Country: South Korea

We are simultaneously conducting cell and gene therapy (CGT) CDMO business and cell therapy development business. Since its establishment as a spin-off from Samsung Medical Center in 2018, our CDMO business has accumulated differentiated technological capabilities based on diverse experiences in producing advanced biopharmaceuticals such as stem cells, CAR-T, AAV, and exosomes. We have executed 17 companies and 33 projects to date. Furthermore, In-Korea, our company holds the record for the most IND approvals among CGT CDMOs, establishing us as the leading company in this field domestically. We have filed a total of 23 patents related to our CDMO business, including markers for detecting stem cell proliferation and high-efficiency proliferation methods using them, expansion culture methods for cord blood-derived natural killer cells, artificial intelligence-based real-time cell image analysis methods, and their applications. Among these, four patents have been registered, and one paper has been published. | ENCell Co., Ltd. was founded in 2018 by Jongwook Chang, a professor at Samsung Medical Center and Sungkyunkwan University, who also serves as a professor. We are committed to offering end-to-end cell and gene therapy CDMO services of advanced biopharmaceuticals such as cell and gene therapies. Since the establishment of the company, starting with a consignment production contract for Hanmi’s glioblastoma treatment, we have carried out 33 projects to date, including consignment production of clinical trial drugs for 17 customers. including 10 clinical trial plan approvals for our clients. In December 2020, it was designated as a CCPC (Central cell processing center) to supply raw cells for CAR-T products for clinical trials of Janssen’s CAR-T products, and in April 2022, it was designated as a CCPC for Novartis’ CAR-T product Kymriah and is supplying raw cells. To date, the cumulative number of patients is more than 110. ENCell’s headquarters is located in Songpa-gu, Seoul, and the research center and GMP 1st factory are located within Samsung Medical Center. In 2021, GMP’s second factory, measuring approximately 1,000 pyeong, will be completed in Hanam City and is producing cell and gene therapy products, gene therapy products (AAV, etc.), exosomes, etc., including CAR-T products for clinical trials. In January 2022, the third GMP plant, a facility dedicated to the production of viral vectors, has been completed and is currently carrying out consignment production of AAV product for clinical trials. The exosome therapy consignment produced at GMP’s second plant in Hanam received approval for phase 1 clinical trials in the U.S., and CAR-T cell therapy and NK cell therapy received approval for domestic phase 1/2 clinical trials, so clinical products are also being supplied. In addition, we are accelerating orders for the production of various clinical grade viruses (Lentivirus, AdV, etc.), including AAV. In addition, ENCell completed the phase 1 clinical trial of a next-generation stem cell treatment under development for rare muscle diseases Charcot-Marie-Tooth disease and Duchenne muscular dystrophy as indications in 2022, along with CDMO business. In addition, the company is expanding its own pipeline with anti-cancer immune cell therapy products. Based on its solid research and development capabilities, ENCell has global-level CDMO capabilities. Currently, as the only CDMO company in Korea that can produce cell and gene therapy products simultaneously, it is leading Korea’s cell and gene therapy consignment production market and is continuing to grow to establish itself as a competitive global bio company.