A Dose Ranging Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Relmacabtagene Autoleucel (Relma-cel) in Patients With Refractory/Progressive Systemic Sclerosis

Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis. Efficacy will be explored too. If enrolled, participants will undergo leukapheresis, lymphodepleting chemotherapy and administration of Relma-cel.

开始日期2024-06-12

申办/合作机构

上海明聚生物科技有限公司

100 项与瑞基奥仑赛相关的临床结果

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100 项与瑞基奥仑赛相关的转化医学

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100 项与瑞基奥仑赛相关的专利（医药）

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项与瑞基奥仑赛相关的文献（医药）

2024-12-01·CYTOTHERAPY

CD19 CAR-T treatment shows limited efficacy in r/r DLBCL with double expression and TP53 alterations

Article

作者: Zhang, Wenjun ; Zhou, Jie ; Luo, Xiu ; Liu, Yifan ; Ye, Shiguang ; Lu, Ying ; Zhou, Lili ; Qian, Wenbin ; Liang, Aibin ; Lu, Yan ; Xiu, Bing ; Xue, Bin ; Li, Ping

OBJECT:

Autologous CD19 chimeric antigen receptor T-cell therapy (CAR-T) significantly modifies the natural course of chemorefractory diffuse large B-cell lymphoma (DLBCL). However, 25% to 50% of patients with relapsed/refractory DLBCL still do not achieve remission. Therefore, investigating new molecular prognostic indicators that affect the effectiveness of CAR-T for DLBCL and developing novel combination therapies are crucial.

METHODS:

Data from 73 DLBCL patients who received CD19 CAR-T (Axi-cel or Relma-cel) were retrospectively collected from Shanghai Tongji Hospital of Tongji University, The Second Affiliated Hospital Zhejiang University School of Medicine, and The Affiliated People's Hospital of Ningbo University. Prior to CD19 CAR-T-cell transfusions, the patients received fludarabine and cyclophosphamide chemotherapy regimen.

RESULTS:

Our study revealed that relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) patients with both Double-expression (MYC > 40% and BCL2 > 50%) and TP53 alterations tend to have a poorer clinical prognosis after CAR-T therapy, even when CAR-T therapy is used in combination with other therapies. However, CAR-T therapy was found to be effective in patients with only TP53 alterations or DE status, suggesting that their prognosis is in line with that of patients without TP53 alterations or DE status.

CONCLUSIONS:

Our study suggests that r/r DLBCL patients with both DE status and TP53 alterations treated with CAR-T therapy are more likely to have a poorer clinical prognosis. However, CAR-T therapy has the potential to improve the prognosis of patients with only TP53 alterations or DE status to be similar to that of patients without these abnormalities.

2024-05-01·Journal for ImmunoTherapy of Cancer

Real-world experience of commercial relmacabtagene autoleucel (relma-cel) for relapsed/refractory central nervous system lymphoma: a multicenter retrospective analysis of patients in China

Article

作者: Niu, Ting ; Yu, Wenyan ; Mi, Jian-Qing ; Zou, Dehui ; Li, Hui ; Wu, Jianqiu ; Cai, Qingqing ; Liu, Peng ; Li, Yuhua ; Liu, Yao ; Wang, Zhi ; Huang, Liang ; Mei, Heng ; Zhang, Huilai

Background:

Relapsed/refractory (R/R) central nervous system lymphomas (CNSLs) are associated with a poor prognosis. Relmacabtagene autoleucel (relma-cel), expressing the same chimeric antigen receptor (CAR) as lisocabtagene maraleucel, with an optimized commercial-ready process developed in China, demonstrated remarkable efficacy and manageable safety in the pivotal RELIANCE study. However, no published data are available on the “real-world” use of relma-cel, especially for patients with CNS involvement.

Patients and methods:

Retrospective analyses were conducted for commercial relma-cel used in patients with R/R CNSL at 12 clinics. The primary endpoint was to evaluate the proportion of patients who achieved complete response (CR) at 3 months. Secondary endpoints included best complete response (BCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS), and the incidence of adverse events.

