This phase II trial tests how well itacitinib works in in patients with immune related adverse events (irAEs) arising from immune checkpoint inhibitors (ICI) that do not respond to steroids (steroid refractory). Steroids are the usual treatment for these side effects. However, sometimes steroids do not improve or fix the side effects. Giving itacitinib may be effective in treating patients with known or suspected problems coming from ICIs, that do not resolve or improve with steroids, by reducing the patients immune system response that can cause the irAEs.

开始日期2025-01-30

申办/合作机构

The Vanderbilt-Ingram Cancer Center

[+1]

CTIS2022-501661-47-00 / Recruiting

INCB 39110-801 A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110) - INCB 39110-801

开始日期2023-08-23

申办/合作机构

Incyte Corp.

NCT05823571 / Recruiting临床1期IIT

Phase 1a/1b Study of Itacitinib (INCB039110) for Cytokine Release Syndrome Prevention and Minimization of Immunosuppression Following Nonmyeloablative Related Partially HLA-mismatched Peripheral Blood Stem Cell Transplant (PBSCT) With High-dose Posttransplantation Cyclophosphamide in Older Patients (Age 60 Years)

This research is being done to learn whether drug called itacitinib, which is a novel inflammation- and immune-lowering drug (immunosuppressant), can be given before and after non-myeloablative peripheral blood stem cell transplantation (PBSCT; also known as a 'mini' transplant) to help prevent certain complications such as cytokine release syndrome (CRS) for patients with blood cancers, using peripheral blood from a relative. The investigators will also examine if by using itacitinib the investigators can reduce the duration of MMF (other immune suppressive drug administration posttransplant).

开始日期2023-07-06

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

100 项与伊他替尼相关的临床结果

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100 项与伊他替尼相关的转化医学

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100 项与伊他替尼相关的专利（医药）

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项与伊他替尼相关的文献（医药）

2024-12-01·Current Hematologic Malignancy Reports

Contemporary Updates in the Prevention and Treatment of Graft-Versus-Host Disease

Review

作者: Abedin, Sameem ; Hamadani, Mehdi

PURPOSE OF REVIEW:

Graft-versus-host disease (GVHD) is a serious complication after allogeneic HCT. Recently, several pivotal studies have been conducted demonstrating significant improvements in the management of GVHD. Here, we review important trials pertaining to GVHD prevention, acute GVHD treatment, and treatment of steroid refractory acute and chronic GVHD.

RECENT FINDINGS:

Clinical trials in preventing GVHD demonstrate lower rates of severe acute GVHD and chronic GVHD with post-transplant cyclophosphamide. For acute GVHD, lower risk acute GVHD appears amenable to steroid-sparing therapies, such as sirolimus and itacitinib. Combinations with novel agents such as itolizumab appear promising for high risk acute GVHD. For steroid-refractory acute GVHD, ruxolitinib should be considered first line therapy. For chronic GVHD requiring therapy beyond steroids, ruxolitinib, belumosudil, and ibrutinib are now available and should be considered. Increasingly, GVHD has become a manageable complication after allogeneic HCT potentially translating to greater success with allogeneic HCT in the future.

2024-11-16·Future Oncology

Safety and efficacy of itacitinib, a selective JAK1 inhibitor, in advanced hepatocellular cancer: Phase 1b trial (JAKAL)

Article

作者: Sharma, Rohini ; Benartzi, Charlotte Wilhelm ; Troiani, Alessandro ; Ward, Caroline ; Martinez, Maria ; Pinato, David J

Overactivation of the JAK/STAT pathway is one of the drivers for the pathophysiology of hepatocellular carcinoma (HCC). We propose a Phase Ib study to evaluate the safety and efficacy of itacitinib, a selective JAK1 inhibitor, as a second-line treatment for patients with advanced or metastatic HCC.Twenty-five patients will receive 400 mg itacitinib orally daily, 28-day cycle. Safety will be reviewed prior to each cycle. Tumor response assessed every 2 months until disease progression, death or withdrawal. Tumor biopsies and blood samples will be taken for presence of JAK1 mutations.Activation of JAK/STAT pathway drives HCC development and is associated with immunotherapy resistance. Itacitinib is hypothesized to be safe and effective in HCC patients that have progressed after first-line therapies.Clinical Trial Registration: EudraCT: 2017-004437-81 NCT04358185 (ClinicalTrials.gov).

