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Seoul, Korea / Syracuse, NY – September 02, 2025 - LOTTE BIOLOGICS (CEO James Park) today announced that it has entered a late-stage to commercial contract manufacturing partnership with a U.S.-based global biopharmaceutical company.

The partnership covers a late-stage Phase 3 program that is advancing into multiple new indications, and extends to commercial supply following potential regulatory approvals. By aligning with its partner’s meaningful pipeline expansion into new therapeutic areas, LOTTE BIOLOGICS will be playing a pivotal role in supporting patient access to innovative medicines.

In accordance with confidentiality obligations, the client’s identity has not been disclosed. The term of the contract extends until middle of 2030.

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 U.S. manufacturing footprint.

This marks the third major partnership secured in 2025, underscoring LOTTE BIOLOGICS’ tangible progress in line with the industry’s reshoring trend and supply chain realignment in the U.S. biomanufacturing sector. Through close collaboration with clients and by leveraging its differentiated capabilities, the company continues to achieve tangible results amid these industry dynamics. Leveraging its dual-site operations at Syracuse NY and Songdo, Korea under one unified quality system, the company continues to expand collaboration with U.S.-based firms and broaden its global client base by providing proximity to key biopharma hubs, reliable supply, and flexible response to dynamic demand needs.

A LOTTE BIOLOGICS representative said, “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 U.S., we are building foundation for bold science and dependable delivery to the patients worldwide.”