Celltrion, Inc. (Korean: 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.[2] Celltrion's founder, Seo Jung-jin, is the richest person in South Korea.[3]
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.[4]
In 2008, Nexol and Celltrion established a global distribution agreement.[5]
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).[6][7]
Productsedit
The company's products are manufactured at mammalian cell culture facilities designed and built to comply with the United States FDA’s cGMP,[8] and the European Medicines Agency’s GMP standards.[9]
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[11]biosimilarmonoclonal antibody (mAb) approved by the EMA.[10]
^MacDonald, Gareth (15 October 2014). "Biosimilars going global but EMA still setting the regulatory pace". BioPharma-reporter.com.
^Indukern Group Press Release 2015. Indukern Group Press Release
^"S.Korea's Celltrion gets FDA OK to make Bristol-Myers' Orencia". Reuters. 18 December 2007. from the original on 24 September 2015. Retrieved 30 June 2017.
^"Europe approves first biosimilar antibody drug". Reuters. 10 September 2013. from the original on 24 September 2015. Retrieved 30 June 2017.
^ ab"Remsima Assessment report" (PDF). Committee for Medicinal Products for Human Use (CHMP). June 27, 2013.
^Stanton, Dan (17 July 2013). "EMA Approves First MAb Biosimilars". BioPharma-reporter.com.
^"Biosimilar trastuzumab approved in Korea". Generics and Biosimilars Initiative. 17 January 2014.
^"Herzuma approved by the Ministry of Food and Drug Safety of the Republic of Korea". Ministry of Food and Drug Safety of the Republic of Korea. 15 January 2014.
^"Celltrion gets nod for 2nd biosimilar in local market". JoongAng Ilbo. 16 January 2014.
^"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", ACR/ARHP Annual Meeting 2013, ACR/ARHP Annual Meeting, 2013, archived from the original on 2015-04-15, retrieved 2013-10-28
^Brinks, Vera (December 15, 2005), Immunogenicity of biosimilar monoclonal antibodies, Generics and Biosimilars Initiative, retrieved September 20, 2013
^"Celltrion's Rituximab Biosimilar Truxima Approved in Europe - GEN". GEN. 22 February 2017.
External linksedit
Official website
Business data for Celltrion:
Bloomberg
Google
Reuters
Yahoo!
December 15, 2023
celltrion, korean, 주식회사, 셀트리온, biopharmaceutical, company, headquartered, incheon, south, korea, healthcare, conducts, worldwide, marketing, sales, distribution, biological, medicines, developed, founder, jung, richest, person, south, korea, typepublictraded, . Celltrion Inc Korean 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 2 Celltrion s founder Seo Jung jin is the richest person in South Korea 3 Celltrion Inc TypePublicTraded asKRX 068270IndustryBiopharmaceuticalFounded2002 21 years ago 2002 FounderSeo Jung jinHeadquartersYeonsu gu Incheon South KoreaArea servedWorldwideKey peopleSeo Jung jin Chairman Kee Woo sung CEOProductsRemsima Truxima Herzuma Biosimilar DrugRevenue 828 917 million 2017 1 Operating income 517 385 million 2017 1 Net income 403 181 million 2017 1 Total assets 3 255 319 million 2017 1 Total equity 2 522 076 million 2017 1 OwnerCelltrion Holdings Co Ltd 23 03 Ion Investments B V 9 54 National Pension Service 6 07 SubsidiariesCelltrion EntertainmentWebsitewww wbr celltrion wbr com wbr en Contents 1 History 2 Products 2 1 Inline product 3 See also 4 References 5 External linksHistory editIn 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 4 In 2008 Nexol and Celltrion established a global distribution agreement 5 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 6 7 Products editThe company s products are manufactured at mammalian cell culture facilities designed and built to comply with the United States FDA s cGMP 8 and the European Medicines Agency s GMP standards 9 Inline product edit Remsima infliximab is a biosimilar monoclonal antibody against tumor necrosis factor alpha TNF a 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 10 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 11 biosimilar monoclonal antibody mAb approved by the EMA 10 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 12 13 14 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 15 16 It was approved by the EMA in February 2017 17 See also editList of pharmaceutical companiesReferences edit a b c d e Financial Information Celltrion Co Ltd Celltrion Company Overview of Celltrion Healthcare Co Ltd Bloomberg Kang John Korea s New No 1 Celltrion Cofounder Becomes First Self Made Billionaire To Claim Top Spot Forbes Retrieved 2021 08 06 History ABOUT US www celltrionhealthcare com Retrieved 2020 01 22 VaxGen Biopharmaceutical Manufacturing Plant Pharmaceutical Technology Retrieved 2020 01 22 MacDonald Gareth 15 October 2014 Biosimilars going global but EMA still setting the regulatory pace BioPharma reporter com Indukern Group Press Release 2015 Indukern Group Press Release S Korea s Celltrion gets FDA OK to make Bristol Myers Orencia Reuters 18 December 2007 Archived from the original on 24 September 2015 Retrieved 30 June 2017 Europe approves first biosimilar antibody drug Reuters 10 September 2013 Archived from the original on 24 September 2015 Retrieved 30 June 2017 a b Remsima Assessment report PDF Committee for Medicinal Products for Human Use CHMP June 27 2013 Stanton Dan 17 July 2013 EMA Approves First MAb Biosimilars BioPharma reporter com Biosimilar trastuzumab approved in Korea Generics and Biosimilars Initiative 17 January 2014 Herzuma approved by the Ministry of Food and Drug Safety of the Republic of Korea Ministry of Food and Drug Safety of the Republic of Korea 15 January 2014 Celltrion gets nod for 2nd biosimilar in local market JoongAng Ilbo 16 January 2014 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 ACR ARHP Annual Meeting 2013 ACR ARHP Annual Meeting 2013 archived from the original on 2015 04 15 retrieved 2013 10 28 Brinks Vera December 15 2005 Immunogenicity of biosimilar monoclonal antibodies Generics and Biosimilars Initiative retrieved September 20 2013 Celltrion s Rituximab Biosimilar Truxima Approved in Europe GEN GEN 22 February 2017 External links editOfficial website Business data for Celltrion BloombergGoogleReutersYahoo Retrieved from https en wikipedia org w index php title Celltrion amp oldid 1185468685, wikipedia, wiki, book, books, library,
