This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).

开始日期2024-08-23

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

NCT06253663

/ Active, not recruiting临床2期

A Phase 2 Multicenter Study Evaluating the Safety and the Efficacy of KTE-X19 in Adult Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic Leukemia (B-ALL).
The primary objectives of this study are to evaluate the efficacy of KTE-X19, as measured by:
* Objective response rate (ORR) per investigator assessment, in adult Japanese participants with r/r MCL
* Overall complete remission (OCR) defined as complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per investigator assessment, in adult Japanese participants with r/r ALL

开始日期2024-03-18

申办/合作机构

Kite Pharma, Inc.

NCT06482684

/ Recruiting临床2期

Early Treatment Intensification in Patients With High Risk Mantle Cell Lymphoma Using CAR-T-cell Treatment After an Abbreviated Induction Therapy With Rituximab and Ibrutinib and 6 Months Ibrutinib Maintenance (Arm A) as Compared to Standard of Care Induction and Maintenance (Arm B)

First-line CAR-T-cell consolidation after an abbreviated induction with 2 cycles of Rituximab and Ibrutinib prior to CAR-T-cell treatment and followed by 6 months of maintenance with Ibrutinib in patients with high risk MCL.

开始日期2024-02-15

申办/合作机构

Ludwig-Maximilians-Universität München

[+1]

100 项与布瑞基奥仑赛相关的临床结果

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100 项与布瑞基奥仑赛相关的转化医学

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100 项与布瑞基奥仑赛相关的专利（医药）

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153

项与布瑞基奥仑赛相关的文献（医药）

2026-02-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Chimeric antigen receptor T-cell therapy and immune effector cell-associated neurotoxicity syndrome: A meta-analysis

Review

作者: Bunevicius, Adomas ; Munteh, Diana ; Mekary, Rania A ; Mammi, Marco ; D'Amore, Fabio ; Hundel, Jessie ; Donthineni, Karun ; Thirugnanam, Ashwini

BACKGROUND:

Chimeric antigen receptor (CAR) T-cell therapy, a form of adoptive immunotherapy, has expanded treatment options for various hematologic malignancies. However, CAR T therapy is associated with a range of side effects, including immune effector cell-associated neurotoxicity syndrome (ICANS), with variable incidence and severity.

OBJECTIVE:

To evaluate the incidence and characteristics of ICANS following CAR T therapy in different hematological diseases, with a focus on product-specific variations.

METHODS:

We searched PubMed, Embase, and Cochrane Library through 2/16/2024. Pooled incidence and 95% confidence intervals (CIs) for ICANS (overall, more severe, and less severe) were estimated via a random-effects model. Separate meta-analyses were conducted for each lymphoma type - large B-cell lymphoma (LBCL), multiple myeloma (MM), and mantle cell lymphoma (MCL).

RESULTS:

Of 259 articles reviewed, 30 studies were meta-analyzed. Among LBCL patients, the incidence of ICANS appeared lower with tisagenlecleucel (16.5%, 95% CI: 12.9-20.9; n = 1,108 patients) than with axicabtagene ciloleucel (45.6%, 95% CI: 39.6-51.7; n = 1,579). In MM patients, the incidence appeared lower with ciltacabtagene autoleucel (10.4%, 95% CI: 5.2-19.9; n=348) than with idecabtagene vicleucel (18.3%; 95% CI: 15.4-21.5; n=631). For MCL patients (n=198), brexucabtagene autoleucel showed a high overall incidence of ICANS (61.2%; 95% CI: 54.2-67.8), with more severe events (32.9%; 95% CI: 26.7%-39.7%) slightly exceeding less severe ones (28.6%; 95% CI: 22.7%-35.3%).

CONCLUSION:

Tisa-cel and cilta-cel showed a more favorable ICANS safety profile in LBCL and MM patients, respectively, while brexu-cel showed a higher ICANS incidence in MCL patients. Further comparative studies are needed to adjust for treatment-related confounders.

2026-01-01·HEMATOLOGICAL ONCOLOGY

Managing Treatment‐Emergent Immune Effector Cell‐Associated Hemophagocytic Lymphohistiocytosis‐Like Syndrome Following CAR‐T Cell Therapy: A Case‐Based Review of the use of Emapalumab

Review

作者: Di Rocco, Alice ; Torelli, Giovanni Fernando ; Piazzolla, Mario ; Donzelli, Livia ; Zullino, Veronica ; Ruberto, Franco ; De Propris, Maria Stefania ; Martelli, Maurizio

ABSTRACT:

