MEDIPOST disclosed on 29 July that the premature child bronchial pulmonary dysplasia preventive treatment drug ‘same type cord blood originated mesenchyma stem cell component (injection)’ has been designated as ‘orphan drug in development stage’ by the FDA.

This ‘same type cord blood originated mesenchyma stem cell component (injection)’ is ‘PNEUMOSTEM^®’ being clinically tried by MEDIPOST, for which FDA has recently given notice of its designation as orphan drug in development stage and the announcement thereof.

MEDIPOST has developed preventive treatment drug for such diseases from mesenchyma stem cell extracted from cord blood (blood from umbilical cord), and is carrying out phase 2 clinical trial at Samsung Seoul Hospital and Seoul Asan Hospital.

MEDIPOST personnel stated that ‘with the designation as orphan drug in development stage, we became able to receive benefits such as exemption from prior review and processing fee, and support of administrative process, and we are also able to anticipate obtaining of early item approval.

MEDIPOST further explained that ‘in order to be designated orphan drug at the development stage a high assessment of the medical importance and the possibility of commercialization required, therefore regardless of the benefits the designation itself has significant meaning’

Prior to this designation, ‘PNEUMOSTEM^®’ has also been designated orphan drug by US FDA in December last year.