更新于：2024-11-21

Idarubicin Hydrochloride

盐酸伊达比星

更新于：2024-11-21

概要

概要

基本信息

药物类型

小分子化药

别名

(1S,3S)-3-acetyl-3,5,12-trihydroxy-6,11-dioxo-1,2,3,4,6,11-hexahydronaphthacen-1-yl 3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranoside、4-Demethoxydaunomycin、4-Demethoxydaunorubicin

+ [17]

靶点

DNA x Top II

作用机制

DNA抑制剂(DNA抑制剂)、Top II抑制剂(拓扑异构酶II抑制剂)

治疗领域

肿瘤血液及淋巴系统疾病

在研适应症

急性髓性白血病

非在研适应症-

原研机构

Pfizer Inc.

在研机构

Pfizer Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (1990-09-27),

急性髓性白血病

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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结构

分子式C26H28ClNO9

InChIKeyJVHPTYWUBOQMBP-RVFAQHLVSA-N

CAS号57852-57-0

查看全部结构式(2)

关联

247

项与盐酸伊达比星相关的临床试验

NCT06643962 / RecruitingN/AIIT

A Single-Center Prospective Cohort Study to Evaluate the Efficacy and Safety of Intensifying Treatment with Venetoclax in Patients with Newly Diagnosed Acute Myeloid Leukemia (non-APL) and Exhibiting Lower Early Peripheral Blast Clearance Rate After Standard Intensive Induction Chemotherapy

This single-center prospective cohort study aims to evaluate the efficacy and safety of Intensifying treatment with Venetoclax along with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) except acute promyelocytic leukemia (non-APL) and exhibiting lower early peripheral blast clearance rate (EPBCR) after standard Intensive Induction therapy (3+7 regimen).

开始日期2024-10-31

申办/合作机构

南通大学附属医院

NCT06497062 / Not yet recruiting临床2期IIT

Risk-stratified Treatment of Sonrotoclax Combined With Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia: a Multicenter, Phase II Study

This single-armed study aims to investigate the safety and efficacy of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML. Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet (ELN) recommendations and MRD status to receive specific consolidation therapy after the induction therapy.

开始日期2024-09-04

申办/合作机构

上海交通大学医学院

[+2]

NCT06492421 / Recruiting临床2期IIT

Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Stage I-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection

This phase II trial studies how well intra-tumor injection of double checkpoint inhibitors work when given alone and in combination with chemotherapy or/and bevacizumab in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as ipilimumab, pembrolizumab or durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in interventional radiological chemotherapy, such as idabubicin, can directly kill the cancer cell and release tumor antigens to activate DC function in situ. Giving intra-tumor injection of checkpoints inhibitors with or without chemotherapy and/or bevecizumab may work better than in vein infusion of the drugs in treating patients with non-small cell lung cancer.

开始日期2024-07-01

申办/合作机构

广州医科大学附属第二医院

100 项与盐酸伊达比星相关的临床结果

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100 项与盐酸伊达比星相关的转化医学

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100 项与盐酸伊达比星相关的专利（医药）

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2,140

项与盐酸伊达比星相关的文献（医药）

2024-12-31·Hematology

Clinical features and outcomes of patients with acute myeloid leukemia: the single-center experience of 668 patients in China

Article

作者: Yang, Jiabang ; Su, Yang ; Li, Nan ; Meng, Qianchao ; Chen, Li ; Liu, Chi ; Ding, Jie ; Ruan, Yinglu

OBJECTIVETo investigate efficacy and prognostic factors in the treatment of adult newly-diagnosed acute myeloid leukemia (AML) with or without allogeneic hematopoietic stem cell transplantation (Allo-HSCT).METHODSWe retrospectively analyzed 668 patients with newly-diagnosed AML (non-M3 type) in the Department of Hematology at Shanghai Changhai Hospital from January 2012 to December 2021. Based on different induction chemotherapy regimens, patients were categorized into an IA (idarubicin, IDA + cytarabine, Ara-C) (3 + 7, regimen) group (n = 303) and a DA (daunorubicin, DNR + cytarabine, Ara-C) (3 + 7, regimen) group (n = 365) with or without allo-HSCT. Minimal residual disease (MRD), complete response (CR), overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse effects (AE) were analyzed and compared. Characteristics significantly associated with overall or progression-free survival (OS or PFS) upon univariate analysis were subsequently included in a Cox proportional hazard model.RESULTSThis study used data from 668 AML patients. After induction therapy, the CR rate in the IA group was 70.63% and ORR was 79.87%, which were significantly higher than those in the DA group (with a CR rate of 56.99% and an ORR of 70.14%) (P = 0.0002 and P = 0.0035, respectively). There were no significant differences in drug safety between the two chemotherapy regimens used in IA and DA (P > 0.05). The recurrence rate was lower in patients with an MRD < 0.001 than in patients with an MRD ≥ 0.001. A continuous negative MRD during the period is significant because it is associated with prolonged OS and PFS of AML patients. Data from 100 patients in the two groups who underwent allo-HSCT were analyzed using univariate analysis and the Cox proportional hazards model. From the multivariate analysis, MRD was found to be the only independent predictor of OS (P = 0.042; HR 1; 95%CI 0.00-0.76).CONCLUSIONIn the treatment of adult AML patients, IA regimen is associated with a high CR rate and ORR rate and does not increase treatment-related toxicity. IA regimen prolongs OS and PFS in AML patients and reduces the likelihood of leukemia cells' subsequent infiltration into the central nervous system. There is a high correlation between the level of MRD after treatment and the patient's bone marrow recurrence. To obtain superior treatment effects for patients undergoing allo-HSCT, the MRD should be reduced to less than 0.001 before pretreatment. A negative MRD before allo-HSCT can prolong OS in patients with AML. We examined the clinical characteristics and outcomes of AML patients in China, finding novel information on prognostic factors and primary treatment of AML that may be applicable in routine clinical practice.

2024-12-01·Molecular Biology Reports

Development of mesoporous magnetic nanoparticles supported idarubicin and investigation of apoptotic and cytotoxic effects on cancer cell lines

Article

作者: Ulusal, Hasan ; Ulusal, Fatma ; Özdemir, Nalan

BACKGROUNDMany methods are used for cancer treatment, especially chemotherapy. In addition to the their therapeutic effects, chemotherapeutic drugs also have serious disadvantages, such as not being cell and tissue-specific, causing toxicity in many tissues, and developing drug resistance. Many methods, especially nanocarriers, have been designed to overcome these disadvantages.METHODS AND RESULTSIn this study, we synthesized mesoporous silica iron oxide nanoparticles with different pore diameters and loaded idarubicin (6MFe₃O₄-NH₂-IDA and 35MFe₃O₄-NH₂-IDA). The synthesized molecules were characterized using FT-IR, XRD, and SEM methods. The cytotoxic effects of unbound idarubicin and idarubicin-loaded nanoparticles on MCF7 and HL-60 cell lines were examined by MTT test. Additionally, the expression of anti-apoptotic (Survivin and BCL-2) and apoptotic (BAX, PUMA, and NOXA) genes of the nanoparticles were measured by PCR method. As a result of the analyses, it was seen that nanoparticles with the desired properties and sizes were synthesized. In MTT analysis, it was observed that both nanoparticles dramatically decreased the IC₅₀ value in cell lines. However, the 35MFe₃O₄-NH₂-IDA molecule was found to have lower IC₅₀ values. IC₅₀ values for pristine IDA, 6MFe₃O₄-NH₂, and 35MFe₃O₄-NH₂ at 24 h were found to be 3.56, 1.24 and 0.25 µM in the MCF7 cell line and 4.15, 1.16 and 0.34 µM in the HL-60 cell line, respectively. Additionally, apoptotic gene expression increased, and anti-apoptotic gene expression decreased.CONCLUSIONSOur study demonstrates that the effectiveness of idarubicin can be significantly enhanced by its application with mesoporous nanocarriers. This enhancement is attributed to the controlled release of idarubicin from the nanocarrier, which circumvents drug resistance mechanisms, improves drug solubility, and increases the drug-carrying capacity per unit volume due to the porous structure of the carrier. These findings underscore the potential of the synthesized nanocarrier in cancer treatment and provide a clear direction for future research in this field.

2024-12-01·Hematology (Amsterdam, Netherlands)

Successfully treatment of PLZF-RARα positive acute promyelocytic leukemia by Venetoclax combining with decitabine: a case report and literature review.

