The goal of this clinical trial is to learn about treatment for a type of brain cancer called glioma. This clinical trial is for people with glioma who have been cancer-free for a period of time but their cancer has come back. The primary goals of this clinical trial are the following:
* To determine the recommended dose of PCI-24781/Abexinostat with metronomic temozolomide
* To evaluate side effects associated with using PCI-24781/Abexinostat with metronomic temozolomide

开始日期2023-06-26

申办/合作机构

University of Nebraska

[+1]

CTR20191596 / Recruiting临床2期

对甲苯磺酸艾贝司他片单药治疗复发或难治的滤泡性淋巴瘤患者的开放性、单臂、多中心、II期临床研究

主要目的：评估艾贝司他（abexinostat）治疗复发/难治性滤泡性淋巴瘤(FL)患者的客观缓解率（ORR）。次要目的：评估艾贝司他（abexinostat）治疗复发/难治性滤泡性淋巴瘤(FL)患者的缓解持续时间（DOR）；无进展生存期（PFS）；最佳总疗效（BOR）；总生期（OS）；安全性和耐受性。

开始日期2020-06-17

申办/合作机构

百时益医药研发（北京）有限公司

100 项与艾贝司他相关的临床结果

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100 项与艾贝司他相关的转化医学

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100 项与艾贝司他相关的专利（医药）

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项与艾贝司他相关的文献（医药）

2024-12-05·LEUKEMIA & LYMPHOMA

A phase 1 trial of abexinostat with ibrutinib in relapsed/refractory mantle cell lymphoma and non-germinal center diffuse large B cell lymphoma

Article

作者: Bantilan, Kurt S. ; Zhu, Menglei ; Zelenetz, Andrew D. ; Kumar, Anita ; Matasar, Matthew ; Joseph, Ashlee ; von Keudell, Gottfried ; Salles, Gilles ; Gurumurthi, Ashwath ; Biggar, Erin ; Castro, Ali ; Hamlin, Paul A.

2024-11-01·JCO Precision Oncology

Updated Survival Follow-Up for Phase Ib Trial of the Histone Deacetylase Inhibitor Abexinostat With Pazopanib in Patients With Solid Tumor Malignancies

Article

作者: Aggarwal, Rahul R. ; Bergsland, Emily K. ; Chaudhuri, Sibapriya ; Tsang, Erica S. ; Thomas, Scott ; Rozie, Alexandrine ; Calabrese, Susan ; Grabowsky, Jennifer ; Pawlowska, Nela ; Dhawan, Mallika S. ; Munster, Pamela N.

PURPOSE:

Histone deacetylase (HDAC) inhibition downregulates hypoxia-inducible factor-1α and modulates multiple metabolomic pathways relevant in cancer. Here we report a potential novel biomarker to predict exceptional responders (>3 years) in patients receiving HDAC and vascular endothelial growth factor (VEGF) inhibition.

PATIENTS AND METHODS:

Patients with solid tumor malignancies were enrolled in this phase Ib trial of abexinostat (4/7 ×21 days) and pazopanib (28/28 days), with a dose expansion in renal cell carcinoma (RCC). Plasma was analyzed for metabolomics and peripheral blood mononuclear cells (PBMCs) for VEGF and HDAC2 expression levels.

RESULTS:

Fifty-one patients were enrolled: n = 36 patients in dose escalation and n = 15 in dose expansion. After the initial report in 2017, six patients had remained on study: four with RCC and one each with medullary thyroid and thymic neuroendocrine carcinoma. One patient with RCC remains on treatment for >11 years after progression on five systemic therapies. Overall, the median duration of therapy measured 5.6 (1-133) months. The median duration of therapy in exceptional responders measured 44.1 (39.8-133+) months. The median overall survival in patients with high PBMC HDAC2 expression versus low HDAC2 was 32.3 versus 9.2 months ( P = .004) for all patients and 43.3 versus 25.1 months for patients with RCC ( P = .09). Exceptional responders had lower kynurenine levels both pre- and post-treatment ( P = .002, P < .001, respectively). HDAC2 and kynurenine expression levels were inversely correlated ( P = .02).

CONCLUSION:

Abexinostat added to pazopanib shows extended tolerability and long-term responses and survival. PBMC HDAC2 levels, the abexinostat target, are relevant predictors of response. In addition, metabolomic assessment points to kynurenine as a predictor for exceptional response to combined VEGF plus HDAC inhibition.

