South Korea’s LOTTE BIOLOGICS has signed a late-stage to commercial contract manufacturing agreement with a US-based global biopharmaceutical company.

The partnership covers a late-stage Phase 3 programme that is advancing into multiple new indications, and extends to commercial supply following potential regulatory approvals. The term of the contract extends until the middle of 2030.

However, the partner’s identity has not been disclosed, citing confidentiality obligations.

"This late-stage to commercial partnership demonstrates strong client confidence in our global network and technical expertise. LOTTE is proud to support our partner's indication expansion strategy and to help accelerate the availability of innovative therapies for patients worldwide. By combining our dual-site reliability with one of the largest conjugation capacities in the US, we are building a foundation for bold science and dependable delivery to the patients worldwide,” a company representative said.

LOTTE BIOLOGICS stated that the partnership reaffirms the company's commercial scale manufacturing capabilities and quality leadership in the global market, while highlighting the geographical advantages of its US manufacturing footprint.

This marks LOTTE BIOLOGICS' third major partnership secured in 2025, underscoring its tangible progress in line with the industry's reshoring trend and supply chain realignment in the US biomanufacturing sector.

Leveraging its dual-site operations at Syracuse, New York, and Songdo, Korea, under one unified quality system, the company aims to expand collaboration with US-based firms and broaden its global client base by providing proximity to key biopharma hubs, reliable supply, and flexible response to dynamic demand needs.  

This year, the company ramped up its CDMO business expansion with the completion of an ADC (Antibody-Drug Conjugate) facility expansion at its Syracuse Bio Campus and the signing of its first production contract.

The company has invested approximately USD 100 million into its Syracuse Bio Campus to establish advanced ADC production infrastructure, including conjugation suites with capacities of up to 1,000L. This has further solidified its position as a North American production hub for next-generation biologics.

In April, LOTTE BIOLOGICS signed a production agreement with an Asia-based biotech company for an ADC clinical candidate, officially launching its efforts to expand ADC CDMO partnerships.

LOTTE BIOLOGICS is currently constructing a large-scale commercial bio campus in Songdo, Korea, with the first plant scheduled to begin operations in 2027.

While the Syracuse campus serves as a One-Stop CDMO Hub from Antibody to ADC in North America, the Songdo site is designed to function as a Large-scale Production Base.