This is a phase 2, multicenter, open-label study to evaluate the efficacy of abivertinib with abiraterone in patients with metastatic castration-resistant prostate cancer.

开始日期2025-09-01

申办/合作机构

Sorrento Therapeutics, Inc.

NCT06894511

/ Recruiting临床2期

A Phase II, Open-label, Multi-Center, Randomized Study Comparing the Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the castrate resistant prostate cancer (CRPC) setting.

开始日期2025-08-29

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

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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3,770

项与醋酸阿比特龙相关的文献（医药）

2025-12-31·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Pyridine indole hybrids as novel potent CYP17A1 inhibitors

Article

作者: Wróbel, Tomasz M. ; Pandey, Amit V. ; Grudzińska, Angelika ; Björkling, Fredrik ; Harrington, Jeremiah C. ; Jørgensen, Flemming Steen ; du Toit, Therina ; Yakubu, Jibira ; Sharma, Katyayani

Prostate cancer (PCa) is one of the most prevalent malignancies affecting men worldwide, and androgen deprivation therapy (ADT) is a primary treatment approach. CYP17A1 inhibitors like abiraterone target the steroidogenic pathway to reduce androgen levels, but their clinical efficacy is limited by drug resistance and adverse effects. This study reports the synthesis and evaluation of novel CYP17A1 inhibitors derived from a previously identified hit compound. Several analogs were synthesised, including an unexpected di-cyano derivative, which demonstrated increased potency against CYP17A1 compared to abiraterone. Biological assays revealed that these compounds significantly inhibited CYP17A1 enzymatic activity and altered steroid biosynthesis. Among the newly synthesised inhibitors, compound 11 showed the highest potency (IC₅₀ = 4 nM) and the related compound 14 presented a template for further development. A combined docking and molecular dynamics approach was used to identify the possible target binding modes of the compounds.

2025-09-01·Cancer Genetics

Efficacy of pembrolizumab in MSI-high and BRCA-positive castration-resistant prostate cancer

Article

作者: Higa, Keita ; Kanaoka, Sanji ; Nakamura, Kazuyoshi ; Kurokawa, Koichiro ; Watanabe, Koki ; Yamamoto, Satoshi ; Bamba, Hiroki

This report presents a rare case of metastatic castration-resistant prostate cancer (CRPC) in an adult patient characterized by dual molecular alterations: microsatellite instability-high (MSI-H) and a BRCA2 mutation. Despite initial treatment with castration, Abiraterone, and sequential chemotherapy with docetaxel and cabazitaxel, the patient progressed to CRPC. Genetic testing revealed MSI-H and a BRCA2 mutation, prompting pembrolizumab therapy. The treatment led to a dramatic prostate-specific antigen (PSA) reduction . This case underscores the importance of comprehensive genomic profiling for advanced prostate cancer. MSI-H tumors often respond to immune checkpoint inhibitors (ICIs) such as pembrolizumab, while BRCA2 mutations are associated with poly(ADP-ribose) polymerase inhibitors (PARPi) sensitivity. This dual alteration presents therapeutic challenges, as evidenced by pembrolizumab's remarkable efficacy in this patient, highlighting its potential as a treatment option for MSI-H and BRCA-positive CRPC. Moreover, next-generation sequencing (NGS) played a crucial role in identifying actionable biomarkers not detected by earlier BRCA analyses, emphasizing the necessity of thorough genetic testing. Further research is needed to optimize treatment strategies for cases with coexisting MSI-H and BRCA mutations, including exploring the synergistic effects of ICIs and PARP i. This case demonstrates the promise of pembrolizumab and advances the understanding of genetic testing's role in tailoring therapies for complex molecular profiles in prostate cancer.

2025-07-01·PHYTOMEDICINE

Erchen Decoction ameliorates the rat model of polycystic ovary syndrome by regulating the steroid biosynthesis pathway

Article

作者: Zhu, Biran ; Zhang, Jinrong ; Huang, Hongming ; Huang, Min ; Zhao, Min ; Xiao, Min ; Wang, Shang ; Jiang, Xiaocui ; Yang, Yong

BACKGROUND:

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder associated with chronic inflammation and metabolic issues, including insulin resistance, weight gain, and lipid imbalance. It may cause infertility, menstrual irregularities, and increase the likelihood of developing type 2 diabetes, immune system disturbances, and cardiovascular conditions.

OBJECTIVE:

To identify the key components, underlying mechanisms, and therapeutic targets of Erchen decoction (ECD) for treating PCOS.

