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Biotech

Celltrion looks beyond biosimilars to develop its own mRNA drugs

The Korean firm also aims to secure various drug development platforms such as ADC to grow its business

By Nov 16, 2021 (Gmt+09:00)

Celltrion’s COVID-19 treatment Regkirona
Celltrion’s COVID-19 treatment Regkirona

South Korea’s Celltrion Inc. has long been a biosimilar player, producing replicas of original drugs, a growing market in the pandemic era.

Earlier this week, Celltrion went out of its way to become the world’s first biosimilar maker to win approval from the European Commission for the sale in Europe of a monoclonal antibody COVID-19 treatment.

The approval by the European Medicines Agency (EMA) has also made Celltrion Korea’s first biosimilar firm to enter the European market with its own drug development technology.

With the authorization of its product, Regkirona, the company is now looking to develop its own messenger ribonucleic acid (mRNA) vaccines and secure drug platform technology to go beyond its mainstay biosimilar products.

“The authorization proves our technological prowess to develop our own new drugs, not just biosimilars. We expect the breakthrough to pave the way for us to further expand into the global biopharmaceutical market,” said Kee Woo-sung, Celltrion’s chief executive and vice chairman.

In February, Rekirona won the Korean drug safety agency’s approval, becoming the first locally made treatment for COVID-19, and is seeking approval from other countries, including the US.

Company officials said the company is now setting its sights on new drug development with its own technology as well as consolidating its position as a global biosimilar player.

Celltrion researchers
Celltrion researchers

WORKING ON mRNA VACCINE

In August, Celltrion said it tied up with TriLink BioTechnologies Inc., a US life sciences company, to develop a next-generation mRNA vaccine platform that can be applied to coronavirus variants.

The move came as the Korean government plans to have local drug makers and biotech companies develop their own mRNA vaccines by next year.

The mRNA vaccine, employed by Pfizer Inc. and Moderna Inc., is a type that uses a copy of a natural chemical called messenger RNA to produce an immune response.

Messenger RNA has been used to treat hepatosis and rare diseases, but given its relatively short development time, the RNA molecule is now used not just for vaccines but for the treatment of cancer and other illnesses.

Biopharmaceutical companies have been active in forging partnerships with and pursuing acquisitions of smaller competitors specialized in mRNA vaccine development.

Some other Korean companies working on mRNA vaccines include Samsung Biologics Co., Gene One Life Science Inc. and Quratis Co.

“We are considering applying the mRNA technology to develop not just COVID-19 vaccines but also anticancer medicines and vaccines for other diseases such as shingles,” said a Celltrion official.

Celltrion
Celltrion

ADC-BASED DRUGS

Celltrion is also striving to secure new drug development platforms such as antibody-drug conjugate (ADC), a next-generation technology designed to specifically target cancer cells.

The company said in June it joined hands with Mirae Asset Group to invest a combined $47 million in Iksuda Therapeutics, a UK-based ADC developer.

Celltrion expects the investment to expand its cancer drug pipeline beyond blood cancer treatment Truxima and breast cancer medication Herzuma. Iksuda has four ADC-based biopharmaceutical drugs in preclinical development, including for B-cell lymphomas.

The Korean biosimilar maker entered the ADC space in 2019 when it inked a deal with iProgen Biotech, an Indian biotech startup, to develop ADCs.

Celltrion said that ADC-based treatments qualify for fast-track drug development because most of them are designated for rare diseases or otherwise innovative. 

Celltrion's representative biosimilar Remsima
Celltrion's representative biosimilar Remsima

BIOSIMILARS, A CASH COW 

The company, which controls more than half the biosimilar market of Janssen's Remicade in Europe with its monoclonal antibody biosimilar Remsima, said it will continue to expand its biosimilar business to secure funds needed to start new promising businesses.

Celltrion has so far launched four biosimilar products globally and has five drugs in the pipeline, with an aim to launch at least one every year until 2025.

It is seeking approval from the authorities in Korea, the US and Europe for its anticancer biosimilar candidate Avastin (Bevacizumab). Four other pipeline products are currently in the final phase 3 clinical trials.

Bevacizumab, sold under the brand name Avastin, is a medication used to treat a number of types of cancers, including colorectal, lung and kidney cancer.

Celltrion, which unveiled the world’s first subcutaneous (SC)-injection type of Remsima, a biosimilar version of Janssen’s Remicade that is also a brand name of infliximab, said last year it is working to develop a pill version of infliximab.

Write to Jae-young Han and Ju-Hyun Lee at jyhan@hankyung.com

In-Soo Nam edited this article.

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