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Pharma & CDMOKOSDAQ 456070Orphan Drug1 approvals5 trials

ENCell Co., Ltd.

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Founded in 2018 and listed on the KOSDAQ in 2024, ENCell is a cell and gene therapy CDMO and next-generation mesenchymal stem cell drug developer.

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Products & technology

  • EN001-CMTCharcot-Marie-Tooth disease therapy (next-gen mesenchymal stem cell therapy)
  • EN001-DMDDuchenne muscular dystrophy therapy (next-gen mesenchymal stem cell therapy)
  • EN001-SPSarcopenia therapy (next-gen mesenchymal stem cell therapy)
  • Advanced biopharmaceutical CDMO serviceContract development and manufacturing for cell therapy, organoid-based therapy, and gene therapy

Regulatory approvals

1 Orphan Drug designations · 2022

  • Orphan1. 주성분: 동종탯줄유래중간엽줄기세포 (5.0x10^6), 2. 현탁화제: 동결보존배지 (10mL)2022-05-27
    Orphan Drug designation · in development20220087792

Clinical trials

data.go.kr

5 MFDS clinical trial authorisations · 2021–2024 (Phase 1/2 2 · Phase 1 2 · Phase 1/2a 1)

  • Phase 1/2aEN0012024-06-27

    1 trial site

  • Phase 1/2EN0012023-09-19

    1 trial site

  • Phase 1/2EN0012023-06-22

    5 trial sites

  • Phase 1EN0012021-06-29

    1 trial site

  • Phase 1EN0012021-05-04

    1 trial site

R&D and key agreements

Source: DART corporate disclosure

EN001-CMT · 샤르코-마리-투스병(CMT) · 임상2상 진행 예정(조건부허가 신청 계획) · Designated an orphan drug in development in April 2022.

EN001-DMD · 듀센 근디스트로피(DMD) · 임상2상 진행 예정(조건부허가 신청 계획) · Designated an orphan drug in development in May 2022.

조직특이 타게팅 AAV 플랫폼 · 비임상 검증 후 라이선싱 추진 · Developing a tissue-specific targeted AAV platform, including a muscle-targeting AAV platform, to be validated preclinically and then licensed out.

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Companies in the same categoryPharma & CDMO

IL DONG PHARMACEUTICAL CO., LTD.100

Founded and listed on the KOSPI in 2016, Il Dong Pharmaceutical manufactures products including the Aronamin vitamin line.

Yuyu Pharma, Inc.100

Founded in 1941 and listed on the KOSPI in 1975, Yuyu Pharma is a pharmaceutical company with a co-promotion agreement with Dong-A ST for Tanamin.

ILDONG HOLDINGS CO.,LTD100

Founded in 1941 and listed on the KOSPI in 1975, Ildong Holdings is the holding company of the Ildong Pharmaceutical Group, overseeing pharmaceutical, aesthetic medical device, and drug development affiliates.

Medy-Tox Inc.99

Founded 2000, KOSDAQ-listed 2009, Medy-Tox develops and exports botulinum toxin biopharmaceuticals including Meditoxin and Innotox.

GC Biopharma Corp.97

KOSPI-listed comprehensive pharmaceutical company specializing in blood products and vaccines, with FDA-approved immunoglobulin ALYGLO.

BIO-FD&C CO.,LTD.85

Founded 2005, KOSDAQ-listed 2022, BIO-FD&C develops plant-cell platform-based cosmeceutical materials and biopharma pipelines.

DAEWON PHARMACEUTICAL CO.,LTD85

KOSPI-listed pharmaceutical company behind Coldwon cold medicine and Jangdaewon probiotics, developing a P-CAB drug pipeline.

SAMSUNG BIOLOGICS CO.,LTD.85

Founded 2011, listed 2016 — Samsung Biologics is a biopharma CDMO with 785,000L capacity across five Songdo plants.

GENOLUTION INC.85

Founded in 2006 and listed on KOSDAQ in 2020, Genolution is a molecular diagnostics and RNAi company producing nucleic acid extraction reagents and devices.

HANDOK Inc.85

KOSPI-listed comprehensive pharma company behind Amaryl diabetes drug and the USD 86.25M HL5101 anticancer out-license deal.

HL GENOMICS Co., Ltd.85
Kolmar BioTech, Inc.85

Founded and listed on KOSDAQ in 2015, Kolmar BioTech is a nonclinical CRO providing efficacy testing for anticancer and metabolic disease drug candidates.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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