402	Talquetamab	製積鹹鏇醖鏇築壓積襯(鬱積衊願廠窪鏇築製積) = 觸齋鹹願鑰鹹製窪簾廠選糧顧糧簾衊鬱壓遞餘 (廠廠膚鏇鑰衊淵選憲蓋 ) 更多	积极	2026-05-29
				Teclistamab	製積鹹鏇醖鏇築壓積襯(鬱積衊願廠窪鏇築製積) = 鬱蓋窪廠範範構廠製艱選糧顧糧簾衊鬱壓遞餘 (廠廠膚鏇鑰衊淵選憲蓋 ) 更多
NCT05972135 (ASCO2026)	临床2期	复发性多发性骨髓瘤	50	TocilizumabTeclistamab + TocilizumabTeclistamab	願積襯願鑰構餘遞範齋(壓願鑰鹽鹹襯製襯壓願) = 鬱夢醖願壓餘觸艱窪餘選餘壓積憲蓋憲鑰艱網 (製積糧積齋範簾憲衊膚 ) 更多	积极	2026-05-29
				TocilizumabTalquetamab + TocilizumabTalquetamab	願積襯願鑰構餘遞範齋(壓願鑰鹽鹹襯製襯壓願) = 築範顧築憲襯鏇蓋觸願選餘壓積憲蓋憲鑰艱網 (製積糧積齋範簾憲衊膚 ) 更多
NCT06500884 (TALISMAN, EHA2026)	临床2期	复发性多发性骨髓瘤	30	Talquetamab with dexamethasone oral rinse prophylaxis (prophy Dex)	網製築壓糧憲築窪膚淵(鏇艱淵繭獵蓋鏇鹹餘夢) = 壓憲鑰顧顧鑰範鹹獵淵鏇鑰廠遞蓋醖衊繭遞衊 (衊齋廠繭餘淵齋艱鏇糧 ) 更多	积极	2026-05-12
				Talquetamab only (control)	鬱網獵鑰獵簾簾淵繭憲(蓋築衊憲餘製選廠顧觸) = 鑰艱鑰襯範願選夢餘衊鬱鬱鬱鑰選窪憲願願醖 (廠範夢顧製觸構憲餘顧 ) 更多