20th Anniversary of Celltrion: "We Will Grow More This Year"

Expansion of Biosimilar Product Line
Strengthening Development of COVID Variant Solutions

[Asia Economy Reporter Lee Gwan-joo] Celebrating its 20th anniversary this year, Celltrion is focusing on expanding its follow-up biosimilar portfolio and strengthening the development of solutions for COVID-19 variants. Having achieved record-breaking business results last year with consolidated sales of 1.8908 trillion KRW and operating profit of 753.8 billion KRW, the company plans to continue its growth momentum this year.

According to Celltrion on the 2nd, the company's major antibody biosimilar product lines have recently shown remarkable growth in overseas markets. Expansion of the market for Celltrion’s flagship product, the autoimmune disease treatment ‘Remsima SC,’ is also anticipated. As of the third quarter of last year, Remsima held a stable market share of 54%, Truxima 34%, and Herzuma 13% in major European markets, and in the U.S. market as of the fourth quarter of last year, Remsima (sold as Inflectra in the U.S.) had a 22.6% share, while Truxima held 25.4%.

Celltrion is also strengthening its follow-up antibody biosimilar portfolio. The company is currently developing six additional antibody biosimilars. Of these, at least five products are planned to expand their launch regions or be newly launched by next year to foster new growth engines. Last year, Celltrion obtained sales approval for the high-concentration Humira biosimilar Yuflyma (CT-P17) in Korea, Europe, and Canada for major indications held by Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS). The colorectal cancer treatment CT-P16 (Avastin biosimilar) completed its approval application in Europe last October, following Korea and the U.S. In addition, global Phase 3 clinical trials are underway for CT-P39 (Xolair biosimilar), CT-P41 (Prolia biosimilar), CT-P42 (Eylea biosimilar), and CT-P43 (Stelara biosimilar), and Phase 1 clinical trials for CT-P47 (Actemra biosimilar), a rheumatoid arthritis treatment, began in the fourth quarter of last year.

Remsima (above) and Diatrust Antigen Rapid Diagnostic Kit.

Preparations are also underway to respond to COVID-19 variants and prepare for future pandemics. Celltrion confirmed safety in Phase 1 clinical trials of its inhalable antibody treatment for COVID-19 and the COVID-19 therapeutic candidate ‘CT-P63,’ and has entered global Phase 3 clinical trials for the inhalable cocktail COVID-19 antibody treatment. According to tests conducted by the U.S. National Institutes of Health (NIH), CT-P63 demonstrated strong neutralizing ability against Omicron and the so-called ‘stealth Omicron,’ and is expected to effectively counter COVID-19 variant viruses. Additionally, Celltrion has established a messenger RNA (mRNA) platform and is collaborating with its U.S. partner to develop an Omicron-specific vaccine.

‘DiaTrust COVID-19 Professional Antigen Rapid Test Kit’ and ‘DiaTrust COVID-19 Antigen Home Test,’ co-developed by Celltrion and an in vitro diagnostics specialist company, have shown strong detection capabilities against variants and are targeting the market with differentiated competitiveness. Both received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) in April and October of last year, respectively. Celltrion recently received purchase orders totaling approximately 460 billion KRW for DiaTrust products and is supplying them, with plans to provide to about 10 companies and government agencies including the U.S. Department of Defense Procurement Office and Amazon.

A Celltrion official stated, "After achieving record-high sales and operating profit last year, we are continuing efforts to develop pipelines and expand markets to strengthen our biopharmaceutical business this year. We will proceed without delay in developing the inhalable cocktail antibody treatment for COVID-19 currently under development and will do our best in supplying diagnostic kits and establishing the mRNA vaccine platform."

This content was produced with the assistance of AI translation services.