SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, announced today that the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for SCG101V, marking the first-ever investigational cell therapy to enter regulatory approved Phase 1/2 clinical trial for chronic hepatitis B virus (HBV) infection..

SCG细胞治疗有限公司（SCG），一家处于临床阶段的生物技术公司，致力于开发针对传染病及其相关癌症的TCR T细胞疗法，今天宣布中国国家药品监督管理局（NMPA）已批准SCG101V的研究性新药（IND）申请，这标志着首个进入监管批准的I/II期临床试验的慢性乙型肝炎病毒（HBV）感染研究性细胞疗法的诞生。

SCG101 is designed to cure chronic hepatitis B by eliminating HBV cccDNA and HBV-DNA integration within HBV-infected hepatocytes, which are the fundamental source of persistent infection and antigen production. These infected hepatocytes serve as the long-term viral reservoir that current antiviral therapies fail to eradicate.

SCG101旨在通过清除HBV感染的肝细胞内的HBV cccDNA和HBV-DNA整合来治愈慢性乙型肝炎，这些是持续感染和抗原产生的根本来源。这些被感染的肝细胞作为长期病毒储存库，是当前抗病毒治疗无法根除的。

“SCG101 is designed to mimic the natural immune response observed in individuals who are able to clear HBV infection spontaneously. HBV-specific T cells play a central role in this process and, remarkably, through genetic engineering of T cells, we were able to replicate this natural process as demonstrated in our preclinical models and clinical data in hepatocellular carcinoma, providing strong evidence that this promise holds true in hepatitis B patients”, said Professor Ulrike Protzer, Scientific Founder of SCG Cell Therapy and Director of Institute of Virology Technical University of Munich / Helmholtz Munich..

“SCG101旨在模拟那些能够自发清除HBV感染的个体所观察到的自然免疫反应。HBV特异性T细胞在此过程中发挥核心作用，值得注意的是，通过基因工程改造T细胞，我们能够在肝细胞癌的临床前模型和临床数据中复制这一自然过程，这为乙型肝炎患者提供了强有力的证据，证明这一前景确实可行。” SCG细胞治疗公司的科学创始人、慕尼黑工业大学/赫尔姆霍兹慕尼黑病毒学研究所所长乌尔里克·普罗策教授表示。

In Phase 1 clinical trial of SCG101 in patients with HBV-related hepatocellular carcinoma (HCC), SCG101 demonstrated a good safety profile and sustained clearance of serum hepatitis B surface antigen (HBsAg), even in heavily pre-treated patients. Among the treated patients, 94% of patients had previously received nucleoside analogue (NA) antiviral therapy, and 72% presented with baseline liver cirrhosis.

在SCG101针对HBV相关肝细胞癌（HCC）患者的I期临床试验中，SCG101显示出良好的安全性，并且即使在经过多线治疗的患者中，也实现了血清乙型肝炎表面抗原（HBsAg）的持续清除。在这些接受治疗的患者中，94%之前曾接受过核苷类似物（NA）抗病毒治疗，72%基线时已出现肝硬化。

Following a single  infusion of SCG101, all patients experienced a rapid decline in HBsAg level. Notably, 94% achieved a 1.0–4.6 log₁₀ reduction in HBsAg within 28 days, with HBsAg levels remained <100 IU/mL for up to one year without rebound. Furthermore, 23% of patients achieved complete HBsAg loss, a critical benchmark for a cure..

单次输注SCG101后，所有患者的HBsAg水平均迅速下降。值得注意的是，94%的患者在28天内实现了1.0–4.6 log₁₀的HBsAg降幅，并且HBsAg水平在长达一年的时间内保持在<100 IU/mL，未出现反弹。此外，23%的患者实现了完全的HBsAg清除，这是治愈的关键指标。

Professor Niu Jinqi, Vice President and Chief Physician of The First Hospital of Jilin University, commented: “SCG101 has demonstrated significant breakthrough potential in HBV-related liver cancer, remarkably, achieving HBsAg loss following a single dose. This IND approval by the NMPA marks a pioneering step toward a functional cure for chronic hepatitis B.

吉林大学第一医院副院长、主任医师牛俊奇教授评论道：“SCG101 在 HBV 相关肝癌中展现了显著的突破潜力，尤其在单次给药后实现了 HBsAg 的清除。NMPA 批准该药的 IND，这标志着在慢性乙型肝炎的功能性治愈方向上迈出了开创性的一步。”

We are excited about the prospects of this therapy and the benefit it could bring to millions of patients, helping to reduce the burden of liver disease in China and globally”..

我们对这种疗法的前景及其可能为数百万患者带来的益处感到兴奋，有助于减轻中国和全球肝脏疾病的负担。

Chronic HBV infection affects an estimated 300 million people globally and is a leading cause of liver cirrhosis and hepatocellular carcinoma, contributing to more than 820,000 deaths each year. While current standard-of-care therapies can suppress viral replication, they rarely achieve a functional cure and therefore cannot fundamentally halt disease progression..