Results:

Among the 22 CNSL patients (12 primary CNSLs; 10 secondary CNSLs), the best overall response rate was 90.9% and the BCR rate was 68.2%. With median follow-up of 316 days (range, 55–618 days), the estimated 1-year PFS rate, DOR, and OS rate were 64.4%, 71.5%, and 79.2%, respectively. Significant clinical benefits were observed in patients who were in durable CR or partial response to the most recent prior therapy preleukapheresis and received relma-cel as consolidation therapy (n=8), with 1-year PFS rate of 100.0% versus 41.7% (p=0.02). In addition, in terms of primary endpoint, non-CR at 3 months postinfusion seemed to be predictive of a worse prognosis, with an estimated 1-year PFS of 83.3% versus 37.0% (p=0.03), respectively. CRS occurred in 72.9% of patients (grade 3: 4.5%) and immune effector cell-associated neurotoxicity syndrome in 36.4% of patients (grade 3: 4.5%). With the add-on agent PD-1 inhibitor (tislelizumab) to the ongoing BTKi, significant re-expansions of CAR T-cell were detected by quantitative PCR or flow cytometry after a median of 2 weeks (range, 12–32 days).

Conclusions:

This study was the first and largest real-world study of commercial relma-cel for R/R CNSL, demonstrating promising efficacy and acceptable safety. We reaffirmed the benefit of immuno-agents such as BTKi or PD-1 inhibitor on CAR T-cell re-expansion and hypothesized a dual-agent CAR-T related combinatorial therapies, which warrants further validation. Most importantly, we highlighted the earlier use of CAR T-cell therapy as a consolidative therapy for patients sensitive to salvage therapy, which provided an impetus and inspired-future strategy.

2023-09-01·Applied health economics and health policy

Value for Money of CAR-T Cell Therapy for Patients with Diffuse Large B-cell Lymphoma in China: Evidence from a Cost-Effectiveness Analysis.

Article

作者: Comans, Tracy ; Dong, Hengjin ; Wang, Yannan ; Zhou, Yuping ; Keramat, Syed Afroz ; Yang, Yi ; Wu, Weijia ; Balasooriya, Namal N ; Zhao, Zixuan

OBJECTIVE:

This research assesses the cost effectiveness of Axicabtagene ciloleucel (Axi-cel), Tisagenlecleucel (Tis-cel), Relmacabtagene autoleucel (Rel-cel) and Lisocabtagene maraleucel (Lis-cel) against standard of care (SOC) for patients with diffuse large B-cell lymphoma (DLBCL) in the first-line setting (1L), second-line setting (2L) and third-line or later setting (3L+).

METHODS:

Markov modelling based on a flexible survival model was adopted to evaluate four chimeric antigen receptor T-cell (CAR-T) therapies compared with SOC for patients with diffuse large B-cell lymphoma (DLBCL). The clinical inputs and utility values of the model were derived from the most recent clinical trials and the health care costs from a Chinese provincial clinical center. Costs and quality-adjusted life years (QALYs) were used to derive incremental cost-effectiveness ratios (ICERs) from the Chinese health care system perspective.

RESULTS:

The ICER of Axi-cel (1L) versus SOC was approximately Chinese Yuan (CNY) 2,125,311 per QALY. The ICER for Axi-cel (2L), Tis-cel (2L) and Liso-cel (2L)) versus SOC in transplant-eligible patients were approximately CNY363,977, CNY32,066,781 and CNY347,746 per quality-adjusted life year (QALY), respectively. The ICER for Liso-cel (2L) versus SOC in transplant-ineligible patients was approximately CNY1,233,972 per QALY. The ICERs for Axi-cel (3L+), Tis-cel (3L+), Rel-cel (3L+) and Liso-cel (3L+) versus SOC were approximately CNY346,009, CNY654,344, CNY280,964 and CNY436,858 per QALY, respectively. In the scenario analysis using mixture cure models, the long-term survival benefit for CAR-T and SOC groups was found higher, and only Rel-cel (3L+) was found to be cost effective.

CONCLUSION:

Our results demonstrated that CAR-T treatments are not cost effective in any-line settings for DLBCL patients at the WHO-recommended willingness-to-pay threshold (CNY257,241 per QALY) in the base-case analysis. Price reduction of CAR-T therapies is the main approach for lowering ICERs and ensuring that the drug costs are proportional to patient health benefits.

