An Open-label, Multi-center, First in Human Phase I Global Dose Escalation and Expansion Study of INR731 Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer

The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastatic prostate cancer.

开始日期2026-05-26

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

CTIS2025-524440-35-00

/ Not yet recruiting临床4期IIT

Standard dosed abiraterone versus Therapeutic Drug Monitoring guided abiraterone dosing – The Adapt Abi trial

开始日期2026-05-01

申办/合作机构-

NCT07237269

/ Recruiting临床2期IIT

Abiraterone/Prednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy

The advent of PSMA-PET has improved sensitivity and specificity in staging prostate cancer, particularly in intermediate- and high-risk disease. This has created uncertainty in the management of patients with PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e., <1 cm in smallest diameter).
This study evaluates outcomes of enhanced androgen deprivation therapy (ADT) with abiraterone and prednisone compared to standard ADT, both in combination with radiation therapy, in patients with prostate cancer and PSMA-positive but conventionally negative pelvic lymphadenopathy.
A total of 140 eligible participants will be randomized to receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy. Participants will be followed for 5 years after completion of ADT to assess outcomes.
The primary objective is to determine whether enhanced ADT improves 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of toxicity, quality of life, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival.
Exploratory objectives include evaluation of tumor growth and regression rates using PSA values and assessment of the relationship between treatment outcomes and blood-based heme oxygenase-1 (HO-1) levels.

开始日期2026-04-03

申办/合作机构

University of Nebraska

100 项与醋酸阿比特龙相关的临床结果

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100 项与醋酸阿比特龙相关的转化医学

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100 项与醋酸阿比特龙相关的专利（医药）

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3,282

项与醋酸阿比特龙相关的文献（医药）

2026-09-26·ENDOCRINE-RELATED CANCER

Body composition in recurrent prostate cancer and the role of steroidogenic genotype

Article

作者: Pilie, Patrick G ; Mukhida, Sagar S ; Corn, Paul G ; Koutroumpakis, Efstratios ; McQuade, Jennifer L ; Tidwell, Rebecca S ; Gregg, Justin R ; Zurita, Amado J ; Hahn, Andrew W ; Aparicio, Ana ; Frigo, Daniel E ; Huff, Chad ; Logothetis, Christopher J ; Subudhi, Sumit K ; Siddiqui, Bilal A ; Venkatesh, Neha ; Yu, Yao

Hormone therapy (HT) to treat prostate cancer is reported to cause adverse changes in body composition. Clinically, interpatient body composition changes are heterogeneous, but the biological and clinical determinants of body composition toxicity are unknown. Herein, we test the hypothesis that inherited polymorphisms in steroidogenic genes are associated with differential changes in body composition after HT. Men with biochemically recurrent prostate cancer (BCR) who received 8 months of LHRH analog (LHRHa) +/− abiraterone acetate (AAP) were eligible if they had: i) CT imaging of L3 prior to and after treatment; and ii) nucleated cells collected. Cardiometabolic co-morbidities were retrospectively extracted. Body composition was measured using an AI-based segmentation tool. Germline DNA whole exome or genome sequencing was performed. In 162 men treated with 8 months of HT, median skeletal muscle mass (SMMi) loss was 6.6% and subcutaneous adipose gain was 12.3%. Men with type 2 diabetes had higher losses of SMMi after treatment (−11.1% vs −6.3%, P = 0.003). For the 150 men with germline NGS, SRD5A2 rs523349 genotype was associated with differential loss in skeletal muscle density after HT, (−1.3% vs −7.1%, P = 0.04). In addition, the HSD3B1 rs104703 genotype was associated with decreased baseline visceral adipose tissue (63.0 cm2/m2 vs 77.9, P = 0.05). In men with BCR, HT induced notable loss of skeletal muscle and increased subcutaneous adipose tissue. An inherited polymorphism in SRD5A2 and T2DM was associated with differential skeletal muscle toxicity. These findings suggest that inherited polymorphisms may contribute to the body composition toxicity observed with HT.

2026-06-01·Health policy OPEN

Price transparency & out-of-pocket payments for medications: Implications of associated delivery fees in the United States

Article

作者: Kaye, Deborah R ; Scales, Charles D ; George, Daniel J ; Lee, Hui-Jie ; Bundorf, M Kate

Background:

Price transparency has been cited as a tool to reduce out-of-pocket (OOP) payments to patients. These tools for prescription drugs often focus on the price to patients for the drug alone. However, costs associated with drug delivery (i.e. infusion center fees, labs, etc) are often unknown and could impact the effectiveness of price transparency tools. Objective: To examine total OOP payments on day of drug receipt ("full day", i.e. drug + drug administration fees) out-of-pocket (OOP) payments associated with six first-line treatments for metastatic castrate resistant prostate cancer and compare these with payments for drug alone and by insurance type.

Methods:

Using the IBM Marketscan databases, we identify male patients who initiated treatment with one of six focus drugs (docetaxel, abiraterone, enzalutamide, sipuleucel-T, cabazitaxel, and radium-223) used to treat mCRPC from 07/01/2013-06/30/2019. We calculated total OOP payments on day of drug receipt (full day OOP payments) by drug type for six first line treatments. We then used a two-part model to assess the association of first-line therapy with OOP payments for the four most frequently prescribed during the study time period.

