Sailxen Bio's Treg Cell Therapy NP001 Receives Ethical Approval for Clinical Trial in Neurodegenerative Diseases

Approval Document of the Ethics Committee of the First Affiliated Hospital of Zhengzhou University

Review Number S2024-K010-002

The leading unit of this project research isThe First Affiliated Hospital of Zhengzhou UniversityThe principal investigators of the project are Professor Zhang Yi from the Biological Cell Therapy Center/Biological Immunotherapy Ward and Professor Xu Yuming from the Department of Neurology III. The ethical review approval numbers are: S2024-K010-001, S2024-K010-002. NP001 Treg cell injection will be used in amyotrophic lateral sclerosis (ALS), Multiple System Atrophy (MSA), and Alzheimer's Disease (AD) patients for an open, single-arm, single-center clinical study on safety and tolerability.

This study isFor the First Time GloballyApplicationIntrathecal InjectionThe Treg clinical research will be conducted in this manner, and through this study, the safety and effective dose of NP001 for the first-in-human (FIH) intrathecal injection will be preliminarily explored.

As the only company in China dedicated to the research and development of Treg cell therapy drugs, NOVABIOTX's research team is accelerating the implementation of the IIT clinical trial for the NP001 project with rigorous caution. NOVABIOTX’s Treg R&D pipeline holds the leading position in this field in China. In addition to the NP001 project, which has made the fastest progress and received ethical approval, the company has multiple gene-editing and allogeneic projects under development. The entire R&D pipeline consists of projects that are fully independently innovated by NOVABIOTX.

Treg cell therapy drugs have not yet been approved for marketing globally, and most are still in the preclinical research stage.NOVABIOTXThe ethical approval of the NP001 project indicates that the development of Treg cell therapy drugs in China has reached an internationally leading level. Based on the globally-oriented development strategy and the extensive patient resources already established, NOVABIOTX is striving to become a world-leading company in this therapeutic field within a few years. By addressing the current situation where there are almost no effective treatments available in this field, the company aims to bring more hope to patients and contribute to advancing the cellular therapy drug industry. This collaboration with the First Affiliated Hospital of Zhengzhou University also represents a significant step forward for medical innovation research in China, moving toward world-class standards. The hospital will actively screen eligible participants and expedite the evaluation of safety, tolerability, and preliminary efficacy in clinical studies.

About the Biological Cell Therapy Center of the First Affiliated Hospital of Zhengzhou University

The Biological Cell Therapy Center/Biological Immunotherapy Ward of the First Affiliated Hospital of Zhengzhou University is an influential research and clinical center for the development of immunotherapy technology. Under the leadership of Professor Zhang Yi, it focuses on tumor immunity and cell therapy, emphasizing the integrated development of scientific research, transformation of results, clinical treatment, and precision testing. It has the capability to independently carry out the entire chain of work from the research and development of tumor immunotherapy technology to its application, covering the whole process of immunotherapy technology R&D, clinical-grade cell production, clinical trials, and monitoring of clinical patient indicators. Since 2016, through independent R&D and collaborative development, it has led over 50 clinical studies in immunotherapy and cell therapy, including CAR-T cells, TCR-T cells, neoantigen vaccines for tumors,Tumor-Infiltrating Lymphocytes(TIL) and other internationally leading immunotherapy technologies.

About the Department of Neurology, First Affiliated Hospital of Zhengzhou University

The Department of Neurology at the First Affiliated Hospital of Zhengzhou University is a national regional medical center for neurological diseases, and a key specialty in neurology under the National Health Commission. It hosts several clinical and research platforms, including the Henan Branch of the National Clinical Research Center for Neurological Diseases, one of the first advanced stroke centers designated by the National Health Commission, one of the first demonstration centers for standardized diagnosis and treatment of brain health and cognitive disorders under the National Health Commission, the Medical Quality Control and Treatment Center for Neurogenetic Degenerative Diseases in Henan Province, the Key Laboratory for Cerebrovascular Disease Prevention and Treatment under the National Health Commission (co-built), and the Key Medical Laboratory for Neurogenetic Degenerative Diseases in Henan Province.

About NOVABIOTX

NOVABIOTX was founded in 2022, focusing on the development of multi-modal Treg cell therapies for treating neurodegenerative and autoimmune diseases. It is the only biopharmaceutical innovation company in China dedicated to the development of Treg cell-based therapeutics and is advancing at the fastest pace. Treg cells can effectively suppress the proliferation and function of pro-inflammatory cells through multiple mechanisms. After years of research, it has been discovered that Tregs also possess tissue repair capabilities. Based on the pathogenic mechanisms of different indications, NOVABIOTX has designed a fully independent and innovative R&D pipeline aimed at achieving disease cures through immunosuppression, tissue repair, and immune tolerance. Adhering to its core mission of "addressing unmet clinical needs," and upholding the core values of "patient-centricity, integrity, pragmatism, and perseverance," NOVABIOTX is leading the industrial development of Treg-based therapies.