METHODS:

Abbreviations: Abi group, abiraterone group; AKR, aldo-keto reductase; AMH, anti-Müllerian hormone; BC, betweenness; BP, biological process; BSA, bovine serum albumin; CC, cellular component; CCK-8, cell counting kit-8; Con group, control group; DC, degree centrality; DDA, data-dependent acquisition; DHEA, dehydroepiandrosterone; DHEAS, DHEA sulfate; DHT, dihydrotestosterone; ECD, Erchen decoction; Ecd group, Erchen decoction group; ELISA, enzyme-linked immunosorbent assay; E2, estradiol; FSH, follicle-stimulating hormone; GO, gene ontology; HE, hematoxylin and eosin; H-Ecd group, high-dose Erchen decoction group; HFD, high-fat diet; HSD, hydroxysteroid dehydrogenases; KEGG, Kyoto encyclopedia of genes and genomes; KGN, human granulosa-like tumor cells; LAC, local average connectivity; l-Ecd group, low-dose Erchen decoction group; LH, luteinizing hormone; Met group, metformin (Glucophage) group; MF, molecular function; MIS, Müllerian inhibiting substance; MST, microscale thermophoresis; PCOS model group, PCOS group; PCA, principal component analysis; PCOS, polycystic ovary syndrome; PPI, protein-protein interaction; T, testosterone; TCM, traditional Chinese medicine; Tcm group, traditional Chinese medicine group; UHPLC, ultra-high-performance liquid chromatography Bioinformatics was used to predict the targets of ECD components for treating PCOS. Sprague-Dawley rats were assigned to control (Con) and PCOS model groups. The latter was induced via letrozole (Femara) gavage (1 mg/kg) combined with a high-fat diet. The PCOS group was then subdivided for 28 days of intervention. Body weight was recorded, ovarian morphology was assessed through hematoxylin and eosin staining, and serum hormones were quantified using enzyme-linked immunosorbent assay. Proteomic analyses were performed to examine the underlying mechanisms and potential targets, which were validated using immunofluorescence, western blotting, and RT-qPCR. The pharmacological effects of the key ECD components were confirmed in dihydrotestosterone (DHT)-treated human granulosa KGN cells.

RESULTS:

The body weight of the rats in the Con and high-dose ECD (H-Ecd) groups decreased compared with that in the PCOS group. The H-Ecd and metformin (Glucophage) groups had significantly elevated levels of testosterone (T), luteinizing hormone, anti-Müllerian hormone (AMH), and follicle-stimulating hormone (p < 0.05), whereas the low-dose Ecd (l-Ecd) group showed no significant change. Thirteen blood-entering components and 168 potential therapeutic targets for PCOS were identified. Kyoto encyclopedia of genes and genomes and gene ontology analyses indicated the involvement of the steroid biosynthesis pathway. Principal component analysis revealed notable differences among the Con, H-Ecd, and PCOS groups. Microscale thermophoresis (MST) validated the binding affinities of liquiritin, glycyrrhizic acid, esculetin, and genistein to cytochrome P450 family 17 subfamily A member 1 (CYP17A1) as 5.4, 12.55, 32.8, and 17.6 μM, respectively. Immunofluorescence, western blotting, and RT-qPCR analyses revealed significantly decreased protein expression of CYP17A1 and 11β-hydroxysteroid dehydrogenase type 1 (HSD11B1) (p < 0.01) and significantly increased the expression of aldo-keto reductase family 1 member D1 (AKR1D1) and HSD11B2 in the Con, Met, and H-Ecd groups relative to that in the PCOS group, whereas the l-Ecd group showed no significant difference. The cell counting kit-8 assay demonstrated that abiraterone (100 μM), DHT (100 nM), glycyrrhizic acid (50 μM), liquiritin (600 μM), genistein (300 μM), and esculetin (100 μM) significantly decreased T and AMH levels (p < 0.05). E2 levels recovered significantly (p < 0.05) in the Con, abiraterone (Abi), and traditional Chinese medicine (Tcm) groups compared to that in the DHT group. Western blot analysis indicated a significant reduction in CYP17A1 and HSD11B1 protein expression (p < 0.01) and a significant increase in AKR1D1 and HSD11B2 expression (p < 0.01) in the Con, Abi, and Tcm groups compared to that in the DHT group.

CONCLUSION:

We sought to identify the active constituents of ECD for treating PCOS and found that ECD enhances ovarian function by modulating the expression of CYP17A1, HSD11B1, AKR1D1, and HSD11B2 in the steroid hormone biosynthesis pathway resulting in improved hormone levels and follicular development. These results highlight the potential mechanism underlying ECD-mediated effects for PCOS therapy. Molecular docking validated the interaction of liquiritin, glycyrrhizic acid, esculetin, and genistein with CYP17A1, HSD11B1, AKR1D1, and HSD11B2. These interactions were further confirmed in vitro using MST and validated at the cellular level. Our results offer a scientific foundation for the therapeutic application of ECD in PCOS treatment.

