Scheduled for U.S. Launch in 2026
Aiming for Annual Sales Exceeding 100 Billion KRW Within Five Years
CMG Pharmaceutical, a subsidiary of Cha Biotech, announced on the 16th that it has obtained approval from the U.S. Food and Drug Administration (FDA) for its schizophrenia treatment drug, Mezzopi.
Mezzopi is an oral film-type schizophrenia treatment (active ingredient aripiprazole) developed by CMG Pharmaceutical. It is the fourth product developed by a Korean pharmaceutical company to receive FDA approval as an improved new drug. Mezzopi is the first to obtain approval through a 'formulation change.' Previous improved new drugs involved changing the salt form of the main ingredient (to improve solubility or stability) or combining existing active ingredients into a compound drug. Mezzopi changed its formulation to an oral film to differentiate its formulation technology and enhance patient-centered medication adherence.
Patients with schizophrenia and other mental illnesses often refuse or voluntarily discontinue medication, making the method of drug delivery crucial to maintaining treatment continuity. Mezzopi’s film formulation can be taken without water and dissolves easily in the mouth, addressing these issues.
The recent approval of Mezzopi is significant because it was authorized as an 'improved new drug.' Improved new drugs have much higher prices compared to generics and can be marketed and prescribed under a brand name rather than the generic name, allowing them to build strong market recognition and loyalty. However, obtaining approval is difficult because the formulation must be differentiated while simultaneously meeting the U.S. FDA regulatory requirements.
Joo Hyung Lee, CEO of CMG Pharmaceutical, said, "Due to the high entry barriers, approval of improved new drugs by the FDA has so far been the exclusive domain of large pharmaceutical companies. CMG Pharmaceutical has achieved the milestone of being the first mid-sized pharmaceutical company to obtain FDA approval for an improved new drug through accumulated practical expertise in drug approvals and close collaboration with global companies."
This approval by CMG Pharmaceutical is the result of over five years of effort. CMG Pharmaceutical initially applied for FDA approval in December 2019. However, the review was delayed due to impurity issues in products manufactured by other companies at overseas raw material factories and the COVID-19 pandemic. Subsequently, CMG Pharmaceutical reapplied for approval in October 2024 and received marketing authorization within six months.
Accordingly, CMG Pharmaceutical is preparing differentiated strategies for a successful product launch. First, the product name was changed from Dephipjo to Mezzopi. This change was made in collaboration with Brand Institute, the world’s leading pharmaceutical branding company. After conducting brand naming tests with medical professionals in the U.S., the name was changed to one that is less prone to prescription errors and easy to remember.
CMG Pharmaceutical plans to expand the market for film-type schizophrenia treatments by leveraging Mezzopi’s superior technology and product differentiation as competitive advantages. Mezzopi applies CMG’s proprietary STAR FILM™ technology, giving it an edge over competing products in terms of film formulation and quality. It is also produced at Labtec GmbH in Germany, which holds both U.S. and European GMP certifications, enhancing its reliability.
The company aims to launch the product in the U.S. market in 2026 and achieve annual sales exceeding 100 billion KRW within five years. According to Data Monitor, a U.S. market research and analysis firm, the U.S. schizophrenia treatment market is approximately 12 trillion KRW, making it the largest market worldwide. Expanding indications to include bipolar disorder, major depressive disorder, autism spectrum disorder, and Tourette syndrome is expected to grow the market to over 22 trillion KRW.
To this end, CMG Pharmaceutical plans to finalize the selection of a local U.S. distribution partner by the second half of this year. In cooperation with the distribution partner, the company intends to demonstrate the product’s value through price negotiations and establish a competitive pricing strategy. Considering the time required for distribution partner negotiations and price approval, Mezzopi’s U.S. market launch is expected in the first half of 2026.
CEO Joo Hyung Lee stated, "The FDA approval of Mezzopi provides an alternative for Korean pharmaceutical companies to enter the global market. After proving Mezzopi’s excellence in the U.S. market, we plan to expand into the global market."
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