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.

In the first half of 2025, a major piece of news emerged in China's regenerative medicine field: the total financing amount of iPSC (induced pluripotent stem cells, iPS cells) therapy companies surpassed that of T-cell therapy companies for the first time.

This article conducts a comprehensive review of domestic pipelines under research and development