2024-06-21·SCIENCE

Combined JAK inhibition and PD-1 immunotherapy for non–small cell lung cancer patients

Article

作者: Marmarelis, Melina E ; Mathew, Divij ; Wherry, E John ; Jun, Soyeong ; Diehn, Maximillian ; Zorc, Robert ; Ghinnagow, Reem ; Minn, Andy J ; Giles, Josephine R ; Foley, Caitlin ; Zhang, Nancy R ; Hwang, Wei-Ting ; Carpenter, Erica L ; Davis, Christiana W ; Zhang, Zhaojun ; Langer, Corey J ; Bauml, Joshua M ; Klapholz, Max ; Schoenfeld, Adam J ; Ngiow, Shin Foong ; Ye, Darwin ; Huang, Alexander C

Persistent inflammation driven by cytokines such as type-one interferon (IFN-I) can cause immunosuppression. We show that administration of the Janus kinase 1 (JAK1) inhibitor itacitinib after anti–PD-1 (programmed cell death protein 1) immunotherapy improves immune function and antitumor responses in mice and results in high response rates (67%) in a phase 2 clinical trial for metastatic non–small cell lung cancer. Patients who failed to respond to initial anti–PD-1 immunotherapy but responded after addition of itacitinib had multiple features of poor immune function to anti–PD-1 alone that improved after JAK inhibition. Itacitinib promoted CD8 T cell plasticity and therapeutic responses of exhausted and effector memory–like T cell clonotypes. Patients with persistent inflammation refractory to itacitinib showed progressive CD8 T cell terminal differentiation and progressive disease. Thus, JAK inhibition may improve the efficacy of anti–PD-1 immunotherapy by pivoting T cell differentiation dynamics.

项与伊他替尼相关的新闻（医药）

2024-11-21

·Business Wire

City of Hope Reveals New Data on Cancer Immunotherapies, Microbiome and Other Innovative Topics at 2024 American Society of Hematology (ASH) Annual Meeting

