CMG 피망 바카라’s film-type schizophrenia treatment 'Mezofy' approved by U.S. FDA as improved novel drug product

[by Ji, Yong Jun] CMG 피망 바카라, a subsidiary of CHA Biotech, announced on April 16 that it had received product approval from the U.S. Food and Drug Administration (FDA) for ‘Mezofy,’ a treatment for schizophrenia. Mezofy is an ‘oral Film’ formulation containing aripiprazole, developed by CMG 피망 바카라 for the management of schizophrenia.

CMG 피망 바카라 obtained FDA approval for Mezofy as an ‘improved new drug’ by modifying the formulation. An improved new drug refers to a compound that alters the salt (ingredient for improving solubility or stability) form of the active ingredient or combines existing active ingredients. Mezofy was reformulated as an oral film to strengthen the differentiation of its drug delivery technology and improve patient adherence. “As an approved new drug, Mezofy is expected to achieve strong brand awareness and generate royalties by leveraging drug price competitiveness and prescriptions under its proprietary brand name,” CMG 피망 바카라 explained.

CMG 피망 바카라’s acquisition of FDA product approval for Mezofy marks the culmination of a five-year development effort. The company initially submitted its application in December 2019. However, the approval process was delayed due to impurity-related issues in third-party products manufactured at overseas raw material facilities, as well as disruptions caused by the COVID-19 pandemic. CMG 피망 바카라 resubmitted the application in October 2024 and successfully received marketing authorization in just six months.

“FDA approval for improved new drugs has traditionally been the domain of large 피망 바카라 companies due to the high entry barriers,” said Lee Joo-hyung , CEO of CMG 피망 바카라. “Our company was able to achieve this milestone through practical capabilities and close collaboration with global partners.”

CMG 피망 바카라 is implementing a differentiated strategy to ensure the successful launch of Mezofy. As part of this effort, the product name was changed from Depipzo to Mezofy, following a brand naming study conducted in collaboration with U.S. medical experts and the ‘Brand Institute,’ a global leader in 피망 바카라 branding. Furthermore, Mezofy is manufactured at the Labtec GmbH manufacturing plant in Germany, which is certified under both U.S. and European GMP standards.

CMG 피망 바카라 has set a target of achieving annual sales of at least KRW 100 billion (approximately USD 70.4 million) for Mezofy within five years of its entry into the U.S. market. According to U.S. market research firm Data Monitor, the U.S. market for schizophrenia treatment is valued at KRW 12 trillion. CMG 피망 바카라 plans to finalize the selection of a local distribution partner in the United States by the second half of this year, with the official launch of Mezofy scheduled for the first half of 2026.

“Mezofy’s FDA product approval serves as a model for how Korean 피망 바카라 companies can pursue alternative pathways to enter the global market,” Lee stated. “We aim to prove Mezofy’s clinical excellence in the U.S. market, which will serve as a foundation for broader global expansion,” he added.