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Pharma & CDMOKOSPI 06827047 approvals63 trials

Celltrion, Inc.

Official website

Celltrion markets 11 biosimilars including Remsima, Truxima, and Herzuma, plus the new drug Zymfentra (CT-P13 SC).

As of 2026-10-10, Celltrion, Inc. has 35 Korean MFDS drug approvals, 12 US FDA clearances/approvals, 190 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

Price

Change

Market cap

Business overview

Source: DART corporate disclosure

Founded in 1991, Celltrion listed on the KOSPI in 2018 as an antibody biosimilar and biopharmaceutical company. It has obtained global marketing approvals for 11 biosimilars including Remsima (CT-P13), Truxima, and Herzuma, and in 2023 received US FDA approval for Zymfentra (CT-P13 SC), the world's first subcutaneous infliximab formulation. In 2025 it recorded sales of KRW 4.1625 trillion and operating profit of KRW 1.1685 trillion, operates a 250,000-liter domestic manufacturing facility plus a 66,000-liter drug-substance facility in Branchburg, US, and completed an integrated development-manufacturing-sales entity through its December 2023 merger with Celltrion Healthcare.

Products & technology

  • Remsima (CT-P13)Antibody biosimilar for autoimmune disease treatment
  • TruximaAntibody biosimilar
  • HerzumaAntibody biosimilar
  • Zymfentra (CT-P13 SC)World's first subcutaneous infliximab formulation