Results:

We find that there is variation in the proportion of payments for drug alone relative to full day payments across first-line treatments. However, regression-adjusted mean full day OOP payments are not statistically different across first-line treatments for mCRPC for the four most frequently prescribed drugs. There are differences in the likelihood that an individual will incur any OOP payment by first-line treatment type and by health plan type.

Conclusion:

These analyses suggest that when accounting for additional services required on the day of drug receipt, the amount a patient pays to receive a medication for mCRPC can be very different from the OOP payment for the drug alone; these payments also vary by drug and health plan type. Therefore, price transparency for drug alone may not lead to reduced OOP payments for patients.

2026-06-01·JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

Serendipity, steroids and science

Review

作者: Sharifi, Nima

The androgen signaling pathway is probably the most important pathway in enabling prostate cancer progression but it also plays essential roles in numerous processes in normal physiology. Both testosterone and dihydrotestosterone are potent androgens that activate the androgen receptor (AR). The essentiality of the androgen pathway in prostate cancer is evidenced in part by the reactivation of AR in prostate cancer that becomes resistant to treatment by gonadal testosterone deprivation. Furthermore, steroid metabolic processes that allow the regeneration of potent androgens in prostate cancer tissues drive this treatment-resistant state, as is made clear by the survival benefit of blocking the synthesis of non-gonadal androgens, e.g., with abiraterone. Here, I narrate and review the process that led to a series of discoveries in androgen metabolism from our group. In this perspective and mechanistic narrative review, I give an honest description of the accidental nature of some of our initial findings, followed by data-driven hypothesis refinement and subsequent studies that illuminate elements of androgen metabolism, with a focus on metabolism of carbon 3, carbon 5 and carbon 17 of the steroid backbone.

