Celltrion

{{Infobox company

| name = Celltrion, Inc.

| logo = Celltrion CI.svg

| logo_caption =

| image =

| image_caption =

| type = Public

| traded_as = {{kse|068270}}

| industry = Biopharmaceutical

| predecessor =

| foundation = {{start date and age|2002}}

| founder = Seo Jung-jin

| defunct =

| location = Yeonsu-gu, Incheon, South Korea

| area_served = Worldwide

| key_people = Seo Jung-jin, Chairman
Kee Woo-sung, CEO

| products = Remsima™, Truxima™, Herzuma™, Biosimilar Drug

| production =

| services =

| revenue = {{Increase}} {{KRW|828,917 million}} (2017){{cite web |url=http://celltrion.com/en/ir/financeInfo.do?tabNo=2&radioNo=1 |title=Financial Information Celltrion Co., Ltd. |work=Celltrion}}

| operating_income = {{Increase}} {{KRW|517,385 million}} (2017){{cite web |url=http://celltrion.com/en/ir/financeInfo.do?tabNo=2&radioNo=1 |title=Financial Information Celltrion Co., Ltd. |work=Celltrion}}

| net_income = {{Increase}} {{KRW|403,181 million}} (2017){{cite web |url=http://celltrion.com/en/ir/financeInfo.do?tabNo=2&radioNo=1 |title=Financial Information Celltrion Co., Ltd. |work=Celltrion}}

| aum =

| assets = {{Increase}} {{KRW|3,255,319 million}} (2017){{cite web |url=http://celltrion.com/en/ir/financeInfo.do?tabNo=2&radioNo=1 |title=Financial Information Celltrion Co., Ltd. |work=Celltrion}}

| equity = {{Increase}} {{KRW|2,522,076 million}} (2017){{cite web |url=http://celltrion.com/en/ir/financeInfo.do?tabNo=2&radioNo=1 |title=Financial Information Celltrion Co., Ltd. |work=Celltrion}}

| owner = Celltrion Holdings Co., Ltd. (23.03%)
Ion Investments B.V. (9.54%)
National Pension Service (6.07%)

| num_employees =

| parent =

| divisions =

| subsid = Celltrion Entertainment

| homepage = {{URL|www.celltrion.com/en}}

| footnotes =

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}}

Celltrion, Inc. ({{Korean |hangul=주식회사 셀트리온}}) is a biopharmaceutical company headquartered in Incheon, South Korea. Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion.{{cite web |url=https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=79743107 |title=Company Overview of Celltrion Healthcare Co., Ltd. |work=Bloomberg}} Celltrion's founder, Seo Jung-jin, is the richest person in South Korea.{{Cite web|last=Kang|first=John|title=Korea's New No. 1: Celltrion Cofounder Becomes First Self-Made Billionaire To Claim Top Spot|url=https://www.forbes.com/sites/johnkang/2021/06/01/koreas-new-no-1-celltrion-cofounder-becomes-first-self-made-billionaire-to-claim-top-spot/|access-date=2021-08-06|website=Forbes|language=en}} Seo Jung-jin, its founder was awarded the 2021 EY World Entrepreneur Of The Year.{{Cite web |title=Jung Jin SEO - EY World Entrepreneur Of The Year™ 2024 Judges |url=https://www.ey.com/en_gl/weoy/judges/jung-jin-seo |access-date=2024-11-08 |website=www.ey.com |language=en}}

History

In 1999, Nexol, Inc. (now Celltrion Healthcare Co., Ltd.) was founded as a global business management consulting firm. In 2002, Celltrion, Inc. was founded as a biopharmaceutical company.{{Cite web|url=https://www.celltrionhealthcare.com/en-us/aboutus/history|title=History {{!}} ABOUT US|website=www.celltrionhealthcare.com|access-date=2020-01-22}}

In 2008, Nexol and Celltrion established a global distribution agreement.{{Cite web|url=https://www.pharmaceutical-technology.com/projects/vaxgen/|title=VaxGen Biopharmaceutical Manufacturing Plant - Pharmaceutical Technology|language=en-GB|access-date=2020-01-22}}

In 2009, distribution channels were established in America, Oceania, Europe (Hospira) and Nexol, Inc. renamed as Celltrion Healthcare Co., Ltd.

In 2010, distribution channels were established in Japan (Nippon Kayaku), Commonwealth of Independent States (CIS), Eastern Europe, and the Middle East (Egis).

In 2013, distribution channels were added in Europe (Mundipharma, Biogaran, and Kern).{{cite web |url=http://www.biopharma-reporter.com/Markets-Regulations/Biosimilars-going-global-but-EMA-still-setting-the-regulatory-pace |title=Biosimilars going global but EMA still setting the regulatory pace |first=Gareth |last=MacDonald |work=BioPharma-reporter.com |date=15 October 2014}}Indukern Group Press Release 2015. [http://www.grupoindukern.com/wp-content/uploads/2015/01/150114_-Indukern-Group-Press-Release1.pdf?lang=en Indukern Group Press Release]

In September 30, 2024, Celltrion completed the establishment of its oversees corporation in Vietnam.https://n.news.naver.com/mnews/article/008/0005095329

22 Oct. 2024. Celltrion secured a 100.4 billion won ($72.8 million) deal for contract development and manufacturing (CDMO) with TEVA Pharmaceuticals International for the migraine treatment Ajovy.{{cite web |url=https://koreajoongangdaily.joins.com/news/2024-10-22/business/industry/Celltrion-signs-728-million-deal-for-migraine-drug-Ajovy/2160919/|title=Celltrion signs $72.8 million deal for migraine drug Ajovy |date=2024|website=Korea JoongAng }}

