Sailxen Bio's Treg Cell Therapy Receives CDE Approval for Multiple System Atrophy Clinical Trial

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Recently, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) officially approved the clinical trial application (Acceptance No.: CXSL2500817) for "Human Autologous Polyclonal Regulatory T-Cell Injection" developed by Shanghai Saierxin Biomedical Technology Co., Ltd. (NOVABIOTX), indicated for Multiple System Atrophy (MSA). This marks a significant breakthrough in the clinical development of this therapy for MSA, bringing new hope to patients with rare diseases worldwide who currently lack effective treatment options.

Dr. Mingqi Lü from NOVABIOTX stated,MSA is classified as one of the Parkinson's plus syndromes under the category of parkinsonism. Compared with Parkinson's disease, it usually progresses more rapidly, has a poorer prognosis, and shows limited response to existing drug treatments, making it one of the most challenging neurodegenerative diseases to treat.The team will accelerate the preparation of clinical trials and launch this clinical study covering two major subtypes of MSA as soon as possible. The study will systematically evaluate the safety, tolerability, and preliminary efficacy of Treg cells (i.e., NP001 cell injection), thoroughly explore their therapeutic potential in different MSA subtypes, strive to bring clinical benefits to a broader patient population, and build a solid data foundation for optimizing subsequent development strategies.

Approval of NP001 Cell Injection for Clinical Trials Marks an Important Milestone in MSA Treatment. The product's entry into the clinical stage not only significantly enriches treatment options but also represents a key strategy for this challenging disease. It signifies substantial progress in China’s rare disease cell therapy field, and its exploration will also accumulate valuable experience for addressing more severe diseases with similar mechanisms.

About NOVABIOTX

Shanghai Saierxin Biomedical Technology Co., Ltd. (NOVABIOTX) was established in early 2023, focusing on the development of multi-modal Treg cell therapies for treating neurodegenerative diseases, autoimmune diseases, and metabolic disorders. After years of research, it has been discovered that Treg cells can effectively suppress the proliferation and function of pro-inflammatory cells in autoimmune diseases through multiple pathways, thereby achieving therapeutic goals. Relying on its proprietary and highly efficient Treg isolation and expansion technology, the company has formed strategic partnerships with several top research institutions and clinical centers in China, overcoming limitations of traditional treatment methods. Together, they are advancing the translation of Treg therapy from the laboratory to clinical practice, accelerating the implementation and application of innovative treatments.

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