824

项与醋酸阿比特龙相关的新闻（医药）

2025-06-24

·ioncology

初心如磐，循新致远——2025版《CSCO前列腺癌诊疗指南》全新发布！

点击蓝字，关注我们泌尿外科领域目光聚焦，翘首以盼，2025版《CSCO前列腺癌诊疗指南》重磅发布时刻如约而至！回溯历程，CSCO前列腺癌专委会指南编写组于今年2月启动指南更新修订工作，全体编委和执笔专家立足中国国情、紧跟国际前沿，经过反复研讨，最终正式定稿。6月19日线上发布会的顺利召开，将持续为我国前列腺癌诊疗实践注入专业指引，守护前列腺癌患者健康福祉。接下来，就让我们一同深入探寻2025版指南的更新要点，解码前列腺癌诊疗领域的全新方向！大咖擎旗，破局拓新，锚定前列腺癌诊疗新航向会议开始，由CSCO前列腺癌专委会主任委员、CSCO前列腺癌诊疗指南编写组组长、复旦大学附属肿瘤医院叶定伟教授做了精彩致辞，指出：自CSCO前列腺癌诊疗指南首版发布以来，凭借其不可或缺的临床价值，已成为国内泌尿外科同仁日常工作的重要参考与依据。《CSCO前列腺癌诊疗指南》的年度更新工作，始终坚持立足中国患者特点，紧密追踪国际前沿进展，旨在为国内真实诊疗场景提供最科学、最实用的实践指引。本次更新历时数月，是全体编委经过反复讨论，多次修改的智慧结晶。2025年CSCO前列腺癌诊疗指南的发布，将进一步推动全国前列腺癌诊疗规范化，助力“健康中国2030”战略，最终惠及广大前列腺癌患者！循证为基，探新求进，开启前列腺癌诊疗新篇章在复旦大学附属肿瘤医院叶定伟教授、北京大学肿瘤医院郭军教授的主持引导下，首先由CSCO前列腺癌专家委员会秘书长、复旦大学附属肿瘤医院朱耀教授解读了2025 CSCO前列腺癌指南更新要点，指出本次指南更新围绕“诊断技术革新，精准判型升级；疾病策略优化，多元治疗并进；联合治疗创新，患者精细管理”这三个主题。朱耀教授指出：全球前列腺癌病例激增，中国前列腺癌近十年发病率与死亡率逐年增加，疾病负担较重，需开展早筛早诊。新型诊断技术的普及与穿刺策略的优化将带来更高的临床显著性前列腺癌（csPC）检出率、更准确的疾病分期。在疾病治疗策略方面，多种治疗模式齐头并进。在局限性和转移性激素敏感性前列腺癌中，局部治疗与全身治疗的加法极大地提升了患者获益。而对于激素抵抗性前列腺癌，PARP抑制剂联合NHA等联合治疗方案不断创新，未来依托基因分型/分子影像/转移部位等指导的更为精细化的患者个体化治疗将为前列腺癌治疗带来新的选择和希望。四川大学华西医院曾浩教授介绍了“前列腺癌的MDT诊疗模式”、“前列腺癌基因检测和液体活检”、“随访”三个章节的更新要点，具体如下：“前列腺癌基因检测和液体活检”章节：转移性前列腺癌Ⅱ级推荐基因类型新增“肿瘤突变负荷（TMB）或肿瘤微卫星不稳定（MSI）”，局限性或区域淋巴结转移性前列腺癌Ⅲ级推荐基因类型新增描述“如TP53、RB1、PTEN等”，同时新增检测方式的推荐。主要基于免疫检查点抑制剂和AKT抑制剂等的临床研究进展。“随访”章节：调整优化治愈后诊疗及综合治疗后随访检查内容与频率。