COMPANY Advanced cell / gene-based biopharmaceutical development and CDMO

History

  • 2022
    • 01
      • Government research grant outsourced by MFDS : ‘Development of evaluation technology for quality and safety of immuno-oncology cell-based gene therapy’
  • 2021
    • 12
      • Awarded by the Korean Minister of SMEs and Startups
        (‘Promoting startups 2021’)
        Initiation meeting for two Phase 1 clinical trials of DMD and CMT
    • 11
      • Awarded by the Korean Minister of Health and Welfare
        (‘Healthcare technology advancement 2021’)
    • 10
      • Completion of 2nd GMP Plant Construction
    • 06
      • IND Approval for Phase 1 Clinical Trial of Charcot-Marie-Tooth Disease
        ‘Cell Processing Facility’ Approval by MFDS (KFDA)
    • 05
      • IND Approval for Phase 1 Clinical Trial of Duchenne Muscular Dystrophy
        Designated as Cell Processing Center (CPC) for KYMRIAH® ‘(Novartis)
        Series B Investment (22.4 million USD) Secured
    • 03
      • ‘Human Cell Management Business’ Approval by MFDS (KFDA)
    • 01
      • Designated as Central Cell Processing Center (CCPC) for Car-T Product of Janssen
  • 2020
    • 09
      • Awarded as “Innovative Biotech Company in Excellent Progress”
        by the Ministry of Trade, Industry and Energy of Korea
    • 08
      • ISO 9001:2015 Certificate Received by KFDA – Our 1st GMP Plant (Seoul)
    • 07
      • R&D Project Collaborated with Small and Medium Business Administration of Korea Granted
    • 06
      • Strategic Partnership with ThermoFisher Scientific™
    • 02
      • Series A Investment (8.8 million USD) Secured
        GMP System Design and Establishment Started
  • 2019
    • 08
      • 2nd GMP Plant Site Purchased
    • 07
      • Awarded as “Company with Outstanding Performance”
        by Korea Health Industry Development Institute
  • 2018
    • 08
      • GMP Declaration Issued by MFDS(KFDA)
    • 07
      • TIPS Program Granted
        (R&D Grant by Korean Ministry of SMEs and Startups)
    • 05
      • Signed a Contract Providing CMO Services for
        Anticancer Gene-modified MSC Therapy with Hanmi Pharmaceuticals
    • 03
      • Corporation Establishment
        [Headquarters] 6th Floor, W Tower (Cheongdam-dong)
        [1st GMP Plant] B3 Future Medicine Hall, Samsung Medical Center
    • 02
      • Founded ENCell as Faculty Startup in Samsung Medical Center