Hangzhou Qihan Biotech Co., Ltd. an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for QT-019B. This universal, dual-target CAR-T cell therapy is designed to treat refractory systemic lupus erythematosus (rSLE), and the clearance enables the initiation of a Phase 1/2 clinical trial in the United States, marking a significant milestone in the development of novel cell-based therapies for autoimmune diseases..

杭州启函生物科技有限公司，一家在将多重基因组编辑技术应用于细胞治疗和器官移植领域的行业领导者，今天宣布美国食品药品监督管理局（FDA）已批准其QT-019B新药临床试验（IND）申请。这种通用的双靶点CAR-T细胞疗法旨在治疗难治性系统性红斑狼疮（rSLE），该批准使得公司可以在美国启动1/2期临床试验，标志着基于细胞的自身免疫疾病新型疗法开发的一个重要里程碑。

“Developing off-the-shelf cell therapies for autoimmune diseases is a core strategic priority for Qihan Biotech,” said Dr. Luhan Yang, Founder and CEO. “QT-019B is our first fully in-house CAR-T therapy with global rights. In investigator-initiated clinical studies in China, it has shown promising results against multiple refractory autoimmune diseases, including systemic lupus erythematosus.

“开发针对自身免疫疾病的现成细胞疗法是启涵生物的核心战略重点，”创始人兼首席执行官杨璐菡博士表示。“QT-019B是我们首个拥有全球权益的完全自主研发的CAR-T疗法。在中国的研究者发起的临床研究中，它已显示出对多种难治性自身免疫疾病（包括系统性红斑狼疮）的良好效果。”

Based on a comprehensive assessment of multiple factors, we are prioritizing the development of QT-019B for refractory SLE.”.

基于对多种因素的全面评估，我们将优先开发用于难治性系统性红斑狼疮（SLE）的QT-019B。

Dr. Yang added, “Patients with refractory SLE continue to face significant unmet medical needs. With a clear regulatory pathway and a strong likelihood of trial success, Qihan is confident in advancing QT-019B rapidly into clinical studies and registration-enabling trials in pursuit of marketing approval.

杨博士补充说：“难治性系统性红斑狼疮患者仍然面临显著的未满足医疗需求。凭借明确的监管路径和试验成功的高度可能性，启翰有信心快速将QT-019B推进到临床研究和注册支持试验中，以争取获得上市批准。”

We have a well-defined global clinical development plan and hope that QT-019B, as a potential breakthrough therapy, can transform the treatment landscape for refractory autoimmune diseases, providing safe, effective, and affordable options for patients worldwide. Beyond QT-019B, the company is developing next-generation off-the-shelf CAR-T therapies that will not require patients to undergo lymphodepletion.

我们有明确的全球临床开发计划，希望QT-019B作为潜在的突破性疗法，能够改变难治性自身免疫性疾病的治疗格局，为全球患者提供安全、有效且可负担的选择。除了QT-019B，该公司还在开发下一代无需患者进行淋巴清除的现货型CAR-T疗法。

We look forward to bringing these therapies into clinical trials and reshaping the global treatment paradigm for autoimmune diseases.”.

我们期待将这些疗法投入临床试验，重塑全球自身免疫性疾病的治疗模式。"

About QT-019B

关于 QT-019B

QT-019B is an off-the-shelf allogeneic CAR-T cell therapy independently developed by Qihan Biotech. The therapy is derived from healthy donor leukapheresis products and engineered through gene editing to stably express two distinct chimeric antigen receptors (CARs) targeting CD19 and BCMA, enabling simultaneous recognition and elimination of cells expressing either antigen.

QT-019B是启函生物自主研发的现成同种异体CAR-T细胞疗法。该疗法来源于健康供体的白细胞分离产物，并通过基因编辑技术进行工程化改造，以稳定表达两种不同的嵌合抗原受体（CAR），分别靶向CD19和BCMA，从而实现对表达任一抗原的细胞的同时识别和清除。

To reduce the risk of graft-versus-host disease (GvHD), the T cell receptor (TCR) is knocked out. Additionally, multiplexable gene editing is employed to induce hypoimmunity, meaning the CAR-T cells are less likely to be recognized and attacked by the patient’s own NK and T cells, thereby reducing immune rejection and cytotoxicity while enhancing persistence..