2024-09-01·Clinical Pharmacology in Drug Development

The Bioequivalence of Abexinostat (CRA‐024781) Tosylate Tablets (20 mg) in Chinese Healthy Subjects Under Fasting Conditions

Article

作者: Li, Xiang ; Chen, Jian ; Tan, Gewen ; Guo, Wenqiang

Abstract:

This study aimed to investigate the pharmacokinetic parameters of single oral administration of postchange and prechange abexinostat (CRA‐024781) tosylate tablets in Chinese healthy subjects under fasting conditions, and assess the bioequivalence (BE) of the 2 formulations (Test [T1] and Reference [T2]). This study was a randomized, open‐label, 2‐formulation, fasting administration, single‐dose, 2‐sequence, 2‐cycle, crossover BE study. Thirty‐six subjects were enrolled in the study and 33 subjects completed 2 cycles. The plasma concentrations were determined by liquid chromatography‐tandem mass spectrometry. The 90% confidence intervals (CIs) for the Cmax, AUC0‐t, and AUC0‐∞ of CRA‐024781 and its 2 major metabolites (PCI‐27789 and PCI‐27887, both metabolites are pharmacologically inactive on HDAC1) fell within the acceptable range of 80%‐125%. The results suggest that the CRA‐024781 test preparation (Test [T1]) is bioequivalent to the reference preparation (Reference [T2]) in healthy Chinese subjects under fasting conditions.

项与艾贝司他相关的新闻（医药）

2024-11-28

·PRNewswire

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法引进/卖出临床3期疫苗细胞疗法

2024-11-08

·医药魔方Info

专利事件| 维得利珠单抗登记专利无效结案，赛立奇单抗首次登记1件序列结构专利

为助力医药行业专利从业者第一时间获取最新专利事件及进展，医药魔方推出了专利事件栏目，将每周对药品相关重要专利事件进行汇总，主要涉及：专利登记/声明、药品专利到期、专利复审与无效、专利PTE/PTA获批等情报。专利情报数据均来源于医药魔方NextPat数据库。本周（2024.10.28-2024.11.03）主要涉及以下内容： 1.中国上市药品专利登记及仿制药专利声明重点内容简介：本周CDE中国上市药品专利信息登记平台新增登记药品专利5件。8月份新获批上市的国产创新药赛立奇单抗注射液首次登记了1件序列结构专利。正大天晴药业将枸橼酸依奉阿克胶囊的晶型专利、富马酸安奈克替尼胶囊的晶型专利新增登记到平台中等。本周2类、3类、4类声明中唯一涉及的生物药是帕妥珠单抗注射液，杭州博之锐生物对帕妥珠单抗的6件登记专利进行了声明，此前已经有齐鲁制药、正大天晴药业提交申报上市，登记专利中的3件此前遭到过齐鲁或正大天晴的无效挑战，1件被宣告部分无效，2件被全部无效。 2.美国FDA桔皮书、紫皮书、美国PTE专利新增重点内容简介：本周FDA桔皮书新增专利数十件，本周FDA桔皮书新增专利数十件，涉及品种Cycloset（溴隐亭）、Caplyta（卢美哌隆）、Orilissa（恶拉戈利）、Artesunate（青蒿琥酯）、Cobenfy（呫诺美林+曲司氯铵）等。 3. 中国药品专利复审、无效情况精选重点内容简介：本周精选的数件药品相关专利有复审决定发文或在驳回后提交了复审请求，涉及达雷妥尤单抗+重组人玻璃酸酶、维拉卡肽、卡格列净等。本周内有1件药品相关专利无效决定发文，烟台蓝纳成生物的临床1期管线177Lu-LNC1003的核心化合物专利被维持专利权有效。维得利珠单抗的一件医药用途专利迎来一份无效宣告案件结案通知书，应是请求人撤回了无效请求。 4. 中国药品专利PTE、PTA情况精选重点内容简介：本周有多件专利权期限补偿审批决定发文，多个药品相关专利获批专利权期限延长，列举了部分本周获批PTA的药品相关专利，涉及lorigerlimab、subasumstat、艾贝司他、dapiglutide等。药品专利事件周报的详细内容请点击阅读原文查看，或者加入文末医药魔方专利信息群获取。医药魔方专利信息群，旨在提供医药行业专利重点事件监控和解读，群内提供以下信息： 1. 及时的医药专利无效信息、复审跟踪、PTE/PTA专利补偿提醒； 2. 中国上市药品专利登记平台最新登记/声明； 3. 桔皮书专利最新登记； 4. 热点医药专利事件解读； 5. 医药专利研究报告； 6. 医药专利相关资讯。目前免费开放中（限前500人）添加左下方微信号，备注“专利-公司-职位"，拉您进群；如想申请NextPat数据库试用，可扫右侧二维码申请试用。