在四川大学华西医院魏强教授、北京大学第一医院何志嵩教授的主持引导下，山东大学齐鲁医院的陈守臻教授、北京大学第一医院范宇教授、中山大学肿瘤防治中心李永红教授分别对“前列腺癌的筛查和诊断”、“局限性前列腺癌的风险分层和极低危、低危前列腺癌的治疗”“局限性和区域淋巴结转移前列腺癌”部分进行了更新解读，具体如下：“前列腺癌的筛查”章节：筛查对象Ⅰ级推荐中“年龄＞45岁且有前列腺癌家族史的男性”的描述调整为“年龄＞45岁且为家族性或遗传性前列腺癌家系中的男性”，并增加相应注释。“前列腺癌的诊断”章节：前列腺癌的检查方法：Ⅱ级推荐新增“前列腺癌抗原3（PCA3）”，在PSA升高的患者中，使用PCA3作为诊断标志物比使用tPSA、fPSA比值等更能提高前列腺癌的诊断准确率。前列腺穿刺：在前列腺初次穿刺指征中，增加了PCA3。PCA3基因表达检测可作为辅助诊断工具，用于评估总PSA水平在4～10ng/ml范围内的患者是否需要进行前列腺穿刺活检。“局限性前列腺癌的治疗”章节：极低危局限性前列腺癌的治疗：将“观察等待（1B类）”由Ⅱ级推荐提升为Ⅰ级推荐，并添加了适用人群的描述“预期寿命<10年”。低危局限性前列腺癌的治疗：根治术后辅助治疗Ⅰ级推荐“观察随访（术后，无淋巴结转移或无多种高危特征（1A类）”删除了“或无多种高危特征”的适用人群描述。中危局限性前列腺癌的治疗：Ⅰ级推荐“前列腺癌根治术±盆腔淋巴结清扫（1A类）”注释更新：目前盆腔淋巴结清扫术是否带来生存获益仍不明确，PSMA PET/CT较传统影像学诊断盆腔淋巴结转移敏感性更高，有研究认为可替代盆腔淋巴结清扫术，但扩大盆腔淋巴结清扫术仍为当前盆腔淋巴结分期的金标准。建议术前与患者讨论盆腔淋巴结清扫术与PSMA-PET/CT的风险和获益。高危和极高危局限性前列腺癌的治疗：更新了高危和极高危的定义。主要基于STAMPEDE研究对high-risk局限晚期前列腺癌的定义。区域淋巴结转移前列腺癌的治疗：初始治疗Ⅱ级推荐新增“ADT+阿比特龙（2年）（2A类）”，基于STAMPEDE研究，无论是否接受放疗，ADT联合阿比特龙均可降低患者治疗失败风险。在山东大学齐鲁医院史本康教授、中山大学肿瘤防治中心周芳坚教授的主持引导下，中山大学肿瘤防治中心何立儒教授、上海交通大学医学院附属新华医院刘海龙教授、北部战区总医院的郭放教授分别对“前列腺癌的放射治疗”、“前列腺癌治愈性治疗后复发的诊疗”、“转移性激素敏感性前列腺癌的诊疗”部分进行了更新解读。“前列腺癌的放射治疗”部分：基于最新证据对放疗联合ADT的证据等级进行了调整。局限性前列腺癌的治疗：对根治术后辅助治疗的Ⅱ级推荐“EBRT±ADT（淋巴结转移）（1B类）”由1B类证据调整为2A类。基于缺乏3期RCT的明确OS获益证据。区域淋巴结转移前列腺癌的治疗：将初始治疗的Ⅰ级推荐“EBRT+ADT（2～3年）（2A类）”由2A类证据提升为1B类。基于多项回顾性大样本研究显示放疗联合ADT疗效优于单纯ADT。