Celltrion Obtains Construction Permit for New Finished Pharmaceutical Plant

Annual Production of 8 Million Liquid Vials
Rapid Response to Demand Driven by New Products and Market Share Expansion

Celltrion announced on the 14th that it has obtained construction approval from the Incheon Free Economic Zone Authority (IFEZ) for a new finished drug product (Drug Product·DP) factory being expanded in Yeonsu-gu, Songdo, Incheon.

The new DP factory will have the capacity to manufacture approximately 8 million liquid vials (glass containers for injections) annually. It will be built on a site near the existing Plant 1. Celltrion decided to expand the DP factory in September 2023, and after completing design and contractor selection last year, it has finalized the construction approval process this month, thus commencing full-scale construction.

Celltrion plans to complete the new DP factory by the first half of next year and begin full-scale commercial production starting in 2027. This DP factory will produce existing products such as Truxima and Vegzelma, as well as follow-up liquid vial products recently approved, including Idenselt, Stekima, and Aptozma.

Pharmaceuticals are broadly divided into active pharmaceutical ingredients (Drug Substance·DS), produced through processes such as cell culture and purification, and finished drug products (DP), which are formulated for patient administration.

Through the expansion of the new DP factory, Celltrion expects to strengthen competitiveness in various aspects, including drug supply stability and cost reduction.

In particular, it is anticipated that there will be about a 30% cost reduction compared to the unit price per product currently produced through contract manufacturing organizations (CMO), which will lead to enhanced cost competitiveness and is expected to result in more active participation in overseas bidding markets and increased sales. Additionally, flexible production linked with the existing Plant 2 DP production line will shorten product shipment schedules, and operational efficiency within the production complex will be improved, maximizing overall manufacturing competitiveness.

Furthermore, as the internalization ratio of DP production increases, greater flexibility in global supply strategies is expected. In the future, with more options for DS and DP supply, timely supply tailored to each country's situation and export purposes will be possible.

In other words, outside the United States, cost savings from internalization could significantly increase sales factors such as securing bidding competitiveness, while in the U.S., flexible operations focused on local CMO production considering potential tariff risks will enable a 'two-track' strategy, greatly enhancing market responsiveness aligned with the global economic environment.

The DP factory under construction incorporates isolators that block harmful substances during operations to reduce contamination risks and is designed to minimize issues between processes, thereby improving productivity. Additionally, the introduction of the latest production equipment and automation of process lines will enable more efficient operations.

Celltrion is strengthening production competitiveness in response to the expansion of its product portfolio and increasing global pharmaceutical demand. The DS division has already secured a total production capacity of 250,000 liters, including the existing Plant 1 with 100,000 liters, Plant 2 with 90,000 liters, and the recently commenced commercial production at Plant 3 with 60,000 liters.

In the DP division, in addition to the existing Plant 2 production line capable of producing about 4 million liquid vials annually, the expansion with the new DP factory capable of producing about 8 million liquid vials will bring the total annual production capacity to 12 million liquid vials.

A Celltrion official stated, "Through this DP factory expansion, Celltrion can proactively respond to the global demand increase and new product launches, enabling smoother supply of high-quality pharmaceuticals. We will do our best to accelerate global market entry and expand company growth by strengthening production capacity and cost competitiveness."