专利无效专利到期

2024-10-16

·徐诺药业官微

印度瑞迪博士实验室国际商务团队访问徐诺药业上海肿瘤临床医学研究中心

中国上海近日，印度知名制药企业瑞迪博士实验室（Dr. Reddy's）国际商务团队一行到访徐诺药业上海肿瘤临床医学研究中心，受到公司董事长兼首席执行官徐英霖先生及其商务团队的热情接待。此次访问旨在探讨双方在全球抗肿瘤药物领域的合作机会。在座谈交流会上，徐诺药业商务团队与瑞迪博士实验室的代表就未来合作的可能性进行了深入探讨。双方一致表示，抗肿瘤药物研发是当前医药领域的重点方向，双方在该领域有着共同的目标和愿景。瑞迪博士实验室作为全球知名的制药企业，在抗肿瘤药物研发领域积累了丰富的经验和资源。徐诺药业则凭借艾贝司他等创新药物的研发实力，展现出了强大的市场竞争力。双方期待在印度和新兴市场如拉丁美洲、南非等国家共同开展艾贝司他的研发与商业化合作。徐诺药业徐英霖先生表示：“我们很高兴有机会与瑞迪博士实验室这样的知名企业进行交流，这将使我们在为肿瘤患者提供更多优质产品方面又向前迈出了一步。我们的目标是在抗肿瘤药物领域建立起强大而全面的产品组合，为全球患者带来福音。” 关于徐诺徐诺药业(南京)有限公司是一家以患者需求为导向专注开发抗肿瘤药物的全球性生物制药公司，在自主研发和License in（授权引进）双引擎驱动下，旨在为全球患者提供更有效的治疗方案。目前的产品管线主要包括三款候选药物，艾贝司他、 XP-105 和 XP-102。公司拥有这些药物的全球独家研发、生产和商业化权益。公司全球总部在南京，分别在上海、美国加州都设有办公室。公司创立团队曾在跨国生物制药公司（先灵、礼来、默克、罗氏、施贵宝等）从事研发、临床、商务等工作。公司联合创始人、董事长、首席执行官兼总裁徐英霖先生是一位成功的连续创业家，曾联合创办了两家美中生物制药公司并成功退出。此外，公司与Pharmacyclics / AbbVie，Boehringer Ingelheim和Janssen等知名跨国药企深度合作。投资者关系、媒体和商务拓展请联系： angela.feng@xynomicpharma.com

引进/卖出

100 项与艾贝司他相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10060	艾贝司他	-	DB12565

研发状态

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
局部晚期肾细胞癌	临床3期	美国	-	2018-10-12
局部晚期肾细胞癌	临床3期	中国	-	2018-10-12
局部晚期肾细胞癌	临床3期	捷克	-	2018-10-12
局部晚期肾细胞癌	临床3期	法国	-	2018-10-12
局部晚期肾细胞癌	临床3期	意大利	-	2018-10-12
局部晚期肾细胞癌	临床3期	波兰	-	2018-10-12
局部晚期肾细胞癌	临床3期	韩国	-	2018-10-12
局部晚期肾细胞癌	临床3期	西班牙	-	2018-10-12
局部晚期肾细胞癌	临床3期	英国	-	2018-10-12
转移性肾细胞癌	临床3期	美国	-	2018-10-12

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临床结果

适应症

分期

评价

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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


