On Wednesday, CMG Pharmaceutical, a subsidiary of CHA Biotech, announced that it received approval from the U.S. Food and Drug Administration (FDA) for its schizophrenia treatment, Mezofy (active ingredient: aripiprazole).
Mezofy is an oral film formulation developed by CMG Pharmaceutical for treating schizophrenia. It marks the fourth product from a South Korean pharmaceutical company to receive FDA approval for a modified drug. Mezofy is the first to obtain approval through a Formulation Change.
Previous modified drugs mainly involved changing the salt components to improve solubility or stability or combining existing drug active ingredients into a compound. Mezofy changed its formulation to an oral film to enhance the differentiation of formulation techniques and improve patient adherence to medication.
Patients with schizophrenia and other mental illnesses often refuse to take their medication or stop taking it on their own. Therefore, the method of drug delivery is crucial for maintaining continuity in treatment. Mezofy can be taken without water and dissolves easily in the mouth, addressing these issues.
The recent approval of Mezofy is significant because it was granted as a Modified Drug. Modified drugs typically have higher prices than generics and can be marketed and prescribed under their brand names, allowing them to build strong market recognition and loyalty.
Obtaining approval for a modified drug with a formulation change is challenging because it must meet both differentiation and FDA regulatory requirements. This approval for Mezofy is seen as a testament to CMG Pharmaceutical’s research and development (R&D) competitiveness.
Lee Joo-Hyung, CEO of CMG Pharmaceutical, noted that FDA approval for modified drugs has traditionally been the domain of large pharmaceutical firms due to significant entry barriers. He explained that CMG Pharmaceutical became the first mid-sized company to secure such approval, attributing the achievement to the company’s accumulated experience in securing various drug approvals and its close partnerships with global companies.
Marking a Major Step Toward Entering the U.S. Market
CMG Pharmaceutical’s recent approval comes after more than five years of effort. The company submitted its application to the FDA in December 2019. However, the approval process faced delays due to impurity issues with third-party products produced at overseas raw material plants and the COVID-19 pandemic. CMG Pharmaceutical resubmitted its application in October of 2024 and received market approval six months later.
While CMG Pharmaceutical applied for FDA approval for Mezofy as the world’s first film formulation for schizophrenia treatment in December 2019, during the delay, a Chinese pharmaceutical company’s aripiprazole film treatment, Opipza, received FDA approval in July 2024.
CMG Pharmaceutical is preparing a differentiated strategy for a successful product launch. They changed the product name from Depipzo to Mezofy after conducting brand naming tests with healthcare professionals in the U.S. through collaboration with Brand Institute, the world’s leading pharmaceutical branding firm. This new name minimizes the potential for prescription errors and is easier to remember.
CMG Pharmaceutical plans to leverage Mezofy’s superior technology and product differentiation to expand its market share in the film formulation schizophrenia treatment sector. Mezofy utilizes CMG’s proprietary STAR (Smooth, Thin, Advanced Stability, Refreshing Taste) film technology, giving it an edge in both formulation and quality compared to competing products.
Produced at Labtec GmbH, a German facility that has received Good Manufacturing Practice(GMP) approvals from both the U.S. and Europe, Mezofy’s reliability is another strong point.
Aims to Achieve Around $80 Million Within 5 Years
With FDA approval in hand, CMG Pharmaceutical is optimistic about achieving its goal of ranking among the top 30 publicly listed pharmaceutical companies by 2030.
According to Data Monitor, the U.S. schizophrenia treatment market is valued at approximately $9.2 billion, making it the largest in the world. If CMG Pharmaceutical expands its indications to include bipolar disorder, major depressive disorder, autism spectrum disorder, and Tourette syndrome, the target market could grow to over $16.9 billion.
CMG Pharmaceutical aims to achieve annual sales of over $76.9 million within five years of entering the U.S. market, leveraging excellent medication adherence and competitive pricing strategies.
To this end, the company plans to finalize the selection of U.S. distribution partners by the end of this year. In collaboration with these partners, CMG will negotiate pricing to validate the product’s value and establish a competitive pricing strategy. Considering the time required for negotiations and price approvals, Mezofy is expected to launch in the U.S. market in the first half of 2026.
CEO Lee of CMG Pharmaceutical remarked that the FDA approval of Mezofy demonstrates the potential for South Korean pharmaceutical companies to enter the global market. He added that the company plans to expand internationally after proving Mezofy’s effectiveness in the U.S. market.