STAMPEDE研究的亚组分析显示，放疗显著改善2年无失败生存率（89% vs. 64%）“前列腺癌治愈性治疗后复发的诊疗”章节：前列腺癌根治术后复发的治疗：生化复发/局部复发的Ⅱ级推荐新增“ADT+阿帕他胺（2B类）”，主要基于PRESTO研究：ADT+阿帕他胺较ADT显著降低疾病进展风险，中位PSA-PFS为24.9个月对比20.3个月（HR=0.52）。注释中添加了22基因GC评分有助于指导EBRT联合内分泌治疗决策，基于RTOG 9601研究事后分析。“转移性激素敏感性前列腺癌的诊疗”章节：低瘤负荷转移性激素敏感性前列腺癌：新增Ⅰ级推荐“ADT+达罗他胺（1A类）“和Ⅱ级推荐“ADT+瑞维鲁胺（2B类）”；高瘤负荷转移性激素敏感性前列腺癌：新增Ⅰ级推荐“ADT+达罗他胺（1B类）”。主要基于：ARANOTE研究显示达罗他胺联合ADT对比安慰剂联合ADT可显著改善mHSPC患者rPFS（HR 0.54）；国内一项真实世界研究表明瑞维鲁胺联合ADT可作为低瘤负荷转移性激素敏感性前列腺癌的治疗选择。并更新了注释。在北部战区总医院谢晓冬教授、上海交通大学医学院附属新华医院齐隽教授的主持引导下，北京大学肿瘤医院的盛锡楠教授解读了“去势抵抗性前列腺癌的诊疗”的更新要点，复旦大学附属肿瘤医院的卞晓洁教授对于“前列腺癌特定亚型的诊疗”章节进行了更新解读。“去势抵抗性前列腺癌的诊疗”章节：优化了“转移性去势抵抗性前列腺癌的诊疗”章节中治疗方案的推荐，并更新了注释。在既往未经新型内分泌治疗和化疗组别里，Ⅰ级推荐新增“镭-223+恩扎卢胺（骨转移）（1A类）”，Ⅱ级推荐新增“他拉唑帕利+恩扎卢胺（2A类）”，“氘代恩扎卢胺（2B类）”。既往新型内分泌治疗失败且未经化疗组别中，Ⅱ级推荐新增“177Lu-PSMA-617（1A类）”，“氘代恩扎卢胺（2B类）”，删除“卡巴他赛（1B类）”。既往多西他赛化疗失败且未经新型内分泌治疗组别中，Ⅲ级证据新增“他拉唑帕利（HRR突变）（2B类）”。既往新型内分泌治疗和多西他赛化疗失败组别中，Ⅰ级推荐新增“177Lu-PSMA-617+SOC（1A类）”，“氘代恩扎卢胺（1A类）”，Ⅱ级推荐新增“卡巴他赛（1B类）”，Ⅲ级证据新增“他拉唑帕利（HRR突变）（2B类）”并删除“镭-223+恩扎卢胺”。主要基于PEACE3、PSMAfore、HC-1119-04、TALAPRO-2等研究结果。预防及治疗骨相关事件的骨改良药物中新增推荐“纳鲁索拜单抗”，并在注释中增加相应证据。“前列腺癌特定亚型的诊疗”章节：更多高等级循证医学证据的产生将有助于指导前列腺癌特定亚型的诊疗。在发布会的最后，CSCO前列腺专委会主任委员，大会主席叶定伟教授对大会进行了精彩的总结：感谢各位编写组成员的辛劳付出和详细解读，2025版《CSCO 前列腺癌诊疗指南》的更新和修订，凝集了我国顶尖泌尿外科专家的智慧与经验，期待本指南能够最大化的在泌尿外科医生的临床工作中发挥作用，指南的落地将进一步引领我国前列腺癌临床诊疗的规范化，共创2030健康中国！（来源：CSCO PC）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。