LOS ANGELES--( BUSINESS WIRE )-- City of Hope ® , one of the largest and most advanced cancer research and treatment organizations in the United States and ranked among the nation’s top 5 cancer centers by U.S. News & World Report, announced today that its doctors and scientists will take part in 100 oral and poster presentations, scientific symposia/workshops, education programs and other events at ASH annual meeting from Dec. 7 to 10 in San Diego. City of Hope in ASH Press Program Two City of Hope researchers will present at ASH press briefings , and one of its leaders is a senior author on an abstract that will be discussed in the press program as well. Title: Increased Fiber Intake Results in Better Overall Survival and Lower GI-aGVHD in Allo-HCT Recipients and Pre-Clinical Gvhd Models Oral Abstract Number: 259 Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST Presenter: Jenny Paredes , Ph.D., City of Hope staff scientist, who will also receive an ASH Outstanding Abstract Achievement Award for this research Title : A High-Fiber Dietary Intervention (NUTRIVENTION) in Precursor Plasma Cell Disorders Improves Biomarkers of Disease and May Delay Progression to Myeloma Oral Abstract Number: 671 Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST City of Hope Senior Author: Marcel van den Brink , M.D., Ph.D., president, City of Hope Los Angeles/City of Hope National Medical Center and Deana and Steve Campbell Chief Physician Executive Distinguished Chair in Honor of Alexandra Levine, M.D. Title: Epcoritamab Monotherapy in Patients (Pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from CLL Expansion and Optimization Cohorts of Epcore CLL-1 Oral Abstract Number: 883 Press Briefing Date/Time and Embargo Lift Time: Sunday, Dec. 8, 8 a.m. PST Presenter: Alexey Danilov , M.D., Ph.D., City of Hope Marianne and Gerhard Pinkus Professor in Early Clinical Therapeutics, and associate director, Toni Stephenson Lymphoma Center City of Hope ASH Oral Presentations In addition, City of Hope doctors will present 22 oral abstracts with the following highlights: Title: 980 Results From the First Phase 1 Clinical Study of DR-01, a Non-Fucosylated Anti-CD94 Targeting Antibody in Patients With Relapsed/Refractory Cytotoxic Lymphomas: Dose Escalation and Optimization Session Date and Time: Monday, Dec. 9, 4:45 p.m. PST Presenter: Jasmine Zain , M.D., City of Hope professor, Division of Lymphoma, and director, T Cell Lymphoma Program Title: 468 Randomized Phase 2 Trial of the Anti-PD-L1 Monoclonal Antibody Durvalumab Plus Lenalidomide Versus Single-Agent Durvalumab in Patients With Refractory/Advanced Cutaneous T Cell Lymphoma Session Date and Time: Sunday, Dec. 8, 10:45 a.m. PST Presenter: Christiane Querfeld , M.D., Ph.D., City of Hope professor, Division of Dermatology, and director, Cutaneous Lymphoma Program Title: 211 Updated Results and Longer Follow-Up From the AUGMENT-101 Phase 2 Study of Revumenib in All Patients With Relapsed or Refractory (R/R) KMT2Ar Acute Leukemia Session Date and Time: Saturday, Dec. 7, 2 p.m. PST Presenter: Ibrahim Aldoss , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation Title: 524 Real-World Outcomes of CD19CAR T Cell Therapy in Adult Patients With Relapsed Refractory Transformed Indolent Lymphoma Session Date and Time: Sunday, Dec. 8, 9:45 a.m. Presenter: Swetha Kambhampati Thiruvengadam , M.D., City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation Title: 210 Disrupting Mitochondrial Dynamics and Metabolism in Leukemic Stem Cells through Mitochondrial PCNA Inhibition: The Role of AOH1996 Session Date and Time: Saturday, Dec. 7, 3:15 p.m. PST Presenter: Hyunjun Kang, Ph.D., City of Hope staff scientist, Department of Hematologic Malignancies Translational Science Title: 1043 Final Analysis of Phase 2a Study of Adding Itacitinib to Tacrolimus/Sirolimus Gvhd Prophylaxis After Fludarabine/Melphalan-Based Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, Myelodysplastic Syndrome (MDS), or Myelofibrosis (MF) Session Date and Time: Monday, Dec. 9, 5:30 p.m. PST Presenter: Haris Ali , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and section leader, Myeloproliferative Neoplasms Program Title: 966 CD19-CAR T Cells As Definitive Consolidation for Older Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission: A Pilot Study Session Date and Time: Monday, Dec. 9, 5:45 p.m. PST Presenter: Ibrahim Aldoss , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation Title: 685 The Composite Health Risk Assessment Model (CHARM) Predicts Risks of Toxicities, Functional and Cognitive Decline Among Survivors of Allogeneic Hematopoietic Cell Transplantation (allo-HCT): A Prospective BMT-CTN Study 1704 Session Date and Time: Sunday, Dec. 8, 4:30 p.m. PST Senior Author: Andrew Artz , M.D., M.S., City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and director, Aging and Blood Cancers Program City of Hope doctors will also lead in the following ASH events: The 13th Annual BMT & Cell Therapy Winter Workshop , co-chaired by Dr. Van den Brink, will be held on Friday, Dec. 6, 2024, prior to the ASH conference. The workshop focuses on innovative research pertinent to hematopoietic stem cell transplantation and cell therapy. Dr. Van den Brink will also speak at a scientific symposium titled “Placing the Brakes on Accelerated Aging” about targeting rejuvenation therapies to decelerate aging on Monday, Dec. 9, 2024. Jianjun Chen , Ph.D., Simms/Mann Family Foundation Chair in Systems Biology, will speak at a scientific workshop titled “Therapy Resistance Mechanisms in Blood Malignancies Program” about RNA modification and therapy resistance in acute leukemia on Friday, Dec. 6, 2024. About City of Hope City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines , as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™ . For more information about City of Hope, follow us on Facebook , X , YouTube , Instagram and LinkedIn .

临床2期临床结果免疫疗法ASH会议细胞疗法

2024-10-22

·PRNewswire

JAK Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 50+ Companies Working in the Domain