1,271

项与醋酸阿比特龙相关的新闻（医药）

2026-05-06

·ioncology

指南共识丨晚期前列腺癌应用新型内分泌治疗多学科管理专家共识（2026版）要点

点击上方蓝字关注我们编者按：晚期前列腺癌的治疗已进入以雄激素剥夺治疗（ADT）为基础、联合新型内分泌治疗（NHT）和多西他赛化疗的综合强化时代，鉴于我国患者多为共病多、存在多重用药的老年人群，针对心血管毒性、神经系统毒性和药物相互作用的精细化管理尤为重要。本共识基于现有循证医学证据和多学科临床经验，系统梳理了NHT相关不良反应的风险评估、分层管理和跨学科协作路径，并聚焦于不同NHT药物的心血管和神经系统安全性差异、联合其他合并症常用药物的相互作用风险和长期风险管控策略，以期推动晚期前列腺癌全程多学科的规范化管理。专家共识推荐汇总强烈共识在前列腺癌应用NHT的全程管理中，建议有条件的单位尽可能开展MDT讨论。一般共识在制订前列腺癌患者的强化治疗方案时，可选择将肿瘤负荷作为依据之一，但同时需将危险分层、患者年龄、转移特征、化疗耐受性、特殊病理类型和基因检测结果纳入综合评估。强烈共识对于mHSPC患者应用三联方案，建议优先选择达罗他胺。一般共识 mHSPC患者应用三联方案时，可选择新一代ARi+ADT同时或者2个月内联合多西他赛化疗。强烈共识 mHSPC患者应用三联方案时，建议重点监测血液学不良反应。未达成共识多西他赛治疗期间应关注患者综合体能状态，但同时应将器官功能以及治疗史和年龄纳入评估范围。一般共识对于合并心血管疾病的晚期前列腺癌患者，应用NHT时可选择达罗他胺。强烈共识前列腺癌患者（特别是既往有心血管病史的患者）应用NHT前，建议进行基线心血管风险评估。一般共识为减少中枢神经系统毒性风险，晚期前列腺癌患者应用NHT时可选择达罗他胺。强烈共识对于有癫痫病史、有认知障碍病史或疲乏/跌倒危险因素的前列腺癌患者，应用NHT前建议进行基线神经系统相关症状评估。强烈共识对于具有多重用药史的前列腺癌患者，应用NHT前建议进行全面用药评估。一般共识对于合并心血管疾病史且正在服用口服抗血栓类或他汀类药物的晚期前列腺癌患者，基于药物相互作用（DDI）相关风险考虑，应用NHT时可选择达罗他胺。强烈共识对于有高血压病史且正在服用降压药物的晚期前列腺癌患者，基于DDI相关风险考虑，应用NHT时可选择达罗他胺。一般共识对于有糖尿病病史且正在服用口服降糖药物的晚期前列腺癌患者，基于DDI相关风险考虑，应用NHT时可选择达罗他胺。一般共识对于需长期服用精神药物的晚期前列腺癌患者，基于DDI相关风险考虑，应用NHT时可选择达罗他胺。强烈共识对于应用NHT的晚期前列腺癌患者，建议优先通过提供宣教手册、电话随访宣教和（或）门诊宣教等方式向患者宣教DDI风险。 MDT管理问题1 在前列腺癌应用NHT的全程管理中，是否有必要开展MDT模式？（单选）调研结果：62%的专家认为MDT“非常重要，应常规开展”；34%的专家认为“重要，但临床实施受限”；4%的专家认为作用“一般，仍以单科管理为主”。合并来看，高达96%的专家认同MDT在NHT全程管理中的重要性。强化治疗的应用和管理 1. ADT+NHT+多西他赛三联方案作为mHSPC阶段一线选择决策问题2 在临床实践中针对特定的患者决定使用三联方案时，最重要的考量因素包括哪些？（单选）调研结果：74%的专家选择“高瘤负荷/低瘤负荷”；6%的专家选择“复发/新发”；6%的专家选择“高危/低危”；6%的专家选择“年龄”；8%的专家选择“其他”。有7位专家提及，决定使用强化治疗需综合考虑多方面因素，除上述考量因素外，还包括是否合并特殊病理类型、免疫组化染色检查结果、基因检测结果、化疗耐受性等。问题3 mHSPC患者应用三联方案时，NHT药物应如何选择？（单选）调研结果：90%的专家选择“达罗他胺”；4%的专家选择“阿比特龙”；4%的专家选择“无差异”；2%的专家选择“恩扎卢胺”“阿帕他胺”或“瑞维鲁胺”。问题4 mHSPC患者应用三联方案，应如何确定启动多西他赛化疗的时机？（单选）调研结果：65%的专家选择“同步治疗，新一代ARi+ADT同时或者2个月内联合多西他赛方案”；20%的专家选择“序贯治疗，新一代ARi+ADT起始，待前列腺特异性抗原（prostate-specific antigen，PSA）无法进一步下降时启动多西他赛治疗”；14%的专家选择“序贯治疗，新一代ARi+ADT起始，初始疗程完成后若PSA呈上涨趋势，启动多西他赛治疗”。 2. 多西他赛不良反应管理问题5 对于接受三联方案治疗的mHSPC患者，应重点监测哪些不良反应？（单选）调研结果：90%的专家选择“血液学毒性（如中性粒细胞减少、贫血等）”；4%的专家选择“神经系统损伤（如认知障碍、周围神经病变、癫痫发作等）”；2%的专家选择“心血管系统不良反应（如高血压、心律失常等）”；2%的专家选择“消化道反应（恶心、呕吐、腹泻、便秘等）”；2%的专家选择“疲乏及体能下降”或“肝毒性”。