Regulatory approvals

data.go.kr · openFDA

35 Korean MFDS drug approvals · 2012–2026 / 12 US FDA drug approvals · 2016–2026

  • MFDS drugCelltrion Yuflyma Prefilled syringe inj. 20mg/0.2mL2026-02-24
    Drug · Prescription · Approval202600554
  • MFDS drugCelltrion Yuflyma Prefilled syringe inj. 40mg/0.4mL2026-02-24
    Drug · Prescription · Approval202600555
  • FDA drugAVTOZMA2026-01-21
    FDA drug approval · BLABLA761498
  • MFDS drugOmlyclo Pen Inj.(Omalizumab)2025-12-19
    Drug · Prescription · Approval202503335
  • MFDS drugEdardipine Tablets 80/10mg2025-10-29
    Drug · Prescription · Approval202502797
  • MFDS drugEdardipine Tablets 80/5mg2025-10-29
    Drug · Prescription · Approval202502798
  • MFDS drugEdardipine Tablets 40/10mg2025-10-29
    Drug · Prescription · Approval202502799
  • MFDS drugEdardipine Tablets 40/5mg2025-10-29
    Drug · Prescription · Approval202502800
  • FDA drugEYDENZELT2025-10-02
    FDA drug approval · BLABLA761377
  • FDA drugOMLYCLO2025-03-07
    FDA drug approval · BLABLA761399
  • FDA drugOSENVELT2025-02-28
    FDA drug approval · BLABLA761404
  • MFDS drugAvtozma Inj. 80mg2025-02-12
    Drug · Prescription · Approval202500308
Show 35 more
  • MFDS drugAvtozma S.C Inj.2025-02-12
    Drug · Prescription · Approval202500309
  • FDA drugAVTOZMA2025-01-24
    FDA drug approval · BLABLA761420
  • MFDS drugAvtozma Inj.2024-12-20
    Drug · Prescription · Approval202403038
  • FDA drugSTEQEYMA2024-12-17
    FDA drug approval · BLABLA761338
  • MFDS drugStoboclo Pre-filled Syringe2024-11-21
    Drug · Prescription · Approval202402753
  • MFDS drugOsenvelt Injection2024-11-21
    Drug · Prescription · Approval202402754
  • MFDS drugSteqeyma IV Injection2024-09-27
    Drug · Prescription · Approval202402336
  • MFDS drugOmlyclo Pre-filled Syringe Inj.(Omalizumab)2024-06-24
    Drug · Prescription · Approval202401521
  • MFDS drugSteqeyma Pre-filled syringe2024-06-12
    Drug · Prescription · Approval202401434
  • MFDS drugEydenzelt Injection (Aflibercept)2024-05-29
    Drug · Prescription · Approval202401326
  • MFDS drugEydenzelt Pre-filled Syringe (Aflibercept)2024-05-29
    Drug · Prescription · Approval202401327
  • FDA drugZYMFENTRA2023-10-20
    FDA drug approval · BLABLA761358
  • FDA drugYUFLYMA2023-05-23
    FDA drug approval · BLABLA761219
  • MFDS drugCelltrion Yuflyma Pen inj. 40mg/0.4mL2022-11-10
    Drug · Prescription · Approval202204054
  • MFDS drugCelltrion Remsima Pen Inj. 120mg2022-10-28
    Drug · Prescription · Approval202203940
  • MFDS drugVegzelma2022-09-28
    Drug · Prescription · Approval202203696
  • FDA drugVEGZELMA2022-09-27
    FDA drug approval · BLABLA761268
  • MFDS drugYuflyma Prefilled Sysringe Inj. 80mg/0.8mL2022-06-15
    Drug · Prescription · Approval202202504
  • MFDS drugYuflyma Pen inj. 80mg/0.8mL2022-06-15
    Drug · Prescription · Approval202202505
  • MFDS drugCelltrion Remsima Pre-filled Syringe Inj. 120mg2022-03-07
    Drug · Prescription · Approval202200974
  • MFDS drugDonerion Patch 87.5mg(donepezil)2021-11-05
    Drug · Prescription · Approval202107340
  • MFDS drugDonerion Patch 175mg(donepezil)2021-11-05
    Drug · Prescription · Approval202107341
  • MFDS drugYuflyma Prefilled Sysringe Inj. 40mg/0.4mL2021-10-15
    Drug · Prescription · Approval202106947
  • MFDS drugYuflyma Pen inj. 40mg/0.4mL2021-10-15
    Drug · Prescription · Approval202106948
  • MFDS drugRegkirona Inj. 960mg2021-02-05
    Drug · Prescription · Approval202101124
  • MFDS drugRemsima Pen Inj. 120mg2020-10-12
    Drug · Prescription · Approval202006923
  • MFDS drugRemsima Pre-filled Syringe Inj. 120mg2020-02-25
    Drug · Prescription · Approval202001325
  • FDA drugHERZUMA2018-12-14
    FDA drug approval · BLABLA761091
  • FDA drugTRUXIMA2018-11-28
    FDA drug approval · BLABLA761088
  • FDA drugINFLECTRA2016-04-05
    FDA drug approval · BLABLA125544
  • MFDS drugTruxima Inj.2015-07-16
    Drug · Prescription · Approval201504895
  • MFDS drugMycovox Tab. 600mg(for export)Revoked2014-07-31
    Drug · Prescription · Approval201403539
  • MFDS drugHerzuma inj.150mg2014-01-15
    Drug · Prescription · Approval201400158
  • MFDS drugHerzuma inj. 440mg2014-01-15
    Drug · Prescription · Approval201400159
  • MFDS drugRemsima Inj. 100mg2012-07-20
    Drug · Prescription · Approval201206204