JAK inhibitors are a class of medications that work by blocking Janus kinases (JAKs), enzymes that are involved in the signaling pathways of various cytokines and growth factors. JAK inhibitors offer a more targeted approach to treating immune-mediated diseases compared to traditional therapies like corticosteroids or conventional immunosuppressants; this specificity reduces side effects and increases efficacy and is a major driver for the demand for JAK inhibitors. LAS VEGAS, Oct. 22, 2024 /PRNewswire/ -- DelveInsight's ' JAK Inhibitors Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline JAK inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the JAK inhibitors pipeline domain. Key Takeaways from the JAK Inhibitors Pipeline Report DelveInsight's JAK inhibitors pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline JAK inhibitors. Key JAK inhibitors companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical and others are evaluating new JAK Inhibitors drugs to improve the treatment landscape. Promising pipeline JAK inhibitors such as Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others are under different phases of JAK inhibitors clinical trials. In October 2024, Pelabresib in combination with ruxolitinib showed benefit in treating patients with JAK Inhibitor-Naïve Myelofibrosis significantly reduced splenomegaly, and improved anemia that has not been previously treated with Janus kinase inhibitors (JAKis). In September 2024, Eli Lilly and Company and EVA Pharma announced that the companies have agreed to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. In May 2024, Ajax Therapeutics, Inc., announced that it had received clearance for its Investigational New Drug application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical study of AJ1–11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis. In February 2024, Novartis announced that it intends to acquire MorphoSys. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. In January 2024, NS Pharma received orphan drug designation (ODD) from the European Commission (EC) for NS-229, which is being developed to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. In December 2023, Sun Pharmaceuticals Inc. announced that it has entered a licensing agreement with Aclaris Therapeutics Inc., the company announced in a regulatory filing. Under the agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma's JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA). Request a sample and discover the recent advances in JAK inhibitors drugs @ JAK Inhibitors Pipeline Report The JAK inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage JAK inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the JAK inhibitors clinical trial landscape. JAK Inhibitors Overview Janus kinase (JAK) inhibitors are a class of medications designed to interfere with the activity of the Janus kinase family of enzymes, which play a crucial role in the signaling pathways of immune responses. These enzymes are key mediators in transmitting signals from cytokines and growth factors, which regulate blood cell production and immune system function. By blocking these signals, JAK inhibitors help to control the overactive immune response seen in several inflammatory and autoimmune diseases. They have shown significant efficacy in treating conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, among others. The most common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, which are administered orally. Beyond their role in autoimmune diseases, JAK inhibitors are also being explored for use in treating certain cancers and myeloproliferative disorders, where abnormal JAK signaling contributes to uncontrolled cell growth. In diseases like myelofibrosis and polycythemia vera, JAK inhibitors can help reduce symptoms and improve quality of life. However, there are potential side effects associated with their use, including increased susceptibility to infections, blood clots, and cardiovascular risks, given their impact on the immune system. As research continues, the therapeutic potential of JAK inhibitors is expanding, offering new hope for patients with difficult-to-treat conditions. Find out more about JAK inhibitors drugs @ JAK Inhibitors Analysis A snapshot of the Pipeline JAK Inhibitors Drugs mentioned in the report: Learn more about the emerging JAK inhibitors @ JAK Inhibitors Clinical Trials JAK Inhibitors Therapeutics Assessment The JAK inhibitors pipeline report proffers an integral view of the emerging JAK inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the JAK Inhibitors 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: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key JAK Inhibitors Companies: Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical, and others. Key JAK Inhibitors Pipeline Therapies: Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others. Dive deep into rich insights for new JAK inhibitors, visit @ JAK Inhibitors Drugs Table of Contents For further information on the JAK inhibitors pipeline therapeutics, reach out @ JAK Inhibitors Therapeutics Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Eli Lilly and Company, Suzhou Zelgen Biopharmaceuticals Co., Ltd, Incyte Corporation, Kartos Therapeutics, Inc., Dompé Farmaceutici S.p.A, Sanofi, Kiniksa Pharmaceuticals, Ltd., Celgene, Abivax S.A., Telios Pharma, Inc., AstraZeneca, Karyopharm Therapeutics Inc, TWi Biotechnology, Inc., Geron Corporation, Ajax Therapeutics, Inc., among others. JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. KRAS Inhibitors Market KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key KRAS inhibitors companies, including Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio , among others. PD/L-1 Inhibitors Market PD/L-1 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PD/L-1 inhibitors companies, including Merck, Laekna Therapeutics, Genentech, Tracon Pharmaceuticals Inc., Celgene, MedImmune, Hangzhou Sumgen Biotech, 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

