DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.

开始日期2026-11-01

申办/合作机构

The University of Chicago

NCT07142551

/ Not yet recruiting临床2期IIT

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)

The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.

开始日期2026-02-20

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT07344779

/ Not yet recruitingN/A

ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to enroll approximately 1,600 male patients (800 per cohort) from multiple countries, primarily in Europe, who have a diagnosis of mHSPC and for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment. The primary objective is to estimate the proportion of patients achieving undetectable prostate-specific antigen (PSA) levels (<0.2 ng/mL) at 1 year of treatment in each cohort. Secondary objectives include describing patient demographics, clinical characteristics, prior and concomitant treatments, adverse events, and clinical effectiveness measures such as overall survival, time to new treatment, time to castration resistance, and time to PSA progression. Further objectives involve assessing quality of life, reasons for not adding docetaxel, outcomes by patient subgroups (e.g., Gleason score, disease volume, ECOG status), genomic testing results, and hospitalization rates. Data will be collected using electronic case report forms (eCRF) during routine clinical practice, with no additional diagnostic or monitoring procedures required beyond standard care. All patients must provide informed consent prior to participation. The study will comply with applicable regulatory requirements, including IEC/IRB approval in all participating countries. Statistical analyses will be descriptive and exploratory, with interim analyses planned after 200, 400, and 600 patients per cohort have completed at least 12 months of treatment or discontinued therapy. The study is expected to provide valuable insights into the real-world use of darolutamide in mHSPC, supporting clinical decision-making and enhancing understanding of treatment patterns, effectiveness, and safety in diverse patient populations.

开始日期2026-02-17

申办/合作机构

Bayer AG

100 项与达罗他胺相关的临床结果

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100 项与达罗他胺相关的转化医学

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100 项与达罗他胺相关的专利（医药）

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467

项与达罗他胺相关的文献（医药）

2026-01-01·European Urology Open Science

Integration of Darolutamide in the Treatment Landscape for Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis of Efficacy and Safety

Article

作者: Bektic, Jasmin ; Horninger, Wolfgang ; Kafka, Mona ; Artamonova, Nastasiia ; Ladurner, Michael ; Giannini, Giulia ; Melchior, Felix ; Koett, Magdalena ; Heidegger, Isabel ; Keller, Felix ; Neuwirt, Hannes

Background and objective:

Recent advances have led to the introduction of multiple combination treatments for metastatic hormone-sensitive prostate cancer (mHSPC), but their comparative efficacy and toxicity remain uncertain owing to the absence of head-to-head comparisons. We evaluated the efficacy and safety profile of darolutamide plus androgen deprivation therapy (ADT) in comparison to other treatments.

Methods:

A systematic search was conducted in the Cochrane Library up to September 30, 2024 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Hazard ratios (HRs) and confidence intervals (CIs) for progression-free survival (PFS) and overall survival (OS) were extracted. Odds ratios (ORs) for treatment-emergent adverse events (TEAEs) were calculated from the events reported.

Key findings and limitations:

Eleven trials involving 11 389 patients were included. Darolutamide triplet therapy was associated with the highest overall PFS (HR 0.24, 95% CI 0.20-0.29) and OS (HR 0.54, 95% CI 0.44-0.66). The highest PFS in low-volume disease was observed with enzalutamide (HR 0.29, 95% CI 0.21-0.38) and darolutamide (HR 0.30, 95% CI 0.15-0.60). All androgen receptor pathway inhibitors (ARPIs) had higher toxicity than ADT, except for darolutamide (OR 0.99, 95% CI 0.71-1.39). In comparison to darolutamide, enzalutamide (OR 2.03, 95% CI 1.08-3.80) and abiraterone (OR 3.18, 95% CI 1.74-5.80) were associated with higher risk of hypertension. Enzalutamide was associated with a higher risk of fatigue (OR 3.22, 95% CI 1.28-8.07). Limited direct comparisons between treatments may affect our conclusions regarding relative efficacy.

Conclusions and clinical implications:

Our findings support the role of darolutamide as an effective and well-tolerated ARPI for mHSPC, particularly in low-volume metachronous disease and comorbidity-limited cases. These results may assist clinicians in planning personalized treatment strategies that balance efficacy and safety.

Patient summary:

We compared different medical treatment options for metastatic hormone-sensitive prostate cancer, with a special focus on a drug called darolutamide. Darolutamide is well tolerated and is effective, particularly in patients with a low volume of metastasis and patients with other health conditions that may limit their treatment options.