问题6 晚期前列腺癌患者接受多西他赛治疗时，应重点评估的因素包括哪些？（单选）调研结果：53%的专家选择“最关注体能状态”；25%的专家选择“最关注器官功能状况”；16%的专家选择“最关注年龄”；4%的专家选择“最关注既往治疗史及耐药情况”；2%的专家选择“其他”或“最关注合并症”。 NHT对心血管系统的作用和AE管理 1. NHT对心血管系统的作用问题7 对于合并心血管疾病的晚期前列腺癌患者，应用NHT时应如何选择药物？（单选）调研结果：79%的专家选择“达罗他胺”；9%的专家选择“无差异”；6%的专家选择“阿帕他胺”；4%的专家选择“恩扎卢胺”；2%的专家选择“瑞维鲁胺”或“阿比特龙”。 2. 心血管毒性管理问题8 在前列腺癌内分泌治疗可能会带来心血管风险的基础上，计划接受NHT的晚期前列腺癌患者是否有必要进行基线心血管风险评估？（单选）调研结果：51%的专家选择“是，对所有患者进行评估”；41%的专家选择“是，对既往有心血管病史的患者进行评估”；8%的专家选择“否，一般不评估”。合并选项后，92%的专家认为在前列腺癌内分泌治疗时应对所有患者（特别是既往有心血管病史的患者）进行基线心血管风险评估。 NHT对神经系统的作用和AE管理 1. NHT对神经系统的作用问题9 为减少中枢神经系统毒性风险，晚期前列腺癌患者应用NHT时应如何选择药物？（单选）调研结果：72%的专家选择“达罗他胺”；9%的专家选择“阿帕他胺”；9%的专家选择“阿比特龙”；6%的专家选择“瑞维鲁胺”；4%的专家选择“无差异”或“恩扎卢胺”。 2. 神经系统损伤管理问题10 在前列腺癌内分泌治疗会带来神经系统损伤风险的基础上，计划接受NHT的晚期前列腺癌患者是否有必要进行基线神经系统相关症状评估？（单选）调研结果：55%的专家选择“是，仅限于有癫痫病史、有认知障碍病史或疲乏/跌倒危险因素的特定患者”；35%的专家选择“是，对所有患者进行评估”；10%的专家选择“否，一般不评估”。合并选项后，90%的专家认为，针对有癫痫病史、有认知障碍病史或疲乏/跌倒危险因素的患者，在开始NHT前应进行基线神经系统相关症状评估。应用NHT与药物相互作用（DDI）的关系和管理 1. NHT应用与DDI的关系问题11 晚期前列腺癌患者在接受NHT治疗前，是否有必要进行全面用药评估？（单选）调研结果：51%的专家选择“是，对所有患者常规进行评估”；43%的专家选择“是，仅对有病史的患者进行评估”；6%的专家选择“否，一般不评估”。合并选项后，94%的专家建议对有多重用药史的前列腺癌患者开始NHT治疗时进行全面用药评估。问题12 对于有心血管疾病史且正在服用口服抗血栓类或他汀类药物的晚期前列腺癌患者，应用NHT时应如何选择药物？（单选）调研结果：72%的专家选择“达罗他胺”；11%的专家选择“恩扎卢胺”；11%的专家选择“无差异”；2%的专家选择“阿帕他胺”；2%的专家选择“瑞维鲁胺”；2%的专家选择“阿比特龙”。问题13 对于有高血压病史且正在服用降压药物的晚期前列腺癌患者，应用NHT时应如何选择药物？（单选）调研结果：80%的专家选择“达罗他胺”；11%的专家选择“无差异”；4%的专家选择“阿帕他胺”；2%的专家选择“恩扎卢胺”；2%的专家选择“阿比特龙”或“瑞维鲁胺”。问题14 对于有糖尿病病史且正在服用口服降糖药物的晚期前列腺癌患者，应用NHT时应如何选择药物？（单选）调研结果：70%的专家选择“达罗他胺”；11%的专家选择“恩扎卢胺”；11%的专家选择“无差异”；4%的专家选择“瑞维鲁胺”；2%的专家选择“阿帕他胺”；2%的专家“阿比特龙”。问题15 对于需长期服用精神类药物的晚期前列腺癌患者，应用NHT时应如何选择药物？（单选）调研结果：77%的专家选择“达罗他胺”；7%的专家选择“瑞维鲁胺”；4%的专家选择“恩扎卢胺”；4%的专家选择“阿帕他胺”；4%的专家选择“阿比特龙”；4%的专家选择“无差异”。 2. NHT应用与DDI管理问题16 对于应用NHT的晚期前列腺癌患者，应采取何种方式向患者宣教DDI风险？（单选）调研结果：60%的专家选择“提供宣教手册、电话随访宣教和（或）门诊宣教”；18%的专家选择“提供宣教手册”；10%的专家选择“门诊宣教”；8%的专家选择“目前还没有开展”；4%的专家选择“电话随访宣教”。 ▌参考文献：中国医师协会泌尿外科医师分会，中华医学会泌尿外科学分会. 晚期前列腺癌应用新型内分泌治疗多学科管理专家共识（2026版）. 中华泌尿外科杂志，2026，47(00):1-12. DOI:10.3760/cma.j.cn112330-20260305-00069 （来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

