ROCKVILLE, Md. and SHANGHAI

马里兰州罗克维尔和上海

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，

Aug. 16, 2026

2026年8月16日

/PRNewswire/ -- AbelZeta Pharma, Inc. ('AbelZeta' or the 'Company'), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the Company received the U.S. Food and Drug Administration (FDA) clearance of IND application for C-CAR039, also known as Prizloncabtagene Autoleucel (Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T, for the treatment of relapsed or refractory (r/r) Large B-cell Lymphoma (LBCL)..

/美通社/ -- 全球临床阶段生物制药公司AbelZeta Pharma, Inc.（“AbelZeta”或“公司”），专注于发现和开发创新且拥有自主知识产权的细胞治疗产品，今日宣布，公司已获得美国食品药品监督管理局（FDA）对其C-CAR039（也称为Prizloncabtagene Autoleucel，简称Prizlon-cel）新药临床试验申请（IND）的批准。C-CAR039是一种靶向CD20/CD19的双特异性CAR-T细胞疗法，用于治疗复发或难治性（r/r）大B细胞淋巴瘤（LBCL）。

In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights relating to C-CAR039. The Company is currently working with the FDA to finalize the protocols for clinical development in third- or later-line LBCL patients previously treated with CAR-T therapies and second-line LBCL patients that are CAR-T therapy treatment naïve..

2026年7月，AbelZeta重新获得了与C-CAR039相关的所有开发、监管、生产、商业化、对外许可及其他合作权利。公司目前正与美国食品药品监督管理局（FDA）合作，最终确定针对既往接受过CAR-T疗法治疗的三线或后线弥漫性大B细胞淋巴瘤（LBCL）患者，以及未接受过CAR-T疗法治疗的二线LBCL患者的临床开发方案。

The program is supported by encouraging long-term clinical data presented at European Society for Blood and Marrow Transplantation (EBMT) in March 2026. Results from 48 patients with r/r B-cell non-Hodgkin lymphoma (B-NHL) enrolled in the Company's early clinical trials in China demonstrated a favorable safety profile and deep and durable responses, with an overall response rate (ORR) of 91.5% and complete response (CR) rate of 85.1%.

该项目得到了2026年3月在欧洲血液与骨髓移植学会（EBMT）会议上公布的长期临床数据的支持。该公司在中国早期临床试验中入组的48例复发/难治性B细胞非霍奇金淋巴瘤（r/r B-NHL）患者的结果显示，其安全性良好，且缓解深度大、持久性强，总缓解率（ORR）为91.5%，完全缓解率（CR）为85.1%。

Median PFS was 60.1 months at a median follow-up of 53.9 months..

中位随访时间为53.9个月时，中位无进展生存期为60.1个月。

'We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio,' said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. 'Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies.

“我们很高兴欢迎C-CAR039回归我们的血液恶性肿瘤产品组合，”AbelZeta董事长兼首席执行官Tony（Bizuo）Liu表示。“迄今为止的临床试验结果表明，C-CAR039在复发/难治性LBCL患者中具有良好的安全性和令人鼓舞的疗效。我们相信，它有望帮助那些已经接受过治疗并对已获批上市的CAR-T疗法产生复发的患者。”

This population has significant unmet medical needs and C-CAR039 represents a solution. We will also explore the potential of C-CAR039 in early lines of LBCL. We remain confident about the potential of C-CAR039 and are fully committed to accelerating the global development of C-CAR039, leveraging our extensive expertise in cell therapy.'.

该患者群体存在巨大的未满足医疗需求，而C-CAR039提供了一种解决方案。我们还将探索C-CAR039在弥漫性大B细胞淋巴瘤（LBCL）早期治疗线中的潜力。我们对C-CAR039的潜力充满信心，并致力于凭借我们在细胞疗法领域的深厚专业知识，加速推进C-CAR039的全球开发进程。

The registrational Phase II clinical trial of C-CAR039 for r/r LBCL in CAR-T therapy naïve patients in China is still ongoing.

C-CAR039 用于中国未经过 CAR-T 治疗的复发/难治性大 B 细胞淋巴瘤（r/r LBCL）患者的注册性 II 期临床试验仍在进行中。

About AbelZeta Pharma, Inc.

关于 AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies, inflammatory and immunological diseases and solid tumors.

AbelZeta 是一家全球临床阶段的生物制药公司，在马里兰州罗克维尔和上海设有卓越中心。AbelZeta 专注于开发创新且拥有自主知识产权的细胞治疗产品，致力于推动定制化治疗方案，利用人体自身免疫系统对抗血液系统恶性肿瘤、炎症与免疫性疾病以及实体瘤。

AbelZeta advances research and development in its own GMP facilities at its centers of excellence, with a pipeline comprised of multiple CAR-T therapies..

AbelZeta 在其卓越中心的自有 GMP 设施中推进研发工作，其产品线包含多种 CAR-T 疗法。

Forward-Looking Statements

前瞻性陈述

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors.

本沟通中涉及计划、战略、具体活动以及其他非历史事实描述的陈述均为前瞻性陈述。前瞻性信息本质上受风险和不确定性的影响，由于众多因素，实际结果可能与当前预期存在重大差异。

Forward-looking statements are based on the current beliefs and management's expectations and are subject to significant risks and uncertainties outside of AbelZeta Pharma, Inc.'s ('AbelZeta' or the 'Company') control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof.

前瞻性陈述基于当前的信念及管理层的预期，并受到艾博智医药公司（“AbelZeta”或“公司”）控制范围之外的重大风险和不确定性的影响。鉴于这些不确定性，您不应过度依赖这些前瞻性陈述，它们仅反映截至本文件发布之日的情况。

Except as otherwise required by law, AbelZeta does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise..

除法律另有规定外，AbelZeta 不承担任何义务，并明确声明不承担任何义务，以更新、修改或以其他方式修订不时作出的任何前瞻性陈述（无论是书面还是口头），无论是否因新信息、未来事件或其他原因所致。

Company Contact:

公司联系人：

Sarah Kelly

莎拉·凯利

Director of Communications

传播总监

AbelZeta Pharma, Inc.

阿贝尔泽塔制药公司

+1 (240) 552 5870

+1 (240) 552 5870

[email protected]

[email protected]

www.abelzeta.com

www.abelzeta.com

SOURCE AbelZeta Pharma, Inc.

来源：AbelZeta Pharma, Inc.

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