Review

作者: Tong, Juan ; Zhu, Yingqiao ; Zhu, Lijun ; Zhou, Ziwei ; Jiang, Jiqian ; Zheng, Changcheng ; Xue, Lei ; Chen, Erling ; Hu, Xing

INTRODUCTIONAcute promyelocytic leukemia (APL) is mainly due to the chromosome translocation t(15; 17) (q22; q12), leading to the formation of PML-RARα fusion protein. However, some patients carried rare translocation involving RARα gene, and they were referred to as variant APL caused by the RAR family (RARα, RARB, and RARG) and partner genes. PLZF-RARα was a rare type of molecular genetic abnormality with unfavorable prognosis that has been reported in few cases in variant APL. Knowledge of PLZF-RARα (+) APL treatment remains limited understood.CASE REPORTWe presented a case of variant APL in a 47-year-old female, who was PLZF-RARα positive detected by reverse transcription polymerase chain reaction (RT-PCR). The patient did not respond to all-trans retinoic acid (ATRA), idarubicin, and arsenic trioxide (As₂O₃) combined induction chemotherapy. Then, the patient was treated with Venetoclax combining with decitabine as the salvage therapy and achieved morphological remission and PLZF/RARα gene negative.CONCLUSIONVenetoclax combining with decitabine can be used as an effective therapy in the PLZF-RARα positive APL.