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项与瑞基奥仑赛相关的新闻（医药）

2025-01-10

·PRNewswire

JW Therapeutics Announces Receipt of Breakthrough Therapy Designation for Carteyva® in China as Second-line Treatment in Relapsed or Refractory adult Large B-cell Lymphoma

SHANGHAI, Jan. 10, 2025 /PRNewswire/ -- JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation for Carteyva® (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) . Carteyva® is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics. Continue Reading The Breakthrough Therapy Designation was supported by the results from the clinical study aimed to assess the efficacy and safety of Carteyva® in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical result obtained in Chinese patients. Large B-cell lymphoma is a highly aggressive non-Hodgkin's lymphoma and is the most common subtype of lymphoma in adults. LBCL is a potentially curable disease, but 30-40% of patients still experience refractory or relapse1. Patients who fail first-line treatment have a poor outcome, and although conventional treatment options such as high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HDCT/ASCT) are the standard of care, approximately more than half of the patients are not suitable for ASCT due to a variety of reasons such as advanced age, comorbidities, and so on, and there is no standard of care with a very poor outcome2. There are still urgent unmet medical needs to develop additional active therapeutic approaches for the treatment of r/r LBCL. About Relmacabtagene Autoleucel Injection Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations. About JWCAR029-216 Study (NCT06093841) This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva® in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical study to evaluate such novel therapy in Chinese LBCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients. The study is currently ongoing. Preliminary clinical data found Carteyva® providing outstanding efficacy and good safety profile for r/r LBCL patients, with a best overall response rate of 84%. About JW Therapeutics JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit . Forward-Looking Statements The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: . SOURCE JW Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床2期上市批准突破性疗法细胞疗法

