An advanced therapy for blood cancers that are called myelodysplastic syndromes or MDS – developed in the Hefei high-tech zone, in Hefei city, capital of East China's Anhui province – recently got an important green light in its development.

The NCR300 therapy is administered by injection and it was developed by Hefei's Nuwacell Biotechnologies Co Ltd. It was granted permission on April 20 to undergo clinical trials by the Center for Drug Evaluation at the National Medical Products Administration.

The exterior of Nuwacell Biotechnologies in the Hefei high-tech zone. [Photo/WeChat ID: zhongguoshenggu111]

It is also the first induced pluripotent stem cell (iPSC)-derived natural killer cell (iNK) therapy approved for clinical trials in China.

Currently, several laboratories worldwide have developed iPSC-differentiated NK cell processes, but only the companies Fate Therapeutics and Century Therapeutics have entered clinical trials for iPSC-derived NK cell therapies.

That means the approval of the NCR300 injection signals that China's iPSC-derived NK cell therapy has reached the leading global level.

The NCR300 Injection is an iNK product prepared for commercialized and large-scale production under cGMP standards, which can be used in the clinical treatment of various malignant tumors and improve the efficiency and stability of cell therapy.

Based on the CMC technology platform and around the core iPSC technology, Nuwacell Biotechnologies is said to have advanced the development of multiple types of cellular drug pipelines.

Of these, the iPSC-derived mesenchymal-like cells therapeutic product obtained a clinical license from China's Center for Drug Evaluation last year and was the first iMSC cell drug approved for clinical use in China.