Chimeric antigen receptor T (CAR‐T) cell therapies have revolutionized the treatment of hematological malignancies, achieving high response rates in patients with relapsed or refractory disease. Despite these benefits, CAR‐T cell therapies are associated with unique toxicities, including cytokine release syndrome (CRS), immune effector cell‐associated neurotoxicity syndrome (ICANS), immune cell‐associated hematotoxicity (ICAHT), and immune effector cell‐associated hemophagocytic lymphohistiocytosis‐like syndrome (IEC‐HS), which is characterized by a rare and life‐threatening hyperinflammatory response. This paper presents a case of a 56‐year‐old woman with relapsed mantle cell lymphoma (MCL) treated with the CAR‐T cell therapy, brexucabtagene autoleucel, who had subsequently developed CRS and later IEC‐HS. Initial management included tocilizumab, corticosteroids, and anakinra, followed by the compassionate use of emapalumab, an interferon‐γ blocker. To provide broader context, we conducted a literature review of CAR‐T cell‐related toxicities, focusing on IEC‐HS and its management with emapalumab. Clinical and laboratory manifestations, such as elevated ferritin levels, cytopenias, and organ dysfunction, underpin the diagnostic criteria for IEC‐HS. Vigilant monitoring and tailored therapeutic approaches are required to effectively manage toxicities associated with CAR‐T cell therapy, to maximize its benefits and minimize adverse effects. In more severe IEC‐HS cases, emapalumab may be used as an effective targeted therapy.

2025-12-01·Current Hematologic Malignancy Reports

Transforming the Treatment of Acute Lymphoblastic Leukemia: the Role of Bispecific Antibodies, Antibody-Drug Conjugates, and CAR T-cell Therapy

Review

作者: Chalhoub, Joe ; Haddad, Fadi G ; Khanfour, Sarah ; Sakkal, Shereen ; Kourie, Hampig Raphael ; Najdi, Tala

PURPOSE OF REVIEW:

B-cell acute lymphoblastic leukemia (B-ALL) is a highly aggressive hematologic malignancy, with particularly poor outcomes in relapsed or refractory cases. Relapses remain a major challenge, often resulting in short remission durations and limited survival. This review summarizes emerging therapeutic strategies for B-ALL, focusing on novel immunotherapies and targeted approaches beyond the relapsed/refractory setting.

RECENT FINDINGS:

Transformative therapies such as chimeric antigen receptor (CAR) T-cell therapy, antibody-drug conjugates (ADCs), and bispecific antibodies have shown promising efficacy. Beyond the R/R setting, both blinatumomab and inotuzumab ozogamicin demonstrated high rates of eradication of measurable residual disease (MRD) up to 97% and 80%, respectively. Furthermore, the addition of blinatumomab following chemotherapy in the frontline setting in patients with patients with Philadelphia chromosome (Ph)-negative B-ALL who achieved negative MRD was showing to improve outcomes with a 3-year overall survival rate of 85% compared to 68% with chemotherapy alone. Tisagenlecleucel, brexucabtagene autoleucel, and obecabtagene autoleucel, are chimeric antigen receptor (CAR) T-cell therapies that improved survival compared to chemotherapy alone in patients with relapsed/refractory ALL. In newly diagnosed Ph-positive ALL, chemotherapy-free regimens combining blinatumomab with TKIs resulted in high rates of MRD negativity and improved survival. The combination of blinatumomab and ponatinib led to a 98% MRD negativity rates by next-generation sequencing and a 3-year overall survival of 91% without reliance on allogeneic stem cell transplantation. Novel immunotherapies and targeted agents offer new avenues to improve outcomes in B-ALL. Expanding the use of blinatumomab, inotuzumab ozogamicin, and CAR T-cell therapy across treatment phases, together with strategic sequencing, may help overcome relapsed/refractory disease. These approaches provide renewed hope for achieving durable remissions and extending survival in patients with B-ALL.

563

项与布瑞基奥仑赛相关的新闻（医药）

2025-12-29

·同花顺财经

复星集团2025年战略突破与全球布局

据复星消息，复星集团2025年在生物医药、旅游度假、AI应用及国际合作等领域实现多项关键突破，推动全球业务拓展。 10月9日，复宏汉霖自主研发的PD-1抑制剂H药汉斯状在胃癌围术期III期临床研究（ASTRUM-006）中达到无事件生存期主要终点，成为全球首个以免疫单药取代术后辅助化疗的方案，有望开启“无化疗治愈时代”。同年，其PD-L1 ADC HLX43有望成为“广谱抗癌药”，抗HER2单抗HLX22成为全球首款获欧盟和美国孤儿药资格认定的胃癌疗法。6月18日，复星医药（600196）1类新药复迈宁在全国开出首批处方，填补国内肿瘤罕见病治疗空白；9月，小分子CDK4/6抑制剂复妥宁首张处方开出，CAR-T产品布瑞基奥仑赛注射液注册申请获受理。复星医药已构建抗体、ADC、小分子等创新平台，12月与Clavis Bio就前沿靶点达成合作。复宏汉霖成功推动6款自主研发产品出海，触达60个国家和地区；3月汉贝泰在玻利维亚获批，11月HLX11获美国FDA批准上市，成为首个“中国籍”帕妥珠单抗出海产品，HLX14在欧美英获批为“中国籍”地舒单抗。12月9日，药友制药与辉瑞签订口服GLP-1药物YP05002全球独家许可协议，首付款及里程碑付款超20亿美元。 11月28日，复星旅文发布超级度假村、超级度假区与超级文旅Mall三大产品线，签约18个项目，加速旅游向度假转型；Club Med地中海白日方舟·杭州龙坞度假村计划2026年5月开业，太仓阿尔卑斯国际度假区二期将创5项世界室内雪场之最，超级文旅Mall“Hi·重庆”计划2026年下半年开业。2025上半年，Club Med营业额达92.5亿元，同比增长3.8%，全球新增26个度假村，营业额从2015年15亿欧元增至2024年21亿欧元。复星葡萄牙保险2025年上半年国际业务占比近30%，7月获标普A评级；10月举办Pensar Maior大会。4月28日，复星医药与沙特Fakeeh Care Group合作，11月复星凯瑞与其签署备忘录，推动细胞疗法出海；翌耀科技与沙特KJC合资，海南矿业（601969）马里布谷尼锂矿首批3万吨锂精矿10月启运回国。 9月，复星国际完成9.9亿美元银团贷款，创2025年离岸民企纪录，并发行4亿美元债和4亿欧元债；5月标普确认其信用展望为“稳定”。7月15日，“豫园夏日奇幻夜”活动吸引超750万客流，日均16万人次；上海国际珠宝时尚功能区揭牌，10月举办首届主题月和高级定制周；2026年豫园灯区将全域亮灯。6月28日，泰国豫园灯会在曼谷亮灯，成为全球性文化IP。 2月，复星医药发布决策智能体平台PharmAID，医药健康内容生成准确率提升；9月复星旅文AI G.O上线度假村，复星葡萄牙保险应用AI提升效率。5月17日，上海复星公益基金会捐赠1亿元支持医疗发展；11月捐赠1000万港币援助火灾；复星入标普全球《可持续发展年鉴2025》中国版最佳1%。