CSCO会议

2025-06-24

·PRNewswire

CivicaScript® Launches Low-Cost Multiple Sclerosis Treatment to Increase Patient Access, Create Significant Savings

Generic dimethyl fumarate delayed-release capsules are 2nd launch in 3 months Average savings of $4,300/month compared with other generic versions LEHI, Utah, June 24, 2025 /PRNewswire/ -- CivicaScript®, LLC, a nonprofit company dedicated to bringing low-cost generic medicines to U.S. patients, today announced the availability of dimethyl fumarate delayed-release capsules. Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. CivicaScript will offer dimethyl fumarate 240 mg capsules for sale to pharmacies for $47 per bottle of 60 capsules – typically a month's supply. CivicaScript recommends that pharmacies charge patients no more than $68 per bottle (CivicaScript's maximum retail price, or MaxRP TM). CivicaScript's MaxRP policy provides a way for healthcare providers, caregivers, patients and others to compare prices; consumers can confirm they are being charged no more than the MaxRP by scanning the QR code featured on the CivicaScript product label. CivicaScript will offer the 120 mg and 240 mg strengths of dimethyl fumarate capsules for sale. CivicaScript's MaxRP for dimethyl fumarate is about $4,300 per month less than the average claim cost for prescriptions filled at traditional PBM-affiliated pharmacies. 1 It could significantly reduce patients' out-of-pocket costs during the deductible phase of their health insurance, in which they pay full price for their medicines. Savings also could be substantial for patients with co-insurance, which charges them a percentage of their medicines' price. "Today's launch is yet another step in our journey to make necessary medications more affordable for the patients who need them," said CivicaScript President Brent J. Eberle. "We're bringing transparency and affordability to the generic drug market in a sustainable way – saving money for patients and payers and making medicines more accessible." The launch comes on the heels of a report in The New England Journal of Medicine Catalyst that CivicaScript's abiraterone saved consumers 64% and payers 92% when they switched from other versions of the same drug. CivicaScript partners with manufacturers to produce low-cost generic medicines, then works with payers and pharmacies across the country to pass along the cost savings to patients. CivicaScript's business model focuses on transparency and collaboration throughout the value chain from manufacturing through dispensing — with every stakeholder along the way knowing the price of the medicine and driving savings through to the patient. Dimethyl fumarate was chosen by CivicaScript members as a priority generic medicine based on its high list price from other manufacturers and significant patient need for the product. While many generic medicines cost less than brand-name drugs, some high-cost generics are more expensive than they need to be. Numerous studies confirm that medication costs can dictate whether patients ration their prescriptions or even fill them in the first place. About CivicaScript CivicaScript is bringing unprecedented transparency to the drug supply chain to make quality generic medicines affordable and available for everyone. A nonprofit company, CivicaScript is committed to the principles of providing affordable, essential generic medicines to promote the social welfare and health of the community. For more information on the organization and our mission, visit our website. CivicaScript is the Civica, Inc. operating unit for outpatient medications to help drive affordability and price transparency. About dimethyl fumarate For full prescribing information and patient information, including important warnings and precautions, potential adverse reactions and drug interactions, please refer to the Package Insert, available here. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. MEDIA CONTACT: Liz Power [email protected] +1 860 501 3849 1 Compared with 2021 average reimbursement rate for all strengths of Dimethyl Fumarate. See Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers, Federal Trade Commission Second Interim Staff Report, January 2025, at Fig. A2, Table A (pg. 34), available at SOURCE CivicaScript WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025-06-20

