Breakthrough News

On December 20, 2024, Shanghai UniXell Biotech Co.,Ltd("UniXell Bio") received implicit approval from China's Center for Drug Evaluation (CDE) (Application No.: CXSL2400673) for its investigational iPSC-derived cell therapy product UX-DA001 (human midbrain dopaminergic neural precursor cell injection) for Parkinson's disease, marking its official entry into clinical trials. This breakthrough represents a significant advancement in China's neurodegenerative disease treatment landscape and brings new hope to Parkinson's patients.

UX-DA001 is China's first and the world's second IND-approved autologous iPSC-derived cell therapy for Parkinson's disease to receive clinical trial authorization.

Parkinson's disease is a common neurodegenerative disorder characterized by motor impairments such as tremors, muscle rigidity, and bradykinesia. As the disease progresses, patients' quality of life deteriorates. Current medications only alleviate symptoms without halting neuronal degeneration.

Transplanting stem cell-derived dopaminergic neurons to replenish lost cells in patients' brains represents the most promising approach for functional cure of Parkinson's, making it a global research focus.

UX-DA001 utilizes UniXell Bio's proprietary pluripotent stem cell platform (including high-throughput differentiation tracing, efficient neural differentiation, and iPSC reprogramming technologies) to generate high-purity, stable midbrain dopaminergic precursors. Unlike symptomatic drugs, this cell therapy aims to reconstruct neural circuits by regenerating dopamine neurons.

With global cell therapy trials at a critical juncture, this innovation may redefine Parkinson's treatment. UniXell Bio has filed 10+ patents and won the 2024 National Disruptive Technology Innovation Award, demonstrating its commitment to pioneering therapies.

Dr. Haiyan Fang, COO of UniXell Bio, stated: "This approval represents a crucial step against Parkinson's. For patients beyond the 'honeymoon period' of medications, we aim to deliver not just symptom relief but potential cure through cell therapy."

The seamless approval without supplementary requirements validates UniXell Bio's expertise. While clinical trials pose challenges, the team remains committed to innovation and patient benefits through this groundbreaking therapy.