2026-01-01·Cancer Medicine

Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS

Article

作者: Smith, Matthew ; Shore, Neal D. ; Ribal, Maria J. ; Adorjan, Patrick ; Halabi, Susan ; Wallis, Christopher J. D. ; Rigaud, Jérôme ; Birtle, Alison ; Damber, Jan‐Erik ; Semenov, Andrey ; Saar, Matthias ; Srinivasan, Shankar ; Mohamed, Ateesha F. ; Morgans, Alicia K. ; Fizazi, Karim ; Grimm, Marc‐Oliver ; Armstrong, Andrew J. ; Verholen, Frank ; Siemens, D. Robert

ABSTRACT:

Background:

Darolutamide plus androgen‐deprivation therapy (ADT) improved metastasis‐free survival (MFS) by 2 years and reduced the risk of death by 31% in nonmetastatic castration‐resistant prostate cancer (nmCRPC) in ARAMIS. Prior local therapy may influence the efficacy of subsequent systemic therapy. This post hoc analysis of ARAMIS evaluated the effect of prior local therapy on the efficacy and health‐related quality of life (HRQoL) of darolutamide.

Methods:

Patients with nmCRPC were randomized to darolutamide ( n = 955) or placebo ( n = 554) while continuing ADT. MFS, overall survival (OS), time to prostate‐specific antigen (PSA) progression, and HRQoL deterioration‐free survival (DetFS) were estimated for patients with and without local therapy and by treatment using Kaplan–Meier methods.

Results:

Darolutamide increased MFS versus placebo in patients with (HR, 0.36; 95% CI, 0.26–0.48) and without (HR, 0.46; 95% CI, 0.36–0.59) local therapy. Median OS was 48.6 months for placebo without local therapy and not reached in either the darolutamide group or placebo group with local therapy. Darolutamide 3‐year OS rates were 86.9% (95% CI, 83.0–90.8) and 79.0% (95% CI, 66.2–78.1) in patients with and without local therapy, respectively. Darolutamide showed evidence of improved OS versus placebo in patients with prior local therapy (HR, 0.80; 95% CI, 0.50–1.30) and a greater effect in those without local therapy (HR, 0.67; 95% CI, 0.50–0.90). Darolutamide delayed time to PSA progression and HRQoL deterioration regardless of local therapy.

Conclusions:

Darolutamide versus placebo improved MFS, OS, time to PSA progression, and HRQoL DetFS independent of prior local therapy, consistent with the overall ARAMIS population.Trial Registration: ClinicalTrials.gov registration: NCT02200614

2025-12-15·INTERNATIONAL JOURNAL OF CANCER

Severe cutaneous adverse reactions associated with novel antiandrogens: A disproportionality analysis of three databases

Article

作者: Huang, Zhaohui ; Jiang, Jie ; Yang, Ziwen ; Zhu, Jianhong ; Li, Sha ; Li, Xinyu ; Huo, Xiaotong ; Wu, Junyan

Abstract:

Severe cutaneous adverse reactions (SCARs) encompassing Stevens‐Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are increasingly reported among patients treated with novel antiandrogens, but the signals of disproportionate reporting and clinical features remain inadequately defined. This study was an observational retrospective pharmacovigilance study using the publicly available FAERS/EudraVigilance/JADER databases. To explore the signals of disproportionate reporting, disproportionality analysis was conducted using information component (IC) and reporting odds ratio (ROR) methodologies. Descriptive statistics were calculated for baseline and demographic information, onset time, and reaction outcomes. There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. Significant over‐reporting signals for apalutamide were observed in SJS (FAERS, ROR 025 = 4.12, IC 025 = 1.70, N = 30; EudraVigilance, ROR 025 = 11.54, IC 025 = 2.84, N = 55; JADER, ROR 025 = 2.90, IC 025 = 1.33, N = 25), TEN (FAERS, ROR025 = 4.40, IC025 = 1.75, N = 29, EudraVigilance, ROR 025 = 30.96, IC 025 = 3.74, N = 58; JADER, ROR 025 = 5.34, IC 025 = 1.85, N = 25), DRESS (FAERS, ROR025 = 2.68, IC025 = 1.33, N = 38; EudraVigilance, ROR 025 = 25.06, IC 025 = 3.53, N = 55; JADER, ROR 025 = 0.62, IC 025 = 0.19, N = 6) and AGEP (FAERS, ROR025 = 1.16, IC025 = 0.55, N = 7; EudraVigilance, ROR 025 = 4.18, IC 025 = 1.02, N = 5; JADER, ROR 025 = 1.05, IC 025 = 0.45, N = 4). Incorporated data from 3 databases, the lethal rates of apalutamide‐related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS. The median time to onset was 41 days for SJS, 29 days for TEN, and 40 days for DRESS, respectively. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide‐SCARs risk.

