Advanced biopharmaceutical CMO company ENCell Co., Ltd. announced that they acquired "Human Cell Management Business Approval" from MFDS(KFDA) on March 4th, 2021.
"Human Cell Management Business Approval" is essential to continue the CMO business for a company processing human cells and tissue to manufacture advanced biological products.
"Human Cell Management Business Approval" was lately defined according to “Advanced Regenerative Medicine and Advanced Biopharmaceutical Product Safety and Provision Act” (‘Effective date, August 2020’)

ENCell Co., Ltd., a biotech company focusing on developing next-generation stem cell therapy, filed 2 IND applications with the next-generation stem cell therapy for Duchenne Muscular Dystrophy and Charcot-Marie-Tooth Disease for phase1 clinical trials, respectively, in South Korea.

It is anticipated that our biotech industry could make a major breakthrough to fight the difficulties that Covid-19 pandemic made worldwide. This hopeful prospect was shown in the virtual event, BIOPLUS-INTERPHEX KOREA 2020, held by Korea Biotechnology Industry Organization(KoreaBIO), from Sept. 23rd, 2020.
ENCell Co., Ltd. and GeneMedicine got KoreaBIO President Awards, in the “Startup Sector” and “Small/Medium/Large company Sector” respectively, at this event.

BREXOGEN announced it singed MoU with ENCell Co., Ltd. for a strategic partnership for a large-scale GMP production of MSC-derived exosomes. BREXOGEN is a startup company developing new pharmaceutical with exosome-based drug delivery system.

ENCell Co., Ltd., a biotech company focusing on developing therapeutic next-generation stem cell and CMO business of cell therapy, and Thermo Fisher Scientific Limited signed MoU on a strategic partnership to expand their CMO business of cell and gene therapy into a global market.