Celltrion announced on the 17th that it has signed a contract manufacturing organization (CMO) agreement with a global pharmaceutical company for the production of biopharmaceutical drug substances (DS, Drug Substance). Due to business confidentiality, the company decided not to disclose the name of the pharmaceutical company, nor the location of the production plant for the contracted volume (such as Korea, the United States, etc.).

Under this agreement, Celltrion will supply biopharmaceutical drug substances over a period of about three years from next year through 2029. The contract amount has been set at approximately KRW 294.9 billion. Depending on future discussions, it could be expanded to as much as KRW 375.4 billion. Celltrion stated that it plans to complete production preparations at an early stage and pursue stable supply to the client company.

Celltrion has consistently demonstrated high quality, stable supply capabilities, and efficient production process management in its biopharmaceutical business. The latest contract is assessed as a result of the client company recognizing Celltrion’s excellent production quality and stable supply system that meet global standards. In fact, since declaring the full-scale launch of its global CMO business last year, Celltrion has shown rapid growth. Earlier this year, it signed a CMO contract worth about KRW 678.7 billion with U.S. pharmaceutical company Eli Lilly, and with the latest deal, its accumulated CMO order backlog in the first quarter of this year has surpassed KRW 1 trillion.

Celltrion ultimately aims to expand into the contract development and manufacturing organization (CDMO) business. As part of this effort, its subsidiary Celltrion BioSolutions is said to be accelerating the systematization of CMO business operations by further strengthening its global sales and project management (PM) capabilities. The company explained that it is focusing on differentiation by providing a business model based on advanced technologies and thereby reinforcing its CMO business. Representative examples include “formulation-change CMO” projects that provide subcutaneous (SC) formulation-switching technologies accumulated through products such as Remsima SC (marketed as Zymfentra in the United States) and Herzuma SC to external clients. The strategy is to provide high value-added CMO services that go beyond simple contract manufacturing to enhance the competitiveness of clients’ products.

In practice, as the global biopharmaceutical market expands, demand is increasing for securing stable production partners, drawing greater attention to Celltrion’s manufacturing capabilities. Currently, Celltrion has total production capacity of 316,000 liters, including 250,000 liters at its Songdo Plants 1–3 and 66,000 liters at its Branchburg, New Jersey plant in the United States. However, a significant portion of its existing capacity is scheduled to be used for production of its own products, including the global sales expansion of Zymfentra and new products. Therefore, analysts say that additional production facilities will be needed over the medium to long term in order to accommodate CDMO demand.

Reflecting these market conditions, Celltrion is currently reviewing plans to additionally expand production facilities in Korea and overseas. The company intends to secure production infrastructure capable of responding to global CDMO demand.

A Celltrion official said, “This CMO contract is a result of Celltrion’s production quality competitiveness and stable supply capabilities being recognized once again in the global market,” and added, “We plan to actively pursue the securing of additional production capacity, taking into consideration the expansion of our own product manufacturing and global demand for the growth of the CDMO business.”

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