·恒瑞医药

恒瑞医药EZH2抑制剂SHR2554与免疫治疗、ADC等联合治疗实体瘤获批临床

近日，恒瑞医药及子公司苏州盛迪亚生物医药有限公司、上海恒瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，批准开展SHR2554联合或不联合阿得贝利单抗或瑞拉芙普-α注射液（SHR-1701）联合或不联合瑞康曲妥珠单抗或SHR-A1904或SHR-A2102，或联合醋酸阿比特龙或二代AR抑制剂用于实体瘤的临床研究。Zeste基因增强子同源物2 (EZH2，Enhancer of Zeste Homolog 2)是组蛋白甲基化转移酶的核心成分，通过催化组蛋白H3氨基末端第27位赖氨酸发生三甲基化(H3K27Me3)来控制对细胞的增殖、分化至关重要的基因转录。EZH2功能失调与多种癌症相关，包括胃癌、非小细胞肺癌等，因此成为抗癌药物的理想靶点[1]。SHR2554是恒瑞医药开发的新型口服EZH2抑制剂，拟用于恶性肿瘤的治疗。2024年10月，SHR2554片的药品上市许可申请获国家药监局受理，且被纳入优先审评品种公示，适应症为：用于既往接受过至少1线系统性治疗的复发或难治外周T细胞淋巴瘤（PTCL）。2023年2月，恒瑞医药将自主研发的抗癌创新药EZH2抑制剂SHR2554在大中华区以外的全球范围内开发、生产及商业化的独家权利许可给美国Treeline Biosciences公司。阿得贝利单抗是恒瑞医药自主研发的人源化抗PD-L1单克隆抗体，能通过特异性结合PD-L1分子从而阻断导致肿瘤免疫耐受的PD-1/PD-L1通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。阿得贝利单抗注射液（商品名：艾瑞利®）已于2023年获批上市，获批的适应症为与卡铂和依托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。公司现有多项阿得贝利单抗注射液临床研究正在进行，以评估其在非小细胞肺癌、小细胞肺癌、肝细胞癌、胆道癌、晚期胃癌及食管癌等多种实体瘤中的抗肿瘤作用。瑞拉芙普-α注射液（SHR-1701）是恒瑞医药自主研发的抗PD-L1/TGF-βRII双功能融合蛋白，可以促进效应性T细胞的活化，同时还可有效改善肿瘤微环境中的免疫调节作用，最终有效促进免疫系统对于肿瘤细胞的杀伤。2024年9月，瑞拉芙普-α注射液上市许可申请获国家药监局受理，适应症为本品联合氟尿嘧啶类和铂类药物用于局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌的一线治疗。经查询，国内外尚无同类产品获批上市。瑞拉芙普-α注射液在胃癌或胃食管结合部癌等治疗领域现有多项临床研究正在进行。注射用瑞康曲妥珠单抗是恒瑞医药自主研发的、以HER2为靶点的抗体偶联药物（ADC，antibody-drug conjugates），可通过与HER2表达的肿瘤细胞结合并内吞，在肿瘤细胞溶酶体内通过蛋白酶剪切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细胞凋亡。今年5月，注射用瑞康曲妥珠单抗（商品名：艾维达®）上市，用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。这是国内首个获批用于HER2突变NSCLC患者的中国自主研发抗体偶联药物（ADC）。瑞康曲妥珠单抗目前在肺癌、乳腺癌、结直肠癌、胃癌或胃食管结合部腺癌、胆道癌以及上皮性卵巢癌、输卵管癌或原发性腹膜癌、宫颈癌治疗领域的8项适应症均获国家药品监督管理局突破性疗法认定，未来有望造福更广泛的患者群体。SHR-A1904是恒瑞医药自主研发的靶向Claudin18.2的抗体偶联药物（ADC），其有效载荷是拓扑异构酶抑制剂（TOPOi），通过与肿瘤细胞表面的靶抗原结合，使得药物被内吞进入细胞后释放小分子毒素杀伤肿瘤细胞。目前该产品正在中国、美国、澳大利亚进行临床试验。SHR-A2102为恒瑞医药自主研发的靶向Nectin-4的抗体偶联药物（ADC），其有效载荷是拓扑异构酶Ⅰ抑制剂（TOPi）。多项研究表明Nectin-4在肿瘤中的高表达与肿瘤的发展和不良预后密切相关。注射用SHR-A2102正在中国进行多项临床试验，涵盖尿路上皮癌、食管癌、非小细胞肺癌、晚期妇科恶性肿瘤等多项适应症。2024年12月，注射用SHR-A2102单药治疗既往含铂化疗和PD-(L)1抑制剂治疗失败的局部晚期或转移性尿路上皮癌被国家药品监督管理局药品审评中心纳入突破性治疗品种名单。2024年4月，该产品用于治疗晚期尿路上皮癌适应症已获得美国食品和药物监督管理局（FDA）授予快速通道资格（fast track designation, FTD）。参考文献：1.Yuan R, Du W, Guo W. EZH2: a novel target for cancer treatment. J Hematol Oncol. 2020;13(1):104. doi:10.1186/s13045-020-00937-8.声明：1.本新闻旨在分享研发前沿资讯，仅供医疗卫生专业人士参阅，非广告用途。2.瑞医药不对任何药品和/或适应症作推荐。3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。撰稿：程梦真排版：程梦真责编：王玲往期精选| 研发创新 |恒瑞创新药瑞坦宁®获批，用于预防成人高度致吐性化疗引起的急性和迟发性恶心呕吐| 国际化 |恒瑞医药再次与德国默克集团达成合作，推进辅助生殖领域口服GnRH拮抗剂商业化落地恒瑞医药与默沙东就Lp(a)抑制剂HRS-5346签订独家许可协议| 重磅奖项 |捷报！恒瑞医药创新药海曲泊帕乙醇胺片（恒曲®）专利荣获中国专利金奖喜报！恒瑞医药荣获2023年度国家科技进步奖| 社会公益 |“健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