临床3期引进/卖出免疫疗法抗体药物偶联物细胞疗法

2025-12-29

·复星

复星故事2025：攀登的每一步

10月9日，复宏汉霖自主研发的创新型PD-1抑制剂H药汉斯状联合化疗新辅助/单药辅助治疗胃癌的III期临床研究（ASTRUM-006）期中分析达到了主要研究终点无事件生存期（EFS）。汉斯状成为全球首个胃癌围术期（术前/术后）以免疫单药取代术后辅助化疗的治疗方案，有望开启癌围术期的“无化疗治愈时代”。今年复星生物药创新迎来多项突破，自主研发的PD-L1 ADC HLX43作为一款创新型PD-L1 ADC（靶向PD-L1的抗体偶联药物），有望成为“广谱抗癌药”。创新型抗HER2单抗HLX22成为全球首款同时获得欧盟和美国孤儿药资格认定的胃癌抗HER2靶向疗法。自主研发的创新型PD-L1 ADC HLX43有望成为“广谱抗癌药”。 6月18日，复星医药自主研发的1类新药芦沃美替尼片复迈宁在多个省市医院开出首批处方，正式投入临床使用，弥补了国内相关肿瘤罕见病治疗领域空白。9月另一款自主知识产权的创新型小分子CDK4/6抑制剂复妥宁在国内开出首张处方，第二款CAR-T产品布瑞基奥仑赛注射液的药品注册申请获国家药品监督管理局受理。持续提升源头创新能力，复星医药已构建起抗体、ADC、小分子、细胞治疗等创新平台，并在12月与生物技术公司Clavis Bio就前沿靶点共同开发创新疗法达成战略合作。 6月，自主研发复迈宁全国首批发货并正式投入临床使用，弥补了国内相关肿瘤罕见病治疗领域空白。 12月9日，复星医药控股子公司药友制药与辉瑞签订全球独家许可协议，授予辉瑞口服小分子GLP-1药物YP05002的开发及商业化权利，首付款及潜在里程碑付款超20亿美元，药友制药还将获得产品获批销售后的分层特许权使用费。今年以来，复星生物药出海进入爆发期，3月汉贝泰在玻利维亚获批，成为复宏汉霖第四款海外获批自研产品。11月，复宏汉霖HLX11获美国FDA批准上市，成为首个成功出海的“中国籍”帕妥珠单抗。HLX14相继在美国、欧洲、英国获批上市，成为首个国际获批的“中国籍”地舒单抗。复宏汉霖成功推动6款自主研发产品出海，产品触达60个国家和地区 11月28日，复星旅文正式发布超级度假村、超级度假区与超级文旅Mall三大核心产品线，并完成18个合作项目的集中签约，将加速推动旅游从观光向度假的转型。三大产品线中，Club Med地中海白日方舟·杭州龙坞度假村，计划于2026年5月正式开业，将成为国内第三家地中海·白日方舟。今年6月正式开工的太仓阿尔卑斯国际度假区二期，建成后将成为刷新5项世界室内雪场之最的超级度假区。总体量达50万平方米的“Hi·重庆”作为超级文旅Mall国内首个落地项目，计划于2026年下半年开业。左右滑动查看超级文旅Mall“Hi·重庆” 将提供一个"可逛、可玩、可感、可沉浸"的复合场景。 Club Med地中海白日方舟·杭州龙坞度假村，计划于2026年5月正式开业 2025上半年，复星旅文旗下Club Med营业额再创创历史新高，达到92.5亿元，同比增长3.8%。今年是Club Med地中海俱乐部创立75周年，自2010年加入复星以来，Club Med在中国市场获得了加速发展。2015年，复星完成对Club Med全面要约收购，在复星全球化战略驱动下，10年来Club Med全球共计新增26个度假村，从2015年到2024年，Club Med全球营业额从15亿欧元增长至21亿欧元，运营利润增长超5倍。 2026年，Club Med将在南非开业全球首个“海滨+Safari（野生探险）”组合度假村：Club Med Beach & Safari 2025年，复星葡萄牙保险继续深化国际业务布局，在全球13个国家深度运营，拉美、欧洲、非洲等海外市场对葡保品牌的认可和信任度不断提升。国际化运营让葡保的发展更具韧性,2025年上半年，复星葡萄牙保险国际业务占比近30%，今年7月复星葡萄牙保险首次获国际评级机构标普（S&P）覆盖，并被授予A评级。标普预计未来两年，复星葡萄牙保险将在葡萄牙及国际市场保持领先的市场地位。10月，三年一度的Pensar Maior（Think Bigger）汇聚葡保旗下海外公司代表、集团内员工、分销商、业务合作伙伴及股东等4000余人，为复星葡萄牙保险未来数年的全球化运营战略、进一步提升海外业务收入占比凝聚共识。 