LOTTE BIOLOGICS to Present at the 2025 J.P. Morgan Healthcare Conference

• New CEO James Park Delivers First Presentation at J.P. Morgan Healthcare Conference on "Advancing as a Global CDMO Leader"
• Unveiling of Next-Generation ADC Platform 'SoluFlex Link': Enabling High-Potency, High-Yield ADC Development and Manufacturing
• Incheon Songdo Bio Campus Plant 1 Under Construction, Targeting Commercial Production by 2027

SEOUL, South Korea, Jan. 16, 2025 /PRNewswire/ -- LOTTE BIOLOGICS (CEO James Park) announced on January 16 that it had presented at the "Asia-Pacific (APAC)" track of the J.P. Morgan Healthcare Conference (JPMHC).

The 2025 J.P. Morgan Healthcare Conference, now in its 43rd year, is the largest event in the pharmaceutical and biotechnology industries. Held in San Francisco, it runs from January 13 to 16 and brings together global pharmaceutical companies, biotech ventures, and healthcare investment professionals to discuss research and development (R&D), investment opportunities, and partnerships.

In his presentation, CEO James Park highlighted the successful transformation of the Syracuse Bio Campus in New York into a CDMO facility and outlined the vision for the Songdo Bio Campus. Notably, he unveiled the company's innovative proprietary ADC platform, SoluFlex Link, and announced plans to collaborate with drug product partners in North America to provide a comprehensive one-stop ADC service. Through these initiatives, he expressed LOTTE BIOLOGICS' ambition to accelerate its growth in the global CDMO market.

SoluFlex Link is a proprietary ADC platform featuring a linker technology jointly developed by LOTTE BIOLOGICS and Kanaph Therapeutics, a biotech venture specializing in drug-conjugation technology.

SoluFlex Link overcomes the major challenge of instability in antibody-drug conjugate (ADC) therapeutics. Its flexible design supports compatibility with a wide range of antibodies and payloads, empowering ADC developers to innovate with diverse applications. Additionally, the platform is engineered to boost both production efficiency and therapeutic performance, positioning it as an ideal solution for next-generation ADC development and manufacturing.

Meanwhile, LOTTE BIOLOGICS' Syracuse Bio Campus received a flawless quality evaluation last year, with no findings reported during inspections by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and a routine audit by the U.S. Food and Drug Administration (FDA). CEO Park emphasized, "Even after the acquisition of the facility, we have maintained a high-quality production system, demonstrating our capabilities as a global CDMO company."

He explained that this served as an opportunity to demonstrate that LOTTE BIOLOGICS has established a global quality management system capable of producing high-quality biopharmaceuticals in compliance with international standards.

In addition, construction of Plant 1 at the Songdo Bio Campus began in March last year, with a total investment of $1 billion. The facility is currently under active development, aiming to commence full-scale commercial production by 2027.

CEO Park stated, "The Songdo Bio Campus Plant 1, scheduled for completion this year, will be a flexible, large-scale production facility equipped with an optimized operational system. By incorporating automated production processes and advanced manufacturing technologies, and leveraging the geographical advantages of Songdo and New York, we will maximize operational efficiency. We are committed to becoming a global company that not only ensures customer satisfaction but also achieves competitive quality standards."

Yu-Yeol Shin, Vice President and Head of Global Strategy at LOTTE BIOLOGICS, also attended the J.P. Morgan Conference for the first time since his appointment in late 2023. During the event, he participated in presentation sessions by companies such as Roche, Johnson & Johnson (J&J), and BMS to gain insights into pharmaceutical and biotechnology trends. Additionally, alongside CEO James Park, he actively engaged in business and partnership meetings with global pharmaceutical companies and potential clients, demonstrating a strong commitment to advancing LOTTE Group's new biopharmaceutical business.

[Appendix: Summary of CEO James Park's 2025 JPMHC Presentation]

• Unveiling of the Next-Generation ADC Platform 'SoluFlex Link'

In this presentation, CEO James Park unveiled LOTTE BIOLOGICS' innovative ADC platform, SoluFlex Link, for the first time. SoluFlex Link is an ADC platform with the flexibility to be applied to most linkers and payloads used in ADCs, meeting the diverse needs of various clients.

CEO Park explained, "SoluFlex Link enhances the hydrophilicity of ADCs, demonstrating improved efficacy in terms of in vivo performance, stability, productivity, and pharmacokinetics. This makes it an effective and accelerated drug development solution for next-generation ADC development and manufacturing."

He added, "A key advantage is that the Syracuse Bio Campus in New York can meet a wide range of client needs, from clinical development-scale production to large-scale commercial manufacturing."

• Establishing ADC End-to-End Service Partnerships

Additionally, it was emphasized that with the operation of the ADC conjugation facility in Syracuse, the launch of the SoluFlex Link platform, and partnerships for ADC drug product (DP) manufacturing, the company is now capable of providing end-to-end ADC services within North America.

At the Syracuse Bio Campus, antibodies and ADC drug substances (DS) will be produced and supplied to drug product (DP) CDMO partners located on the East and West Coasts of the United States. The collaboration is structured to handle all stages of ADC drug development and production, from process development to manufacturing.

• Accelerating Construction of the Songdo Bio Campus with Targeted Commercial Production by 2027

LOTTE BIOLOGICS also shared updates on the progress of the large-scale biopharmaceutical production facility under construction at the Songdo Bio Campus. CEO Park stated, "The construction of Plant 1 is progressing smoothly, with the goal of commencing full-scale commercial production in 2027."

In addition, the "TiterFlex Quad Bioreactor System," designed to meet the demand for high-titer drug production, is currently undergoing Factory Acceptance Testing (FAT). Alongside this, automation technologies are being implemented to enhance efficiency from raw material handling to production, with a strong focus on optimizing operational efficiency.

About LOTTE BIOLOGICS

Headquartered in Seoul, South Korea, LOTTE BIOLOGICS was founded in 2022 with a mission to deliver therapies that contribute to a healthier world.

At the Syracuse Bio Campus in New York, LOTTE BIOLOGICS provides high-quality GMP manufacturing services for drug substances. The facility offers a total production capacity of 40,000L, supported by eight 5,000L stainless steel bioreactors. Additionally, the campus includes extensive analytical QC testing laboratories and warehouse facilities that have received approval from over 62 regulatory agencies worldwide. LOTTE BIOLOGICS is also advancing into a new area of expertise with Antibody-Drug Conjugates (ADCs) conjugation services, expected to be fully operational by early 2025. With over $80 million invested in ADC modalities, including both drug substance and conjugation capabilities on-site, we offer a seamless, end-to-end service from drug substance manufacturing to conjugation.

Looking ahead to 2030, LOTTE BIOLOGICS is constructing three advanced bio plants in Songdo, South Korea. With construction of the first plant already underway and expected to be operational by 2027, each facility will feature eight 15,000L stainless steel bioreactors for large-scale commercial production, along with multiple 2,000L single-use bioreactors to meet clinical production needs. Collectively, these plants will provide a manufacturing volume exceeding 360,000L in bioreactor capacity.

More information about LOTTE BIOLOGICS, please visit: www.lottebiologics.com 

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