慢性乙型肝炎病毒感染影响全球约3亿人，是导致肝硬化和肝细胞癌的主要原因之一，每年导致超过82万人死亡。尽管目前的标准治疗可以抑制病毒复制，但很少能实现功能性治愈，因此无法从根本上阻止疾病进展。

“This IND clearance represents a historic milestone—not only for SCG but for the broader field of hepatitis B treatment. With indications across HBV-related hepatocellular carcinoma, HBV-related cholangiocarcinoma, and chronic hepatitis B, this IND clearance further validates our development strategy—expanding from virus-induced cancers to chronic infectious diseases, said Christy Ma, Chief Executive Officer of SCG Cell Therapy.

“这项IND许可不仅对SCG而言是一个历史性里程碑，对于更广泛的乙肝治疗领域也是如此。该许可涵盖了与HBV相关的肝细胞癌、HBV相关的胆管癌以及慢性乙型肝炎，进一步验证了我们从病毒诱发的癌症扩展到慢性传染性疾病的研发策略。”SCG细胞治疗公司的首席执行官Christy Ma表示。

“SCG101 is the first cell therapy product to receive regulatory approval to enter a Phase 1/2 clinical trial specifically for  HBV and HBV-induced cancer, and we are proud to lead the way in advancing toward a long-term functional cure. We remain on track for initiation of a pivotal study, following the recent completion of our Phase 1 study in patients with HBV-HCC.

“SCG101是首个获得监管批准进入针对乙肝病毒（HBV）及HBV诱导的癌症的1/2期临床试验的细胞治疗产品，我们很自豪能够引领迈向长期功能性治愈的进展。在近期完成HBV-HCC患者的1期研究后，我们仍将按计划启动一项关键性研究。

We look forward to sharing additional clinical data as we continue to push the boundaries of what’s possible in cell therapy.”.

我们期待在继续突破细胞治疗可能的界限时，分享更多的临床数据。"

About SCG101

关于SCG101

SCG101 is an investigational autologous T cell receptor (TCR) T cell therapy designed to selectively target specific epitope of the hepatitis B surface antigen (HBsAg). Powered by SCG’s proprietary GianTCR™ screening platform, which enables the discovery of natural, high-affinity, high-avidity TCRs against intracellular antigens presented via the major histocompatibility complex (MHC).

SCG101是一种研究性的自体T细胞受体（TCR）T细胞疗法，旨在选择性靶向乙型肝炎表面抗原（HBsAg）的特定表位。该疗法依托于SCG公司专有的GianTCR™筛选平台，该平台能够发现针对通过主要组织相容性复合体（MHC）呈递的胞内抗原的天然、高亲和力、高avidity的TCRs。

SCG101 delivers precise immune-mediated clearance of infected and malignant cells demonstrating significant tumour inhibition and the eradication of HBV covalently closed circular DNA (cccDNA) in preclinical and clinical studies..

SCG101在临床前和临床研究中显示出通过精确的免疫介导清除受感染和恶性细胞，显著抑制肿瘤并根除乙型肝炎病毒共价闭合环状DNA（cccDNA）。

About HBV

关于HBV

Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection is a major global health issue, affecting nearly 300 million people across the world.

乙型肝炎是由乙型肝炎病毒（HBV）引起的可能危及生命的肝脏感染。HBV可导致慢性感染，增加因肝硬化和肝癌而死亡的风险。慢性HBV感染是一个重大的全球健康问题，影响着全球近3亿人。

Approximately 1.1 million people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options..

尽管有有效的疫苗和当前的治疗选择，每年仍有大约110万人死于与慢性乙型肝炎病毒感染相关的并发症。

About SCG Cell Therapy

关于SCG细胞治疗

SCG Cell Therapy is a leading biotechnology company dedicated to developing novel immunotherapies for infectious diseases and associated cancers. The company focuses on targeting some of the most common cancer-causing infections, including Helicobacter pylori, HPV, HBV, and EBV. SCG is advancing a broad pipeline of TCR-based therapeutics aimed at preventing and curing infection-related cancers.

SCG细胞治疗公司是一家领先的生物技术公司，致力于开发针对传染病及其相关癌症的新型免疫疗法。该公司专注于针对一些最常见的致癌感染，包括幽门螺杆菌、HPV、HBV和EBV。SCG正在推进一系列基于TCR的治疗药物，旨在预防和治愈与感染相关的癌症。

Headquartered in Singapore, SCG operates across Singapore, China, and Germany, leveraging regional strengths to cover the entire value chain, from innovative drug research and discovery to manufacturing, clinical development, and commercialization. For more information, please visit www.scgcell.com..

总部位于新加坡，星汉德生物在新加坡、中国和德国开展业务，利用区域优势覆盖从创新药物研究发现到生产、临床开发和商业化的整个价值链。欲了解更多信息，请访问www.scgcell.com。

For media enquiries, please contact:

媒体查询，请联系：

SCG Cell Therapy Pte. Ltd.

新加坡细胞治疗有限公司

HP: +65 6040 6698

惠普：+65 6040 6698

Email: info@scgcell.com

电子邮件：info@scgcell.com

Source: scgcell.com

来源：scgcell.com