476

项与达罗他胺相关的新闻（医药）

2026-01-26

·Pharmaceutical Technology

NICE greenlights Pfizer’s Talzenna for NHS use

The UK health watchdog has changed its stance on Pfizer’s Talzenna, now recommending the once-daily drug for NHS use. Image credit: NMK-Studio via Shutterstock.com. The UK’s National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Talzenna (talazoparib) in a step forward for patients in England with prostate cancer. Following the NICE’s decision on 23 January, the once-daily pill will be available to patients with metastatic prostate cancer through the National Health Service (NHS) – adding to its previous recommendation for the drug’s use in metastatic breast cancer . NICE is recommending Talzenna’s use when taken alongside hormonal therapy Xtandi (enzalutamide). Talzenna-Xtandi is specifically indicated for patients with prostate cancer who are not eligible to receive treatment with standard of care (SoC) hormonal therapy plus corticosteroid combinations such as abiraterone-prednisolone. This recommendation marks a shift in stance for NICE, which provisionally stated last year it would not support the drug’s use in prostate cancer. However, the UK health watchdog has since reconsidered its position based on the outcome of a public consultation. Talzenna is a poly-ADP ribose polymerase (PARP) inhibitor that acts by blocking the repair of single-strand breaks in cancer cells, causing genomic instability and cancer cell death. According to Helen Knight, director of medicines evaluation at NICE, the Talzenna recommendation is an “important step forward” for patients with prostate cancer – particularly for those who are unable to receive treatment with chemotherapy or other commonly used medicines. 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 Knight also touted Talzenna-Xtandi’s at-home administration, which provides a “convenient and flexible” treatment option for patients. The Institute of Cancer Research welcomed the news, stating: “The recommendation marks an important step forward in giving people more treatment options – especially those who cannot undergo chemotherapy. Patients can take the once-daily pill at home, offering convenience and flexibility.” Talzenna is one of three drugs for prostate cancer treatment to recently secure NICE approval, with Bayer and Orion’s oral androgen receptor therapy Nubeqa (darolutamide) and Zytiga (abiraterone) plus its generics being recommended for NHS use in October 2025. The combination therapy first gained US regulatory approval alongside androgen receptor inhibitor Xtandi in prostate cancer in 2023 while the European Commission (EC) approved Talzenna-Xtandi in 2024. Talzenna faces competition in prostate cancer market While the NICE’s decision is a win for Pfizer, Talzenna is part of a competitive metastatic prostate cancer market. This includes AstraZeneca’s PARP inhibitor Lynparza (olaparib), which GlobalData estimates will bring in global sales of $3.5bn at its sales peak across all indications in 2027. However, the drug’s market exclusivity expires in 2027, leaving it vulnerable to generic competition. GSK’s PARP inhibitor Zejula (niraparib) is also a strong market contender, with GlobalData estimating that the drug will generate $791m in global sales at its 2027 peak. Pharma & Schweiz’s Rubraca (rucaparib) also cemented itself in the US market recently, as the PARP inhibitor gained full approval from the US Food and Drug Administration (FDA) in late December 2025. Pharma & Schweiz previously acquired the drug from Clovis Oncology for up to $135m as the latter company looked to sell its assets amid Chapter 11 bankruptcy. GlobalData forecasts that Rubraca will make $139m at its 2029 sales peak in prostate cancer. GlobalData, parent company of Pharmaceutical Technology , forecasts that Talzenna will make global sales of $636m in 2031.