2024-12-24

·药时代

再创一夜致富新神话？创新药企的NewCo之路应该怎么走

2024年，NewCo作为一种新的交易模式迅速发展，并成为国内创新药企出海的重要途径之一。这种由资本攒局，企业进行海外授权的新型模式，兼具了BD（商务拓展）和融资两种属性，让深陷寒冬的国产创新药企看到了一缕曙光。今年5月，恒瑞医药将3款GLP-1产品组合以NewCo形式进行交易，开启了国内NewCo热潮的第一步。随后，多家企业先后跟上，在今年多次吸引大额融资，成为第九届医药创新与投资大会（以下简称“大会”）的热门议题。 12月1日，大会新药研发监管国际化论坛在广州召开（点击查看论坛新闻）。中国药促会国际创新药物监管专委会主委、荣昌生物首席战略官、国投创新医疗健康首席科学家、前国家食品药品监督管理总局药品审评中心首席科学家何如意以《创新接力—对外授权NewCo模式的思考》为题，围绕NewCo模式展开深入探讨。何如意表示，对于当前的市场环境来说，NewCo模式不失为企业脱困的一个好方法，他建议企业在进行NewCo交易时尽量选取早期阶段的产品，并提出了“改良型NewCo”的新思路，即中国基金和美元基金联合，共同开发和投资中国创新药，为中国药企提供新的国际化发展机遇。最高超60亿美元，NewCo创融资神话 “出海不是选择题，而是必答题”已经成为近年来创新药业内的共识。更合理的定价体系所带来的高回报是企业出海的本质原因。数据显示，中国药品价格相比国际各国同一药品最低参考价的中位值还低大约39%，已成为全球价格的“洼地”。以CAR-T产品为例，何如意介绍，已在国内上市的复星凯特的奕凯达、药明巨诺的倍诺达价格分别为120万元/针和129万元/针，而传奇生物CAR-T在美售价46.5万美金。今年三季度，传奇生物公布其明星产品Carvykti销售额为2.86亿美元，同比增长87.7%。但高昂的临床成本、相异的审批程序和商业化环境挡住了大部分企业的出海进程。叠加国内日益加剧的内卷趋势和资本寒冬，NewCo模式应运而生。这种在国内新兴的交易模式实际上早就存在于国际创新药企之间。何如意举例，2022年，辉瑞公司与Roivant Sciences共同成立NewCo Telavant，并将RVT-3101以4500万美元授权于这家NewCo，辉瑞对此保留25%的股份。一年后，罗氏就以71亿美元收购了Telavant。此外，这种模式也曾广泛存在于大量License-in阶段的中国。何如意介绍，国外的产品通过与中国资本成立NewCo，并在国内IPO的例子屡见不鲜。而真正意义上成为热潮，则是今年年初恒瑞医药的成功。5月，恒瑞3款GLP-1产品组合HRS-7535、HRS9531、HRS-4729以NewCo形式达成出海交易，将除大中华区以外的全球范围内开发、生产和商业化的独家权利有偿许可给美国Hercules公司，获得首付款和未来的里程碑付款总计高达60亿美元及19.9%的股权。随后，康诺亚、嘉和生物、岸迈生物、维立志博等企业纷纷入局，交易品种集中在自免、代谢及双抗药物等近年大热的赛道。其中，康诺亚分别在今年7月及11月两次进行交易，获得超6亿美元收入。 NewCo要趁早中国创新药企为什么会产生NewCo热？在何如意看来，IPO无望、并购无门、转让无路是最直接的三大原因。当前，BD已成为创新药重要的资金来源。数据显示，截至11月，2024年license-out总交易金额超过20亿美元的交易数量共3笔，占已披露金额交易总量的6%。此外，信银（香港）资本研究部在研报中指出，今年7-10月国产创新药共录得33笔对外授权，统计少数披露金额的交易，首付款已达23亿美元，总额超126亿美元。何如意表示，随着近年来中国创新药管线布局的完善和技术人才的积累，创新成果逐步得到国际认可，吸引了美国资本的目光。何如意表示，无论是常规BD还是NewCo，其最终的出路都是IPO或者卖给MNC。当前，美国有IPO及并购等明确的退出机制，于是NewCo纷纷前往美国，落地生根。但并不是所有企业都适合NewCo模式，何如意提出，NewCo交易本质是“击鼓传花”的投资逻辑，资本一定会作为中间商赚差价，所以选择NewCo的产品一定要选择早期有增值空间的产品，一般认为Ⅰ期到Ⅱ期阶段最为合适。如果一个产品已经在国内上市了，那国外的想象空间也会减小。此外，里程碑一定要短。今年已经发生的NewCo交易有的半年就转手，多则一年就转手，这更要求企业选择早期阶段的产品，才能尽快完成临床试验。最后，何如意提出，在进行NewCo交易时，一定要尽量贴合MNC的需求。“产品不一定要新，但一定要好。” NewCo最大的不同在于管理方式在进行NewCo交易时，何如意还提醒企业，一定要注重美元资本的管线运作能力。与常规BD模式不同，NewCo的资本来自于美国，落地在美国，未来也将在美国IPO或被MNC收购。NewCo能够成立的前提，就是美元基金的成熟度。何如意指出，NewCo更多是指：美国一亿美金以上投资额的财团，它们准备好管理团队，有成熟的管线运作能力，带着指定的方向去搜寻合适的新药资产。NewCo股份大致占比为：基金50-70%；管理团队10-30%；资产方0-30%。此外，最重要的是管理方式的不同。何如意强调，NewCo必须有经验丰富且强有力的美国管理团队，背后有连续孵化成功经验的VC。团队的管理交由国际大股东来负责，资金来源也由大股东解决，原公司只需要出资产。他表示，NewCo本质是一家biotech，临床推进能力最关键，要选对适应症，找到靠谱CRO，有适应症领域的大PI背书，招募到患者并管理好临床试验。当前，一些药企的子公司走向和NewCo越来越像，比如百利天恒的全资子公司SystImmune与BMS就EGFRxHER3双抗ADC达成授权合作后，就将BL-B01D1管线剥离出去，聘请BMS高级副总裁就任CMO，搭建管理团队。何如意提示企业，地域政治等因素对于公司的运作有一定程度的影响，搭建本土化团队更有利于融资和临床的开展。保护核心资产，还应探索新NewCo模式尽管NewCo在今年开展得如火如荼，但也并非所有企业都适合这一模式，最终的决定因素是企业对自身的定位。何如意指出，当前，国内创新药行业已经出现分化趋势，未来的行业会更加精细化分工，技术壁垒高筑。 “成为Biopharma的窗口期已经越来越少。”何如意表示，不论是BD还是NewCo，企业一定要抓准时机进行决策。比如当前大部分交易中，原公司都保留了大中华权益，但企业如果在未来的规划中并不打算继续靠自身开展III期试验，也没有精力组建销售团队，那就不要跟风，及时卖出，以免错过交易的最佳时机。 NewCo未来的发展仍取决于今年成功的几笔交易。何如意表示，未来几年将是对中国创新药产品的验证期，产品出海之后能否获得临床数据的支撑至关重要。此外，何如意还提出了“改良型NewCo”，即中国基金或中美基金联合，在中国共同开发和投资被MNC看好的国产创新药。事实上，核心资产流失、资产被贱卖是国内创新药企在进行NewCo交易时担心的主要问题。改良型的NewCo模式则避免了这一难题，同时也为中国药企提供新的国际化发展机遇。封面图来源：123rf 往期推荐医保药品目录解读重点列举的新cGVHD疗法，创新价值体现在哪里？一起穿越生物医药的炎夏和寒冬！——全球知名投资机构Atlas Venture 2018至2024年年度演讲荟萃又一MASH FIC新药III期临床失败！股价一夜腰斩版权声明/免责声明本文为授权转载文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击，查看更多精彩!