10月，复星葡萄牙保险三年一度的Pensar Maior（Think Bigger）大会在葡萄牙举办。 4月28日，复星医药与沙特知名综合性医疗保健集团Fakeeh Care Group达成战略合作，将共同推进多项领先疗法在沙特阿拉伯的落地。11月复星凯瑞与Fakeeh Care Group正式签署战略合作备忘录，为中国尖端细胞疗法“出海”规划出了一条崭新的“沙特路径”。复星持续拓展以中东、非洲为代表的全球新兴市场，今年上半年，翌耀科技与沙特KJC签署合资协议，为沙特电动车行业提供自动化生产线解决方案。海南矿业布局的马里布谷尼锂矿，首批3万吨锂精矿于今年10月启运回国，加速了海南矿业覆盖西非、中东、东南亚的“矿产+能源”网络的落地。左右滑动查看 11月复星凯瑞与Fakeeh Care Group正式签署战略合作备忘录。海南矿业马里布谷尼锂矿，首批3万吨锂精矿于今年10月启运回国 9月，复星国际完成9.9亿美元等值银团贷款签约，刷新了 2025 年以来离岸市场民营企业同类贷款的规模纪录，创下复星国际近 5 年离岸银团贷款的最高规模，显示出全球金融机构对复星业务战略及未来发展的高度认可与坚定信心。同月，复星国际成功发行4年期4亿美元债，成为自2022年1月以来，中资民企同类美元债券发行中期限最长的一笔。11月，复星国际成功发行5年期 4亿欧元债，时隔4年重返欧元债市场，自2019年首发欧元债以来，复星国际仍为欧洲高收益市场中唯一的中资企业。近年来，随着 “聚焦主业、瘦身健体”战略的推进，复星资产结构持续优化，财务保持稳健，现金储备充裕，2025年5月，国际评级机构标普确认复星国际信用指标评级展望为“稳定”。 5月国际评级机构标普确认复星国际信用指标评级展望为“稳定”。 7月15日，“豫园夏日奇幻夜—国创豫宙漫游季”正式在大豫园启幕，上海文化地标变身国漫“痛城”，46天吸引了超750万客流，日均客流突破16万人次，其中超过60%为年轻人。作为全球时尚文化秀场，今年上海国际珠宝时尚功能区在黄浦区大豫园片区正式揭牌，10月首届国际珠宝时尚主题月暨2025上海高级定制周在大豫园文化片区启幕。强大的集聚效应正在加速大豫园的蝶变。2026年1月26日豫园民俗艺术灯区将正式亮灯，2月1日大豫园全域亮灯，从福佑路和方浜中路，延伸至BFC、外滩，以灯光联动，大豫园片区将形成一条独具特色的“历史—现代—未来”光影叙事带。左右滑动查看首届国际珠宝时尚主题月暨2025上海高级定制周在大豫园文化片区启幕。 “豫园夏日奇幻夜”让文化地标变身国漫“痛城”，吸引超750万客流 6月28日，在中泰建交50周年的历史性时刻，2025泰国豫园灯会在曼谷正式亮灯。此番出海泰国，豫园灯会延续以《山海经》为蓝本打造的IP“山海奇豫记”进行延展，在设计中更是注重融入泰国本土特色，用东方生活美学构建出了一个既神秘绚烂又充满烟火气的大型户外沉浸式体验场景。豫园灯会2023年底首次出海法国后，先后在越南、泰国、新加坡等地点亮，已成为一个世界性的中国文化活动IP，成为向世界传播中国文化、讲好中国故事的重要平台。 6月28日， 2025泰国豫园灯会在曼谷正式亮灯。今年2月，复星医药发布了行业首个决策智能体平台PharmAID。整合全球多个临床资讯与管线数据库，PharmAID医药健康内容生成准确率优于通用大模型，在研发决策评估与管线优化方面，信息萃取效率提升50%。复星全面拥抱AI浪潮，选择做行业领先的AI应用者，将AI技术深度融入复星丰富的场景中，推动业务创新提速和运营效率提升。今年9月，复星旅文全场景AI度假智能体的AI G.O相继多个度假村上线。复星葡萄牙保险依托AI应用系统，全面提升业务全流程效率，并提高数据准确性，推动保险业务快速发展。左右滑动查看复星医药全面进行AI应用布局。复星旅文全场景AI度假智能体的AI G.O相继多个度假村上线。 5月17日，上海复星公益基金会捐赠1亿元人民币，支持复旦大学附属医院在医疗、教学、科研及管理等方面的持续发展。11月，香港新界大埔宏福苑多栋住宅楼火灾，复星联合生态企业、爱心人士和机构捐赠1000万港币，用于紧急救援和灾后重建等工作。凭借在ESG领域的持续努力，复星连续第二年入标普全球《可持续发展年鉴2025》，并在标普全球《可持续发展年鉴（中国版）2025》名列最佳1%。复星连续第二年入标普全球《可持续发展年鉴2025》，并在标普全球《可持续发展年鉴（中国版）2025》名列最佳1%。