上市批准并购

2026-01-23

·药咖荟

J.P.摩根 week：礼来、AZ、默沙东、罗氏巨头战略布局全景图

每年年初的JP摩根医疗健康大会（JPM Healthcare Conference）被誉为全球生物医药行业的“风向标”，不仅是企业展示年度成绩与未来蓝图的关键舞台，更是洞察产业趋势、资本动向与研发重心的窗口。本文将梳理多家领军企业在本次大会中释放的核心信号，勾勒出制药行业在新时代下的竞争图景。礼来 AI赋能研发，构建“减肥王国” PART.1 礼来在肥胖及相关并发症治疗领域已建立起显著优势，但其目光已投向更广阔的“帮助更多患者”的生态构建。公司宣布在全球有13个生产基地正在建设中，以保障其代谢明星产品的全球供应。更为重要的是，礼来正积极向“全方位健康解决方案提供者”演进。公司展示了其超越药物开发的创新：1月12日，礼来与英伟达合作建设行业领先的超级计算机以加速研发；通过风险投资支持超过180家生物科技公司，构建外部创新网络；以及直接服务患者，在2025年服务患者超过100万人。在研发层面，礼来正快速推进抗体偶联药物、放射性配体疗法、siRNA和基因治疗等新平台，并通过积极的并购（2025年完成39项交易，部署超40亿美元资本）将前沿科学快速纳入自身体系，旨在从药物发现、开发到患者支持的整个价值链建立竞争优势。阿斯利康剑指2030年800亿美元营收 PART.2 阿斯利康在其展示中重申了“到2030年实现800亿美元总收入”的雄心。公司2025年前九个月表现强劲，总收入增长11%，核心每股收益增长15%。其战略核心在于五大重点治疗领域（肿瘤、心血管、肾脏与代谢、呼吸与免疫、疫苗与免疫疗法）的均衡发展，并通过全球布局与多元化业务来源支撑增长。值得关注的是，阿斯利康将人工智能定位为贯穿价值链的核心驱动力。其介绍的“AI开发代理（AIDA）”系统旨在变革端到端的合成药物开发流程，有望将CMC开发时间缩短50%。此外，定量连续评分（QCS）技术应用于计算病理学，以更精准识别治疗响应人群。在潜力技术管线方面，公司重点展示了其在体重和心血管风险管理、抗体偶联药物（ADC）、双特异性抗体、细胞疗法等前沿领域的领先布局，例如rilvegostomig在非小细胞肺癌中的数据，以及AZD0120在多发性骨髓瘤中的潜力。百时美施贵宝通过BD引领企业增长 PART.3 百时美施贵宝（BMS）提出“构建一家财务强劲、在2030年代及以后实现行业领先可持续增长的公司”的目标。公司2025年的增长产品组合销售额增长了17%，并通过战略性业务发展增强了管线。 BMS着重介绍了其具有数十亿美元潜力的管线资产，包括神经科学领域的Cobenfy（KarXT）、心血管领域的milvexian、免疫领域的admilparant、肿瘤领域的pumitamig（PD-L1 x VEGF双抗）以及血液学领域的iberdomide/mezigdomide等新型蛋白降解剂。公司预计到2030年将有超过10个新产品上市机会，并强调严格的研发执行和资本配置纪律。其资本部署策略包括投资业务、通过股息和回购回报股东，以及战略性业务开发，近期与BioNTech、SystImmune等公司的合作即是例证。默沙东构建“后K药时代”的增长支柱 PART.4 默沙东的核心战略是“用下一波创新产品组合实现转型”。公司目前拥有约80项正在进行的三期研究，预计将有超过20个新药上市，其中绝大多数具备重磅炸弹潜力。其新增长驱动力的中期商业机会已增至超过700亿美元，显著高于市场对K药在2028年销售额的共识。这一增长主要来源于通过积极的“科学驱动型业务开发”所构建的丰富管线。公司正通过外部合作与自主研发，系统性地填补管线。例如，与第一三共合作的B7-H3 ADC（I-DXd）和HER3 ADC（P-DXd），与Kelun合作的TROP2 ADC（sac-TMT），以及自身在心血管代谢（如口服Lp(a)抑制剂）、感染性疾病（如长效HIV预防药MK-8527）和免疫学（TL1A抗体tulisokibart）等领域的布局。默沙东强调，这些在临床上已降低风险的产品，其收入机会几乎能完全抵消KEYTRUDA专利到期的影响，为公司平稳过渡至2030年代奠定了坚实基础。