ENCell is a company specializing in contract development and manufacturing (CDMO) and new drug development for cell and gene therapies. The ENCell factory in Hanam Technovalley, Gyeonggi Province, visited on the 2nd, is a dedicated negative pressure GMP facility for the production of cell and gene therapies, producing clinical-grade cell and gene therapies (CAR-T, CAR-NK), exosome therapies, and more. The factory was made of transparent glass so that outsiders could see all internal processes. Inside the sterile room, researchers in professional gowns were producing cell gene therapies. CEO Jang Jong-wook of ENCell provided detailed insights into the key business operations conducted here.

―ENCell's contract development and manufacturing (CDMO) business is….

“Think of it as making cell or gene therapies that a client company is developing on their behalf. In other words, through ENCell's unique know-how, the business completes the entire cycle of the desired pharmaceutical product from development to production. ENCell views the cell gene therapy market as the third-generation biopharmaceutical market, which is a future growth engine. It anticipates that demand for high-value-added therapies through multi-product small-batch production will increase in the future and is proactively working to dominate the CDMO market.”

―It is heard that you are conducting new drug development for cell gene therapies while simultaneously running a CDMO business.

“That's correct. Through a global-level GMP facility capable of simultaneous production of cells and viruses, we provide pharmaceuticals to clients with a one-stop service and a differentiated production and quality management system. We are the first company with a business model that engages in both CDMO and new drug development. Focusing solely on new drug development carries significant risk, so ENCell is pursuing a dual-track approach of 'CDMO' and 'new drug development.' As a result, in the CDMO business segment, ENCell has secured 34 projects from 18 clients to date, with cumulative orders amounting to approximately KRW 43 billion. ENCell is expanding its contract agreements with globally renowned pharmaceutical companies, including Novartis and Janssen.”

―It is understood that you are also developing a new drug (EN001) treatment for rare diseases such as Charcot-Marie-Tooth disease and Duchenne muscular dystrophy.

“That's correct. We have confirmed safety through the administration of a stem cell therapy under development to patients with these conditions. In particular, statistically significant efficacy was confirmed in six patients with Charcot-Marie-Tooth disease. Charcot-Marie-Tooth disease is a rare disorder where mutations occur in the motor and sensory nerves of certain genes, causing weakness in the hands and feet and gradually diminishing muscle strength, leading to a loss of balance. Despite being a rare disease with a high incidence rate, there is currently no approved treatment. Phase 1 clinical trials have been completed, and we have applied for Phase 2 trials. We expect to start Phase 2 trials by the end of this year or early next year. We are closely collaborating with hospitals to alleviate the suffering of patients with rare diseases.”

―The significance of the adeno-associated virus (AAV) platform recently contracted by ENCell is….

“Gene therapy involves the use of viruses, with adenoviruses being particularly utilized. In July, we signed a contract with the Korea Research Institute of Bioscience and Biotechnology to establish a clinical production platform for the development and production of customized AAV gene therapies, which account for approximately 80% of last year's total sales, amounting to about KRW 5.7 billion. This is the largest single contract amount among ENCell's orders. This revenue is pure revenue generated from contract development and manufacturing, and it will serve as the first step in producing commercial AAV gene therapies domestically, creating domestic treatments through public-private collaboration. In the future, this will reduce dependence on overseas sources and decrease insurance expenses associated with the use of imported AAV gene therapies.”

―What kind of company do you want to develop into in the future?

“ENCell aims to generate profits through the CDMO business and reinvest them into new drug development, creating a virtuous cycle to grow into a leading global company specializing in cell and gene therapies. Although we are currently a small venture company with about 110 employees, our employees' capabilities are at a global level. In the second half of the year, we plan to focus on partnerships with global companies to accelerate our entry into the global market.”

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