Shanghai UniXell Biotechnology Co Ltd, located in the China (Shanghai) Pilot Free Trade Zone, recently announced a Parkinson's treatment breakthrough. Its UX-DA001 injection, an autologous iPSC-derived cell drug, received clinical trial approval from the National Medical Products Administration's Center for Drug Evaluation (CDE) in China. It is the world's second and China's first such drug to enter trials.

UniXell Biotechnology is a stem cell tech company focused on the research and development of cell drugs. Utilizing proprietary technology in human pluripotent stem cell prep, culture, differentiation, and gene editing, it develops innovative stem cell therapies for neurodegenerative diseases, rare diseases, and more, aiming to improve human health through stem cell technology.

UniXell Biotechnology is a stem cell tech company focused on cell drug R&D. [Photo/WeChat ID: gh_3842b6cadc5d]

Parkinson's disease causes motor disorders like tremors and muscle rigidity. Current drugs can ease symptoms but not cure the disease. Stem cell-derived dopaminergic neuron transplantation is a promising treatment and possible functional cure. It is a key area of international pharmaceutical competition.

The UX-DA001 injection, approved for clinical trials by CDE, uses innovative cell therapy. Leveraging UniXell Biotechnology's stem cell technology platforms, it produces high-purity, stable, efficient midbrain dopaminergic neural precursors. This could repair neural tissue and restore brain dopamine, improving Parkinson's symptoms. Unlike traditional drugs, cell therapy aims to regenerate neurons, potentially improving neurological function at a fundamental level.

Benefiting from the solid industrial base and unique locational and policy advantages of Shanghai FTZ in biopharmaceutical development, UniXell Biotechnology established an innovative R&D center and a GMP clean workshop in the free trade zone in 2023, helping the company to further advance technological R&D, clinical translation, and pipeline progress.