项与盐酸伊达比星相关的新闻（医药）

2024-11-07

·ioncology

2024 ASH大会摘要公布！70+篇中国学者研究入选口头报告，创历史新高！

编者按第66届美国血液学会（ASH）将于2024年12月7～10日在美国圣迭戈（San Diego）盛大召开。作为全球血液学领域规模最大、涵盖最全面的国际学术盛会之一，每年吸引着成千上万名来自世界各地的专家学者，分享最前沿的血液学进展和突破性临床数据。日前，大会官网公布了入选摘要，引人瞩目的是，70+篇由中国学者主导的研究入选口头报告（Oral），创历史新高！这些研究成果不仅是血液学领域探索的最前沿标志，更彰显了中国在血液学研究版图上的坚实步伐与卓越贡献。本刊特此精心整理，带您领略中国血液学专家的非凡风采与卓越成就。恶性血液肿瘤篇 PART.01 01 摘要号：38 标题：The TFG-ROS1 Fusion Is an Oncogenic Driver of Human Myeloid Leukemia 中文标题：TFG-ROS1融合是人类髓系白血病的一个致癌驱动因素汇报人：Jie Sun（浙江大学医学院附属第一医院骨髓移植中心）汇报时间：Saturday, December 7, 2024: 9:45 AM汇报地点：Room 6A （San Diego Convention Center） 02 摘要号：89 标题：Targeted-Delivery Strategy of Engineered EV Functionalized By Anti-CD3/CD19 Bi-Specific T-Cell Engager in Treating B-Cell Malignancies 中文标题：抗CD3/CD19双特异性T细胞衔接器功能化EV治疗B细胞恶性肿瘤的靶向递送策略汇报人：Xiuiu Yang（华中科技大学同济医学院同济医院血液科）汇报时间：Saturday, December 7, 2024: 10:30 AM汇报地点：Ballroom 20AB （San Diego Convention Center） 03 摘要号：91 标题：Rituximab, Lenalidomide, and Zanubrutinib （ZR2） with Sequential CAR-T Cell As First-Line Therapy for High-Risk Large B Cell Lymphoma 中文标题：利妥昔单抗联合来那度胺和泽布替尼（ZR2）序贯CAR-T细胞疗法作为高危大B细胞淋巴瘤的一线治疗汇报人：Mingming Zhang（浙江大学医学院附属第一医院骨髓移植中心）汇报时间：Saturday, December 7, 2024: 9:30 AM 汇报地点：Marriott Grand Ballroom 11-13（Marriott Marquis San Diego Marina） 04 摘要号：92 标题：IL-10 Expressing CD19 CAR-T Cells Induce Complete Remission and Improve Long-Term Protection in Relapsed or Refractory B-Cell Hematological Malignancies 中文标题：表达IL-10的CD19 CAR-T细胞诱导复发或难治性B细胞血液恶性肿瘤完全缓解并改善长期保护作用汇报人：Jingjing Ren（深圳市莱芒生物科技有限公司）汇报时间：Saturday, December 7, 2024: 9:45 AM汇报地点：Marriott Grand Ballroom 11-13 （Marriott Marquis San Diego Marina） 05 摘要号：156 标题：Potent in Vitro and In Vivo Efficacy of Hdz-C123A, a GSPT1 Degrader-Antibody Conjugate Targeting CD123 in Acute Myeloid Leukemia 中文标题：靶向CD123的GSPT1降解抗体偶联物Hdz-C123A在急性髓系白血病中的体外和体内疗效汇报人：Yu Guo（杭州和正医药有限公司）汇报时间：Saturday, December 7, 2024: 1:15 PM汇报地点：Room 33 （San Diego Convention Center） 06 摘要号：222 标题：Prospective Study of Avapritinib in Patients with Relapsed/Refractory or MRD-Positive Core-Binding Factor Acute Myeloid Leukemia with KIT Mutations中文标题：阿伐替尼治疗伴KIT突变的复发/难治性或MRD阳性核心结合因子急性髓系白血病患者的前瞻性研究汇报人：Xueqing Dou（苏州大学附属第一医院）汇报时间：Saturday, December 7, 2024: 3:15 PM汇报地点：Seaport Ballroom EFGH （Manchester Grand Hyatt San Diego） 07 摘要号：270 标题：Safety and Efficacy of VA Combined with Modified BuCy Conditioning Regimen Followed By Allo-HSCT for High-Risk or Refractory/Relapsed Acute Lymphoblastic Leukemia : A Prospective, Single-Center, Single-Arm Clinical Trial 中文标题：VA联合改良BuCy预处理方案后行异基因造血干细胞移植治疗高危或难治/复发急性淋巴细胞白血病的安全性和有效性：一项前瞻性、单中心、单臂临床试验汇报人：Xiaoqian Chen（苏州大学附属第一医院）汇报时间：Saturday, December 7, 2024: 3:15 PM 汇报地点：Room 6CF（San Diego Convention Center） 08 摘要号：312 标题：Efficacy and Safety of Adding Blinatumomab to First-Line Treatment for Chinese Children with B-Cell Acute Lymphoblastic Leukemia 中文标题：中国儿童B细胞急性淋巴细胞白血病一线治疗中加用布林妥莫单抗的疗效和安全性汇报人：Ruidong Zhang（首都医科大学附属北京儿童医院血液学中心）汇报时间：Saturday, December 7, 2024: 5:15 PM汇报地点：Marriott Grand Ballroom 5-6 （Marriott Marquis San Diego Marina 09 摘要号：328 标题：Integrative Multi-Omics Analyses Identify a High-Risk Subgroup of Patients with Poor Prognosis in t（8;21） Acute Myeloid Leukemia 中文标题：综合多组学分析鉴定出t（8;21）急性髓系白血病中预后不良的高危亚组汇报人：Yu Liu [中国医学科学院血液病医院（中国医学科学院血液学研究所）]汇报时间：Saturday, December 7, 2024: 4:45 PM汇报地点：Seaport Ballroom ABCD （Manchester Grand Hyatt San Diego） 10 摘要号：345 标题：Mitochondrial Transcriptional-Translational Conflict Contributes to Defective Erythropoiesis and Disease Progression in Splicing Factor Mutant Myelodysplastic Syndromes 中文标题：线粒体转录翻译冲突导致剪接因子突变型骨髓增生异常综合征的红细胞生成缺陷和疾病进展汇报人：Qiaoli Li [中国医学科学院血液病医院（中国医学科学院血液学研究所）]汇报时间：Saturday, December 7, 2024: 4:30 PM汇报地点：Ballroom 20CD （San Diego Convention Center） 11 摘要号：372 标题：Modified Dual CLL1-CD15 and CLL1-CD16 Icar-T Cells for Mitigating Granulocytopenia Toxicities in the Treatment of Acute Myeloid Leukemia 中文标题：改良型双靶点CLL1-CD15和CLL1-CD16 Icar-T细胞用于减轻急性髓系白血病治疗中的粒细胞减少毒性汇报人：Rui Zhang（天津市第一中心医院）汇报时间：Saturday, December 7, 2024: 5:15 PM 汇报地点：Grand Hall C（Manchester Grand Hyatt San Diego） 12 摘要号：452 标题：Spatial Architecture of Immune Microenvironment Orchestrating Anti-Lymphoma Immunity and the Response to Immunochemotherapy in EBV+ Diffused Large B Cell Lymphoma Revealed By Imaging Mass Cytometry and Spatial 中文标题：通过成像质谱流式细胞术和空间转录组揭示EBV+弥漫性大B细胞淋巴瘤中调控抗淋巴瘤免疫和免疫化疗反应的免疫微环境空间结构汇报人：Zhijuan Lin（厦门大学附属第一医院血液科）汇报时间：Sunday, December 8, 2024: 9:45 AM汇报地点：Marriott Grand Ballroom 5-6 （Marriott Marquis San Diego Marina） 13 摘要号：477 标题：Safety and Efficacy of Tgrx-678, a Potent BCR::ABL1 allosteric Inhibitor, in Patients with Tyrosine Kinase Inhibitor Resistant and/or Intolerant Chronic Myeloid Leukemia: Updated Results of Phase 1 Study Tgrx-678 -1001 中文标题：强效BCR::ABL1变构抑制剂Tgrx-678在治疗酪氨酸激酶抑制剂耐药和/或不耐受慢性髓系白血病患者中的安全性和有效性：I期研究Tgrx-678-1001的更新结果汇报人：江倩（北京大学人民医院）汇报时间：Sunday, December 8, 2024: 10:00 AM汇报地点：Harbor Ballroom DEFG （Manchester Grand Hyatt San Diego） 14 摘要号：480 标题：Olverembatinib As Second-Line （2L） Therapy in Patients （pts） with Chronic Phase-Chronic Myeloid Leukemia （CP-CML）中文标题：奥瑞巴替尼作为慢性期慢性髓系白血病（CP-CML）患者二线（2L）治疗药物汇报人：Weiming Li（华中科技大学同济医学院附属协和医院血液科）汇报时间：Sunday, December 8, 2024: 10:45 AM汇报地点：Harbor Ballroom DEFG （Manchester Grand Hyatt San Diego） 15 摘要号：484 标题：Rovadicitinib in Patients with Myelofibrosis Who Were Refractory or Relapsed or Intolerant to Ruxolitinib: A Single Arm, Multicenter, Open-Label, Phase Ib Study 中文标题：Rovadicitinib治疗难治、复发性或对Ruxolitinib不耐受的骨髓纤维化患者：一项单臂、多中心、开放标签、Ib期研究汇报人：常春康（上海交通大学医学院上海第六人民医院血液科）汇报时间：Sunday, December 8, 2024: 10:15 AM汇报地点：Grand Hall C （Manchester Grand Hyatt San Diego） 16 摘要号：486 标题：First-in-Human Phase I/IIa Safety and Efficacy of Flonoltinib Maleate, a New Generation of JAK2/FLT3 Inhibitor in Myelofibrosis 中文标题：新一代JAK2/FLT3抑制剂马来酸氟诺替尼治疗骨髓纤维化的首个人体I/IIa期安全性和有效性研究汇报人：Lijuan Chen（四川大学华西医院血液科）汇报时间：Sunday, December 8, 2024: 10:45 AM汇报地点：Grand Hall C （Manchester Grand Hyatt San Diego） 17 摘要号：576 标题：Clinical Implications of CSF-Ctdna Positivity in Newly Diagnosed Diffuse Large B Cell Lymphoma in a Large Cohort 中文标题：大型队列中新诊断的弥漫性大B细胞淋巴瘤患者脑脊液循环肿瘤DNA（CSF-ctDNA）阳性的临床意义汇报人：梁金花 [南京医科大学第一附属医院（江苏省人民医院）血液科]汇报时间：Sunday, December 