CMG Pharmaceutical, a subsidiary of CHA Biotech specializing in chemical drugs, has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting approval for its new schizophrenia treatment, Mezofy. The announcement was made by the company on Wednesday.

Mezofy is a film-type oral medication developed using aripiprazole, a commonly prescribed antipsychotic known for treating a range of mood and psychotic disorders. Unlike traditional tablets, Mezofy is designed to dissolve directly in the mouth without the need for water, offering greater convenience and compliance for patients. This novel delivery format addresses a critical issue in schizophrenia treatment—many patients struggle to consistently take medication, often discontinuing use voluntarily.

This approval marks the fourth instance of a Korean pharmaceutical firm receiving FDA clearance for an incrementally modified drug (IMD), and notably, it is the first time such approval has been granted based solely on a change in formulation. IMDs differ from standard generics in that they involve slight modifications to the chemical structure or delivery mechanism of existing approved drugs. As a result, they can command premium pricing and be marketed under proprietary brand names, providing companies with stronger branding opportunities and higher market potential.

The FDA’s green light for Mezofy is seen as a significant achievement for CMG Pharmaceutical, particularly because IMD approvals in the U.S. have typically been dominated by large, global pharmaceutical firms. “Achieving FDA approval for an IMD is no small feat, especially for a midsize company like ours,” said Lee Joo-hyung, CEO of CMG Pharmaceutical. “This accomplishment opens new doors for us in the global pharmaceutical market.”

Looking ahead, CMG Pharmaceutical plans to complete the selection of its U.S. distribution partner by the second half of 2025. Pricing discussions and final negotiations will follow, with the company aiming to launch Mezofy in the American market in the first half of 2026.

With the introduction of Mezofy, CMG Pharmaceutical is targeting annual sales of 100 billion won (approximately $75 million USD) in the United States within five years of launch. The company believes that the innovative formulation and ease of use will resonate well with patients and healthcare providers, offering a competitive edge in the treatment of schizophrenia and related conditions.

This FDA approval marks a pivotal moment in CMG’s international expansion strategy and highlights the growing influence of Korean pharmaceutical firms on the global stage.