安进六大增长引擎，新秀减肥管线 PART.5 安进强调其通过“六大关键增长驱动因素”实现长期可持续增长的战略，涵盖心血管（Repatha）、骨骼健康（EVENITY）、呼吸（TEZSPIRE）、罕见病、创新肿瘤学和生物类似药。其中，罕见病组合年化销售额已接近50亿美元，而生物类似药业务累计销售额已达约130亿美元。本次大会中，安进着重推介了其肥胖症治疗候选药物Marifide。公司公布了其在2型糖尿病和慢性体重管理方面的二期研究积极结果，强调其作为“首个月度给药型2型糖尿病疗法”的潜力，以及其在维持期治疗中展现出的良好耐受性。六项全球三期研究正在进行中，标志着安进正式加入竞争日益激烈的代谢疾病战场。诺华手握多个重磅新药 PART.6 诺华首席执行官Vas Narasimhan展示了公司在剥离山德士后的强劲增长轨迹。公司战略聚焦于心血管-肾脏-代谢、免疫学、神经科学和肿瘤学四大核心治疗领域，以及化学、生物治疗、xRNA、放射性配体疗法和基因与细胞疗法五大技术平台。公司预计2025-2030年销售额复合年增长率（CER）为5-6%，并在2029年将核心利润率恢复至40%以上。诺华在未来两年拥有超过15项可能支持申报的临床数据读出，管线中拥有30多个高价值新分子实体。近期在心血管领域新增的abelacimab（FXI抑制剂）、pacibektug（抗IL-6单抗）和farabursen（miR-17抑制剂）等项目，进一步丰富了其产品线。罗氏聚焦关键上市产品 PART.7 罗氏制药首席执行官Teresa Graham指出，公司正致力于“交付下一个创新周期”。短期战略围绕最大化在售产品组合、交付关键上市产品（如Gazyva、giredestrant、fenebrutinib）以及推进后期管线。罗氏强调其超过60%的研发管线和制药销售额涉及合作伙伴关系，展现了开放创新的模式。在肿瘤领域，下一代选择性雌激素受体降解剂（SERD）giredestrant有潜力成为ER+乳腺癌的 endocrine therapy 骨干。在神经科学领域，fenebrutinib作为唯一在复发型和原发进展型多发性硬化症三期试验中取得阳性结果的BTK抑制剂，备受关注。此外，罗氏明确表达了在肥胖症领域成为TOP3玩家的决心，预计2026年将公布五款新分子实体的三期启用数据。拜耳聚焦心血管肾病 PART.8 拜耳制药展示了其“焕新收入、提升管线价值、利用新运营模式”三大战略支柱已取得切实成果。尽管面临Xarelto的销售下滑，但新产品Nubeqa（前列腺癌）和Kerendia（心肾疾病）的持续增长势头有效地弥补了缺口。下一代产品，如用于继发性卒中预防的因子XIa抑制剂asundexian（已取得首个阳性三期结果）、用于血管舒缩症状的神经激肽拮抗剂Lynkuet，以及用于转甲状腺素蛋白淀粉样变性心肌病的Beyontra，构成了公司的下一波增长动力。拜耳特别强调了其“独特创新引擎”的重塑。新的、更聚焦的研发模型在2025年取得了五项新适应症或产品批准，完成了16个临床项目的推进。公司通过战略性交易（如从BridgeBio引进Beyontra）和投资细胞与基因治疗等平台公司，弥补了近期管线缺口，并为长远发展储备了项目。拜耳的目标是，最迟在2027年恢复中个位数增长，并在2030年将利润率提升至30%左右。赛诺菲专注创新药，重塑增长路径 PART.9 在本次JPM大会上，赛诺菲明确展示了其向纯粹“研发驱动、AI赋能”生物制药公司转型的战略定力。在完成消费者健康业务剥离后，公司正将资源全面聚焦于具备长期增长潜力的核心制药与疫苗创新。 2025年的业绩初步验证了这一路径。通过积极的“买与卖”，公司在收购Blueprint、Dynavax等强化管线的同时，完成了大规模股份回购。前九个月销售额增长8.7%，12款新产品贡献了39亿欧元收入，其中血友病A疗法ALTUVIIO已成为新的重磅炸弹。公司的未来增长高度依赖于其聚焦免疫炎症、呼吸、罕见病及疫苗的中后期管线。核心资产包括：在特应性皮炎领域已进入三期的OX40L单抗amlitelimab、在化脓性汗腺炎显示潜力的IL-17A/F双抗brivekimig，以及与阿斯利康合作、市场表现强劲的RSV预防药物nirsevimab。赛诺菲强调，2026年将是管线价值验证的关键一年，多项重要临床数据即将读出。