8, 2024: 1:15 PM汇报地点：Marriott Grand Ballroom 5-6 （Marriott Marquis San Diego Marina） 18 摘要号：599 标题：Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Improved Prognosis for Advanced NK/T Cell Lymphoma 中文标题：清髓性异基因造血干细胞移植可改善晚期NK/T细胞淋巴瘤患者的预后汇报人：李智慧（北京高博博仁医院移植科）汇报时间：Sunday, December 8, 2024: 1:00 PM汇报地点：Room 11 （San Diego Convention Center） 19 摘要号：663 标题：Decitabine Plus All-Trans Retinoic Acid Versus Decitabine Monotherapy for Myelodysplastic Syndromes with Excess Blasts: A Multicentre, Randomized Controlled TrialClinically Relevant Abstract 中文标题：地西他滨联合全反式维甲酸对比地西他滨单药治疗伴有过多原始细胞的骨髓增生异常综合征：一项多中心随机对照试验汇报人：佟红艳（浙江大学医学院附属第一医院血液科）汇报时间：Sunday, December 8, 2024: 5:00 PM汇报地点：Harbor Ballroom DEFG （Manchester Grand Hyatt San Diego） 20 摘要号：681 标题：Safety and Efficacy of Bicistronic CD19/CD22 CAR T Cell Therapy in Childhood B Cell Acute Lymphoblastic Leukemia 中文标题：双顺反子CD19/CD22 CAR T细胞疗法在儿童B细胞急性淋巴细胞白血病中的安全性和有效性汇报人：Hua Zhang [SPH生物治疗（上海）有限公司]汇报时间：Sunday, December 8, 2024: 5:00 PM汇报地点：Marriott Grand Ballroom 2-4 （Marriott Marquis San Diego Marina） 21 摘要号：696 标题：Haploidentical Peripheral Blood Stem Cell Combined with Bone Marrow or Unrelated Cord Blood As Grafts for Acute Leukemia/Myelodysplastic Syndrome: An Open-Label, Multicenter, Randomized, Phase 3 Trial 中文标题：单倍体相合外周血干细胞联合骨髓或无关脐带血作为急性白血病/骨髓增生异常综合征移植供体的开放标签、多中心、随机、III期试验汇报人：Sijian Yu（南方医科大学南方医院）汇报时间：Sunday, December 8, 2024: 5:45 PM汇报地点：Room 6A （San Diego Convention Center） 22 摘要号：832 标题：TENT5C As a Target of Chromatin Remodeler SMARCA2 Participates BTK Inhibitor Resistance in Mantle Cell Lymphoma By Regulating ATP Metabolism 中文标题：TENT5C作为染色质重塑剂SMARCA2的靶点，通过调节ATP代谢参与套细胞淋巴瘤对BTK抑制剂的耐药汇报人：Yuting Yan [中国医学科学院血液病医院（中国医学科学院血液学研究所）]汇报时间：Monday, December 9, 2024: 3:30 PM汇报地点：Ballroom 20CD （San Diego Convention Center） 23 摘要号：833 标题：ST6GALNAC4 Promotes Diffuse Large B-Cell Lymphoma Progression Via Mediating Sialylation of Bmpr-1B at Thr24m 中文标题：ST6GALNAC4通过介导BMPR-1B第24位苏氨酸的唾液酸化促进弥漫性大B细胞淋巴瘤进展汇报人：Yu Zhang（山东第一医科大学附属山东省医院血液科）汇报时间：Monday, December 9, 2024: 3:45 PM汇报地点：Ballroom 20CD （San Diego Convention Center） 24 摘要号：836 标题：Venetoclax Combined with Hag Regimen in Newly Diagnosed ETP-ALL: A Prospective, Multicenter, Phase 2 Trial 中文标题：维奈托克联合HAG方案治疗新诊断的早期前体T细胞急性淋巴细胞白血病：一项前瞻性、多中心、II期试验汇报人：Shanshan Suo（浙江大学医学院附属第一医院血液科）汇报时间：Monday, December 9, 2024: 3:00 PM汇报地点：Marriott Grand Ballroom 2-4 （Marriott Marquis San Diego Marina） 25 摘要号：839 标题：Tucidinostat Plus Pediatric-Inspired Chemotherapy As First-Line Therapy for Newly Diagnosed ETP-ALL/Lbl: An Open-Label, Single-Arm, Phase 2 Trial 中文标题：Tucidinostat联合儿童启发化疗作为新诊断的早期前体T细胞急性淋巴细胞白血病/淋巴母细胞淋巴瘤的一线治疗：一项开放标签、单臂、II期试验汇报人：Jieping Lin（南方医科大学南方医院血液科）汇报时间：Monday, December 9, 2024: 3:45 PM汇报地点：Marriott Grand Ballroom 2-4 （Marriott Marquis San Diego Marina） 26 摘要号：843 标题：The Mutated of KRAS gene Determine the Fate of KMT2A-Rearranged AML Patients 中文标题：KRAS基因突变决定KMT2A重排急性髓系白血病患者的命运汇报人：吴一波（浙江大学医学院附属第一医院骨髓移植中心）汇报时间：Monday, December 9, 2024: 3:15 PM汇报地点：Grand Hall C （Manchester Grand Hyatt San Diego） 27 摘要号：874 标题：CD38 Overexpressed Monocytes Play a Critical Role in the Fibrogenesis in Myeloproliferative Neoplasms and Can be Used As a Therapeutic Target to Ameliorate Fibrosis 中文标题：CD38高表达的单核细胞在骨髓增殖性肿瘤纤维化中起关键作用，并可作为改善纤维化的治疗靶点汇报人：Bing Li [中国医学科学院血液病医院（中国医学科学院血液学研究所）]汇报时间：Monday, December 9, 2024: 3:30 PM汇报地点：Seaport Ballroom EFGH （Manchester Grand Hyatt San Diego 28 摘要号：904 标题：CD33 Antibody-Modified Nanoparticles Encapsulated IL-15 Induce ISG15 to Promote MHC I Expression in Leukemia Cells Via Innate Immunity Pathway Inducing Graft-Versus-Leukemia without Aggravating Graft-Versus-Host Disease 中文标题：包裹IL-15的CD33抗体修饰的纳米粒子通过先天免疫途径诱导ISG15促进白血病细胞中MHC I的表达，诱导移植物抗白血病，而不会加重移植物抗宿主病汇报人：Ruowen Wei（华中科技大学同济医学院附属协和医院血液研究所）汇报时间：Monday, December 9, 2024: 3:30 PM汇报地点：Room 6B （San Diego Convention Center） 29 摘要号：921 标题：A Novel Generation of Anti-CD7 Universal CAR-T Therapy for Patients with Relapsed or Refractory CD7 Positive T-ALL/Lbl: A Phase I Clinical Trial 中文标题：新一代抗CD7通用CAR-T疗法治疗复发或难治性CD7阳性T细胞急性淋巴细胞白血病/淋巴母细胞淋巴瘤患者的I期临床试验汇报人：胡永仙（浙江大学医学中心良渚实验室）汇报时间：Monday, December 9, 2024: 3:15 PM汇报地点：Hall B （San Diego Convention Center） 30 摘要号：923 标题：A Prospective Investigator-Initiated Phase 1/2 Study of BCMA/CD19 Dual-Targeting CAR T Therapy in Patients with Relapsed/Refractory Multiple Myeloma Including Those with Extramedullary Disease 中文标题：一项前瞻性研究者发起的BCMA/CD19双靶点CAR T细胞疗法治疗复发/难治性多发性骨髓瘤（包括髓外病变患者）的I/II期研究汇报人：Hua Jiang（同济大学医学院上海第四人民医院）汇报时间：Monday, December 9, 2024: 3:45 PM汇报地点：Hall B （San Diego Convention Center） 31 摘要号：956 标题：A Highly Selective and Orally Bioavailable CK1α Molecular Glue Degrader Targets B-Cell Lymphoma Cells 中文标题：一种高选择性和口服生物可利用的CK1α分子胶降解剂靶向B细胞淋巴瘤细胞汇报人：Ran Kong（山东大学山东省医院血液科）汇报时间：Monday, December 9, 2024: 4:45 PM汇报地点：Ballroom 20CD （San Diego Convention Center） 32 摘要号：958 标题：KPT-330 Combined with Radiation Therapy: Effective Central Nervous System Lymphoma Treatment with Reduced Neurotoxicity 中文标题：KPT-330联合放疗有效治疗中枢神经系统淋巴瘤并降低神经毒性汇报人：Bingzong Li（苏州大学附属第二医院）汇报时间：Monday, December 9, 2024: 5:15 PM汇报地点：Ballroom 20CD （San Diego Convention Center） 33 摘要号：960 标题：CD93+ Myeloid Cells Suppress T-Cell-Mediated Anti-Tumor Immunity 中文标题：CD93+髓系细胞抑制T细胞介导的抗肿瘤免疫汇报人：Hui Yu（北京大学肿瘤医院）汇报时间：Monday, December 9, 2024: 5:45 PM汇报地点：Ballroom 20CD （San Diego Convention Center） 34 摘要号：964 标题：CD7 CAR T-Cell Therapy in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia: A Retrospective Study 中文标题：CD7 CAR-T细胞疗法治疗复发或难治性T细胞急性淋巴细胞白血病的回顾性研究汇报人：潘静（北京高博医院）汇报时间：Monday, December 9, 2024: 5:15 PM汇报地点：Marriott Grand Ballroom 5-6 （Marriott Marquis San Diego Marina） 35 摘要号：971 标题：Venetoclax and Decitabine Compared with Standard Intensive Chemotherapy As Induction Therapy in Newly Diagnosed Acute Myeloid Leukemia: Updated Results of a Multicenter, Randomized, Phase 2b Trial 中文标题：维奈托克联合地西他滨与标准强化化疗作为新诊断急性髓系白血病诱导治疗的比较：一项多中心、随机、IIb期试验的更新结果汇报人：Jing Lu（苏州大学附属第一医院）汇报时间：Monday, December 9, 2024: 5:30 PM汇报地点：Grand Hall B （Manchester Grand Hyatt San Diego） 36 摘要号：972 标题：High-Dose Cytarabine with Idarubicin Versus High-Dose Cytarabine within First Consolidation for Acute Myeloid Leukemia in