上市批准优先审批抗体药物偶联物免疫疗法申请上市

100 项与醋酸阿比特龙相关的药物交易

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外链

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
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

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
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	波多黎各	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

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临床结果

适应症

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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


NCT04497844 (AMPLITUDE, ASCO2025) 人工标引	临床3期	去势敏感前列腺癌同源重组修复缺陷	696	Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP)	顧衊願膚襯壓餘範淵鬱(襯夢憲選鑰遞淵網蓋觸) = 積膚遞鏇窪遞襯淵襯鏇顧網鹹網鑰構廠糧簾鏇 (顧願願選鏇衊壓觸鏇獵 ) 达到更多	积极	2025-05-30
				abiraterone acetate plus prednisone (AAP)	顧衊願膚襯壓餘範淵鬱(襯夢憲選鑰遞淵網蓋觸) = 顧衊衊鹽醖醖築顧顧糧顧網鹹網鑰構廠糧簾鏇 (顧願願選鏇衊壓觸鏇獵, 25.8 ~ NR) 达到更多
Flatiron electronic health records database (ASCO2025)	N/A	转移性去势抵抗性前列腺癌一线 chemotherapy-naïve \| androgen receptor pathway inhibitor (ARPI)-naïve	2,733	Abiraterone acetate	膚選鏇齋齋製餘觸糧鑰(範構顧顧膚鏇夢齋鬱淵) = 獵齋獵膚願構壓鹹壓蓋醖構淵艱獵糧鑰齋憲淵 (繭鹽餘鏇獵範壓窪範壓 ) 更多	不佳	2025-05-30
				Enzalutamide	膚選鏇齋齋製餘觸糧鑰(範構顧顧膚鏇夢齋鬱淵) = 繭顧糧膚鬱蓋淵鹽鬱膚醖構淵艱獵糧鑰齋憲淵 (繭鹽餘鏇獵範壓窪範壓 ) 更多
TriNetX database (ASCO2025)	N/A	去势敏感前列腺癌 Prostate-Specific Antigen (PSA)	-	Abiraterone	構構顧鑰鏇廠憲顧夢範(構窪選獵襯遞憲壓憲憲) = 鹹獵遞簾觸構願廠鹽淵遞鑰齋鬱觸廠鬱積繭築 (齋簾鑰糧積鹽遞壓顧鹽 ) 更多	积极	2025-05-30
				Enzalutamide	構構顧鑰鏇廠憲顧夢範(構窪選獵襯遞憲壓憲憲) = 淵構範觸醖壓鏇餘遞鹽遞鑰齋鬱觸廠鬱積繭築 (齋簾鑰糧積鹽遞壓顧鹽 ) 更多
NCT03565835 (ASCO2025)	临床2期	转移性前列腺癌一线	31	Abiraterone acetate + Prednisone	夢窪製積築窪糧顧淵廠(醖繭構製顧膚醖選鹹獵) = 淵淵淵窪壓壓膚廠廠艱積鑰選觸淵築餘築衊蓋 (淵簾繭製鬱鹽夢顧觸蓋, 163 ~ NR) 更多	积极	2025-05-30
ASCO2025	N/A	转移性去势抵抗性前列腺癌	-	Abiraterone	繭艱膚衊窪齋齋觸簾遞(糧顧壓遞鬱襯鏇選夢鑰): RR = 1.58 (95% CI, 1.11 ~ 2.26), P-Value = 0.01	积极	2025-05-30
				Enzalutamide
AACR2025	N/A	前列腺癌 PTEN loss	-	Abiraterone acetate	範積範鬱蓋鑰餘膚製鹽(範淵積選積憲鑰選膚醖) = mice treated with ADT/Abi+capivasertib exhibited increased apoptotic rates 願鑰鬱製糧襯獵鹽觸遞 (鹹醖憲廠醖選餘窪鹹積 ) 更多	-	2025-04-28
				abiraterone acetate (ADT)
NCT04194554 (ASCLEPIuS, ASCO_GU2025) 人工标引	临床1/2期	前列腺癌	54	Abiraterone acetate + Leuprolide + Niraparib	選窪鬱構壓積積衊夢蓋(衊窪夢鹽糧選襯餘糧膚) = 願鹹築遞襯網醖顧膚鑰鹹膚簾顧遞廠積顧壓鹽 (淵餘鏇餘願夢選鹽襯窪 ) 更多	积极	2025-02-13
NCT03449719 (ARTO, ASCO_GU2025) 人工标引	临床2期	去势抵抗性前列腺癌	157	Abiraterone (BRCA negative)	鏇齋遞廠範蓋齋獵選網(窪餘衊鑰鏇鹹齋夢觸廠): HR = 0.86 (95% CI, 0.3 ~ 2.44), P-Value = 0.773	积极	2025-02-13
				Abiraterone (BRCA positive)
NCT04666129 (ASCO_GU2025) 人工标引	临床1期	晚期前列腺癌	24	Relugolix 120 mg + Abiraterone 1000 mg + prednisone 5 mg/methylprednisolone 4 mg (Part 1)	鑰鏇鬱選廠壓鹹鏇鑰鹹(壓衊積範襯鬱齋淵糧襯) = 繭範願憲窪膚獵夢廠鏇餘鹹廠築鏇鑰醖鬱襯夢 (觸構製願齋範壓簾糧憲, 3.2) 更多	积极	2025-02-13
				Relugolix 240 mg + Apalutamide 240 mg	鑰鏇鬱選廠壓鹹鏇鑰鹹(壓衊積範襯鬱齋淵糧襯) = 構顧構獵壓鹽鬱獵夢淵餘鹹廠築鏇鑰醖鬱襯夢 (觸構製願齋範壓簾糧憲, 8.0) 更多
ASCO_GU2025 人工标引	N/A	去势敏感前列腺癌 Prostate specific antigen	363	Apalutamide (APA)	夢壓願繭獵鹹齋淵衊積(淵網選齋繭網鹽積膚壓) = 觸積願鏇糧廠鏇壓艱壓築選選範鹹襯膚繭醖餘 (齋齋膚壓獵淵選壓繭壓 ) 更多	积极	2025-02-13
				Abiraterone acetate (ABI)	夢壓願繭獵鹹齋淵衊積(淵網選齋繭網鹽積膚壓) = 餘鹹窪遞壓窪簾鏇簾積築選選範鹹襯膚繭醖餘 (齋齋膚壓獵淵選壓繭壓 ) 更多