In November 2024, Celltrion acquired iQone Healthcare Switzerland, a pharmaceutical company for around 30 billion won ($21 million). This move will help its expansion in Europe.{{cite web|url=https://www.thepharmaletter.com/celltrion-acquires-swiss-firm-iqone-healthcare |title=Celltrion acquires Swiss firm iQone Healthcare |work=The Pharma Letter |access-date=15 November 2024}}

Products

The company's products are manufactured at mammalian cell culture facilities designed and built to comply with the United States FDA’s cGMP,{{cite web |url=https://www.reuters.com/article/celltrion-fda-idUSWNAS480020071218 |title=S.Korea's Celltrion gets FDA OK to make Bristol-Myers' Orencia |work=Reuters |date=18 December 2007 |access-date=30 June 2017 |archive-date=24 September 2015 |archive-url=https://web.archive.org/web/20150924125424/http://www.reuters.com/article/2007/12/18/celltrion-fda-idUSWNAS480020071218 |url-status=live }} and the European Medicines Agency’s GMP standards.{{cite web |url=https://www.reuters.com/article/us-celltrion-hospira-europe-idUSBRE9890IX20130910 |title=Europe approves first biosimilar antibody drug |work=Reuters |date=10 September 2013 |access-date=30 June 2017 |archive-date=24 September 2015 |archive-url=https://web.archive.org/web/20150924184520/http://www.reuters.com/article/2013/09/10/us-celltrion-hospira-europe-idUSBRE9890IX20130910 |url-status=live }}

=Inline product=

Remsima (infliximab) is a biosimilar monoclonal antibody against tumor necrosis factor alpha (TNF-α), approved by the European Medicines Agency (EMA) for treatment of:

rheumatoid arthritis,
adult Crohn's disease,
pediatric Crohn's disease,
ulcerative colitis,
pediatric ulcerative colitis,
ankylosing spondylitis,
psoriatic arthritis, and
psoriasis.{{Cite web| url = http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf | title = Remsima Assessment report | date = June 27, 2013 | publisher = Committee for Medicinal Products for Human Use (CHMP) }}

In 2012 Remsima was approved by the Republic of Korea's Ministry of Food and Drug Safety (MFDS), previously known as Korea Food and Drug Administration and in 2013 it became the world's first{{cite web |url=http://www.biopharma-reporter.com/Markets-Regulations/EMA-Approves-First-MAb-Biosimilars |title=EMA Approves First MAb Biosimilars |first=Dan |last=Stanton |work=BioPharma-reporter.com |date=17 July 2013}} biosimilar monoclonal antibody (mAb) approved by the EMA.

Herzuma is a biosimilar trastuzumab approved by the MFDS for treatment of early and advanced (metastatic) HER2+ breast cancer as well as advanced (metastatic) stomach cancer. Herzuma is a HER2+ breast cancer therapy designed to treat aggressive HER positive metastatic and adjuvant breast cancer, as well as HER2 positive adenocarcinoma of the stomach that has spread (metastatic or advanced gastric cancer).{{cite web |url=http://gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea |title=Biosimilar trastuzumab approved in Korea |work=Generics and Biosimilars Initiative |date=17 January 2014}}{{cite web |url=http://www.mfds.go.kr/index.do?mid=675&seq=22584&cmd=v |title=Herzuma approved by the Ministry of Food and Drug Safety of the Republic of Korea |work=Ministry of Food and Drug Safety of the Republic of Korea |date=15 January 2014}}{{cite web |url=http://koreajoongangdaily.joins.com/news/article/Article.aspx?aid=2983589 |title=Celltrion gets nod for 2nd biosimilar in local market

|work=JoongAng Ilbo |date=16 January 2014}}

Truxima (previously known as CT-P10) is the first biosimilar of the reference monoclonal antibody rituximab that targets CD20 molecule primarily found on the surface of B-cells. Its target indications are rheumatoid arthritis, non-Hodgkin lymphoma and chronic lymphocytic leukemia.{{Citation |url=https://ww2.rheumatology.org/apps/MyAnnualMeeting/Abstract/36875 |year=2013 |work=ACR/ARHP Annual Meeting 2013 |title=A Randomized, Controlled, Multicenter, 2‑Arm, Parallel‑Group, Double-Blind Study To Demonstrate The Equivalence Of CT-P10 To Innovator Rituximab With Respect To Pharmacokinetic Profile In Patients With Rheumatoid Arthritis |publisher=ACR/ARHP Annual Meeting |accessdate=2013-10-28 |url-status=dead |archiveurl=https://archive.today/20150415080010/https://ww2.rheumatology.org/apps/MyAnnualMeeting/Abstract/36875 |archivedate=2015-04-15 }}{{Citation | last1 = Brinks | first1 = Vera | title = Immunogenicity of biosimilar monoclonal antibodies | publisher = Generics and Biosimilars Initiative | date = December 15, 2005 | url = http://gabi-journal.net/immunogenicity-of-biosimilar-monoclonal-antibodies.html | accessdate = September 20, 2013 }} It was approved by the EMA in February 2017.{{cite web|url=http://www.genengnews.com/gen-news-highlights/celltrions-rituximab-biosimilar-truxima-approved-in-europe/81253914?q=truxima|title=Celltrion's Rituximab Biosimilar Truxima Approved in Europe - GEN|website=GEN|date=22 February 2017 }}