First Complete Remission: An Open-Label, Multicenter, Randomized, Phase 3 Trial 中文标题：首次完全缓解期急性髓系白血病患者首次巩固治疗中高剂量阿糖胞苷联合伊达比星对比高剂量阿糖胞苷：一项开放标签、多中心、随机、III期试验汇报人：Zinan Feng（南方医科大学南方医院血液科）汇报时间：Monday, December 9, 2024: 5:45 PM汇报地点：Grand Hall B （Manchester Grand Hyatt San Diego） 37 摘要号：977 标题：Faecalibacterium Prausnitzii Confers a Protective Effect Against the Development of NKTCL 中文标题：Prausnitzii粪杆菌对NKTCL的发展具有保护作用汇报人：Zhuangzhuang Shi（郑州大学第一附属医院）汇报时间：Monday, December 9, 2024: 5:30 PM汇报地点：Marriott Grand Ballroom 11-13 （Marriott Marquis San Diego Marina） 38 摘要号：986 标题：Final Analysis of a Phase 1 Study of Zanubrutinib Plus Lenalidomide in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma 中文标题：泽布替尼联合来那度胺治疗复发/难治性弥漫大 B 细胞淋巴瘤患者的I期临床研究最终分析汇报人：宋拯（天津医科大学肿瘤医院）汇报时间：Monday, December 9, 2024: 4:45 PM汇报地点：Pacific Ballroom Salons 18-19 （Marriott Marquis San Diego Marina） 39 摘要号：1002 标题：The Efficacy and Safety of Selinexor in Combination with Ruxolitinib in Ruxolitinib-Treated Myelofibrosis Patients: The Interim Analysis of a Prospective, Open-Label, Multicenter, Parallel-Cohort, Phase 2 Study 中文标题：塞利尼索联合芦可替尼治疗经芦可替尼治疗的骨髓纤维化患者的疗效和安全性：一项前瞻性、开放标签、多中心、平行队列、II期研究的期中分析汇报人：段明辉 [中国医学科学院北京协和医院（北京协和医院）]汇报时间：Monday, December 9, 2024: 5:45 PM汇报地点：Harbor Ballroom DEFG （Manchester Grand Hyatt San Diego） 40 摘要号：1028 标题：A Single-Center, Single-Arm, Phase I Clinical Trial of Anti-BCMA/GPRC5D Bispecific CAR T-Cells in Patients with Refractory and Relapsed Multiple Myeloma with Extramedullary Disease 中文标题：一项单中心、单臂、I期临床试验：抗BCMA/GPRC5D双特异性CAR-T细胞治疗伴有髓外病变的复发/难治性多发性骨髓瘤患者汇报人：Ling Qiu（中国人民解放军西部战区总医院血液科）汇报时间：Monday, December 9, 2024: 4:45 PM汇报地点：Pacific Ballroom Salons 24-26 （Marriott Marquis San Diego Marina） 41 摘要号：1049 标题：Mini-Dosed Blinatumomab Maintenance Therapy Following Allogeneic Hematopoietic Stem Cell Transplantation in Acute B-Cell Lymphoblastic Leukemia 中文标题：异基因造血干细胞移植后微小剂量Blinatumomab维持治疗急性B细胞淋巴细胞白血病汇报人：Jie Ji（四川大学华西医院）汇报时间：Monday, December 9, 2024: 5:30 PM汇报地点：Room 6A （San Diego Convention Center） 42 摘要号：1050 标题：Updated Results from a Phase II Clinical Trial Safety and Efficacy of Azacitidine and Chidamide Maintenance after Allogeneic Hematopoietic Stem Cell Transplantation for Patients with High-Risk Acute Myeloid Leukemia 中文标题：高危急性髓系白血病患者异基因造血干细胞移植后地西他滨和西达本胺维持治疗的II期临床试验安全性和有效性的更新结果汇报人：Rui Huang（南方医科大学珠江医院）汇报时间：Monday, December 9, 2024: 5:45 PM汇报地点：Room 6A （San Diego Convention Center）非恶性血液疾病篇 PART.02 01 摘要号：12 标题：Rbm38 Regulates Heme Biosynthesis Via Fine-Tuning the RNA Alternative Splicing, Stability and Translation of Porphyrin Metabolic Enzyme Gene Ferrochelatase （Fech）中文标题：Rbm38通过精细调节卟啉代谢酶基因铁螯合酶（Fech）的RNA可变剪接、稳定性和翻译来调控血红素生物合成汇报人：Yang Mei（湖南大学附属湘潭中心医院）汇报时间：Saturday, December 7, 2024: 10:45 AM汇报地点：Room 29 （San Diego Convention Center） 02 摘要号：30 标题：Clec16a-Mediated Mitophagy Modulates Zebrafish Definitive Hematopoiesis 中文标题：Clec16a介导的线粒体自噬调节斑马鱼确定性造血汇报人：Shuyang Cai（上海中医药大学上海市中医医院）汇报时间：Saturday, December 7, 2024: 10:45 AM汇报地点：Room 6DE （San Diego Convention Center） 03 摘要号：97 标题：JAK/Rock Inhibitor Rovadicitinib for Glucocorticoid-Refractory or -Dependent Chronic Graft-Versus-Host Disease updated Results of Multicenter, Phase 1b/2a Trial 中文标题：JAK/ROCK抑制剂Rovadicitinib治疗糖皮质激素难治性或依赖性慢性移植物抗宿主病：多中心Ⅰb/Ⅱa期试验的最新结果汇报人：赵妍敏（浙江大学医学院附属第一医院骨髓移植中心）汇报时间：Saturday, December 7, 2024: 9:30 AM汇报地点：Ballroom 20CD （San Diego Convention Center） 04 摘要号：99 标题：A Phase II Study to Evaluate the Efficacy and Safety of Pimicotinib （ABSK021） in Chronic Graft Versus Host Disease （cGvHD） after 1 or More Lines of Systemic Treatment 中文标题：一项评估匹米替尼（ABSK021）在经1种或多种全身治疗后的慢性移植物抗宿主病（cGvHD）中疗效和安全性的II期研究汇报人：吴德沛（苏州大学附属第一医院）汇报时间：Saturday, December 7, 2024: 10:00 AM汇报地点：Ballroom 20CD （San Diego Convention Center） 05 摘要号：101 标题：Multiomic Analyses Uncover Immune Signatures of Steroid-Refractory Graft-Versus-Host Disease 中文标题：多组学分析揭示类固醇难治性移植物抗宿主病的免疫特征汇报人：Zengkai Pan（上海交通大学医学院附属瑞金医院）汇报时间：Saturday, December 7, 2024: 10:30 AM汇报地点：Ballroom 20CD （San Diego Convention Center） 06 摘要号：125 标题：Imbalanced Expression of TACI Isoforms Regulated By TNFRSF13B Variants Promotes the Progression of Epstein-Barr Virus-Associated Lymphoproliferative Diseases 中文标题：由TNFRSF13B变异调控的TACI异构体表达失衡促进EB病毒相关淋巴增殖性疾病的进展汇报人：Xinyue Deng（华中科技大学同济医学院附属同济医院）汇报时间：Saturday, December 7, 2024: 1:00 PM汇报地点：Room 11 （San Diego Convention Center） 07 摘要号：150 标题：Efficient Generation of CAR-T By the First Coacervate-Based Gene Delivery System 中文标题：基于首个共聚体基因递送系统高效生成CAR-T细胞汇报人：Peipei Zhu（西湖大学）汇报时间：Saturday, December 7, 2024: 1:15 PM汇报地点：Room 25 （San Diego Convention Center） 08 摘要号：164 标题：Reconstruction of Megaloblastic Anemia in a Novel Erythroblastic Island Humanized Mouse Model with Mature Circulating Human Red Blood Cells 中文标题：在具有成熟循环人红细胞的新型红系造血岛人源化小鼠模型中重建巨幼细胞性贫血汇报人：Shuang Liu（南京大学医学院模型动物研究中心）汇报时间：Saturday, December 7, 2024: 2:15 PM汇报地点：Room 33 （San Diego Convention Center） 09 摘要号：192 标题：Exploring the Mechanism of Chromatin Spatial Structure Changes and Transcriptional Regulation in Age-Related Clonal Hematopoiesis Caused By DNMT3A Mutations Using Chromatin Capture Technology 中文标题：利用染色质捕获技术探索由DNMT3A突变引起的与年龄相关的克隆性造血中染色质空间结构变化及转录调控机制汇报人：Yujun Dai（中山大学肿瘤防治中心）汇报时间：Saturday, December 7, 2024: 3:15 PM 汇报地点：Grand Hall D (Manchester Grand Hyatt San Diego) 10 摘要号：263 标题：Targeting the Hypoxic Microenvironment in Cutaneous Chronic Graft-Versus-Host Disease through PI3K Inhibition 中文标题：通过PI3K抑制靶向皮肤慢性移植物抗宿主病的缺氧微环境汇报人：Yuxi Xu（陆军军医大学新桥医院血液病医学中心）汇报时间：Saturday, December 7, 2024: 3:00 PM汇报地点：Room 6B （San Diego Convention Center） 11 摘要号：266 标题：Elevated Dosing of Recombinant Human Thrombopoietin Accelerates Platelet Engraftment in Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Dosage-Optimization, Controlled Clinical Study 中文标题：增加重组人血小板生成素剂量可加速异基因造血干细胞移植后血小板植入：一项前瞻性、剂量优化、对照临床研究汇报人：Dan Feng [中国医学科学院血液病医院（中国医学科学院血液学研究所）]汇报时间：Saturday, December 7, 2024: 2:15 PM汇报地点：Room 6CF （San Diego Convention Center） 12 摘要号：268 标题：Epstein-Barr Virus Reactivation and Post-Transplant Lymphoproliferative Disorders after Allo-HSCT in the Era of Letermovir for Cytomegalovirus Prophylaxis 中文标题：在利特莫韦预防巨细胞病毒感染时代异基因造血干细胞移植后EB病毒再激活和移植后淋巴增殖性疾病汇报人：Jingtao