The human-induced pluripotent stem cell (iPSC)-derived dopaminergic neural precursor cell therapy "NCR201" is currently undergoing clinical research at Zhongshan Hospital affiliated to Fudan University.

With the acceleration of global population aging, Parkinson's disease has become the second most common neurodegenerative disorder after Alzheimer's disease, affecting the health and quality of life of over ten million people worldwide.

In recent years, Cell & Gene Therapy (CGT) has been creating a strong wave worldwide.

CMC (Chemistry, Manufacturing and Control) plays a crucial role in the field of biopharmaceuticals, ensuring a smooth transition of biopharmaceuticals from the laboratory to the commercialization stage.

Up to now, nine CGT drugs have been officially launched on the market, covering the three core technologies of CAR-T, stem cells and gene therapy.

According to incomplete statistics, the number of IND applications for new stem cell drugs in China has exceeded 30 in the first half of this year, showing a significant growth trend compared to the 39 applications for the whole of 2024.

Recently, Sumitomo Pharma of Japan and Racthera jointly announced that they have submitted an application for the production and marketing authorization of raguneprocel to the regulatory authorities.

At present, six stem cell therapy projects in China are in the critical Phase III clinical trial stage, which indicates that the field of stem cell drugs is experiencing an important turning point.