CMG Pharmaceutical, an affiliate of Cha Biotech, announced Wednesday that its oral film-type antipsychotic drug has received approval from the US Food and Drug Administration.
According to the company, its newly approved schizophrenia treatment, Mezofy, marks the fourth time a Korean pharmaceutical company has received FDA approval for an incrementally modified drug, and the first time based specifically on a formulation change.
Mezofy has been reformulated into an oral film to enhance medication compliance. The film dissolves easily in the mouth and can be taken without water -- a particularly important feature as patients with schizophrenia and other psychiatric disorders often refuse or discontinue medication.
Drugs classified as incrementally modified drugs generally command higher prices than generics and can be marketed under brand names instead of ingredient names, boosting brand recognition and patient loyalty, the company explained.
This FDA approval represents a milestone for CMG Pharmaceutical, achieved after more than five years.
The company initially applied in December 2019, but the process was delayed due to quality issues at another company's raw materials plant, as well as disruptions caused by the COVID-19 pandemic. CMG Pharmaceutical resubmitted the application in October 2024 and received marketing approval within six months.
With FDA approval secured, the company is targeting annual sales of 100 billion won ($70 million) in the US market within five years. It plans to team up with a local retail partner in the latter half of this year, with Mezofy’s US launch expected in the first half of 2026.
“The FDA approval of Mezofy marks a meaningful pathway for Korean pharmaceutical companies to enter the global market,” said CMG Pharmaceutical CEO Lee Joo-hyung. “After proving Mezofy’s excellence in the US, we plan to expand into additional global markets.”
minmin@heraldcorp.com