免疫疗法细胞疗法并购临床研究IPO

2024-12-19

·药事纵横

盘点2024年上市的ADC、双抗和CAR-T药物

时光荏苒，白驹过隙，转瞬又到了2024年的末尾。作为创新药领域最前沿的技术路径，ADC、双抗、CAR-T等药物备受关注，并催生多项大额交易。2024年，多款ADC、双抗及CAR-T药物获批上市，本文将盘点2024年上市的ADC、双抗和CAR-T药物。（一）ADC药物：2024年仅一款首次上市 2024年，ADC药物的上市动向主要集中于国内，而太平洋彼岸的美国市场则略显寂寞。聚焦国内，2024年，4款ADC药物在国内首次上市，分别是科伦博泰的芦康沙妥珠单抗（TROP2 ADC）、华东医药引进的Elahere（FRα ADC）、Seagen/安斯泰来研发的Padcev（Nectin-4 ADC）及瓴路药业引进的Zynlonta（CD19 ADC）。Elahere、Padcev和Zynlonta均已在美国上市，仅科伦博泰的芦康沙妥珠单抗为首次上市。放眼美国，2024年，FDA并未批准任意新分子形式的ADC药物，除了Enhertu于2024年4月新增HER2阳性（IHC 3+）实体瘤适应症。科伦博泰的芦康沙妥珠单抗（SKB264）可谓是2024年ADC领域首次上市的独苗。2024年11月，科伦博泰宣布芦康沙妥珠单抗获批上市，适应症为既往至少接受过2种系统治疗的不可切除的局部晚期或转移性三阴性乳腺癌（TNBC）。芦康沙妥珠单抗的上市标志着第二款国产ADC的上市，首款为荣昌生物的维迪西妥单抗。芦康沙妥珠单抗采用可裂解连接子，在肿瘤局部与TROP2抗原结合后被肿瘤细胞内吞，在溶酶体作用下胞内裂解释放小分子毒素T030（新型拓扑异构酶I抑制剂），杀伤肿瘤细胞。同时，T030还能透出细胞膜，进一步杀伤周围肿瘤细胞，发挥旁观者效应。芦康沙妥珠单抗的载荷选择了新型拓扑异构酶I抑制剂，药物抗体比（DAR）平均高达7.4，提高了药物的临床疗效。图：芦康沙妥珠单抗结构数据来源：科伦博泰生物宣传资料芦康沙妥珠单抗的上市基于一项名为OptiTROP-Breast01的Ⅲ期研究，研究入组了263名既往接受≥2种化疗方案后复发或难治性三阴乳腺癌（TNBC）患者。试验结果显示，与化疗相比，芦康沙妥珠单抗组的mPFS为6.7m和2.5m（HR=0.32，P<0.00001），总生存期上，芦康沙妥珠单抗组的中位OS尚未达到，化疗组为9.4m（HR=0.53， P=0.0005)，显示出临床意义的改善。与首款上市的TROP2 ADC戈沙妥珠单抗治疗TNBC相比，芦康沙妥珠单抗的PFS和OS均有一定优势，凸显了芦康沙妥珠单抗BIC的治疗潜力。（一）双抗：多款重磅药物上市，填补治疗空白 2024年，双抗药物的研发呈现出一片热闹光景。 2024年，CDE批准了三款双抗药物的上市。康方生物的依沃西单抗（PD-1/VEGF）于2024年5月获批上市，标志着康方生物第二款双抗药物登陆市场。此外，强生的Teclistamab（CD3/BCMA）于2024年6月获CDE批准上市。罗氏的法瑞西单抗(Faricimab)新增湿性年龄相关性黄斑变性及视网膜静脉阻塞继发黄斑水肿两项适应症。在美国，两款重磅双抗获FDA的批准上市。安进的tarlatamab（CD3/DLL3）是首款上市的靶向DLL3药物，填补了末线小细胞肺癌的治疗空缺。Merus的Zenocutuzumab（HER2/HER3）则是首款上市的靶向HER3药物，既往被认为不可成药的Her3靶点迎来突破。（1）依沃西单抗（AK112）是康方生物旗下靶向结合人血管内皮生长因子-A（VEGF-A）和程序性死亡蛋白-1（PD-1）的IgG1亚型人源化双特异性抗体。2024年5月，依沃西单抗获国家药监局批准上市，用于经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者的治疗。依沃西单抗的上市基于一项名为HARMONi的Ⅲ期研究，依沃西方案相对对照组高效降低患者疾病进展或死亡风险达56%（P＜0.001），将中位PFS从4.8个月延长到7.1个月。而更振奋人心的研究则是一项名为HARMONi-2的Ⅲ期研究，HARMONi-2（AK112-303）研究纳入398名未接受过系统治疗的无驱动基因突变的PD-L1阳性晚期非小细胞肺癌（aNSCLC）患者，按1:1随机分配至依沃西单抗或帕博利珠单抗治疗组，与K药相比，依沃西单抗的中位PFS为11.14个月，显著高于帕博利珠单抗的5.82个月，风险比（HR）为0.51，P值小于0.0001，显示出统计学上的显著性。