Celltrion BioSolutions launched to venture into CDMO

Celltrion Inc. on Tuesday launched its contract development and manufacturing organization unit Celltrion BioSolutions Co. in its foray into the CDMO market. As a newcomer to the field, it will produce a wider range of products than its competitors, said its founder and Chairman Seo Jung-jin.

The South Korean biosimilar maker will break ground on its first CDMO plant in Korea in the first half of next year, on which it will spend about 800 billion won ($556 million), according to Seo. It has not disclosed where the factory will be built.

The facility will have an annual production capacity of 100,000 liters, which will later be doubled to 200,000 liters. In line with demand, it may build a new CDMO plant abroad.

“We have received requests continuously from small domestic and foreign bio firms to develop and produce their drug candidate substances,” Seo said in a press conference.

“We have also received many requests from the world’s large cancer hospitals to provide CGT-specific services, so we decided to start our CDMO business." CGT refers to cell and gene therapies.

“Our plant will be optimized to produce a wide range of products in small quantities and via an automated process,” said Seo. It plans to offer CDMO services for research as well.

Seo expects Celltrion BioSolutions to begin generating revenue in 2028. The unit is aiming for 3 trillion won in sales by 2031.

DIFFERENTIATION STRATEGY

To differentiate itself from rivals such as Samsung Biologics Co. and Switzerland-based Lonza, the world’s No. 1 CDMO company, Seo stressed that Celltrion BioSolutions will produce a variety of drug modalities — from monoclonal to trispecific antibody drugs, subcutaneous injection formulation and CGT.

Specifically, it will introduce hyaluronidase, an enzyme used to convert intravenous formulation to subcutaneous injection formulation, for CDMO drugs starting next year.

It will also expand its CDMO portfolio to mRNA vaccines and oral and inhalation drug delivery solutions. MRNA vaccines direct cells to produce copies of a protein that increases an immune response to viruses such as the coronavirus.

“The most important thing is how efficiently we build small facilities that meet current good manufacturing practice (CGMP) standards next to large hospitals,” he explained.

"We will complete CGMP platforms optimized for CGT services within the next two to three years.”

CGMP is enforced by the US Food and Drug Administration. 

Lee Hyuk Jae, senior vice president of Celltrion, will take over as chief executive of Celltrion BioSoultions.

Seo expressed confidence about its venture into the CDMO market, saying its experience in the development, production and sale of biosimilars will give it an edge.

“I think Lonza and Celltrion are the only companies that can provide all types of CDMO services,” he added.

Within three years, he expects both CDO and CRO to generate a combined 100 billion won in sales. Sales from CMO are forecast at 500 billion won in three years.

Meanwhile, Seo said he will unveil new biosimilar candidates at the J.P.Morgan Health Care Conference in the US next month.

Samsung Biologics is Korea's leading CDMO player, trailed by smaller local rivals like Lotte Biologics Co. and stem-cell therapy company Medipost Co.

Write to Jeong Min Nam at peux@hankyung.com
Yeonhee Kim edited this article.