Lotte Biologics secures CMO contract with US biotech for late-stage drug project

Lotte Biologics said it has signed a contract manufacturing organization (CMO) deal with a U.S.-headquartered global biotech company to produce a late-stage drug candidate.

The agreement covers phase 3 clinical production and future commercialization of an immunotherapy candidate that is expanding into multiple indications. While the client company remains undisclosed due to confidentiality terms, the contract is valid through 2030.

Lotte Biologics noted that the partnership highlights its role in supporting the partner’s pipeline expansion and improving patient access to innovative medicines. The company added that additional collaboration opportunities may follow upon regulatory approval.

According to the company, the deal underscores its manufacturing and quality competitiveness in the global market.

Lotte Biologics currently operates the Syracuse Bio Campus in New York and is constructing a second facility in Songdo, Korea, scheduled to begin operations in 2027. The two sites will run under a single quality system, which the company says enables flexible and reliable supply while enhancing collaboration with U.S. pharmaceutical and biotech firms.

The contract also reflects broader industry trends, including the reshoring of biomanufacturing in the U.S. and global supply chain restructuring. Lotte Biologics emphasized that its proactive engagement with customers and differentiated capabilities have led to tangible progress, with three new U.S. contracts secured this year alone.

Looking ahead, the company plans to strengthen its partnerships with U.S.-based firms and further expand its global client network. By leveraging the dual-site strategy of Syracuse and Songdo, Lotte Biologics aims to deliver a distinctive CDMO solution and solidify its position as a trusted global partner.

“This agreement is a clear recognition of our global network and technological competitiveness,” a Lotte Biologics official said. “We will continue working closely with our partners to ensure innovative therapies reach patients worldwide and to reinforce our standing as a global biomanufacturing hub.”