Huang（上海血液学研究所）汇报时间：Saturday, December 7, 2024: 2:45 PM汇报地点：Room 6CF （San Diego Convention Center） 13 摘要号：300 标题：Effects of Low-Molecular-Weight Heparin on Pregnancy Outcomes in Protein S Deficiency: A Prospective, Randomized Controlled Phase II Clinical 中文标题：低分子肝素对蛋白S缺乏症患者妊娠结局的影响：一项前瞻性、随机对照II期临床研究汇报人：Mengtong Zang（北京大学人民医院）汇报时间：Saturday, December 7, 2024: 5:15 PM汇报地点：Room 29 （San Diego Convention Center） 14 摘要号：304 标题：Hetrombopag Added to Immunosuppressive Therapy in First-Line Treatment of Severe Aplastic Anemia: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial 中文标题：一线治疗重型再生障碍性贫血时，在免疫抑制疗法中添加海曲泊帕：一项随机、双盲、安慰剂对照的III期试验汇报人：张凤奎 [中国医学科学院血液病医院（中国医学科学院血液学研究所）] 汇报时间：Saturday, December 7, 2024: 4:45 PM 汇报地点：Room 11 （San Diego Convention Center） 15 摘要号：378 标题：A Multi-Center Clinical Trial of Allogeneic Hematopoietic Stem Cell Transplants in Transfusion Dependent Thalassemia 中文标题：输血依赖性地中海贫血患者异基因造血干细胞移植的多中心临床试验汇报人：Rongrong Liu（广西医科大学附属第一医院血液科）汇报时间：Saturday, December 7, 2024: 5:15 PM汇报地点：Room 6DE （San Diego Convention Center） 16 摘要号：420 标题：A Single-Cell Transcriptomic Atlas of Cytokine Storm in CAR-T Therapy, COVID-19, and SLE 中文标题：CAR-T疗法、COVID-19和系统性红斑狼疮中细胞因子风暴的单细胞转录组图谱汇报人：Xia Li（浙江大学医学院附属第一医院骨髓移植中心）汇报时间：Sunday, December 8, 2024: 10:45 AM汇报地点：Grand Hall D （Manchester Grand Hyatt San Diego） 17 摘要号：425 标题：β2-Adrenergic Receptor Agonist Terbutaline Regulates Macrophage Polarization Via HMGB1 in Immune Thrombocytopenia 中文标题：β2-肾上腺素受体激动剂特布他林通过HMGB1调节免疫性血小板减少症中的巨噬细胞极化汇报人：Qiuyu Guo（北京大学人民医院）汇报时间：Sunday, December 8, 2024: 10:30 AM汇报地点：Room 28 A-D （San Diego Convention Center） 18 摘要号：426 标题：Differentiation Route Generates Functional Biased Platelets and Responses Distinctly to Varying Physiological Demands 中文标题：分化途径产生功能偏倚的血小板，并对不同的生理需求产生不同的反应汇报人：Jingkun Liu（中国国家生物信息中心）汇报时间：Sunday, December 8, 2024: 10:45 AM汇报地点：Room 28 A-D （San Diego Convention Center） 19 摘要号：437 标题：ERAD Activity Distinguishes the Functional Heterogeneity of Hematopoietic Stem Cells 中文标题：ERAD活性区分造血干细胞的功能异质性汇报人：QinLu Peng（湖南省动物模型与分子医学重点实验室）汇报时间：Sunday, December 8, 2024: 10:30 AM汇报地点：Room 7 （San Diego Convention Center） 20 摘要号：438 标题：SNORD113-114 Cluster Maintains Hematopoietic Stem Cell Self-Renewal Via Orchestrating the Translation Machinery 中文标题：SNORD113-114基因簇通过协调翻译机制维持造血干细胞自我更新汇报人：Hui Wang（浙江大学医学院附属第一医院骨髓移植中心）汇报时间：Sunday, December 8, 2024: 10:45 AM汇报地点：Room 7 （San Diego Convention Center） 21 摘要号：538 标题：Polycomb Repressive Complex 2 Regulates Differentiation-Stage-Specific Autophagy Gene Expression and Safeguards Normal Erythropoiesis 中文标题：多梳抑制复合体2调控分化阶段特异性的自噬基因表达并保障正常红细胞生成汇报人：Jiazhuo Li（华南理工大学医学院附属第二医院）汇报时间：Sunday, December 8, 2024: 12:45 PM汇报地点：Room 6DE （San Diego Convention Center） 22 摘要号：539 标题：A Novel Role of LKB1 in Erythroblast Enucleation 中文标题：LKB1在红系细胞脱核中的新作用汇报人：Yuanlin Xu [河南省肿瘤医院（郑州大学附属肿瘤医院）] 汇报时间：Sunday, December 8, 2024: 1:00 PM汇报地点：Room 6DE （San Diego Convention Center） 23 摘要号：562 标题：Procr+ Endothelial Progenitor Cells Modulate Adult Hematopoiesis and Microenvironment Homeostasis Via Notch Signaling 中文标题：Procr+内皮祖细胞通过Notch信号通路调节成人造血和微环境稳态汇报人：Chang Xu [中国医学科学院血液病医院（中国医学科学院血液学研究所）]汇报时间：Sunday, December 8, 2024: 12:45 PM汇报地点：Room 7 （San Diego Convention Center） 24 摘要号：682 标题：CD19 CAR T-Cell Therapy in Refractory Autoimmune Hemolytic Anemia 中文标题：CD19 CAR T细胞疗法治疗难治性自身免疫性溶血性贫血汇报人：Ruonan Li[中国医学科学院血液病医院（中国医学科学院血液学研究所）]汇报时间：Sunday, December 8, 2024: 5:15 PM汇报地点：Marriott Grand Ballroom 2-4 （Marriott Marquis San Diego Marina） 25 摘要号：683 标题：Sequential Infusion of Anti-CD19 and Anti-BCMA Chimeric Antigen Receptor T-Cells: A Promising Treatment Strategy for Refractory Immune-Mediated Platelet Transfusion Refractoriness 中文标题：序贯输注抗CD19和抗BCMA嵌合抗原受体T细胞：一种治疗难治性免疫介导的血小板输注无效的有前景的治疗策略汇报人：Yunju Ma（苏州大学附属第一医院）汇报时间：Sunday, December 8, 2024: 5:30 PM汇报地点：Marriott Grand Ballroom 2-4 （Marriott Marquis San Diego Marina） 26 摘要号：690 标题：Parvovirus B19 Originates from Infected Hematopoietic Stem Cells Following Hematopoietic Stem Cell Transplantation 中文标题：细小病毒B19起源于造血干细胞移植后受感染的造血干细胞汇报人：Xuying Pei（北京大学人民医院）汇报时间：Sunday, December 8, 2024: 5:45 PM汇报地点：Room 6B （San Diego Convention Center） 27 摘要号：711 标题：Preliminary Efficacy and Safety Results of TQB3473, a Novel Syk Inhibitor, in Adult Patients with Immune Thrombocytopenia （ITP）中文标题：新型Syk抑制剂TQB3473治疗成人免疫性血小板减少症（ITP）的初步疗效和安全性结果汇报人：周虎 [河南省肿瘤医院（郑州大学附属肿瘤医院）]汇报时间：Monday, December 9, 2024: 11:00 AM汇报地点：Room 29 （San Diego Convention Center） 28 摘要号：712 标题：Updated Outcome from Biomarker MSC-C5b-9-Guided All-Trans Retinoic Acid Treatment for Resistant/Recurrent ITP: A Multicenter, Randomized, Open-Label, Phase 3 Clinical Trial 中文标题：生物标志物MSC-C5b-9指导的全反式维甲酸治疗难治/复发免疫性血小板减少症（ITP）的最新疗效：一项多中心、随机、开放标签、III期临床试验汇报人：Menglin Li（北京大学人民医院）汇报时间：Monday, December 9, 2024: 11:15 AM汇报地点：Room 29 （San Diego Convention Center） 29 摘要号：806 标题：Rovadicitinib in Patients with Hemophagocytic Lymphohistiocytosis: A Single Arm, Open-Label, Phase I Study 中文标题：Rovadicitinib治疗噬血细胞性淋巴组织细胞增生症患者的单臂、开放标签、I期研究汇报人：王昭（北京友谊医院）汇报时间：Monday, December 9, 2024: 3:00 PM 汇报地点：Room 6DE （San Diego Convention Center） 30 摘要号：810 标题：Pharmacological and Mechanism Study of a New RIPK1 Inhibitor Via Necroptosis to Treat Hemophagocytic Lymphohistiocytosis 中文标题：一种新型RIPK1抑制剂通过坏死性凋亡治疗噬血细胞性淋巴组织细胞增生症的药理学及机制研究汇报人：Jinbing Zhu（四川大学华西医院）汇报时间：Monday, December 9, 2024: 4:00 PM汇报地点：Room 6DE （San Diego Convention Center） 31 摘要号：893 标题：Venetoclax Plus Dexamethasone As First-Line Treatment for t（11; 14） Light-Chain Amyloidosis: Preliminary Result of a Phase II Prospective, Multicenter, Single-Arm Study 中文标题：维奈托克联合地塞米松作为t（11;14）轻链淀粉样变性的一线治疗：一项II期前瞻性、多中心、单臂研究的初步结果汇报人：Kaini Shen [中国医学科学院北京协和医院（北京协和医院）]汇报时间：Monday, December 9, 2024: 3:45 PM汇报地点：Seaport Ballroom EFGH （Manchester Grand Hyatt San Diego） 32 摘要号：1044 标题：A Multicenter Randomized Controlled Trial of Low-Dose Ruxolitinib for Gvhd Prophylaxis in Haploidentical Hematopoietic Stem Cell Transplantation 中文标题：低剂量芦可替尼在同种异基因造血干细胞移植中预防移植物抗宿主病的多中心随机对照试验汇报人：Hengwei Wu（浙江大学医学院附属第一医院骨髓移植中心）汇报时间：Monday, December 9, 2024: 5:45 PM汇报地点：Room 6B （San Diego Convention Center）（来源：《肿瘤瞭望–血液时讯》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。