鉴于K药全球销售额超过250亿美金，HARMONi-2研究的成果标志着依沃西单抗未来有望在肺癌市场挑战K药的霸主地位。图：HARMONi-2研究的mPFS数据数据来源：2024WCLC （2）Tarlatamab是一种双特异性T细胞衔接蛋白（BiTE），能同时与肿瘤细胞上的Delta样配体3（DLL3）和T细胞表面的CD3受体结合。DLL3在85%-94%的小细胞肺癌（SCLC）中高表达，而在正常细胞上几乎没有表达，这为Tarlatamab提供了一个特异且有效的治疗靶点。 Tarlatamab的获批是基于II期DeLLphi-301临床试验的结果，结果显示，10mg剂量组的ORR达40%，mPFS达4.9m，mOS达14.3m。相较于传统治疗15%的客观缓解率，Tarlatamab显著提升了治疗效果。在SCLC缺乏有效三线及以后治疗方案的背景下，Tarlatamab作为一种创新的免疫治疗，为SCLC患者提供了新选择。图：Tarlatamab的疗效数据数据来源：ESMO大会（3）Zenocutuzumab是全球首款获批上市的HER2/HER3双抗，于2024年12月获FDA批准上市，也是首款治疗NRG1阳性癌症的双特异抗体。 Zenocutuzumab的上市基于一项名为eNRGy的二期研究，该研究是一项多中心、开放标签临床研究，招募了晚期不可切除或转移性NRG1+胰腺癌或NRG1+NSCLC 患者，并且患者在既往全身治疗期间或之后出现疾病进展。在NRG1+ 胰腺癌患者中（n=30），Bizengri组的总体缓解率（ORR）为 40% ，缓解持续时间（DOR）为3.7个月至 16.6个月；在NRG1+ NSCLC患者中（n=64），ORR为33%，中位DOR 为7.4 个月。（二）CAR-T：中国企业大放异彩 2024年，CAR-T领域的光芒主要集中于国内企业。科济药业的泽沃基奥仑赛于2024年2月获国家药监局批准上市；8月，传奇生物的西达基奥仑赛也在国内获批上市，药明巨诺的瑞基奥仑赛新增套细胞淋巴瘤适应症。反观美国市场，Breyanzi新增套细胞淋巴瘤、慢性淋巴细胞白血病、小淋巴细胞性淋巴瘤适应症，美国市场并未批准新形式的CAR-T药物。（1）泽沃基奥仑赛（赛恺泽）是科济药业研发的一款自体BCMA靶向的CAR-T细胞产品，用于治疗复发或难治性多发性骨髓瘤成人患者。泽沃基奥仑赛的上市基于一项在中国进行的开放标签、多中心Ⅰ/Ⅱ期临床试验(LUMMICAR 1)结果。截至2023年10月25日，102名R/RMM患者在接受赛恺泽输注后的中位随访时间为20.3个月，ORR达92.2%，CR达71.6%，12个月和18个月的无进展生存期（PFS）率分别为76.3%和61.9%，12个月和30个月的总生存期（OS）率分别为90.2%和79.4%。赛恺泽市场定价为115万元，科济药业预2024年赛恺泽获得订单所对应终端市场销售额将达到1亿元人民币。图：LUMMICAR 1研究结果数据来源：科济药业宣传资料（2）传奇生物的西达基奥仑赛（Carvykti）于2024年8月获国家药监局批准上市，用于治疗复发或难治性多发性骨髓瘤成人患者。2022年2月，西达基奥仑赛已在美国上市。西达基奥仑赛上市后，销售额持续攀升，于2023年已反超同为BCMA CAR-T的Abecma，2023年斩获5亿美元的收入。2024年上半年，西达基奥仑赛的销售额大约为3.43亿美元，同比增长81%，而Abecma仅实现1.77亿美元收入，在Carvykti的冲击下收入下滑。图：2022-2024H1 Carvykti及Abecma全球销售额（亿美元）数据来源：传奇生物和BMS财报（三）小结 2024年已近落幕，作为创新药领域最前沿路径，多款ADC、双抗及CAR-T药物相继获批上市。纵观2024年，双抗药物可谓是最大赢家，依沃西单抗挑战K药成功，tarlatamab（CD3/DLL3）填补了末线小细胞肺癌的治疗空缺，Zenocutuzumab（HER2/HER3）打破了Her3靶点不可成药的魔咒。国产ADC和CAR-T药物在2024年大放异彩，芦康沙妥珠单抗是TROP2 ADC潜在BIC药物，科济药业的泽沃基奥仑赛成功上市，传奇生物的西达基奥仑赛销售额持续攀升，期待未来国产创新药的优异成绩。药事纵横征稿启事