NCT03939182 (NEWS) 人工标引	临床1期	套细胞淋巴瘤	-	艾贝司他，伊布替尼	淵鏇廠衊糧蓋遞膚夢鏇(網簾鏇顧膚構範鏇夢膚) = 艾贝司他联合伊布替尼有效率（CR和ORR）及无进展生存期（PFS）均优于单独使用伊布替尼顧夢範蓋淵醖簾鏇壓夢 (選齋衊蓋襯繭膚醖衊築 )	积极	2024-06-28
				伊布替尼
NCT03934567 (ASCO2024) 人工标引	临床2期	滤泡性淋巴瘤三线	90	Abexinostat 80 mg BID	醖廠齋蓋蓋淵獵廠襯廠(蓋衊簾觸襯製餘構膚鹹) = 淵獵鑰鹽憲顧壓淵製鏇築鑰窪選繭醖廠窪繭夢 (選夢範窪淵網顧繭簾鹹, 55.8 ~ 77.1) 更多	积极	2024-05-24
				Abexinostat 80 mg BID (pts with > 3 lines of prior therapy)	醖廠齋蓋蓋淵獵廠襯廠(蓋衊簾觸襯製餘構膚鹹) = 蓋蓋醖膚製齋獵壓構齋築鑰窪選繭醖廠窪繭夢 (選夢範窪淵網顧繭簾鹹, 49.2 ~ 84.7)
NCT01543763 (Corporate Publications) 人工标引	临床1期	实体瘤	43	艾贝司他+Pazopanib Hydrochloride (HDAC2高表达)	糧積壓壓糧範鹽糧構艱(網繭廠憲艱淵選廠窪憲) = 鹽範壓壓醖遞獵繭壓鏇構蓋襯醖範壓構築鑰窪 (願製鏇願製憲廠遞糧願 ) 更多	积极	2022-06-09
				艾贝司他+Pazopanib Hydrochloride (HDAC2低表达)	糧積壓壓糧範鹽糧構艱(網繭廠憲艱淵選廠窪憲) = 範願鹹蓋鑰廠齋顧鑰簾構蓋襯醖範壓構築鑰窪 (願製鏇願製憲廠遞糧願 ) 更多
NCT03934567 (ASCO2022) 人工标引	临床2期	难治性滤泡性淋巴瘤	41	abexinostat	簾繭獵鹽廠淵餘積鏇齋(壓憲衊構範夢積衊簾築) = 糧夢網糧齋製鏇觸夢繭糧鑰鬱夢壓鏇遞鬱鹽鏇 (顧齋壓憲淵製獵構鑰築 ) 更多	积极	2022-06-02
NCT01543763 (ASCO2022) 人工标引	临床1期	恶性实体肿瘤	51	pazopanib+abexinostat (dose escalation)	遞憲鏇鬱餘構積選襯廠(觸構遞築遞網築簾遞鏇) = 壓構艱憲壓鬱蓋顧願膚齋襯遞壓簾鹹艱遞築顧 (鬱襯鏇鹹構選範鑰獵簾 )	积极	2022-06-02
				pazopanib+abexinostat (RCC + dose expansion)	遞憲鏇鬱餘構積選襯廠(觸構遞築遞網築簾遞鏇) = 衊製醖廠齋簾鑰糧夢繭齋襯遞壓簾鹹艱遞築顧 (鬱襯鏇鹹構選範鑰獵簾 )
NCT01543763 (ASCO 12019 \| ASCO 22019) 人工标引	临床1期	实体瘤 \| 肾细胞癌二线	51	abexinostat+pazopanib	糧壓襯獵獵糧醖襯鹹廠(窪襯醖壓獵鹹觸糧襯淵) = 餘壓築糧鑰醖壓獵獵廠鑰衊餘範積鏇構糧選製 (簾鏇製壓糧淵鹹顧鑰顧 ) 更多	积极	2019-05-26
				abexinostat+pazopanib (RCC)	-
AACR2016	临床1期	晚期恶性实体瘤	52	Abexinostat + Pazopanib	廠鏇鹽衊範艱襯遞製範(遞鹹膚廠襯憲願鏇膚糧) = 10% 簾壓鏇糧鹽積鹽顧獵壓 (鏇鑰齋觸鏇壓鑰鹽顧構 ) 更多	积极	2016-07-15
NCT01543763 (ASCO2016)	临床1期	晚期恶性实体瘤	52	Abexinostat + Pazopanib	衊願顧糧鬱鹽膚遞醖衊(範積構夢繭簾網顧簾夢) = The most common grade ≥ 3 related adverse events observed were diarrhea (10%) 艱選醖選壓選餘鏇鏇選 (淵觸獵鹽積網餘顧壓壓 ) 更多	积极	2016-05-20
NCT01027910 (Pubmed \| Cancer) 人工标引	临床1期	肉瘤	20	doxorubicin+abexinostat (participants received abexinostat 15 mg/m(2) or 30 mg/m(2) twice daily.)	糧鑰選積構鹹衊艱壓蓋(願選繭積衊醖窪築簾積) = DLTs of grade 3 and 4 neutropenia were observed in 2 of 3 participants who received abexinostat 30 mg/m(2) twice daily.Two DLTs were observed at the 60 mg/m(2) twice-daily dose (grade 3 infection, grade 4 thrombocytopenia). 選鏇糧獵築製鹹積廠鹹 (糧積壓願積壓夢齋襯衊 )	积极	2015-04-15
				doxorubicin+abexinostat (participants received abexinostat at doses of 30 mg/m(2), 45 mg/m(2), or 60 mg/m(2) twice daily, all with mandated G-CSF support.)
ISRCTN55052510 (ASCO2014)	临床1期	实体瘤	35	Abexinostat	廠鹹積窪壓觸夢齋蓋積(繭膚壓餘簾淵齋鹽簾繭) = 夢夢願襯醖壓夢廠顧獵選糧夢獵獵膚醖範淵膚 (膚顧窪鏇網糧糧餘製繭 ) 更多	-	2014-05-20