Pharma company Nuwacell Biotechnologies Co Ltd has developed a new product called NCR300 Injection, which was listed on the official website of the Center for Drug Evaluation at the National Medical Products Administration on Aug 23.

The company is based in the Hefei National High-tech Industry Development Zone, located in Hefei, capital of East China's Anhui province.

This injection is an iPSC-derived natural killer cell (iNK) product that is produced through the optimization of production processes and follows the cGMP standard for large-scale production.

It is said to have the potential to be used in the clinical treatment of various malignant tumors, offering improved efficiency and stability of cell therapy.

The recent clinical filing marks a new indication filing for the NCR300 Injection. Previously, it was approved for clinical trials for myelodysplastic syndromes (MDS) on April 20.

The approval made it the first iPSC-derived iNK therapy that was approved for clinical use in China.

A diagram showing the mechanism for tumor cell killing by NK cells. [Photo/WeChat ID: hefeigaoxinfabu]

NK cells are innate immune cells that can kill tumor cells and virus-infected cells without prior sensitization.

They are said to be an essential part of the human immune system and have been found to be effective in tumor treatment and anti-infection therapies.

The iPSC-derived NK cell products are believed to have superior tumor killing performance and are resistant to freeze-storage recovery. These advancements are understood to represent a new direction in the development of NK cell therapies.