抗体药物偶联物免疫疗法上市批准细胞疗法临床3期

100 项与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
复发性套细胞淋巴瘤	中国	上海药明巨诺生物科技有限公司	2024-08-20
难治性套细胞淋巴瘤	中国	上海药明巨诺生物科技有限公司	2024-08-20
滤泡性淋巴瘤	中国	上海药明巨诺生物科技有限公司	2022-09-30
弥漫性大B细胞淋巴瘤	中国	上海药明巨诺生物科技有限公司	2021-09-01
大B细胞淋巴瘤	中国	上海药明巨诺生物科技有限公司	2021-09-01

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
B细胞淋巴瘤	临床2期	中国	上海交通大学医学院附属瑞金医院	2024-04-16
系统性红斑狼疮	临床2期	中国	上海药明巨诺生物科技有限公司	2023-12-25
系统性硬皮病	临床1期	中国	上海明聚生物科技有限公司	2024-06-12
难治性 B 细胞急性淋巴细胞白血病	临床1期	中国	上海明聚生物科技有限公司	2022-05-11
复发性 B 细胞急性淋巴细胞白血病	临床1期	中国	上海明聚生物科技有限公司	2022-04-28
小淋巴细胞淋巴瘤	临床1期	中国	上海明聚生物科技有限公司	2022-02-28
急性淋巴细胞白血病	临床1期	中国	苏州药明巨诺生物科技有限公司	2022-01-30
慢性淋巴细胞白血病	临床1期	中国	苏州药明巨诺生物科技有限公司	2022-01-30
难治性弥漫性大 B 细胞淋巴瘤	临床1期	中国	上海明聚生物科技有限公司	2020-07-10
难治性B细胞淋巴瘤	临床1期	中国	上海明聚生物科技有限公司	2017-11-16

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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