细胞疗法免疫疗法临床研究ASH会议

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·蒲公英Ouryao

参比制剂目录（第82批）正式发布！

转自：国家药监局编辑：wangxinglai2004 2024年08月30日，国家药监局发布了第82批次仿制药一致性评价参比制剂目录，其中新增品种25个、变更及增加持证商品种9个。通知原文经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第八十二批）。涉及品种：氟替美维吸入粉雾剂、阿瑞匹坦干混悬剂、环索奈德鼻喷雾剂、多奈哌齐透皮贴剂、唑尼沙胺片、甲氨蝶呤注射液、注射用盐酸伊达比星、氯化钾口服溶液、盐酸沙丙蝶呤散剂、苯巴那酯片、左甲状腺素钠口服溶液、曲美替尼片、糠酸氟替卡松维兰特罗吸入粉雾剂（II）、马利巴韦片、赖诺普利氢氯噻嗪片、硫普罗宁片、苯甲酸利扎曲普坦口腔崩解片、依折麦布瑞舒伐他汀钙片、恩那司他片/恩那度司他片等；仿制药参比制剂目录（第82批）（点击阅读原文下载附件）仿制药参比制剂目录（第82批）

一致性评价上市批准

2024-08-08

·米内网

南京正大天晴爆发了！拿下4大重磅品种，猛攻1100亿市场，5款新药、7个首仿冲刺

精彩内容近日，南京正大天晴的1类新药NTQ3617片、NTQ5082胶囊相继获批临床，苯磺酸美洛加巴林片国内首家报产……今年以来，南京正大天晴已有4个品种获批上市，累计46个品种过评（12个首家），12个品种备战第十批集采。目前公司有5款新药处于申报临床及以上研发阶段；15个新分类报产品种在审，7个暂无首仿获批。 5款新药发力，1类新药瞄准1100亿市场近日，南京正大天晴2款1类新药NTQ3617片、NTQ5082胶囊相继获得临床试验默示许可。其中，NTQ3617片拟用于MTAP缺失的晚期恶性实体肿瘤患者；NTQ5082胶囊拟应用于补体参与介导的溶血性疾病。近年来，南京正大天晴坚持“自主创新”和“合作创新”，围绕心脑血管用药、抗肿瘤和老慢病用药，形成“一体两翼” 的研发战略，每年研发费用占营收比超10%。自2021年以来，南京正大天晴保持每年至少一款1类新药申报IND的态势，累计有4款1类新药NTQ1062片、NTQ2494片、NTQ3617片、NTQ5082胶囊申报IND并获得批准。此外，公司的首款生物类似药艾美赛珠单抗注射液在国内首家提交IND申请并获得CDE承办。南京正大天晴主要在研新药目前，南京正大天晴已有5款新药处于申报临床及以上研发阶段。其中，抗肿瘤和免疫调节剂有4款，3款1类新药NTQ1062片（治疗乳腺癌）、NTQ2494片（治疗晚期恶性血液肿瘤）、NTQ5082胶囊（治疗溶血性疾病）均已启动Ⅰ期临床试验。米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端抗肿瘤和免疫调节剂化药销售额超过1100亿元，其中抗肿瘤药占据超60%的市场份额。 NTQ2494片、NTQ1062片均属于AKT抑制剂创新药，全球首款获批上市的AKT抑制剂为阿斯利康的Capivasertib（卡帕塞替尼）片，该药于2023年11月获美国FDA批准上市，用于治疗乳腺癌。值得一提的是，目前国内布局AKT抑制剂的药企屈指可数，南京正大天晴有望在该赛道脱颖而出。拿下4大重磅品种！7个首仿冲刺仿制药方面，今年以来南京正大天晴已有4个品种获批上市，包括氯苯唑酸葡胺软胶囊、沙库巴曲缬沙坦钠片、舒更葡糖钠注射液、来特莫韦片，进一步丰富了公司的产品线。其中，来特莫韦片为国内首仿+首家过评，氯苯唑酸葡胺软胶囊为国产第2家。 2024年至今南京正大天晴获批品种来源：米内网中国上市药品（MID）数据库来特莫韦片是由默沙东研发的抗病毒新药，用于接受异基因造血干细胞移植(HSCT)的巨细胞病毒(CMV)血清学阳性的成人受者[R＋]预防巨细胞病毒感染和巨细胞病毒病。米内网数据显示，2023年默沙东的来特莫韦片全球销售额超过6亿美元。目前，国内仅有南京正大天晴获批仿制来特莫韦片。氯苯唑酸葡胺软胶囊是由辉瑞研发的一款罕见病药物，可用于治疗成人转甲状腺素蛋白淀粉样变性多发性神经病（ATTR-PN）I期症状患者，并可有效延缓周围神经功能损害。米内网数据显示，2023年辉瑞的氯苯唑酸全球销售额超过33亿美元。目前，国内仅有齐鲁制药、南京正大天晴获批仿制氯苯唑酸葡胺软胶囊。沙库巴曲缬沙坦钠片是由诺华研发的全球首款血管紧张素受体-脑啡肽酶抑制剂（ARNI），用于射血分数降低的慢性心力衰竭和原发性高血压。米内网数据显示，2023年中国公立医疗机构终端沙库巴曲缬沙坦钠片销售额大涨62.80%，一举突破30亿元。目前，国内已有13家企业获得了沙库巴曲缬沙坦钠片的仿制批文。舒更葡糖钠注射液是目前唯一的特异性、结合性氨基甾类肌松药拮抗剂，可快速、彻底、可靠地逆转不同深度的肌松，改善全麻手术患者预后。米内网数据显示，2023年中国公立医疗机构终端舒更葡糖钠注射液销售额超过6亿元，同比增长93.75%。目前，国内已有18家企业获得了舒更葡糖钠注射液的仿制批文。 8月2日，南京正大天晴的苯磺酸美洛加巴林片仿制4类注册申请获得CDE承办，打响首仿争夺战。目前南京正大天晴还有15个新注册分类品种上市申请在审，获批生产后将视同通过一致性评价，其中抗肿瘤和免疫调节剂、血液和造血系统药物、神经系统药物各有3个。南京正大天晴新注册分类在审且暂无首仿获批的品种7个品种在国内暂无仿制药获批上市，包括苯磺酸美洛加巴林片、奥贝胆酸片、氘丁苯那嗪片、复方维生素C聚乙二醇(3350)钠钾散、达格列净二甲双胍缓释片、来特莫韦注射液、磷酸芦可替尼片等，南京正大天晴有望拿下国内首仿。 46个品种过评，12个备战第十批集采截至目前，南京正大天晴已有46个品种通过/视同通过一致性评价。其中，12个品种为国内首家过评，包括来特莫韦片、芦比前列酮软胶囊、马来酸阿伐曲泊帕片、马昔腾坦片、注射用盐酸伊达比星、西格列汀二甲双胍缓释片、磷酸特地唑胺片等。南京正大天晴通过/视同通过一致性评价品种 46个过评品种涵盖9个治疗大类，主要集中在抗肿瘤和免疫调节剂（9个）、心脑血管系统药物（9个）。米内网数据显示，这两大治疗领域药物2023年在中国公立医疗机构终端销售额均超过1000亿元。第十批集采备受瞩目，南京正大天晴已有12个过评品种满足集采门槛，符合申报资格企业数达5家及以上。12个品种涉及7个口服常释剂型、2个注射剂、1个缓释控释剂型，其中公司的达格列净片、瑞戈非尼片、马昔腾坦片、舒更葡糖钠注射液、沙库巴曲缬沙坦钠片等为2023年以来新获批品种，若被纳入第十批集采，可借助集采中标快速打开市场。南京正大天晴过评但未集采且已满足5家及以上条件的品种 12个品种2023年在中国公立医疗机构终端销售额合计超过120亿元，其中达格列净片销售额超过39亿元、沙库巴曲缬沙坦钠片销售额超过30亿元、磷酸西格列汀片销售额超过20亿元。值得关注的是，这3大重磅品种达格列净片、沙库巴曲缬沙坦钠片、磷酸西格列汀片目前已分别有13家、13家、31家企业过评，竞争日趋激烈。资料来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准临床申请生物类似药免疫疗法临床3期