临床1期引进/卖出并购孤儿药

2024-10-02

·药智网

当国产自免药物，撕开了一个口

2024年，可谓是国产自免药物的爆发之年。尤其最近两个月，有3款国产自免创新药获批上市，包括两款同日获批的IL-17A单抗（智翔金泰的赛立奇单抗、恒瑞医药的夫那奇珠单抗），以及康诺亚的IL-4R单抗司普奇拜单抗。国产自免新药的闪亮登场，犹如破冰之船，成功击碎了外资药企的垄断坚冰。此外，其他国内药企正在各个自免细分赛道全力冲刺，宛如一场风暴席卷而来。两款国产问世，上演激烈比拼在国产IL-17A单抗上市前，国内这一领域仅有进口产品获批。截至目前，国内已有6款IL-17靶向药物获批上市，包括诺华的司库奇尤单抗、礼来的依奇珠单抗、协和麒麟的布罗利尤单抗、优时比的比吉利珠单抗，以及智翔金泰的赛立奇单抗、恒瑞医药的夫那奇珠单抗。其中，司库奇尤单抗、依奇珠单抗是IL-17单抗领域的头部产品，2023年销售额分别高达49.8亿美元、27.6亿美元。这两款产品在中国市场也是迅速放量。数据显示，司库奇尤单抗、依奇珠单抗在2023年的销售额分别为37.64亿元、3.34亿元，合计销售额达40.98亿元。图片来源：国投证券研报如今，国内药企已经在IL-17A单抗市场占据了两个席位，获批的适应症均为患者数量庞大的中重度斑块状银屑病。而且，夫那奇珠单抗针对成人活动性强直性脊柱炎已进入上市申报阶段，赛立奇单抗针对强直性脊柱炎也已处于NDA阶段。特别是，目前还有不少国产IL-17A单抗已处于Ⅲ期临床，包括康方生物AK111（古莫奇单抗）、三生国健SSGJ-608、君实生物JS005、丽珠医药/鑫康合XKH004、荃信生物QX002N等。此外，石药集团、甘李药业和百奥泰还布局了司库奇尤单抗生物类似药。市场参与者的不断增加，无疑推动了国内IL-17单抗市场的快速发展。但面对日益激烈的市场竞争，差异化策略成为药企赢得市场份额的关键。围猎新一代自免“药王” 相较于IL-17A单抗领域，当下的IL-4R药物领域市场竞争较为缓和。目前，全球仅有2款IL-4Rα单抗获批上市，分别是赛诺菲/再生元的度普利尤单抗、康诺亚的司普奇拜单抗（CM310）。其中，司普奇拜单抗在9月12日获NMPA批准上市，用于治疗成人中重度特应性皮炎，成为国产首款、全球第二个IL-4Rα抗体药物。值得一提的是，度普利尤单抗是新一代自免“药王”，继2023年迈入“百亿美元俱乐部”后，今年上半年销售额实现同比增长25.8%至66.3亿美元，超越强生的乌司奴单抗、艾伯维的阿达木单抗，拿下了自免药物销售额TOP1。 2024H1自免药物销售额TOP10 数据来源：公开数据整理度普利尤单抗能成为自免新“药王”，除了具有市场独占优势外，还在于目前已在全球范围内获批包括特应性皮炎、哮喘、慢性阻塞性肺疾病（COPD）等在内的7个适应症。不过，康诺亚也在针对司普奇拜单抗拓展广泛的适应症，其中治疗季节性过敏性鼻炎及慢性鼻窦炎伴鼻息肉的新药上市申请已获NMPA受理。在商业化策略上，康诺亚不仅自建商业化核心团队（预计今年底规模有望突破250人）、打造了18600升的产能，还与石药集团达成部分合作：将司普奇拜单抗的中国地区（不包括港澳台）针对中重度哮喘和COPD等呼吸系统疾病进行开发和商业化的权益授予后者。另一边，其他国内药企正在开展针对度普利尤单抗的“围猎行动”。据不完全统计，目前已有8款国产IL-4R单抗处于临床Ⅲ期阶段，包括康方生物的曼多奇单抗、恒瑞医药SHR-1819、智翔金泰GR1802、三生国健SSGJ-611、康乃德生物CBP-201等。不难预见，未来几年IL-4R药物领域也将展开激烈的厮杀。 IL-12/IL-23药物赛道：新旧“药王”更替说到激烈厮杀，靶向IL-12/IL-23药物领域已经到了新旧“药王”交替的时刻。这一领域的两大头部产品：强生的IL-12/23抑制剂乌司奴单抗、艾伯维IL-23抑制剂利生奇珠单抗（曾用名：瑞莎珠单抗），正上演着激烈的较量。 2023年，乌司奴单抗销售额突破百亿美元大关，但面临专利悬崖的挑战，今年上半年仅同比微增1.8%至53.36亿美元，环比增速已经开始下滑。反过来，在头对头研究中打败乌司奴单抗、阿达木单抗的瑞莎珠单抗，可谓风头正盛，2023年销售额同比增长50.3%至77.63亿美元，今年上半年再以46%的同比增速实现47.35亿美元。另外，强生也有一款IL-23抑制剂古塞奇尤单抗，2023年销售额同比增长17.9%至31.47亿美元，今年上半年实现同比增长27%至17.14亿美元，销售增速不及瑞莎珠单抗；礼来的Mirikizumab于2023年10月获FDA批准上市，成为首个获批用于治疗成人中至重度溃疡性结肠炎（UC）的IL-23抗体。