Celltrion launches subsidiary 'BioSolutions' for CDMO

On December 17, Celltrion acquired 2 million shares of Celltrion BioSolutions for KRW 10 billion

To begin construction on the first plant with a 100,000-liter capacity next year…expected to generate sales by 2028

Plans to establish next-generation modality production facilities for multi-antibody therapies·antibody-drug conjugates (ADC) ·cell and gene therapies

Seo Jung-jin, chairman of Celltrion Group (source: virtual press conference photos).

Celltrion group launches Celltrion BioSolutions, a company specializing in drug contract development and manufacturing organization (CDMO).

 

The company aims to build a manufacturing plant and research center next year and generate sales from 2028.

 

According to the Financial Supervisory Service on December 17, Celltrion acquired 2 million shares of Celltrion BioSolutions for KRW 10 billion.

 

After the acquisition of shares, Celltrion will secure 100% of the shares of Celltrion BioSolutions.

 

"We have decided to commence the CDMO business in September, considering increased demands for biological drugs globally and consistent requests for CDMO services from Korea and foreign markets," Celltrion said.

 

"We have quickly established a corporate body and initiated establishing infrastructure, such as a manufacturing facility, and running the business." The new corporate body plans to provide services for drug development spanning all stages, including new drug candidate identification, cell culture, manufacturing development, clinical trial planning, regulatory document preparation, and commercial production.

 

Lee Hyuk-jae, senior vice president of Celltrion, has been appointed the CEO of Celltrion BioSolutions.

 

Lee has experience in product approval, clinical trials, and production.

 

Based on Celltrion's experience running a contract manufacturing organization (CMO) service, Celltrion BioSolutions aims to challenge the competition.

 

Previously, Celltrion had a history of running a CMO service in 2002.

 

However, as the company reestablished its core value of the company as a biosimilar developer in the late 2000s, the company discontinued the CMO service.

 

"We plan to secure production by reducing the cost of expansion based on Celltrion's experience running a drug CMO service for global pharmaceutical companies spanning all phases of the pharmaceutical business, such as various business project records, proprietary production, and approvals, and also by securing price-cost competitiveness through high production·efficiency," Celltrion said.

 

The company is reviewing site candidates for the new corporation's production facilities.

 

Celltrion plans to design production facilities in South Korea with a maximum capacity of 200,000 liters, beginning construction on the first plant with a 100,000-liter capacity next year.

 

The company will continuously assess the optimal location to ensure sustainable production and supply while expanding production capacity.

 

The investment in the new company will be funded through internal capital and external funding.

 

Initially, Celltrion plans to allocate up to KRW 1.5 trillion of its capital to establish facilities and launch contract development (CDO) services.

 

Following this, the company plans to secure an additional KRW 1.5 trillion in external funding to expand specialized overseas research centers and to develop next-generation modality production facilities.

 

The company plans to place multiple large·small-scale bioreactor placements to enable mass production in the new facility.

 

Celltrion also plans to establish production facilities for next-generation modalities, including antibody-drug conjugates (ADC), multi-antibody therapies, cell and gene therapies, and peptide-based new drugs.

 

To expand into new modality areas, strengthen production capabilities, and enhance technological competitiveness, the company will establish specialized research centers domestically and internationally, including in the United States, Europe, and India.

 

The company aims to offer an integrated CDMO solution through the convergence of technologies.

 

The company expects commercial production to begin in 2028, which is expected to generate significant revenue.

 

"Based on our know-how accumulated over 20 years, Celltrion has commenced a CDMO company that could provide customized service spanning all phases of drug development for clients," Celltrion said.

 

"Celltrion BioSolutions will strive to provide truly end-to-end service based on cost-price competitiveness and customer-oriented policy."