2023 Company Presentations
ENCell Co., Ltd.
Profile
ENCell, Co., Ltd. is a top, leading cell and gene therapy / CDMO company in South Korea, founded in March 2018 as a 2nd spin-off company of the Samsung Medical Center. We are committed to offering end-to-end cell and gene therapy CDMO services and developing stem cell therapeutics to cure rare and intractable diseases. Through the operation of 3 separate GMP facilities, ENCell has the full capability and capacity to carry out both cell (stem cells, CAR-T, NK cells, exosomes) and gene (lentivirus, AAV) therapy manufacturing as a one-stop service for our clients. All of our GMP facilities adhere to the stringent PIC/S regulations and hold requisite licensure in South Korea to manufacture advanced biopharmaceutical products. To date there are 26 completed and ongoing projects, including contract manufacturing of investigational drug products, that we have or are still working for a total of 16 clients. Five phase 1 trials have been completed and a total of 10 IND applications have been granted approval, including IND approval of an exosome product by the US FDA. ENCell has also been officially designated as the central cell processing center (CCPC) of Janssen and the cell processing center (CPC) of Novartis for CAR-T therapy. As of July 2023, cell processing of CAR-T products for 114 patients has been carried out at ENCell. The first-half revenue of our company this year was 7.8 million USD (total revenue: 22 million USD). ENCell has developed an innovative platform, ENCT, designed for large-scale production of high-stemness, early passage allogeneic mesenchymal stem cells with reduced senescence. Leveraging this technology, we have made significant progress in two next-generation stem cell treatment pipelines targeting Charcot-Marie-Tooth (CMT) and Duchenne Muscular Dystrophy (DMD). Having successfully completed two independent Phase 1 trials, we are striving towards securing conditional approval for both pipelines by 2025 due to granted ODD in South Korea.