其战略核心在于，通过彻底的业务聚焦和资本配置，将科学潜力转化为一系列成功的上市产品，重塑其作为领先创新药企的增长轨迹。武田三款重磅产品重塑增长曲线 PART.10 武田将其发展周期划分为两个阶段：FY2021-2025是管理专利悬崖、聚焦研发和建设数字化能力的“蓄力期”；而FY2026-2030+则是凭借变革性后期管线驱动增长的“收获期”。公司明确指出，未来18个月内有望上市的三款新药——用于发作性睡病1型的orexin受体2激动剂TAK-994、用于真性红细胞增多症的hepcidin模拟物rusfertide、以及用于银屑病的高选择性TYK2抑制剂zasocitinib——将把公司带入全新的增长轨道。每款产品都瞄准了存在显著未满足需求的领域，并具备成为标准疗法的潜力。例如，rusfertide在三期研究中展现出持久且稳定的血细胞比容控制能力，能大幅降低患者放血治疗需求，有望革新真性红细胞增多症的全程管理。武田强调，这八款具有数十亿美元潜力的在研产品，加上在2030年前有限的仿制药冲击，将支持公司在投资新药上市和研发的同时，实现利润率的改善。第一三共坚定迈向全球肿瘤领域领导者 PART.11 第一三共明确宣示其目标：“顶级ADC公司，成为全球肿瘤领导者”。公司凭借其独创的DXd ADC技术平台，已衍生出7款在研药物，其中ENHERTU®（trastuzumab deruxtecan）已成为过去五年肿瘤领域最成功的上市产品之一，累计销售额超过1.5万亿日元。DATROWAY®（datopotamab deruxtecan）也展现出快速增长的势头。公司计划到2030年在至少4款ADC药物中推出多项新适应症，覆盖患者数预计将增长近六倍。此外，第一三共正积极布局免疫肿瘤学（IO）及其他新模态（如多特异性抗体、基因治疗等），构建超越ADC的多元化技术矩阵，以确保持续创新。吉利德 HIV领导者与多元化管线并进 PART.12 吉利德的核心信息围绕三大支柱展开：延续至2040年代的HIV治疗与预防领导地位、公司历史上最强劲的临床与上市管线，以及对运营开支和并购的积极主动且 disciplined 的策略。其HIV业务预计2025年收入将超过200亿美元，比卡替拉韦/恩曲他滨/丙酚替诺福韦（Biktarvy）市场地位稳固，而长效注射剂Yeztugo（lenacapavir）用于HIV暴露前预防（PrEP）的上市正开辟全新格局。在肿瘤领域，Trodelvy在转移性三阴性乳腺癌一线治疗的数据，以及BCMA CAR-T疗法anito-cel在复发/难治性多发性骨髓瘤中的潜力，预示着吉利德在肿瘤领域的增长动能。公司预计2026年将有最多10款产品处于上市或即将上市阶段。渤健神经与免疫管线接棒增长 PART.13 渤健正致力于讲述一个“创新与增长新篇章”的故事。公司通过“Fit for Growth”计划完成了成本重组（节省10亿美元），并重建了研发管线，将资源集中于高确信度的项目。目前，其上市新产品（如阿尔茨海默病药物LEQEMBI、弗里德赖希共济失调药物SKYCLARYS等）的收入增长已完全抵消了多发性硬化症产品线的下滑。公司的长期战略依赖于三波增长动力：当前的增长产品、后期注册管线（如狼疮药物litifilimab、IgA肾病药物felzartamab等）以及早期高风险/高回报项目。2026年被渤健视为转型的关键一年，将迎来litifilimab的两项三期数据读出、LEQEMBI皮下制剂的监管决定以及多个早期项目的重要进展。渤健正努力从一个依赖成熟产品的公司，转型为一个由新上市产品和丰富管线驱动的增长型生物科技企业。结语纵观本届JPM大会，制药巨头的战略共性凸显：首先，AI和数字化技术渗透至研发、生产及商业化全链条，以提升效率与精准性；其次，肿瘤、代谢疾病、神经科学成为管线竞争焦点，ADC、细胞疗法等前沿平台屡见突破；最后，资本配置更趋理性，企业通过股息、回购与选择性并购平衡短期收益与长期创新。在患者需求与政策变革的双重驱动下，行业正迈向一个更高效、更个性化的新纪元。参考资料： 1. 2026年摩根大通医疗健康大会官网 END △ 聚焦“国之大者”CBIITA 联合体荣获“中国产学研合作十大好平台” 更多优质内容，欢迎关注媒体合作投稿转载/资料领取/加入社群请添加药小咖与/智/者/同/行为/创/新/赋/能