细胞疗法孤儿药上市批准抗体药物偶联物临床3期

2025-12-29

·PRNewswire

Cell and Gene Therapy Market to Exceed US$105B by 2033, Driving Strategic Value Across Healthcare Portfolios | According to DataM Intelligence

AUSTIN, Texas and TOKYO, Dec. 29, 2025 /PRNewswire/ -- According to DataM Intelligence, the global cell and gene therapy market reached a value of US$13.90 billion in 2024 and is projected to expand significantly to US$105.83 billion by 2033, registering a robust compound annual growth rate (CAGR) of 21.5% during the forecast period from 2025 to 2033. This exceptional growth trajectory reflects the accelerating transition of cell and gene therapies from experimental and early-stage clinical research into commercialized, life-altering treatments. Increasing regulatory approvals, expanding clinical pipelines, and rising investments in advanced therapeutic platforms are positioning cell and gene therapy as one of the most transformative segments within the global biopharmaceutical industry. Request Executive Sample | Cell and Gene Therapy Market Intelligence: Market Overview Cell and gene therapies represent a fundamental shift in how diseases are treated by addressing conditions at their biological root rather than managing symptoms. These approaches can be deployed independently or combined to create gene-modified cell therapies, offering unprecedented therapeutic potential. In combined approaches, a patient's cells are genetically modified through gene therapy techniques and then reintroduced into the body as a cell therapy. One of the most prominent examples is CAR-T cell therapy, where a patient's T cells are engineered to recognize and destroy cancer cells before being reinfused. This approach has demonstrated remarkable success in oncology and continues to expand into additional disease indications. Both cell and gene therapies are increasingly being explored for chronic, inherited, and life-threatening diseases that have limited or no effective treatment options. Their ability to provide long-term or potentially curative outcomes has significantly increased interest from healthcare providers, regulators, and investors worldwide. Market demand is being fueled by a growing number of therapy approvals, a rapidly expanding clinical development pipeline, and rising recognition of the unmet medical needs these therapies can address. Clinical Pipeline Momentum According to the American Society of Cell and Gene Therapy, the sector maintained strong momentum into early 2024, with several notable therapy approvals and sustained growth across all stages of clinical development. Currently, more than 4,000 gene, cell, and RNA-based treatments are in research and development globally. The clinical pipeline has expanded significantly across all phases, with Phase I trials experiencing the highest growth, increasing by approximately 11%. This surge highlights the industry's strong innovation engine and underscores the long-term commercial potential of next-generation therapies entering early-stage development. Market Dynamics Drivers: Advancements in Delivery Vectors One of the most significant growth drivers in the cell and gene therapy market is the increasing utilization of advanced delivery vectors. These vectors are essential for transporting genetic material-DNA or RNA-into target cells safely and efficiently. Traditional delivery systems have limitations related to targeting accuracy, immune response, and dosage efficiency. As a result, next-generation viral and non-viral vectors are being developed to improve therapeutic outcomes while reducing adverse immune reactions. Enhanced delivery systems can also lower dosage requirements, improving both safety and cost-effectiveness. In May 2023, AGC Biologics introduced its BravoAAV and ProntoLVV viral vector platforms, offering faster, scalable, and reproducible production under Good Manufacturing Practice (GMP) conditions. These platforms are designed to support both clinical and commercial-scale manufacturing. Similarly, in May 2024, Charles River Laboratories International, Inc. launched reference materials for adeno-associated virus (AAV) and lentiviral vector (LVV) portfolios to streamline cell and gene therapy research and enable smoother transitions to GMP-quality production. Restraints: High Development and Manufacturing Costs Despite strong growth prospects, high development costs and complex manufacturing processes remain significant restraints for the cell and gene therapy market. Production requires specialized cleanroom facilities, highly skilled personnel, and strict adherence to regulatory standards. Many therapies-particularly autologous treatments such as CAR-T-must be customized for each individual patient, substantially increasing production time and cost. Manufacturing costs for CAR-T therapies can exceed US$100,000 per patient, while certain gene therapies, such as one-time treatments for rare genetic diseases, can cost over US$2 million per patient. These high costs create challenges related to reimbursement, scalability, and patient access. In addition, the production of viral vectors and specialized raw materials is both capital- and time-intensive, with limited suppliers further increasing expenses. According to simulations by the National Institutes of Health (NIH), annual spending on gene therapies could reach approximately US$20.4 billion, even under conservative assumptions. Purchase Corporate License | Cell and Gene Therapy Market Intelligence: Market Segmentation Analysis By Therapy Type The global cell and gene therapy market is segmented into cell therapy and gene therapy, with cell therapy accounting for the dominant share. In 2024, the cell therapy segment held approximately 61.2% of the global market share. The segment demonstrated strong growth, reaching US$13.39 billion in 2022 and increasing further to US$14.66 billion in 2023. Cell therapies have gained widespread adoption due to their strong clinical success, particularly in oncology and regenerative medicine. CAR-T therapies and stem cell-based treatments have shown high efficacy, accelerating approvals and market uptake. A notable milestone occurred in April 2024, when India launched its first indigenously developed CAR-T cell therapy, developed by the Indian Institute of Technology (IIT) Bombay and Tata Memorial Centre. The therapy is being offered at nearly one-tenth of the global cost, significantly improving accessibility and highlighting the role of innovation in cost reduction. Substantial funding from governments and research institutions continues to support cell therapy development. For example, researchers at the University of California, San Francisco (UCSF) initiated a clinical trial for a