Pharma & CDMOKOSPI 06827035 approvals62 trials

Celltrion, Inc.

Official website

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

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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

35 Korean MFDS drug approvals · 2012–2026

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
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
MFDS drugAvtozma Inj. 80mg2025-02-12
Drug · Prescription · Approval202500308
MFDS drugAvtozma S.C Inj.2025-02-12
Drug · Prescription · Approval202500309
MFDS drugAvtozma Inj.2024-12-20
Drug · Prescription · Approval202403038
MFDS drugStoboclo Pre-filled Syringe2024-11-21
Drug · Prescription · Approval202402753
MFDS drugOsenvelt Injection2024-11-21
Drug · Prescription · Approval202402754

Show 23 more

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
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
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
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

62 MFDS clinical trial authorisations · 2013–2026 (Phase 1 38 · Phase 3 16 · Phase 1/3 2 · Phase 2 1 · Phase 2/3 1)

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
Phase 1CT-L022025-05-20
2 trial sites

Show 50 more

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

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

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Company facts

Founded: 1991
Listed: 2018
Market: KOSPI 068270
CEO: 기우성
Location: Incheon
Category: Pharma & CDMO

Performance

Consolidated · DART

Year	Revenue	Op. profit
2025	₩4162.5B	₩1168.5B
2024	₩3557.3B	₩492.0B
2023	₩2176.4B	₩651.5B

AI visibility

2026-08-13

65/ 100

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Keywords

biosimilarantibodybiopharmaceuticaladckospicelltrioninfliximab

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Sources and updates

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

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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