2026-01-23

·Firstwordpharma

NICE U-turn allows NHS funding of Pfizer's Talzenna for prostate cancer

Having recently widened access to abiraterone, the National Institute for Health and Care Excellence (NICE) on Friday issued another decision that will benefit prostate cancer patients in the UK, this time backing use of Pfizer's Talzenna (talazoparib) for those with advanced disease. The recommendation comes a matter of months after the cost-effectiveness body also issued a positive assessment of Bayer's Nubeqa (darolutamide).NICE's ruling on Talzenna represents something of a U-turn, having published draft guidance last August against use of the oral PARP inhibitor with Pfizer and Astellas' androgen receptor signalling inhibitor Xtandi (enzalutamide) for untreated hormone-relapsed metastatic prostate cancer in adults when chemotherapy is not clinically indicated. At the time, NICE noted that the available evidence — which included indirect comparisons with standard treatments such as Xtandi alone or abiraterone plus prednisolone — does not suggest that the combination is value for money in this population.However, NICE said Friday that Talzenna is now recommended, alongside Xtandi, for adults with prostate cancer that has spread. Specifically, Pfizer's once-daily drug is recommended for people where chemotherapy is not suitable and who cannot tolerate or take abiraterone plus prednisolone.Study results showed that in people taking Talzenna with Xtandi, overall survival was 45.8 months compared with 37 months for those on Xtandi alone. The time people lived without their cancer getting worse also increased: 33.1 months compared with 19.5 months. Helen Knight, director of medicines evaluation at NICE, said the combination of Talzenna plus Xtandi "can be taken at home, so provides a convenient and flexible treatment option for people who can't have chemotherapy and are not able to take other medicines so have limited treatment options." NICE noted that this will also reduce pressure on the National Health Service (NHS).The cost-effectiveness body indicated that a confidential commercial arrangement is in place to provide Talzenna to the NHS at a discounted price.

临床结果上市批准临床3期

100 项与达罗他胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11045	达罗他胺	L02BB06	DB12941

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
去势敏感前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2025-06-03
激素依赖性前列腺癌	欧盟	Bayer AG	2023-03-20
激素依赖性前列腺癌	冰岛	Bayer AG	2023-03-20
激素依赖性前列腺癌	列支敦士登	Bayer AG	2023-03-20
激素依赖性前列腺癌	挪威	Bayer AG	2023-03-20
转移性前列腺癌	日本	Bayer AG	2023-02-24
转移性去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2022-08-05
前列腺癌	巴西	Bayer AG	2020-01-01
去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2019-07-30

未上市

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适应症	最高研发状态	国家/地区	公司	日期
局限性前列腺癌	临床3期	法国	Bayer AG	2025-04-10
局限性前列腺癌	临床3期	马提尼克	Bayer AG	2025-04-10
复发性前列腺癌	临床3期	美国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	中国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	日本	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	澳大利亚	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	奥地利	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	比利时	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	巴西	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	加拿大	Bayer AG	2023-04-03

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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


