SJSTORY Blog

History

Feb. 2002 Celltrion is founded

Jun. 2005 Supply Agreement with a US pharmaceutical company

Jul. 2005 Mechanical completion of Plant 1 (capacity: 50,000L)

Dec. 2007 Plant 1 receives cGMP facility approval by the US FDA

Aug. 2009 IND approval of Herzuma for breast cancer treatment

Oct. 2009 Completion of global sales network

Mar. 2010 IND approval of Remsima for rheumatoid arthritis, ankylosing spondylitis treatment

May. 2010 Strategic direct investment by Temasek

Dec. 2010 Mechanical completion of Plant 2 (capacity: 90,000L)

Dec. 2011 IND approval of biosimilar candidate CT-P10 for rheumatoid arthritis and Non Hodgkin’s lymphoma

Jul. 2012 Remsima approved by Korea Ministry of Food and Drug Safety (MFDS, formerly, KFDA)

Apr. 2013 IND approval of CT-P27 (for universal influenza treatment)

Aug. 2013 Remsima approved by the EMA

Nov. 2013 Completion of global clinical trial phase 1 for CT-P27

Jan. 2014 Herzuma approved by the MFDS, Remsima approved by Health Canada

Jul. 2014 Remsima approved by MHLW (Japan), MoH (Turkey)

Aug. 2014 Completion of global clinic trial phase 2a for CT-P27

Feb. 2015 Remsima launched in Europe (12 countries including Germany, France, England, Italy, Spain)

Apr. 2015 Remsima? approved by ANVISA (Brazil), INHRR (Venezuela)

Oct. 2015 TruximaTM (CT-P10) filed for EMA approval

Dec. 2015 TruximaTM (CT-P10) filed for MFDS approval

Apr. 2016 Remsima? approved by the US FDA

Since Celltrion's foundation in 2002, Celltrion has concentrated Celltrion's investments in human resources, facilities and technologies with the singular goal of becoming a global biopharmaceutical company that develops, manufactures and markets affordable advanced therapeutics based on recombinant DNA and molecular biology.

As of 2016, Celltrion has obtained marketing authorizations for Remsima and Herzuma in Korea, Celltrion's two biosimilar monoclonal antibodies (mAbs)


Remsima (or Inflectra), the world’s first biosimilar mAb, has already been approved not only in Korea but also in many countries around the world, including those in Europe and the US.

Herzuma, the world’s first anti neoplastic biosimilar mAb, has thus far been approved in Korea. Application for its approval is planned to be submitted in other countries.

Truxima, Celltrion's Rituxan biosimilar, is awaiting approval by the European Medicines Agency while Herzuma, its Herceptin biosimilar, is in the final stages of phase-III clinical trials and preparing for EMA approval procedures.

Most notably, in August 2014, Celltrion completed phase 2a clinical trial for CT-P27, universal influenza antibody drug, a novel therapeutic antibody under development for treatment against various types of influenza viruses. CT-P27, a cocktail injectable made up of two different monoclonal antibodies developed by Celltrion, has been drawing keen interests from the US and Chinese governments for targeting neutralization of a broad spectrum of influenza viruses including seasonal strains and potential pandemic strains. Through its mode of action which is distinct from existing influenza treatments, CT-P27 aims to neutralize even those influenza viruses that have become resistant to currently existing neuraminidase inhibitors.

Celltrion projects that its non-clinical and clinical studies have the potential to demonstrate CT-P27 as possible treatment of various types of influenza virus infection.

Celltrion's bid to become a world-class biopharmaceutical company continues today with Celltrion's eyes set firmly on serving the needs of patients through development of affordable biosimilar mAbs and innovative next-generation drugs.

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