图片来源：浙商证券研报相比厮杀激烈的IL-17A单抗、IL-4R单抗，当前国内药企较少布局IL-12/IL-23药物，尚且算得上“风景这边独好”。 IL-12药物方面，已进入临床阶段的国产药物，包括翰森制药/荃信生物QX004N（目前针对银屑病、克罗恩病分别处于Ⅱ期、Ⅰa期临床），艾博生物ABO2011（主要针对实体瘤）、嘉晨西海JCXH-211（主要针对实体瘤）。 IL-23抑制剂方面，康哲药业从印度太阳制药引进的替瑞奇珠单抗（Tildrakizumab），已于2023年5月获批用于治疗中重度斑块状银屑病，信达生物的匹康奇拜单抗（IBI112）也已申报上市申请。另外，康方生物IL-12/23单抗AK101（依若奇单抗），已于2023年8月向NMPA递交治疗中重度斑块型银屑病的上市申请。相较之下，竞争较为激烈的是乌司奴单抗生物类似药，目前百奥泰、华东医药/荃信生物均已申报上市，石药集团SYSA-1902也已处于Ⅲ期临床。恒瑞、泽璟发力JAK抑制剂除白介素（IL）抑制剂外，国内药企也在发力小分子JAK抑制剂。这是由于，JAK抑制剂的应用范围相当广泛，不仅可应用于血液系统疾病、肿瘤，还在自免疾病的治疗中得到了进一步拓展。目前，全球已有近20款JAK抑制剂获批上市，其中诺华/Incyte的芦可替尼、艾伯维的乌帕替尼是这一领域的头部产品，2023年销售额分别高达43亿美元、39.7亿美元。今年上半年，乌帕替尼实现同比增长57.3%至25.23亿美元，超越芦可替尼成为JAK抑制剂领域的新任“药王”。如此巨额的市场蛋糕，必然少不了激烈的厮杀。据统计，目前国内已有10款JAK抑制剂获批上市，4款处于NDA阶段，另外还有超过50款在研，适应症主要集中在自免疾病。从进度上看，迪哲医药的戈利昔替尼已获批用于治疗血液瘤，其他在研适应症主要集中在肿瘤领域，自免适应症尚未进入临床阶段。另外，恒瑞医药的艾玛昔替尼（SHR0302）、泽璟制药的吉卡昔替尼（杰克替尼）均已申报上市，尤其艾玛昔替尼已提交4项适应症的上市申请（强直性脊柱炎、特应性皮炎、类风湿关节炎和斑秃），在自免领域是国产JAK抑制剂中进展最快的。紧随其后的其他国产JAK抑制剂，还包括科伦药业KL130008、先声药业/凌科药业的LNK01001、信达生物的伊他替尼（Itacitinib）等。抢占自免新靶点自免赛道是个“群像戏”，“主角”有很多，除了IL、JAK，还有许多潜力新靶点。例如，武田制药的α4β7整合素抑制剂Entyvio（维得利珠单抗），已于2014年获FDA批准用于治疗溃疡性结肠炎（UC）和克罗恩病（CD），其中在针对UC的头对头研究中击败了前任全球“药王”阿达木单抗。 UC和CD是炎症性肠病（IBD）的重要类型，具有反复发作、难以治愈的特点，且患者数量庞大、获批药物较少。由此，Entyvio在2023年实现销售额超过50亿美元。 IBD赛道巨大的市场潜力，吸引了默沙东、罗氏、艾伯维等众多MNC巨头频频重金布局，靶点集中在整合素α4β7和TL1A。其中，艾伯维在今年6月以超17亿美元引进了明济生物的临床前TL1A单抗FG-M701（其中首付款达1.5亿美元）。图片来源：东方证券研报另外，罗氏研发的第二代CD20单抗奥瑞珠单抗，凭借可超长效治疗多发性硬化症（MS）以及可减少患者给药时间的皮下注射剂型，2023年全球销售额超过70亿美元，今年上半年也达到约40亿美元。诺华的奥法妥木单抗也是获批了MS的第二代CD20单抗，今年上半年实现同比增长64%至13亿美元。可见，针对自免疾病的CD20单抗也将是药企竞逐的“香饽饽”。除此以外，还有一些自免药物靶点已验证了成药性，包括BMS的抗CD80/86融合蛋白阿巴西普，靶向BAFF的泰它西普（BAFF/APRIL）、贝利尤单抗，靶向PDE-4的罗氟司特、阿普米司特等。其中，泰它西普是荣昌生物研发的全新双靶点全人源TACI-Fc融合蛋白，已获批治疗系统性红斑狼疮、类风湿关节炎，目前还有多个自免疾病已处于III期临床，包括重症肌无力、免疫球蛋白A肾病（IgAN）、原发性干燥综合征和视神经脊髓炎频谱系疾病。 PDE-4靶向药物方面，济川药业引进了恒翼生物的HPP737，海南海灵的Hemay005也已处于III期临床。结语自免市场是医药行业的又一高地，无疑成为众多药企竞相追逐的焦点。当前，随着国内药企全力冲刺自免领域，不仅在多个细分赛道上成功突围，更实现了从跟跑到并跑的转变。参考资料： 1.各家公司的财报、公告、官微 2.国投证券、浙商证券、东方证券研报声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