NCT02200614 (ARAMIS, Pubmed \| Cancer Med)	临床3期	去势抵抗性前列腺癌	1,509	Darolutamide + ADT	網廠窪觸顧壓鏇壓衊遞(觸觸顧顧夢艱醖願鑰衊): HR = 0.36 (95.0% CI, 0.26 ~ 0.48) 更多	积极	2026-01-01
				Placebo + ADT
ARAMIS (ESMO_ASIA2025)	临床3期	去势抵抗性前列腺癌	76	Darolutamide + androgen-deprivation therapy	構窪鑰膚齋壓繭窪艱壓(繭積憲醖夢糧夢醖窪窪) = 範願願鏇餘鹹廠鬱顧廠鏇獵構簾選夢壓製觸蓋 (窪襯糧鑰選鹽齋製積鏇 ) 更多	积极	2025-12-05
ChiCTR2500096436 (DAPLOM, ESMO_ASIA2025)	临床2期	去势敏感前列腺癌	60	Darolutamide + ADT + prostate arterial docetaxel infusion	顧襯構膚築壓獵膚獵簾(顧襯觸窪觸網獵齋願獵) = 壓窪餘衊鏇網築衊遞構鹽醖獵觸艱糧遞壓鬱鑰 (積遞願衊廠範壓窪艱廠 )	积极	2025-12-05
ESMO_ASIA2025	N/A	激素依赖性前列腺癌	25	Darolutamide + Docetaxel + ADT	襯鹹廠窪鬱積餘艱鹹醖(構顧簾構構鬱網鏇選觸) = 齋網鹽簾積鏇壓獵鬱製襯憲憲鏇鏇艱襯蓋餘糧 (顧鬱衊網艱鹹簾鏇壓範 ) 更多	积极	2025-12-05
ESMO_ASIA2025	N/A	激素依赖性前列腺癌	8	Darolutamide + Trans-arterial chemoperfusion by Docetaxel + ADT	顧鑰遞淵積廠壓膚鹽積(鹽願膚壓築膚獵憲築範) = 糧鬱繭蓋鏇鏇夢糧憲選夢艱願衊艱繭獵壓鏇膚 (壓鏇鑰鹹構製鏇選窪鏇 ) 更多	积极	2025-12-05
NCT05794906 (ARASTEP, Pubmed \| Future Oncol)	临床3期	非转移性前列腺癌	970	Darolutamide + ADT	蓋淵願網窪壓鬱鹽夢觸(鑰餘鹽夢廠築餘繭窪鏇) = 獵襯鹹廠糧積製窪夢艱積鬱獵蓋憲繭窪壓憲顧 (範餘夢鹹鏇糧壓憲廠遞 ) 更多	积极	2025-11-14
				Placebo + ADT	蓋淵願網窪壓鬱鹽夢觸(鑰餘鹽夢廠築餘繭窪鏇) = 鹽築鹹鏇鏇鬱簾蓋繭壓積鬱獵蓋憲繭窪壓憲顧 (範餘夢鹹鏇糧壓憲廠遞 ) 更多
ESMO2025	N/A	激素依赖性前列腺癌	242	Darolutamide+ADT+DOC (DAR)	鹹製鏇餘願壓簾顧獵憲(鬱蓋襯鹹繭壓鹹齋餘膚) = 願鏇觸顧築鏇衊膚選鬱醖淵鏇網醖顧廠廠襯範 (鑰遞鏇鏇願積淵鬱襯鹹, 51.0 ~ 72.9) 更多	积极	2025-10-17
				Abiraterone+ADT+DOC (ABI)	鹹製鏇餘願壓簾顧獵憲(鬱蓋襯鹹繭壓鹹齋餘膚) = 廠觸鑰襯構壓鏇構窪鹽醖淵鏇網醖顧廠廠襯範 (鑰遞鏇鏇願積淵鬱襯鹹, 32.0 ~ 63.0) 更多
ESMO2025	N/A	激素依赖性前列腺癌	1,189	ADT + Docetaxel + Darolutamide	積範鏇蓋鹹醖繭範選膚(築鏇鏇窪衊廠築獵鬱鹹): HR = 0.42 (95.0% CI, 0.21 ~ 0.82)	积极	2025-10-17
				ADT + Docetaxel
NCT04122976 (DAROL, ESMO2025)	N/A	去势抵抗性前列腺癌	799	Darolutamide	憲構膚遞遞艱構艱製繭(壓製鬱範鑰繭廠鏇鬱糧) = 觸鑰顧構鏇糧積膚網遞餘製艱製獵觸選夢繭願 (觸鏇網餘築積觸獵範鬱 ) 更多	积极	2025-10-17
				Placebo	憲構膚遞遞艱構艱製繭(壓製鬱範鑰繭廠鏇鬱糧) = 範顧觸繭獵廠淵艱衊鏇餘製艱製獵觸選夢繭願 (觸鏇網餘築積觸獵範鬱 ) 更多
NCT06029036 (ESMO2025)	临床2期	新辅助	53	Darolutamide + ADT	範鬱範憲淵顧淵製淵鹹(鹽顧窪鏇鹹鹽繭鑰觸構) = 繭淵糧製遞顧醖遞構襯顧衊觸選築顧獵構壓壓 (膚蓋襯網選積獵積鹽廠 ) 更多	积极	2025-10-17