next-generation CAR-T therapy targeting glioblastoma, supported by an US$11 million grant from the California Institute for Regenerative Medicine (CIRM). Geographical Analysis North America North America dominates the global cell and gene therapy market, accounting for approximately 43.7% of the total market share. The region recorded a market size of US$10.94 billion in 2022, which expanded to US$11.97 billion in 2023. The region's leadership is supported by a strong biotechnology ecosystem, advanced healthcare infrastructure, and the presence of leading academic research institutions. The United States, in particular, benefits from proactive regulatory frameworks that accelerate development and commercialization. The U.S. Food and Drug Administration (FDA) has introduced specialized pathways such as the Regenerative Medicine Advanced Therapy (RMAT) designation, which expedites the review of promising therapies. In August 2024, Ocugen, Inc. received FDA clearance to initiate an expanded access program for OCU400, a modifier gene therapy for retinitis pigmentosa, highlighting continued regulatory support for innovative treatments. Competitive Landscape The cell and gene therapy market features a combination of established pharmaceutical companies and innovative biotechnology firms. Leading players focus on expanding clinical pipelines, improving manufacturing capabilities, and forming strategic collaborations. Key Market Players Emerging players such as Editas Medicine, Intellia Therapeutics, Rocket Pharmaceuticals, Regenxbio, and Affinia Therapeutics are contributing to innovation through next-generation gene-editing and vector technologies. Novartis AG Key CGT products: Kymriah (CAR-T), Zolgensma (AAV gene therapy) Technology focus: CAR-T cell therapy, in-vivo AAV gene therapy Competitive positioning: Novartis is a first-mover and scale leader in CGT, with strong manufacturing capabilities, regulatory experience, and global commercialization across oncology and rare genetic diseases. Primary markets served: US, Europe, Japan, China Gilead Sciences, Inc. Key CGT products: Yescarta, Tecartus (CAR-T therapies) Technology focus: Autologous CAR-T cell therapy (via Kite Pharma) Competitive positioning: Gilead is a dominant CAR-T oncology player, focusing on hematological malignancies with continuous innovation in manufacturing efficiency and next-generation CAR designs. Primary markets served: US, Europe Bristol Myers Squibb Company Key CGT products: Breyanzi, Abecma (CAR-T therapies) Technology focus: CAR-T cell therapies for blood cancers Competitive positioning: BMS has built a robust CAR-T franchise through strategic acquisitions and partnerships, emphasizing differentiated safety profiles and broader patient eligibility. Primary markets served: US, Europe, Japan Vertex Pharmaceuticals Incorporated Key CGT products: Casgevy (exagamglogene autotemcel; gene-edited therapy, partnered) Technology focus: CRISPR/Cas9 gene editing (functional cure approach) Competitive positioning: Vertex is redefining CGT with curative, one-time gene-editing therapies, particularly in hemoglobinopathies, moving the market beyond symptomatic treatment. Primary markets served: US, Europe, select global markets Orchard Therapeutics Key CGT products: Libmeldy (ex-vivo gene therapy for metachromatic leukodystrophy) Technology focus: Ex-vivo autologous hematopoietic stem cell gene therapy Competitive positioning: Orchard is a pure-play rare pediatric gene therapy innovator, specializing in ultra-rare, life-threatening genetic disorders. Primary markets served: Europe, United States Krystal Biotech, Inc. Key CGT products: Vyjuvek (topical gene therapy for dystrophic epidermolysis bullosa) Technology focus: Redosable, non-invasive gene therapy platforms Competitive positioning: Krystal stands out for non-systemic, localized gene therapy delivery, significantly lowering safety and manufacturing complexity compared with systemic CGTs. Primary markets served: United States, Europe Request Customized Intelligence Aligned to Your Business Strategy: Recent Industry Developments The market continues to evolve through technological advancements and strategic initiatives: September 2024: CPC (Colder Products Company) launched a new aseptic micro-connector designed specifically for freeze cassettes used in cell and gene therapy processing. April 2024: Walgreens announced plans to work directly with drug manufacturers to expand patient access to cell and gene therapies through its specialty pharmacy division, including AllianceRx. May 2024: ProPharma, in partnership with Italy-based PBL, launched the Cell Factory Box (CF Box)-a fully automated system enabling decentralized CGT manufacturing in controlled environments. Conclusion The global cell and gene therapy market is entering a period of unprecedented growth, driven by rapid innovation, expanding clinical pipelines, and increasing regulatory support. While challenges related to cost, scalability, and manufacturing complexity persist, ongoing advancements in delivery vectors, automation, and decentralized production are expected to address many of these barriers. With strong momentum across research, development, and commercialization, cell and gene therapies are poised to redefine treatment paradigms and deliver long-term value to healthcare systems worldwide through 2033 and beyond. Related Report: Cell and Gene Therapy Manufacturing Services Market How Biopharma Is Scaling Viral Vector Capacity and Reducing Time-to-Market Gene Editing Tools Market Investment Opportunities Across CRISPR, TALEN, and Next-Generation Editing Platforms Gene Therapy Market Commercialization Challenges, Pricing Pressures, and Growth Opportunities Through 2033 Cancer Gene Therapy Market Pipeline Trends, Clinical Success Rates, and Competitive Positioning Japan Gene Therapy Market Regulatory Pathways, Market Entry Strategies, and Growth Potential Japan Cell Therapy Market Demand Drivers, Manufacturing Landscape, and Strategic Opportunities About DataM Intelligence DataM Intelligence is a renowned provider of market research, delivering deep insights through pricing analysis, market share breakdowns, and competitive intelligence. The company specializes in strategic reports that guide businesses in high-growth sectors such as nutraceuticals and AI-driven health innovations. To find out more, visit or follow us on Twitter, LinkedIn, and Facebook. Contact: Sai Kiran DataM Intelligence 4market Research LLP Ground floor, DSL Abacus IT Park, Industrial Development Area Uppal, Hyderabad, Telangana 500039 USA: +1 877-441-4866 Email: [email protected] Logo: SOURCE DataM Intelligence 4 Market Research LLP 21% more press release views with Request a Demo