为了降低移植物抗宿主病 (GvHD) 的风险，敲除了T细胞受体 (TCR)。此外，采用多重基因编辑技术诱导低免疫原性，这意味着CAR-T细胞被患者自身的NK细胞和T细胞识别和攻击的可能性降低，从而减少免疫排斥和细胞毒性，同时增强其持久性。

About Qihan Biotech

关于启函生物

Qihan Biotech is a biotechnology company applying genome editing technology to develop novel cell therapies and organs for transplantation. The company's mission is to use high-throughput, multiplexable genome editing combined with expertise in transplantation immunology to create immunologically privileged allogeneic cells and xenogeneic organs for use as therapies to treat cancer, autoimmune diseases, organ failure, and other complex medical conditions.

启涵生物是一家应用基因组编辑技术开发新型细胞疗法和移植器官的生物技术公司。该公司使命是通过使用高通量、多重基因组编辑技术并结合移植免疫学的专业知识，创造出具有免疫特权的同种异体细胞和异种器官，用于治疗癌症、自身免疫疾病、器官衰竭及其他复杂的医疗状况。

With a vision to create a world in which cell and organ therapies are universally available to patients, Qihan Biotech has raised two financing rounds. It has multiple products at different stages of development, including QN-019a, which had already received IND approval from China NMPA to treat CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.

启函生物致力于创造一个细胞和器官疗法能够普遍应用于患者的美好世界，现已完成两轮融资。公司有多款产品处于不同的研发阶段，其中包括已获得中国国家药品监督管理局（NMPA）批准进行新药临床试验（IND）的QN-019a，用于治疗CD19阳性的复发/难治性侵袭性B细胞非霍奇金淋巴瘤。

Qihan's deep scientific experience and technology advancements have enabled the company to create cutting-edge cell therapy products. Qihan Biotech is headquartered in Hangzhou, China. For more information, please visit the company's website at www.qihanbio.com..

启函生物凭借其深厚的科学经验和科技进步，使公司能够创造出尖端的细胞治疗产品。启函生物总部位于中国杭州。欲了解更多信息，请访问公司网站 www.qihanbio.com。

Forward-looking Statements

前瞻性声明

This release contains statements including, but not limited to, Qihan’s research development and/or relevant programs, its past, ongoing, and planned research studies, and the potential of Qihan’s research candidate. These and any other statements in this release are based on Qihan management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such statements.

本发布包含但不限于奇瀚的研发和/或相关项目、其过去、正在进行和计划中的研究，以及奇瀚研究候选项目的潜力等内容的声明。本发布中的这些声明及其他声明均基于奇瀚管理层对未来事件的当前预期，并受多种风险和不确定因素的影响，可能导致实际结果与这些声明中所述或暗示的结果存在重大且不利的差异。

These risks and uncertainties include, but are not limited to, the risk that Qihan’s research program may not warrant further development, the risk that results observed in prior studies of Qihan’s research candidates will not be observed in ongoing or future studies involving these candidates, the risk of a delay or difficulties in the developing or transforming of Qihan’s research candidates, the risk that Qihan may cease or delay the research development of any of its candidates for a variety of reasons.

这些风险和不确定性包括但不限于：Qihan的研究项目可能不值得进一步开发的风险、之前对Qihan研究候选者进行的研究中观察到的结果在涉及这些候选者的正在进行或未来研究中无法重现的风险、Qihan研究候选者在开发或转化过程中出现延迟或困难的风险，以及Qihan可能出于各种原因停止或延迟其任何候选者研发工作的风险。

Qihan is providing the information in this release as of this date and does not undertake any obligation to update any statements contained in this release as a result of new information, future events, or otherwise. Information concerning therapies and related products contained herein is not intended as medical advice..

启涵提供此发布中的信息截至此日期，并不承担因新信息、未来事件或其他原因更新本发布中任何陈述的义务。此处包含的有关治疗和相关产品的信息不作为医疗建议。

Contacts

联系人

Media:

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Mollee Xu

徐茉莉

Qihan Biotech Public Relations

齐翰生物科技公共关系

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Source: businesswire.com

来源：businesswire.com