100 项与盐酸伊达比星相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01747	盐酸伊达比星	L01DB06	DB01177

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性髓性白血病	美国	Pfizer Inc.	1990-09-27

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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


NCT02310321 (CTgov)	临床1/2期	伴有 FLT3/ITD 突变的急性髓系白血病	97	Cytarabine+Idarubicin+Gilteritinib (Phase 1: Dose Evaluation (DEv))	鬱築築齋範鑰壓蓋鹽齋(簾簾襯遞簾窪糧觸窪醖) = 範憲衊顧餘廠獵醖積觸築鬱鏇觸構膚齋淵鑰襯 (鑰構積繭鹹夢鏇獵範築, 壓鬱範廠觸廠簾簾願鹽 ~ 遞製憲憲淵醖網觸繭廠) 更多	-	2024-10-16
				Cytarabine+Idarubicin+Gilteritinib (Phase 1: Dose Expansion (DEx))	鬱壓鹽願窪鹹餘顧選獵(憲範憲壓膚願醖醖範願) = 鹽鹽夢顧齋艱觸憲簾襯艱簾選夢餘膚製觸壓網 (餘夢遞構願積獵齋糧簾, 鑰糧顧繭簾願淵齋鏇鹹 ~ 淵願糧蓋襯鑰淵構衊窪) 更多
NCT02185768 (IDASPHERE II, CTgov)	临床2期	肝细胞癌	46	Dc- Beads 300-500µm+Idarubicin	壓鬱網構選築獵廠廠蓋(衊襯構膚顧襯餘製簾壓) = 鏇鬱憲願糧艱鬱範網製鑰窪構壓網淵膚餘遞鑰 (艱鬱顧襯鹽簾壓積鏇糧, 蓋遞構餘廠築鏇膚鹹製 ~ 夢蓋艱鑰鏇鏇窪遞鏇艱) 更多	-	2024-10-15
NCT00801489 (EHA2024) 人工标引	临床2期	核心结合因子急性髓系白血病巩固 \| 一线 \| 诱导 RUNX1-RUNX1T1 \| CBFB-MYH11 \| FLT3 ... 更多	179	FLAG regimen + gemtuzumab ozogamicin or idarubicin	(願範窪繭鏇憲蓋窪齋鑰) = 鏇襯繭憲壓醖蓋簾顧鏇遞夢繭鹹襯鑰膚遞鏇築 (餘鏇範艱鹽餘範膚鹹膚 ) 更多	积极	2024-05-14
				FLAG regimen + gemtuzumab ozogamicin	(願範窪繭鏇憲蓋窪齋鑰) = 壓艱遞構鬱顧憲襯衊積遞夢繭鹹襯鑰膚遞鏇築 (餘鏇範艱鹽餘範膚鹹膚 ) 更多
EHA2024	N/A	复发性急性髓细胞白血病 BCL-2	53	FLAG-Ida	簾蓋鬱蓋窪襯願廠憲鏇(襯顧遞獵積蓋醖顧構鹽) = 壓選鏇憲觸鏇簾顧顧遞窪齋積鏇淵餘範鹽遞餘 (網廠壓艱夢築艱製網衊 ) 更多	积极	2024-05-14
NCT02135874 (CTgov)	临床2期	急性髓性白血病 \| 急性双表型白血病 \| 急性双系白血病 \| 复发性混合表型急性白血病	16	Clofarabine+sorafenib+dexamethasone+Rituximab+Vincristine+Cytarabine+Idarubicin	醖獵夢窪艱衊鑰選顧襯(憲構廠顧醖積窪繭獵艱) = 範醖蓋鹽壓鑰積選獵積獵獵鬱簾簾鹽膚構積簾 (築膚夢淵鬱鬱遞願選構, 網獵衊衊簾廠簾齋鹽窪 ~ 構廠顧觸網廠襯範遞鏇) 更多	-	2024-03-19
NCT02283177 (not available, CTgov)	临床2期	FLT3阳性急性髓性白血病	44	daunorubicin+cytarabine+idarubicin+crenolanib (Participants Less Than or Equal to 60 Years of Age)	願鹹鬱網餘壓構遞獵餘(選鬱窪襯壓遞簾繭網願) = 襯製範廠選製鑰壓襯憲夢鬱願簾築積築齋齋鬱 (構選廠選鏇壓繭鹹蓋餘, 鬱餘構廠鬱齋糧鑰廠壓 ~ 鑰壓鑰積構觸築選襯醖) 更多	-	2024-02-02
				daunorubicin+cytarabine+idarubicin+crenolanib (Participants Greater Than 60 Years of Age)	願鹹鬱網餘壓構遞獵餘(選鬱窪襯壓遞簾繭網願) = 顧艱積襯淵衊壓餘壓蓋夢鬱願簾築積築齋齋鬱 (構選廠選鏇壓繭鹹蓋餘, 鏇淵構醖製壓獵積觸糧 ~ 壓衊鬱醖壓願製鹽獵網) 更多
NCT02441803 (CTgov)	临床2期	急性髓性白血病	11	Stem Cell Infusion+Clofarabine+Fludarabine+Busulfan+Decitabine+cytarabine+Idarubicin (Matched Sibling Donor Group)	築膚鏇衊醖襯網廠積築(鬱範獵願襯鹹鑰襯壓襯) = 窪餘製襯觸積鹹蓋餘衊製遞鑰糧齋醖艱鑰簾獵 (製遞餘膚蓋蓋顧鏇衊壓, 餘膚壓齋遞築積襯糧簾 ~ 膚鹽糧憲窪餘鬱艱觸範) 更多	-	2024-01-17
				Stem Cell Infusion+Clofarabine+Fludarabine+Busulfan+Cyclophosphamide+Decitabine+Tacrolimus+mycophenolate mofetil+cytarabine+Idarubicin (Haploidentical Donor Group)	築膚鏇衊醖襯網廠積築(鬱範獵願襯鹹鑰襯壓襯) = 餘艱鏇觸糧窪製鏇鬱襯製遞鑰糧齋醖艱鑰簾獵 (製遞餘膚蓋蓋顧鏇衊壓, 壓製鏇鬱蓋觸鬱襯顧鏇 ~ 積選憲艱膚網夢製夢壓) 更多
NCT01802333 (S1203, Pubmed \| Leukemia) 人工标引	临床3期	急性髓性白血病 NPM1 \| FLT3	738	Daunorubicin and cytarabine (DA)	(願積鏇餘壓衊襯築廠鏇) = 衊構窪製膚築夢築願製膚鹽鏇築鑰糧鑰齋憲繭 (鬱壓構蓋憲積壓壓鬱繭 ) 更多	不佳	2024-01-01
				Idarubicin with higher dose cytarabine (IA)	(願積鏇餘壓衊襯築廠鏇) = 窪構窪積繭鏇構夢選鏇膚鹽鏇築鑰糧鑰齋憲繭 (鬱壓構蓋憲積壓壓鬱繭 ) 更多
ASH2023	N/A	难治性急性髓细胞白血病	142	CPX-351	(鹹構襯艱構製襯鑰齋醖) = 齋鹽夢膚蓋衊觸醖選選醖鏇餘憲網鏇壓餘構憲 (衊廠醖鹹構鹽網顧鏇壓 ) 更多	-	2023-12-11
				FLAG-IDAFLAG-IDAFLAG-IDA	(鹹構襯艱構製襯鑰齋醖) = 夢築鏇艱範淵願簾獵觸醖鏇餘憲網鏇壓餘構憲 (衊廠醖鹹構鹽網顧鏇壓 ) 更多
NCRI AML18 (ASH2023)	N/A	急性髓性白血病	523	DA	(襯觸壓艱選顧繭醖積艱): HR = 0.9 (95% CI, 0.7 ~ 1.16), P-Value = 0.407	-	2023-12-11
				FLAG-IdaFLAG-IdaFLAG-Ida