细胞疗法基因疗法并购

100 项与布瑞基奥仑赛相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
前体B细胞成淋巴细胞白血病淋巴瘤	澳大利亚	Gilead Sciences Pty Ltd.	2022-09-30
复发性套细胞淋巴瘤	欧盟	Kite Pharma EU BV	2020-12-14
复发性套细胞淋巴瘤	冰岛	Kite Pharma EU BV	2020-12-14
复发性套细胞淋巴瘤	列支敦士登	Kite Pharma EU BV	2020-12-14
复发性套细胞淋巴瘤	挪威	Kite Pharma EU BV	2020-12-14
难治性套细胞淋巴瘤	欧盟	Kite Pharma EU BV	2020-12-14
难治性套细胞淋巴瘤	冰岛	Kite Pharma EU BV	2020-12-14
难治性套细胞淋巴瘤	列支敦士登	Kite Pharma EU BV	2020-12-14
难治性套细胞淋巴瘤	挪威	Kite Pharma EU BV	2020-12-14
急性淋巴细胞白血病	美国	Kite Pharma, Inc.	2020-07-24
套细胞淋巴瘤	美国	Kite Pharma, Inc.	2020-07-24

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
伯基特淋巴瘤	临床2期	美国	Kite Pharma, Inc.	2022-11-01
伯基特淋巴瘤	临床2期	奥地利	Kite Pharma, Inc.	2022-11-01
伯基特淋巴瘤	临床2期	法国	Kite Pharma, Inc.	2022-11-01
伯基特淋巴瘤	临床2期	德国	Kite Pharma, Inc.	2022-11-01
伯基特淋巴瘤	临床2期	意大利	Kite Pharma, Inc.	2022-11-01
伯基特淋巴瘤	临床2期	荷兰	Kite Pharma, Inc.	2022-11-01
伯基特淋巴瘤	临床2期	西班牙	Kite Pharma, Inc.	2022-11-01
伯基特淋巴瘤	临床2期	瑞士	Kite Pharma, Inc.	2022-11-01
毛细胞白血病	临床2期	美国	Kite Pharma, Inc.	2022-11-01
毛细胞白血病	临床2期	奥地利	Kite Pharma, Inc.	2022-11-01

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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