上市批准临床3期生物类似药

100 项与伊他替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10944	-	-	DB12154

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
急性移植物抗宿主病	临床3期	美国	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	澳大利亚	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	奥地利	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	比利时	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	捷克	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	芬兰	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	法国	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	德国	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	希腊	Incyte Corp.	2017-07-19
急性移植物抗宿主病	临床3期	以色列	Incyte Corp.	2017-07-19

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04339101 (1043, ASH2024)	临床2期	骨髓纤维化 \| 急性白血病 \| 骨髓增生异常综合征 HGF \| IL17 \| TNFaR ... 更多	59	Itacitinib + Tacrolimus/Sirolimus	觸選簾積獵壓齋願觸鹽(網獵積蓋願壓鹽願衊夢) = 製鹹觸繭選襯構積遞製窪積鹽窪願築鏇壓築願 (醖鑰顧蓋衊鑰襯憲鹽遞, 41 ~ 66) 更多	积极	2024-12-09
				Tacrolimus/Sirolimus	觸選簾積獵壓齋願觸鹽(網獵積蓋願壓鹽願衊夢) = 鹹鹹鬱鹹選廠鏇築製憲窪積鹽窪願築鏇壓築願 (醖鑰顧蓋衊鑰襯憲鹽遞 )
NCT04200365 (CTgov)	临床2期	慢性移植物抗宿主病 \| 类固醇难治性移植物抗宿主病	15	Itacitinib	築夢憲繭廠襯選構糧構(鏇築築遞壓艱簾衊鏇餘) = 憲餘顧獵獵顧積遞鹹觸艱壓獵廠憲鹹網鏇網鹽 (窪積網選簾衊壓艱夢觸, 網膚簾鏇壓築餘願糧鑰 ~ 齋糧願鹹膚糧衊獵鑰糧) 更多	-	2024-11-06
NCT04629508 (CTgov)	临床2期	真性红细胞增多症 \| 原发性血小板增多症后骨髓纤维化 \| 真性红细胞增多症后骨髓纤维化 ... 更多	4	Itacitinib	築願遞繭餘壓淵壓艱襯(網遞遞鹹遞構築獵願範) = 襯齋製艱淵膚齋積鏇窪憲構窪繭積繭鬱醖範膚 (夢醖構鏇艱獵簾選鑰獵, 壓壓觸鹹遞壓顧壓鹹鹹 ~ 鑰製憲構繭衊壓鬱顧鬱) 更多	-	2024-09-19
NCT03425006 (WCLC2024) 人工标引	临床2期	PD-L1阳性肺癌一线 PD-L1 Positive	23	Pembrolizumabitacitinib	齋膚鑰鬱築膚製廠糧壓(繭鹹糧壓齋膚壓衊齋鹹) = 3 patients stopped the trial due to pembrolizumab toxicity (1), CNS progression after pembrolizumab (1) and patient decision (1). 憲餘選襯憲齋窪鹽醖蓋 (鹽膚觸繭夢製積範鏇齋 )	积极	2024-09-08
