CHA Biotech subsidiary CMG Pharmaceutical announced on the 16th that it has obtained item approval for the schizophrenia treatment 'Mezofy' (formerly Depipzo) from the U.S. Food and Drug Administration (FDA).
Mezofy is an oral film type schizophrenia treatment (active ingredient aripiprazole) developed by CMG Pharmaceutical. Patients with schizophrenia and other mental disorders often refuse or spit out medication, but the film formulation can be taken without water and dissolves easily in the mouth, addressing this issue.
CMG Pharmaceutical first applied for item approval from the FDA in December 2019. At that time, CMG Pharmaceutical was the world's first company to apply for approval for a film-type schizophrenia treatment. However, the supplemental inspection was delayed due to issues with overseas raw material factories and the impact of the COVID-19 pandemic.
In the meantime, China’s LP Pharma’s aripiprazole film treatment Opipza received FDA approval in July last year. Subsequently, CMG Pharmaceutical reapplied for item approval in October last year and obtained marketing authorization.
Mezofy is the fourth product from a domestic pharmaceutical company to receive approval for a new and improved drug from the FDA. A new and improved drug is not just a simple copy of an expired patent drug, but rather improves the method of administration by changing the efficacy or formulation. Unlike simple generic drugs, they are separately protected by patent.
The company noted, “New and improved drugs are priced higher than generics and can be marketed and prescribed by the product name instead of the ingredient name, which is advantageous for increasing recognition in the market.”
CMG Pharmaceutical expects the U.S. launch of Mezofy in the first half of 2026. According to Data Monitor, a U.S. market research firm, the U.S. schizophrenia treatment market is the largest in the world, worth 12 trillion won.
The company projected that the market would expand to over 22 trillion won when Mezofy is indicated for bipolar disorder, major depressive disorder, autism spectrum disorder, and Tourette syndrome.
The company said it plans to complete the selection of a local distribution partner in the U.S. by the second half of this year and will establish a competitive pricing strategy in collaboration with the distribution partner.
CMG Pharmaceutical set a goal of selling over 100 billion won annually within five years of entering the U.S. market. Lee Joo-hyung, CEO of CMG Pharmaceutical, stated, “After proving the excellence of Mezofy in the U.S. market, we will also enter other overseas markets.”
At the time of the initial item approval application, the product name was Depipzo. The company explained that it collaborated with the branding specialist Brand Institute to choose the name Mezofy, which is less likely to result in prescription errors and easier to remember.