NCT05765006 (EULAR 12024 \| EULAR 22024) 人工标引	临床1期	系统性红斑狼疮	3	RELMACABTAGENE AUTOLEUCEL	蓋築觸鹹淵窪衊鏇鹹簾(壓齋糧憲壓蓋餘範鹹製) = 積醖繭鑰齋繭範簾範繭選鹽觸顧鏇鹹鬱醖顧廠 (襯憲淵壓鬱觸鬱壓蓋願 ) 更多	积极	2024-06-12
NCT04089215 (RELIANCE, ASCO2024) 人工标引	临床2期	大B细胞淋巴瘤末线 \| 三线 CD19	58	relma-cel 100 × 106 CAR+ T cells	夢膚鹽壓繭鹽醖鏇憲獵(廠簾醖艱艱簾襯鹹齋窪) = 製積鬱願鏇網壓壓繭廠製艱壓獵蓋顧構鏇餘構 (餘壓獵願窪網窪憲築廠 ) 更多	积极	2024-05-24
NCT04089215 (RELIANCE, ASCO2024) 人工标引	临床2期	大B细胞淋巴瘤末线 \| 三线 CD19	58	relma-cel 150 × 106 CAR+ T cells	夢膚鹽壓繭鹽醖鏇憲獵(廠簾醖艱艱簾襯鹹齋窪) = 鏇鏇顧製艱網網鏇窪鏇製艱壓獵蓋顧構鏇餘構 (餘壓獵願窪網窪憲築廠 ) 更多	积极	2024-05-24
NCT05727683 (EHA 12024 \| EHA 22024) 人工标引	临床1期	前体B细胞急性淋巴细胞白血病	6	Relma-cel	鬱衊願鬱齋鹽鏇艱鬱壓(鏇簾廠願獵鹹簾鬱壓艱) = The most common TEAE were cytopenias (6/6) and CRS (6/6). with none of ≥ grade 3 CRS. 2 patients experienced neurotoxicity (NT), with 1 of grade 4 NT. 繭廠鬱鏇膚顧鏇積壓醖 (鏇醖淵淵窪簾鏇壓簾觸 ) 更多	不佳	2024-05-14
NCT04089215 (RELIANCE study, EHA2024)	临床2期	难治性中枢神经系统淋巴瘤 CD19	22	commercial relmacabtagene autoleucel (relma-cel) (Relma-cel)	網窪築觸構膚構鏇憲齋(齋鬱艱壓鹽築齋壓膚廠) = 鑰壓膚鏇艱淵鹽膚繭鹹範鏇蓋鹽積簾廠廠範範 (艱願鑰製網夢網廠齋糧 ) 更多	积极	2024-05-14
PRNewswire 人工标引	N/A	套细胞淋巴瘤	59	Carteyva	窪襯鹹齋蓋齋獵築選遞(鏇襯積蓋鬱襯餘艱選觸) = 選範製網築鏇壓積鏇鹽簾壓醖蓋鹹壓憲繭簾鏇 (築憲顧壓糧積窪鏇衊鏇 ) 更多	积极	2024-01-04
ASH2023	临床2期	套细胞淋巴瘤	66	Relmacabtagene Autoleucel (relma-cel)	襯廠夢選齋範顧壓觸鹹(觸襯鑰醖鹹淵襯襯積夢) = 糧願膚選餘簾築艱糧憲膚遞壓願窪鹽築製鏇憲 (選鑰顧糧製糧壓窪製衊 ) 更多	积极	2023-12-10
NCT04089215 (RELIANCE study, Pubmed)	临床1/2期	大B细胞淋巴瘤 CD19-targeted	68	100 × 10^6 relma-cel	衊鹽餘網選網鏇艱壓膚(廠襯夢衊衊廠選壓憲簾) = 壓餘憲觸簾衊糧憲夢構繭蓋觸遞製遞範繭壓膚 (壓繭艱壓壓醖窪繭憲範, 64.73 ~ 87.49) 更多	积极	2023-02-01
NCT04089215 (RELIANCE, Corporate Publications) 人工标引	临床3期	难治性滤泡性淋巴瘤	-	Relmacabtagene autoleucel	鹽鬱觸顧衊衊膚餘觸廠(遞遞製蓋齋範衊衊淵餘) = 蓋獵蓋遞獵選選製獵遞網壓壓鏇夢廠醖鹹積願 (選簾淵餘夢蓋憲鹽衊鬱 ) 更多	积极	2022-10-10
NCT04812691 (ASCO2022) 人工标引	临床1期	大B细胞淋巴瘤二线	14	Relmacabtagene autoleucel	鬱鹽觸壓壓願鹽積夢夢(憲積構衊壓醖鏇鏇糧廠) = 齋窪淵繭鏇淵願窪鑰範齋鏇襯觸夢鏇鑰鑰鑰鹹 (膚積遞鹽蓋糧壓夢憲鑰, 3.2 ~ NA) 更多	积极	2022-06-02
NCT04089215 (RELIANCE, ASCO2022) 人工标引	临床2期	大B细胞淋巴瘤三线	59	Carteyva	遞鹹顧鬱衊鬱積網顧淵(網衊蓋齋齋衊淵衊願襯) = 積夢鬱糧糧鹹憲願膚餘鹽顧壓糧夢繭鬱鹹簾構 (淵獵觸壓壓願壓憲選壓 ) 更多	积极	2022-06-02