CMG Pharmaceutical, an affiliate of Cha Biotech, announced Wednesday that its innovative oral film-type antipsychotic drug Mezofy has received approval from the US Food and Drug Administration (FDA) for the treatment of schizophrenia.
The newly approved treatment represents a significant milestone as the fourth time a Korean pharmaceutical company has received FDA approval for an incrementally modified drug (IMD), and notably the first approval based specifically on a formulation change rather than chemical structure modification.
Novel Formulation Addresses Critical Treatment Challenges
Mezofy utilizes aripiprazole, a widely prescribed antipsychotic known for treating various mood and psychotic disorders. What distinguishes this medication is its innovative delivery system – a film that dissolves easily in the mouth and can be taken without water, a feature specifically designed to address medication compliance issues common among patients with psychiatric disorders.
"Many patients with schizophrenia and other psychiatric conditions often refuse or discontinue medication, which can lead to relapse and worsening of symptoms," explained Lee Joo-Hyung, CEO of CMG Pharmaceutical. "Mezofy's film formulation directly addresses this challenge by making the medication process simpler and less intrusive."
Commercial Advantages of Incrementally Modified Drugs
As an incrementally modified drug, Mezofy offers significant commercial advantages over standard generics. These medications typically command higher prices in the marketplace and can be marketed under brand names rather than generic ingredient names, boosting brand recognition and patient loyalty.
"Achieving FDA approval for an IMD is no small feat, especially for a midsize company like ours," said Lee. "This accomplishment opens new doors for us in the global pharmaceutical market."
Overcoming Regulatory Hurdles
The FDA approval represents the culmination of more than five years of effort by CMG Pharmaceutical. The company initially applied for approval in December 2019, but faced delays due to quality issues at a raw materials supplier's plant and disruptions caused by the COVID-19 pandemic.
Demonstrating persistence, CMG resubmitted its application in October 2024 and received marketing approval within six months, highlighting the company's commitment to bringing this innovative treatment option to patients.
Market Strategy and Global Expansion
With FDA approval secured, CMG Pharmaceutical has set ambitious commercial targets, aiming for annual sales of 100 billion won (approximately $70-75 million) in the US market within five years of launch. The company plans to finalize a partnership with a US distribution partner in the second half of 2025, with Mezofy's commercial 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 Lee. "After proving Mezofy's excellence in the US, we plan to expand into additional global markets."
Significance for Korean Pharmaceutical Industry
This approval represents more than just a single product success – it signals the growing influence of Korean pharmaceutical companies on the global stage. Traditionally, the approval of incrementally modified drugs in the US market has been dominated by large, multinational pharmaceutical corporations.
CMG Pharmaceutical's achievement demonstrates that mid-sized Korean pharmaceutical companies can successfully navigate the complex FDA approval process and bring innovative formulations to the competitive US market, potentially opening doors for other Korean firms with similar ambitions.