2026-05-06

·astrazeneca.com

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognised a favourable benefit risk profile for AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), based on the CAPItello-281 Phase III trial. The Committee voted 7 to 1, with 1 abstaining. In August 2025, the FDA accepted the supplemental New Drug Application (sNDA) for Truqap in combination with abiraterone and ADTbased on positive results from the CAPItello-281 Phase III trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress and simultaneously published in Annals of Oncology.1 Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the trial, said: “Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes. Their disease significantly impacts their quality of life and inevitably progresses to more advanced stages that are associated with high mortality rates. In addition to this poor prognosis, patients currently have limited treatment options, which is why today’s recommendation of the capivasertib combination is welcome news for both patients and clinicians to address an urgent need for new treatments that delay progression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “CAPItello-281 is the first pivotal trial to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer and its severe course of disease. The Committee’s recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the Truqap combination verifies its potential to address this significant need and optimise outcomes for patients. We are committed to working closely with the FDA to bring the first and only targeted treatment option to the one in four patients with this form of metastatic hormone-sensitive prostate cancer.” Results from the primary analysis of the CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death and a clinically meaningful improvement in median radiographic progression-free survival (rPFS) of 7.5 months with the Truqap combination versus treatment with abiraterone and ADT with placebo (based on a hazard ratio [HR] of 0.81; 95% confidence interval [CI] 0.66-0.98; p=0.034). Median rPFS was 33.2 months for the Truqap combination versus 25.7 months for the comparator arm.1 A consistent benefit was observed with the Truqap combination versus treatment with abiraterone and ADT with placebo in key secondary endpoints of the trial, including prolonged time to castration resistance (29.5 vs. 22.0 months [HR 0.77; 95% CI: 0.63-0.94]) and prostate-specific antigen (PSA) progression (HR 0.73; 95% CI: 0.52-1.01), and fewer and delayed events in terms of symptomatic skeletal event-free survival (SSE-FS) (42.5 vs. 37.3 months [HR 0.82, 95% CI: 0.66-1.02]).1 Overall survival (OS) data were immature at the time of primary analysis; however, subsequent interim results for OS numerically favoured the Truqap combination versus the comparator arm. The trial will continue as planned to further assess OS as a key secondary endpoint. The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine.Consistent with the addition of a targeted treatment to background therapy, Grade 3 or higher adverse events occurred in 67% of patients treated with the Truqap combination versus 40.4% of patients treated with abiraterone and ADT with placebo. The most common Grade 3 or higher adverse events in the Truqap arm were rash (12.3%), hyperglycaemia (10.3%), hypokalaemia (8.7%), diarrhoea (6.2%), hypertension (5.8%) and anaemia (5.2%).1 The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the feedback as it reviews the submission and is not bound by the Committee’s recommendation. A regulatory application for Truqap in combination with abiraterone and ADT for the treatment of PTEN-deficient mHSPC is under review in the EU based on the CAPItello-281 Phase III trial. AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. References Fizazi K, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone sensitive prostate cancer: CAPItello-281 phase III study.Ann Oncol2026; 37(1):53-68. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 Apr 4. doi: 10.3322/caac.21834. American Cancer Society. Key Statistics for Prostate cancer. Available at: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html. Accessed April 2026. Chowdhury S, et al. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020;15(3):301-315. National Cancer Institute. Hormone Therapy for Prostate Cancer Fact Sheet. Available at: https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet. Accessed April 2026. American Society of Clinical Oncology Educational Book. Metastatic Hormone-Sensitive Prostate Cancer: Toward an Era of Adaptive and Personalized Treatment. Available at: https://ascopubs.org/doi/pdf/10.1200/EDBK_390166. Accessed April 2026. Cancer Research UK. Hormone therapy for metastatic prostate cancer. Available at: https://www.cancerresearchuk.org/about-cancer/prostate-cancer/metastatic-cancer/treatment/hormone-therapy-for-metastatic-prostate-cancer. Accessed April 2026. Hussain M, et al. Metastatic Hormone-Sensitive Prostate Cancer and Combination Treatment Outcomes A Review. JAMA Oncol. 2024;10(6):807-820. Cerner CancerMPact database. Accessed April 2026. Cuzick J, et al. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. Br J Cancer. 2013;108(12):2582-2589. Gasmi A, et al. Overview of the Development and Use of Akt Inhibitors in Prostate Cancer. J Clin Med. 2021;11(1):160. The content above comes from the network. if any infringement, please contact us to modify.

Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer

临床结果上市批准

2026-05-06

·医药投资部落

即将亮相：港股合成致死肿瘤药第一股英派药业

汇聚了中国创新药行业核心资产的港股18A板块，即将迎来又一家创新药细分赛道的龙头企业：有着“合成致死肿瘤药第一股”之称的英派药业，已在5月5日开启港股招股流程，预计5月13日于香港联交所主板挂牌上市。立于港交所上市闸门之前，英派药业基本面已储备多重上行催化剂，蓄势待发。从当下看，核心产品塞纳帕利已经完成从临床资产到商业资产的关键转换，具备商业化爆发的显著潜力；从中期看，下一代PARP1选择性抑制剂提供了管线接力和全球化预期；从长期看，双载荷ADC与蛋白降解平台打开了合成致死赛道之外的巨大想象空间。英派药业展现出的，是一家Biotech从产品验证走向平台验证的潜力与优势。商业化兑现：核心资产塞纳帕利拥有BIC数据，欧盟上市申请已受理英派药业目前最为核心的产品，无疑是塞纳帕利。作为一款具备“Best-in-Class”数据的PARP1/2抑制剂，塞纳帕利于2025年1月获国家药监局批准上市，该药物也是国内仅有的三款获批用于卵巢癌“全人群”一线维持治疗的PARP1/2抑制剂之一。凭借在临床研究中体现的优效治疗结果数据，以及出色的安全性表现，塞纳帕利已构筑起临床推广的确定性优势，具备显著的商业化放量潜力。塞纳帕利的商业化确定性，建立在关键III期（FLAMES研究）的优效结果基础之上：塞纳帕利将疾病进展或死亡风险显著降低57%（HR=0.43, p<0.0001）。这一风险比在同类已上市PARP1/2抑制剂中创下最优纪录，该研究数据已于2024年5月在《Nature Medicine》上发表。更为重要的是，相关的临床获益覆盖全人群，尤其在BRCA野生型患者中同样达到HR=0.43，直接攻克传统PARP抑制剂疗效受限的临床痛点。与其他上市的PARP抑制剂相比，塞纳帕利非血液学不良反应发生率更低、整体程度更轻微，不良反应多集中于1~2级，有效提升患者长期用药耐受性和依从性，有助于保证疗效。对英派药业而言，这一适应症决定了塞纳帕利的商业分量，其进入的是卵巢癌维持治疗中患者基数最大、治疗位置最靠前、支付价值最集中的核心市场。根据弗若斯特沙利文数据，到2033年，仅中国卵巢癌一线维持治疗市场规模预计达到人民币108亿元，商业化前景非常值得期待。目前，英派药业为塞纳帕利引入华东医药作为中国大陆市场独家推广伙伴，成功补齐了Biotech在产品末端最稀缺的成熟商业化能力。这一能力的构建，不仅打通了从研发到市场的价值闭环，更标志着公司已具备将创新成果持续转化为稳定现金流的核心竞争力。华东医药长期深耕院内市场，具备成熟的准入、销售和学术推广体系，有助于塞纳帕利更快进入妇科肿瘤核心诊疗场景。叠加塞纳帕利在2025年12月已纳入新版国家医保目录，并自2026年1月1日起进入报销体系，这款药物的商业化开始进入疗效优势、渠道优势、支付优势共同驱动的放量阶段。与此同时，塞纳帕利用于卵巢癌一线维持治疗的欧洲上市许可申请，2025年8月已获EMA（欧洲药品管理局）受理，预计2026年下半年获批，这将成为英派药业从一家本土创新药公司走向国际化价值兑现的关键一步。未来已来：下一代PARP1选择性抑制剂 PARP1/2抑制剂的成功，证明了合成致死路线在肿瘤治疗中的巨大临床价值。传统非选择性PARP抑制剂的血液学毒性，可能与PARP2抑制及捕获效应有关，这在一定程度上限制了剂量强度和联合治疗开发。精准抑制PARP1并保留PARP2功能，成为下一代PARP药物的重要研发方向。英派药业的IMP1734正是这一逻辑下的核心资产。招股书披露，IMP1734对PARP1的选择与PARP2相比高达648倍以上，这种靶点高选择性优势，可转化为更可靠的靶点抑制和更宽治疗窗口。临床研究层面，IMP1734已经进入全球I/II期阶段。I期剂量爬坡中，单药治疗显示良好药代动力学特征，耐受性较好，不良事件多为低级别、可管理或自限性；在经多线治疗的HRR（同源重组修复）突变患者中，观察到初步抗肿瘤活性。公司已启动IMP1734的II期剂量优化试验，并同步探索与阿比特龙、紫杉醇等药物联合，以拓展PARP1选择性抑制剂在实体瘤中的适用空间。如果说IMP1734代表的是PARP1选择性抑制剂的主航道，IMP1707则承担了更具差异化的CNS（中枢神经系统）方向。 IMP1707作为全球少数能高效穿透血脑屏障的PARP1选择性抑制剂，其核心优势在于对PARP1的选择性高达PARP2的800倍以上。临床前研究显示，IMP1707在小鼠和大鼠模型中的脑部游离药物浓度（Kpuu=0.5）已达到治疗相关水平，在脑癌模型中实现肿瘤完全消退，最小有效剂量为0.2mg/kg，因此其潜力不仅限于外周实体瘤，更有望攻克胶质母细胞瘤等传统PARP抑制剂难以企及的颅内病灶。截至招股书披露日，IMP1707已于2025年4月启动全球I/II期临床试验。公司计划在剂量递增阶段完成后探索单药和联合治疗方案。对于英派药业而言，IMP1734和IMP1707构成了塞纳帕利之后的第二层资产：一个指向更安全、更适合联合用药的PARP主流升级，一个指向脑转移和原发性CNS肿瘤的差异化产品，两者共同构成英派药业走向全球合成致死平台公司的关键资产组合。新技术赛道扩展市场往往习惯将英派药业定位为一家深度绑定合成致死赛道的小分子药物公司，这一判断并不全面。招股书披露，英派药业正在建设包括双载荷ADC连接子-载荷平台，以及涵盖PROTAC的靶点降解平台在内的新兴技术平台。这意味着，英派药业的技术半径正从合成致死小分子药物赛道，延伸到围绕肿瘤治疗的多种前沿技术路线。其中，IMP32作为源自公司自主连接子-载荷平台的新型双载荷ADC，把TOP1抑制剂和ATR抑制剂组合进双载荷ADC中。前者诱导DNA损伤，后者削弱肿瘤细胞对损伤的应答和修复能力，应用合成致死原理克服TOP1单载荷ADC耐药或不敏感的缺陷。目前研究数据显示，IMP32在TOP1i敏感和不敏感细胞系中均较TOP1i单载荷ADC表现出更强的肿瘤抑制作用；体内研究也显示，其在TOP1i不敏感CRC CDX模型中具备更优的抗肿瘤疗效。 IMP32是英派药业把合成致死技术能力嵌入ADC载荷设计的一次平台化尝试，把ADC的递送优势与英派药业熟悉的DNA损伤应答机制结合起来，试图在TOP1载荷耐药或不敏感人群中打开治疗窗口，其未来的临床价值具有巨大的想象空间。 IMP27是英派药业在靶向蛋白降解平台上的代表性资产，这款管线用PROTAC（蛋白降解靶向嵌合体）技术解决传统小分子抑制剂难以达成的选择性问题。 KAT6A（赖氨酸乙酰转移酶6A）是一种帮助癌细胞打开基因转录开关的蛋白，在多种癌症中高表达，具备清晰的抗肿瘤开发价值。但是传统的小分子药物很容易同时靶向KAT6A与KAT6B，从而造成血液毒性。 IMP27的技术优势，是用PROTAC（蛋白降解靶向嵌合体）方式选择性降解KAT6A。招股书数据显示，IMP27可实现亚纳摩尔级KAT6A降解，相比于对KAT6B的选择性降解倍数超过1000倍，显示出很强的靶点区分能力。从已披露的临床前结果看，IMP27已经显现出体内有效性和更优的安全性窗口，有望成为蛋白降解赛道的一款潜在重磅资产。双载荷ADC技术平台与靶向蛋白降解技术平台的成型，分别对应两类更高门槛的创新方向，这是英派药业企业护城河的进一步加深，标志着其研发能力正在从单一小分子药物，走向多技术形态、多机制组合和多资产生成的阶段。对于创新药公司而言，真正的稀缺性并非体现在管线数量，而在于其技术平台能否持续产出具有临床差异化和市场竞争力的创新资产，英派药业已经初步向市场证明了自己的这种能力。资本市场的高度认可凭借在细分赛道的显著优势，英派药业获得了资本市场的高度认可。英派药业此次IPO的基石投资者阵容极为豪华，并且横跨多重属性：LAV（礼来亚洲基金）代表顶尖医疗垂直资本的专业认可，腾讯代表跨界巨头对公司底层技术的战略下注，美元基金Exome注入国际化视野，此外还有近千亿级别长线基金Foresight的提前锁定，而江北新区国资则提供了地方产业资本的强力托举。这种跨越了垂直VC、科技巨头、美元基金与地方国资的综合型基石投资者阵容，即使在目前IPO极为活跃的港股市场上，也是不多见的。值得一提的是，礼来亚洲基金于英派药业IPO前已是公司最大机构投资方。此前，英派药业已完成多轮融资，获得Decheng Capital、腾讯，华岭资本、越秀产业基金、高特佳、熙诚金睿、太平洋保险等知名机构投资。此外，高盛与中金公司作为英派药业此次IPO的联席保荐人，二者兼具国际资本市场的覆盖能力与中国创新药企业上市的丰富经验，属于港股IPO保荐阵容的顶级配置。保荐机构的选择，不仅决定了IPO的发行效率，更决定了股票上市后的流动性中枢与机构覆盖广度。高盛与中金公司的联席配置，精准契合了英派药业“立足本土，辐射全球”的战略诉求，有助于实现更高的发行效率。结语从成功研发BIC级别的单品，到跨代管线的持续布局，再到创新底层平台输出，英派药业向资本市场全面展示了一条极具说服力的Biotech产业进阶之路。此次港股IPO，是公司发展历程中的一次具有战略意义的生态位跃迁。不仅将为公司注入加速推进下一代全球核心管线研发的强劲资本动能，亦将为资本市场增添一项具备长期发展潜力的创新药细分赛道的核心资产。

