CMG Pharmaceutical wins FDA approval for Schizophrenia treatment

GMC Pharmaceutical's lab in Seongnam, Gyeonggi Province / Courtesy of CHA Biotech

CMG Pharmaceutical, a chemical drug affiliate of CHA Biotech, has received approval from the U.S. Food and Drug Administration (FDA) for its schizophrenia treatment, Mezofy, the company said Wednesday.

Mezofy is an oral film-type drug based on aripiprazole, a widely used antipsychotic for treating a variety of mood and psychotic disorders.

This is the fourth case of a Korean pharmaceutical company securing approval for an incrementally modified drug and the first done by changing the formulation.

Patients with schizophrenia and other mental health conditions often stop taking their medication voluntarily, making consistent treatment a challenge. To address this, CMG Pharmaceutical formulated Mezofy into an oral film, enabling it to be taken without water and dissolving easily in the mouth.

CMG Pharmaceutical said that Mezofy’s approval is significant because it was approved as an incrementally modified drug (IMD) whose chemical structure or formulation is altered from an already approved drug.

IMDs are eligible for higher prices compared to generic drugs and can be marketed under brand names instead of ingredient names, enabling stronger brand recognition.

“Due to high barriers, securing FDA approvals with IMDs has largely been limited to major pharmaceutical companies,” CMG Pharmaceutical CEO Lee Joo-hyung said. “CMG Pharmaceutical has achieved a milestone by securing this approval as a midsize pharmaceutical firm.”

Following the approval, CMG Pharmaceutical plans to finalize its selection of a U.S. distribution partner by the second half of this year and will engage in pricing negotiations.

Given the time required for negotiations and pricing approval, the company expects to launch Mezofy in the U.S. in the first half of 2026. With the new treatment, the company is targeting annual sales of 100 billion won in the U.S. market within five years

According to U.S.-based market research firm Data Monitor, the U.S. market for schizophrenia treatments is the largest in the world, estimated at 12 trillion won ($8.43 billion). When including bipolar disorder, major depressive disorder, autism spectrum disorder and Tourette’s syndrome, the market size is projected to reach over 22 trillion won.