Clinical trials

data.go.kr

63 MFDS clinical trial authorisations · 2013–2026 (Phase 1 39 · Phase 3 16 · Phase 1/3 2 · Phase 2 1 · Phase 2/3 1)

  • Phase 1CT-P132026-08-31

    1 trial site

  • Phase 2CT-P392026-08-24

    2 trial sites

  • Phase 1CT-P682026-07-14

    5 trial sites

  • Phase 1CT-P452026-06-11

    5 trial sites

  • Phase 1L03TD12026-03-18

    2 trial sites

  • Phase 1CT-P722026-02-04

    4 trial sites

  • Phase 1CT-P522025-11-12

    4 trial sites

  • Phase 1CT-P732025-11-10

    3 trial sites

  • Phase 1CT-P522025-08-07

    5 trial sites

  • Phase 1CT-P712025-07-04

    4 trial sites

  • Phase 1/3CT-P442025-07-02

    15 trial sites

  • Phase 1L03TD12025-06-10

    2 trial sites

Show 51 more
  • Phase 1CT-L022025-05-20

    2 trial sites

  • Phase 1CT-P702025-05-02

    4 trial sites

  • Phase 3CT-P512025-04-28

    8 trial sites

  • Phase 3CT-L022025-04-03

    23 trial sites

  • Phase 1CT-P432025-03-12

    3 trial sites

  • Phase 1CT-P6 SC2025-02-27

    4 trial sites

  • Phase 3CT-P132025-02-21

    2 trial sites

  • Phase 3CT-P132025-02-21

    2 trial sites

  • Phase 1CT-L062024-06-10

    2 trial sites

  • Phase 1CT-L052024-03-14

    2 trial sites

  • Phase 3L03TD12024-02-19

    35 trial sites

  • Phase 1CT-L022024-01-09

    2 trial sites

  • Phase 1CT-L102023-12-01

    2 trial sites

  • Phase 1CT-L042023-04-24

    2 trial sites

  • Phase 1CT-P472022-09-28

    4 trial sites

  • Phase 1CT-L042022-09-23

    2 trial sites

  • Phase 1CT-L042022-08-10

    2 trial sites

  • Phase 1CT-L012022-05-13

    2 trial sites

  • Phase 1CT-L012022-05-13

    2 trial sites

  • Phase 1CT-L012022-03-29

    2 trial sites

  • Phase 1CT-L072022-01-14

    2 trial sites

  • Phase 1CT-P472021-12-06

    7 trial sites

  • Phase 3CTL0501, CTL05022021-11-17

    35 trial sites

  • Phase 1CT-P412021-08-03

    2 trial sites

  • Phase 1CT-L092021-07-20

    2 trial sites

  • Phase 1CT-L082021-07-19

    2 trial sites

  • Phase 3CT-P422021-04-30

    11 trial sites

  • Phase 3CT-P412021-04-29

    6 trial sites

  • Phase 3CT-P432021-01-07

    7 trial sites

  • Phase 1CT-P132020-12-09

    1 trial site

  • Phase 3CT-P592020-10-08

    11 trial sites

  • Phase 3CT-P392020-10-07

    16 trial sites

  • Phase 2/3CT-P592020-09-17

    19 trial sites

  • Phase 1CT-P592020-08-25

    4 trial sites

  • Phase 1CT-P592020-07-17

    1 trial site

  • Phase 1bCT-G20정2020-02-26

    4 trial sites

  • Phase 1CT-P172019-03-06

    10 trial sites

  • Phase 3CT-P172019-03-06

    8 trial sites

  • Phase 3CT-P162018-11-07

    9 trial sites

  • Phase 1CT-G11정, CT-G20정2018-09-18

    1 trial site

  • Phase 2aCT-P272017-11-13

    3 trial sites

  • Phase 1CT-P162017-07-17

    3 trial sites

  • Bioequivalence마이코복스정600밀리그램(리네졸리드)2017-05-30

    2 trial sites

  • Phase 2bCT-P272016-10-11

    40 trial sites

  • Phase 1/3CT-P132016-09-06

    15 trial sites

  • Phase 1CT-P132016-09-06

    15 trial sites

  • Phase 1CT-P132016-05-04

    1 trial site

  • Phase 3CT-P102015-09-14

    13 trial sites

  • Phase 3CT-P102014-08-07

    14 trial sites

  • Phase 3CT-P102014-06-27

    12 trial sites

  • Phase 1CT-P102013-02-28

    3 trial sites

Global clinical trials

ClinicalTrials.gov · sponsor-matched
Show 67 more trials

R&D and key agreements

Source: DART corporate disclosure

차세대 모달리티(ADC, 다중항체 등) · 연구개발 단계 · Developing next-generation modalities such as ADCs and multispecific antibodies through in-house R&D and strategic partnerships

Key disclosures

KRX KIND via OpenDART
Show 78 more events

Publications

PubMed · affiliation-matched
Show 180 more publications

Patents

KIPRIS · applicant-matched
Show 295 more patents

AI reads

MAA server logs · IP-verified
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Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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