ChiCTR2300073872 (ASH2025) 人工标引	临床2期	前体B细胞成淋巴细胞白血病淋巴瘤	28	KTE-X19	製製淵觸餘構範鑰選窪(窪蓋膚選衊範築觸壓觸) = 夢遞窪範遞廠願鬱夢網廠願鏇衊鹽遞膚網鹹網 (窪鏇壓網築餘壓範願鏇, 62.0 ~ 90.2) 更多	积极	2025-12-06
ASH2025	N/A	难治性成人急性淋巴细胞白血病	134	Brexu-cel infusion	築憲構積簾繭願鹹蓋構(窪鑰憲觸遞衊襯獵膚淵) = 獵憲憲齋獵鹹膚鬱顧範鹽願窪鹽醖鑰遞醖鹹製 (鑰積網鏇壓膚選網顧顧 ) 更多	积极	2025-12-06
ASH2025	N/A	费城染色体阴性急性淋巴细胞白血病	165	Brexucabtagene autoleucel (Never HCT)	齋膚糧製鬱鏇蓋遞鹹淵(淵醖製鬱齋蓋艱遞鏇廠) = 築鹹齋網繭鑰獵艱夢遞淵繭網遞鏇範憲淵鏇製 (顧膚艱繭鹽衊遞構遞觸 ) 更多	积极	2025-12-06
ASH2025	N/A	费城染色体阴性急性淋巴细胞白血病	165	Brexucabtagene autoleucel (Pre-CAR HCT)	齋膚糧製鬱鏇蓋遞鹹淵(淵醖製鬱齋蓋艱遞鏇廠) = 構遞鑰廠鹽願網艱糧鏇淵繭網遞鏇範憲淵鏇製 (顧膚艱繭鹽衊遞構遞觸 ) 更多	积极	2025-12-06
NCT05495464 (WINDOW-3, ASH2025)	临床1期	套细胞淋巴瘤一线	20	Acalabrutinib plus rituximab	繭夢衊構壓淵範窪壓艱(鑰餘壓積網艱鹹鏇膚構) = only one patient had grade 3 adverse event (AE, skin rash) 鹽醖製繭製鏇網窪壓鏇 (鑰淵襯醖構繭選膚網簾 ) 更多	积极	2025-12-06
ASH2025	N/A	复发性急性淋巴细胞白血病	92	Obecabtagene autoleucel (obe-cel)	鏇鑰艱積衊鏇襯廠網鑰(觸夢築襯製願遞築淵鹹) = 蓋觸選醖夢淵襯製夢鬱獵夢夢窪網繭淵鹹鹹獵 (窪觸獵選鏇衊製蓋構網 ) 更多	积极	2025-12-06
ASH2025	N/A	复发性急性淋巴细胞白血病	92	Brexucabtagene autoleucel (brexu-cel)	鏇鑰艱積衊鏇襯廠網鑰(艱繭顧簾齋醖憲願鑰夢) = 鹽鏇廠餘鑰淵襯顧觸蓋膚夢夢簾積廠窪築繭遞 (糧壓鹹鏇鏇餘製鏇鏇繭 ) 更多	积极	2025-12-06
NCT05537766 (ZUMA-25, ASH2025)	临床2期	伯基特淋巴瘤	10	Brexucabtagene autoleucel (brexu-cel)	膚醖壓襯膚夢糧憲顧遞(廠築遞襯獵夢齋淵齋衊) = 壓網窪鬱積鹹窪獵艱襯窪淵鹹範鏇鹹選壓製獵 (範廠範壓鏇艱壓鑰鹽壓, 69 ~ 100) 更多	积极	2025-12-06
NCT04880434 (ZUMA-2 Cohort 3, ASH2025)	临床2期	难治性套细胞淋巴瘤	86	Brexucabtagene autoleucel (Brexu-cel)	夢醖淵簾鹹鹹鹹鹽夢鹽(繭鹽觸積簾蓋範壓遞鹹) = 醖夢繭顧鏇顧糧築獵積窪衊鬱醖餘鏇糧窪範糧 (襯顧選鬱淵觸鬱鹹築鏇, 82.5 ~ 95.9) 更多	积极	2025-12-06
ASH2025	N/A	大B细胞淋巴瘤 \| 套细胞淋巴瘤 \| 前体B细胞成淋巴细胞白血病淋巴瘤	430	Immunoglobulin replacement therapy (IGRT)	構憲築夢網糧顧選齋餘(淵鬱構壓齋鹽襯糧鏇願) = Infection was probable in 43 (18.1%). Of episodes with a pathogen identified, 58.3% were viral, 40.7% bacterial, 0.5% fungal and 0.5% other. The primary focus was respiratory in 75%. Infection was grade ≥3 in 44% including grade 5 in 6.8%. 遞願範鑰積醖窪鬱築獵 (糧獵獵選簾繭築衊鹽遞 ) 更多	积极	2025-12-06
ASCO2025	N/A	CD19阳性B细胞急性淋巴细胞白血病巩固 CD19	46	Brexucabtagene autoleucel (Brexu-cel)	憲鹹觸簾齋獵蓋鏇糧鹽(襯衊鹹壓鹹蓋醖簾襯積) = Among the 3 pts with G3-4 CRS/ICANS, the peak CAR T expansion was 102, 1270 and 2222 cells/µL 積簾夢簾衊襯鏇糧壓夢 (窪壓憲窪鹽壓網鑰鏇選 )	-	2025-05-30
EHA2025	临床2期	-	613	Brexucabtagene Autoleucel (Brexu-cel)	積醖齋鹹鏇構蓋夢鑰蓋(鹹繭構鏇艱夢蓋夢簾網) = 構獵願選窪鏇窪窪願顧鏇衊壓顧遞鑰鏇鹹鏇憲 (膚夢網積廠窪積壓艱憲, 85 ~ 90) 更多	-	2025-05-14