近期，深圳虹信生物科技有限公司（MagicRNA，以下简称“虹信生物”）的核心在研项目HN2301的研究成果“体内CD19 CAR-T细胞疗法诱导系统性红斑狼疮（SLE）组织B细胞耗竭”（In Vivo CD19 CAR T-cell Therapy Induces Tissue B-cell Depletion in Systemic Lupus Erythematosus），成功入选第29届ASGCT年会口头报告（Oral Presentation）。
这一成果不仅标志着虹信生物在工程化细胞靶向LNP递送领域取得了全球领先的临床突破，也彰显了中国创新药企在基因与细胞治疗（CGT）前沿赛道的国际影响力。
ASGCT年会是全球基因与细胞治疗领域规模最大、最具影响力的学术盛会，被视为行业技术与临床发展的“风向标”。2026年的ASGCT年会明确指出，CGT行业正从“证明可行”迈向“证明可用”的新阶段，其中“体内递送技术”被公认为突破行业瓶颈的核心关键。
虹信生物此次入选的口头报告将在2026年5月13日下午4:30（美东时间）于MCEC Room 210ABC进行展示。该研究基于虹信生物自主研发的工程化细胞靶向递送平台（EnC-LNP），展示了其核心管线HN2301在系统性红斑狼疮（SLE）治疗中的突破性进展。
作为全球首个进入人体临床试验的细胞靶向LNP药物，HN2301在临床中成功实现了体内CAR-T重编程与B细胞深度清除，并展现出良好的安全性与初步疗效。这一成果完美契合了本届ASGCT关于“从永久编辑走向可调控治疗”以及“解决肝外递送瓶颈”的核心议题，为全球自身免疫性疾病的治疗提供了全新的解决方案。
虹信生物（MagicRNA）成立于2021年，以“深耕RNA药物递送，以RNA疗法造福患者”为企业使命，成功攻克了制约行业发展的“mRNA肝外非APC靶向递送”难题，自主研发出处于国际领先水平的工程化细胞靶向递送平台（EnC-LNP）。基于该平台，虹信生物开发的In vivo CAR-T管线已率先进入临床阶段，成为全球首个进入人体临床试验的细胞靶向LNP药物（First-in-human），其突破性临床研究成果已发表于国际顶级期刊《新英格兰医学杂志》（NEJM）
公司创始人查高峰博士表示：“入选ASGCT口头报告是对虹信生物技术平台与临床策略的高度认可。我们将继续深耕核酸递送技术，加速推动体内细胞重编程疗法的临床转化，致力于以RNA疗法造福全球患者。”
摘要ID：224
报告题目：体内CD19 CAR-T细胞疗法诱导系统性红斑狼疮组织B细胞耗竭（In Vivo CD19 CAR T-cell Therapy Induces Tissue B-cell Depletion in Systemic Lupus Erythematosus）
会议环节：临床试验：体内基因转移与基因编辑疗法
展示时间：2026年5月13日16:30 - 16:45 （美东时间）
展示地点：MCEC Room 210ABC (Level 2)
SHENZHEN, China – 27April026 – Shenzhen MagicRNA Biotechnology Co., Ltd. (MagicRNA), a clinical-stage biotechnology company pioneering next-generation mRNA and lipid nanoparticle (LNP) delivery technologies, today announced that its lead program, “in Vivo CD19 CAR T-cell Therapy Induces Tissue B-cell Depletion in Systemic Lupus Erythematosus,” has been selected for an oral presentation at the 29th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT).
This selection underscores MagicRNA’s clinical leadership in engineered cell-targeted delivery and highlights the expanding global impact of innovative biotechnology in the cell and gene therapy (CGT) sector.
The 2026 ASGCT Annual Meeting marks a pivotal transition for the CGT industry: the shift from bespoke, proof-of-concept interventions to scalable, accessible treatments for broadly prevalent conditions. MagicRNA’s upcoming presentation places the company at the forefront of this evolution, directly addressing the industry's urgent need to overcome extrahepatic delivery bottlenecks using non-viral vectors.
Scheduled for May 13, 2026, the oral presentation will showcase breakthrough clinical data for MagicRNA's lead pipeline asset, HN2301, in the treatment of systemic lupus erythematosus (SLE). The therapy leverages the company's proprietary Engineered Cell-Targeted Delivery Platform (EnC-LNP).
Founded in 2021, MagicRNA is a clinical-stage biotechnology company focused on advancing next-generation mRNA and LNP delivery technologies. Its proprietary Engineered Cell-Targeted LNP (EnC-LNP) platform enables precise mRNA delivery to extrahepatic non-antigen-presenting cells (non-APCs), successfully overcoming a key limitation of conventional LNPs. Powered by this platform, MagicRNA’s in vivo CAR-T program has entered the clinical stage as the world’s first cell-targeted LNP drug to be evaluated in humans. The foundational breakthrough clinical results supporting this approach have been published in the New England Journal of Medicine (NEJM).
"Being selected for an oral presentation at ASGCT is a profound validation of our technology platform and its alignment with the future of genomic medicine," said Dr. Gavin Zha, Founder of MagicRNA. "The industry is actively seeking robust in vivo delivery solutions to make cell therapies accessible for broader patient populations. We will continue to deepen our expertise in nucleic acid delivery, accelerate the clinical translation of our in vivo cell reprogramming therapies, and remain steadfast in our commitment to benefiting patients globally."
Abstract ID: 224
Presentation Title: In Vivo CD19 CAR T-cell Therapy Induces Tissue B-cell Depletion in Systemic Lupus Erythematosus
Session: Clinical Trials: In Vivo Gene Transfer and Gene Editing Therapies
Date & Time: May 13, 2026 |16:30 -16:45 (ET)
Location: MCEC Room 210ABC (Level 2)
2026-07-15
30页
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