Celltrion

• Celltrion will add Plants 4 and 5 at its Songdo HQ with a total capacity of 180,000 liters, while also undertaking a 75,000-liter expansion at its U.S. manufacturing site.
• Celltrion’s total DS production capacity will be expanded to 571,000 liters, with the goal of achieving 100% internalization of DS production by 2031 and further cost reductions.
• Through the establishment of sustainable manufacturing infrastructure, Celltrion aims to strengthen cost competitiveness and supply stability, and build a foundation for its CMO business.
• Celltrion is also expanding DP manufacturing facilities in Songdo and Yesan, which is expected to enable approximately 90% internalization of its global DP supply.
• Celltrion plans to proactively respond to the expanding product portfolio and global demand, while actively considering securing additional manufacturing capacity if necessary.

INCHEON, South Korea – Celltrion announced today that it plans to secure additional manufacturing capacity through a large-scale expansion investment exceeding KRW 1 trillion at its Songdo headquarters to respond to rapidly increasing global demand for its biologics portfolio and further strengthen its global manufacturing competitiveness.

The expansion investment will be implemented in phases from this year through 2030 and will focus on expanding manufacturing infrastructure across the Songdo campus in Korea, the company’s production base in the U.S., and domestic business sites.

This investment goes beyond expanding manufacturing capacity and is intended to establish a long-term growth foundation to support the reliable production and supply of next-generation biosimilars and innovative drug candidates currently under development, while enabling the expansion of the company’s global contract manufacturing (CMO) business.

KRW 1.2Tn investment in the Songdo campus to construct Plants 4 and 5 with a total capacity of 180,000 liters to support pipeline products and CMO demand

Celltrion will invest KRW 1.2265 trillion to construct Plants 4 and 5 with a combined capacity of 180,000 liters at its Songdo campus in Incheon, where the company’s headquarters are located.

The new facilities will incorporate advanced automation systems and smart factory technologies, which are expected to maximize production efficiency and operational flexibility. This will enable a wide range of production capabilities, from small-batch, multi-product production to large-scale manufacturing, allowing the company to respond more rapidly to the production needs of its next-generation biosimilars and novel drugs to be launched in the future as well as its current key products.

The planned facility expansion is intended to support the rapidly growing production demand of the company’s follow-on pipeline while proactively responding to increasing CMO requests.

Branchburg facility in the U.S. to be expanded by 75,000 liters… total DS production capacity to reach 570,000 liters globally

To further strengthen its competitiveness in the United States, Celltrion has finalized the scope of expansion of the manufacturing facility in Branchburg, New Jersey. The planned expansion has been increased from the originally proposed 66,000 liters to 75,000 liters, bringing the facility’s total production capacity for drug substances (DS) from the current 66,000 liters to 141,000 liters.

As demand for local biologics manufacturing in the United States continues to grow rapidly, the Branchburg facility is expected to play a key role in supporting Celltrion’s supply of its products in the U.S. and expanding its CMO business.

Once the facility expansions in Korea and overseas are completed, Celltrion’s DS production capacity will increase significantly from the current 316,000 liters to 571,000 liters. Upon completion of the expansion, Celltrion expects to achieve 100% internalization of DS production while realizing significant additional cost savings.

Company-wide DP manufacturing expansion in Songdo and Yesan, aiming to raise DP production internalization to 90%

In addition to strengthening its DS manufacturing capabilities, Celltrion is making broad investments to enhance its global competitiveness in drug product (DP) manufacturing.

The new DP plant currently under construction at the Songdo campus has reached over 70% completion and is expected to be finished within this year, with commercial operations scheduled to begin next year.

The facility will serve as a DP-only production plant and will be capable of producing up to 6.5 million liquid vials annually. Together with the existing DP line at Plant 2, which has a maximum annual output of 4 million vials, Celltrion will secure total DP capacity of approximately 10.5 million vials per year in Songdo alone.

In addition, Celltrion has also finalized the site for a new DP manufacturing facility in Yesan Industrial Complex, Chungcheongnam-do, and plans to begin design work within this year.

Once the Yesan DP facility is completed and the planned expansion of pre-filled syringe (PFS) manufacturing facilities by Celltrion Pharm is carried out, the company expects to internalize approximately 90% of its global DP supply volume, enabling substantial cost savings compared with overseas DP contract manufacturing.

Meanwhile, Celltrion is conducting thorough reviews of safety management systems across all ongoing construction projects and will prioritize safety as the top priority in all expansion projects, including Plants 4 and 5.

Responding with agility to surging global demand… “Additional manufacturing expansion may be considered, if necessary.”

Through sequential domestic and overseas expansion investments, Celltrion plans to fully implement its global two-track manufacturing strategy and maximize its market responsiveness to rapidly changing economic conditions.

Domestic manufacturing facilities will enhance production internalization and improve cost efficiency, strengthening competitiveness in global tenders and driving revenue growth in markets outside the United States. For its part, the U.S. manufacturing site will serve as a local supply hub for Celltrion’s products and CMO production, thereby proactively mitigating potential trade risks such as tariffs while enhancing local profitability.

“This investment will enable the company to respond swiftly to rapidly growing global demand for biologics while significantly improving profitability through strengthened cost competitiveness and supply stability,” a Celltrion official said. “By establishing a comprehensive manufacturing infrastructure encompassing both innovative drugs and biosimilars as two key growth pillars, along with our expanding CMO business, Celltrion will take another step forward toward becoming a global top-tier biopharmaceutical company.”

Looking ahead, Celltrion plans to actively consider securing additional manufacturing facilities in line with global market conditions and the launch of its pipeline products if necessary.