100 项与醋酸阿比特龙相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D09701	醋酸阿比特龙	L02BX03	DB05812

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
转移性前列腺癌	巴西	Libbs Farmacêutica Ltda.	2018-12-24
神经内分泌前列腺癌	日本	Janssen Pharmaceutical KK	2018-02-16
去势抵抗性前列腺癌	澳大利亚	Janssen-Cilag Pty Ltd.	2012-03-01
激素依赖性前列腺癌	澳大利亚	Janssen-Cilag Pty Ltd.	2012-03-01
转移性去势抵抗性前列腺癌	美国	Janssen Biotech, Inc.	2011-04-28

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适应症	最高研发状态	国家/地区	公司	日期
前列腺腺癌	临床3期	美国	Tavanta Therapeutics, Inc.	2021-05-05
前列腺腺癌	临床3期	法国	Tavanta Therapeutics, Inc.	2021-05-05
前列腺腺癌	临床3期	匈牙利	Tavanta Therapeutics, Inc.	2021-05-05
前列腺腺癌	临床3期	波兰	Tavanta Therapeutics, Inc.	2021-05-05
前列腺腺癌	临床3期	西班牙	Tavanta Therapeutics, Inc.	2021-05-05
前列腺腺癌	临床3期	瑞典	Tavanta Therapeutics, Inc.	2021-05-05
前列腺腺癌	临床3期	英国	Tavanta Therapeutics, Inc.	2021-05-05
去势敏感前列腺癌	临床3期	美国	Tavanta Therapeutics, Inc.	2021-05-05
去势敏感前列腺癌	临床3期	法国	Tavanta Therapeutics, Inc.	2021-05-05
去势敏感前列腺癌	临床3期	匈牙利	Tavanta Therapeutics, Inc.	2021-05-05

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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