NCT04071366 (phase 2 study of itacitinib for the prevention of cytokine release syndrome (CRS) induced by immune effector cell (IEC) therapy \| INCB 39110-211, CTgov)	临床2期	细胞因子释放综合征	112	Itacitinib+Kymriah (Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah)	膚構獵繭廠襯齋鹹製獵(選構鑰齋餘製獵艱繭鹽) = 齋醖簾齋窪鹽壓鑰鏇構餘襯蓋膚淵簾淵獵鏇醖 (醖遞糧願蓋選淵衊觸製, 築製夢夢廠簾範糧獵壓 ~ 鹹餘願製顧簾窪觸蓋遞) 更多	-	2024-03-26
				Itacitinib+Tecartus (Part 1: Itacitinib 200 mg QD + Tecartus)	膚構獵繭廠襯齋鹹製獵(選構鑰齋餘製獵艱繭鹽) = 糧網夢蓋積製願簾選糧餘襯蓋膚淵簾淵獵鏇醖 (醖遞糧願蓋選淵衊觸製, 鹽鬱簾窪範製鬱顧衊憲 ~ 鬱鬱夢製襯鑰窪膚齋齋) 更多
NCT03584516 (GRAVITAS-309, Tandem Meetings ASTCT and CIBMTR2024) 人工标引	临床2/3期	慢性移植物抗宿主病一线 elafin \| osteopontin \| C-X-C motif chemokine ligand (CXCL) 9 ... 更多	-	Itacitinib 300 mg once daily	觸憲衊糧製艱鹹範廠鬱(夢築衊夢壓顧製鑰積艱) = 鏇憲遞窪醖顧齋廠糧簾遞鹹獵窪鏇餘壓積顧遞 (餘夢窪蓋醖襯製鹹糧鏇 )	积极	2024-02-01
				Itacitinib 400 mg once daily	觸憲衊糧製艱鹹範廠鬱(夢築衊夢壓顧製鑰積艱) = 鑰衊網齋製鏇範簾壓鑰遞鹹獵窪鏇餘壓積顧遞 (餘夢窪蓋醖襯製鹹糧鏇 ) 更多
NCT04446182 (FLIGHT, CTgov)	临床2期	慢性移植物抗宿主病	3	itacitinib	鹽餘範範選襯選鬱鬱觸(鹹網構窪鬱衊鏇鬱製觸) = 齋餘艱齋鏇窪觸顧遞廠衊築壓鬱鹹觸獵淵築餘 (觸觸觸醖構網膚觸範簾, 膚襯廠築範膚醖選觸艱 ~ 艱選願窪膚獵艱範衊簾) 更多	-	2024-01-22
NCT02646748 (Pubmed \| Cancer Res Commun)	临床1期	晚期恶性实体瘤	159	Itacitinib	構製積觸觸壓積艱艱憲(願獵製獵憲遞製襯糧遞) = Most common itacitinib treatment-related adverse events (TRAE) were fatigue, nausea, and anemia. 鹹選積膚選醖鬱糧憲艱 (淵淵鹹糧淵廠積夢衊膚 ) 更多	不佳	2023-12-19
				Parsaclisib
ASH2023	N/A	细胞因子释放综合征 \| 移植物抗宿主病	42	Itacitinib 200 mg/day	糧襯壓窪壓築構餘繭積(醖繭鏇鹽夢觸衊鹹鑰艱) = 鏇鑰膚廠範廠鹽製簾壓壓簾壓襯鑰鹹鏇築構構 (製鑰廠構餘顧窪憲窪築, 69% ~ 93%) 更多	-	2023-12-10
NCT04071366 (INCB 39110-211, ASH2023)	临床2期	细胞因子释放综合征	47	Itacitinib 200 mg	夢網壓蓋鑰鏇襯餘糧淵(築繭齋糧淵醖繭鏇淵簾): P-Value = 0.003	-	2023-12-09
				Placebo