NCT02772588 (CTgov)	临床2期	前列腺癌 \| 前列腺腺癌	64	stereotactic, ultra-fractionated radiotherapy+ARN-509+Abiraterone+Leuprolide	積築膚鹹獵積範鏇鬱壓 = 糧醖構簾遞糧憲觸醖構築襯鹹糧選鹹衊襯鹹窪 (顧選憲選鹽鏇觸獵遞遞, 衊齋鹹齋窪憲鏇膚製繭 ~ 廠壓繭鑰壓積繭積觸蓋) 更多	-	2026-04-13
NCT00268476 (STAMPEDE, Pubmed \| J Clin Invest)	临床3期	转移性前列腺癌 Ki-67	1,605	Abiraterone + ADT	餘艱簾繭襯簾鹹廠鬱齋(襯膚繭觸鹽繭製窪獵獵) = 積鑰醖鏇製壓夢窪艱膚選築觸鬱衊網鬱範構艱 (蓋鬱遞願淵製膚壓糧鏇 )	积极	2026-03-31
NCT03012321 (BRCAAway, ASCO_GU2026) 人工标引	临床2期	转移性去势抵抗性前列腺癌一线 DNA repair defects	61	Abiraterone 1000 mg QD + prednisone 5 mg BID	鹹積鑰鹽衊壓遞淵糧襯(繭鑰蓋網製夢簾築夢簾) = 醖遞鑰餘製餘廠簾廠窪膚壓鏇鏇膚範鏇築窪夢 (廠鏇簾簾夢夢膚膚願繭, 13 ~ NR) 更多	积极	2026-02-26
				Olaparib 300 mg BID	鹹積鑰鹽衊壓遞淵糧襯(繭鑰蓋網製夢簾築夢簾) = 糧蓋齋艱鏇築範膚糧網膚壓鏇鏇膚範鏇築窪夢 (廠鏇簾簾夢夢膚膚願繭, 26 ~ NR) 更多
NCT06991556 (ASCO_GU2026)	临床2期	激素依赖性前列腺癌	150	Luxdegalutamide 100 mg QD + abiraterone 1000 mg QD	獵艱餘遞鏇繭壓鏇製願(窪願鬱積願製齋獵願窪) = 顧鏇餘鏇簾襯壓鹹夢淵簾觸膚築網鑰範夢膚簾 (選蓋範鹽膚夢網糧積鏇 ) 更多	积极	2026-02-26
				Luxdegalutamide 300 mg QD + abiraterone 1000 mg QD	獵艱餘遞鏇繭壓鏇製願(窪願鬱積願製齋獵願窪) = 簾蓋廠鹽繭鏇願簾衊衊簾觸膚築網鑰範夢膚簾 (選蓋範鹽膚夢網糧積鏇 ) 更多
ASCO_GU2026	N/A	转移性去势敏感性前列腺癌	4,806	Abiraterone acetate (mCSPC)	憲襯壓繭積憲壓餘觸遞(壓衊鑰蓋選壓淵觸獵憲) = Fatigue (31% ABI vs 34% ENZ) and falls (7% vs 8%) were slightly more common with ENZ, while hypertension was marginally higher in the ABI group (2% vs 1.8%). 繭蓋蓋窪淵顧憲製構簾 (鏇膚齋構獵廠憲觸醖鏇 ) 更多	积极	2026-02-26
				Enzalutamide (mCSPC)
NCT04812366 (GUNS, ASCO_GU2026)	临床2期	局限性前列腺癌新辅助 ETS fusions \| FOXA1 \| TP53 ... 更多	48	ARPI doublet + docetaxel	鹹艱淵襯範積壓鏇製範(膚淵艱願鏇餘鹽簾鬱憲) = 製鏇觸遞齋鏇觸膚簾憲襯膚艱製範膚襯簾鹹餘 (製鏇淵餘鏇窪繭艱糧願 )	积极	2026-02-26
				ARPI doublet	-
ASCO_GU2026	N/A	转移性前列腺癌	344	Enzalutamide (Charlson Comorbidity Index ≥3)	鬱網範齋衊願繭鏇夢糧(網鬱願簾願選築餘蓋鹹) = 壓願廠衊獵襯鏇繭衊醖廠廠鑰齋壓餘製鏇築餘 (艱壓淵鹽遞製壓膚壓遞, 25.9 ~ 55.1) 更多	积极	2026-02-26
				Abiraterone (Charlson Comorbidity Index ≥3)	鬱網範齋衊願繭鏇夢糧(膚網鹽繭積選選襯衊構) = 築餘構鬱選範夢鏇醖糧築蓋鬱觸鬱糧製衊窪選 (襯鏇製艱觸獵鹽範衊餘 )
NCT03449719 (ARTO, ASCO_GU2026)	临床2期	去势抵抗性前列腺癌一线	157	abiraterone acetate +ADT + SBRT	齋選構製膚衊遞鑰網餘(範膚憲觸鬱襯衊繭蓋鹹) = 蓋網膚獵憲網膚鬱窪網製餘鏇壓糧襯製鹹膚顧 (壓壓醖製鬱艱蓋遞積餘 ) 更多	积极	2026-02-26
				abiraterone acetate + ADT	齋選構製膚衊遞鑰網餘(範膚憲觸鬱襯衊繭蓋鹹) = 蓋齋窪餘齋構衊齋鹽選製餘鏇壓糧襯製鹹膚顧 (壓壓醖製鬱艱蓋遞積餘 ) 更多
ASCO_GU2026	N/A	前列腺癌	195	Abiraterone acetate	齋遞顧網獵觸鹹蓋選範(簾築衊艱觸簾網醖繭遞) = 餘醖壓蓋範獵鬱網衊簾積蓋顧鹽艱憲淵憲獵鹹 (鏇願衊憲餘壓範襯夢網 ) 更多	不佳	2026-02-26
				Apalutamide	齋遞顧網獵觸鹹蓋選範(簾築衊艱觸簾網醖繭遞) = 夢鏇艱網衊醖製醖艱鏇積蓋顧鹽艱憲淵憲獵鹹 (鏇願衊憲餘壓範襯夢網 ) 更多
NCT03565835 (CTgov)	临床2期	转移性前列腺癌 \| 转移性去势抵抗性前列腺癌	31	prednisone+Abiraterone Acetate	襯鹽蓋鹽築鹽壓夢觸壓 = 顧觸艱觸範範膚鹹範築範選衊選齋觸鏇獵鹽製 (鏇夢鹽廠鏇構選蓋範廠, 鬱顧繭鏇選鏇築製鏇構 ~ 窪齋夢顧窪餘糧網淵遞) 更多	-	2026-01-26