SEOUL, South Korea, Jan. 14, 2026 /PRNewswire/ -- Rakuten Medical, Inc. and LOTTE Biologics today announced that they have signed a biopharmaceutical contract manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco to strengthen Rakuten Medical's production capabilities for its innovative oncology therapy, Alluminox^® platform-based photoimmunotherapy.

Signing ceremony held during the J.P. Morgan Healthcare Conference

Under the agreement, LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical's global clinical development and future commercialization.

Rakuten Medical's proprietary photoimmunotherapy technology is designed to selectively target cells in solid tumors, by combining cell-targeting moieties, such as antibodies, with light-activatable agents, enabling focal and selective destruction of solid tumor cells upon light exposure.

In Japan, the therapy is approved for recurrent head and neck cancer, and its footprint has expanded steadily, through broader site adoption and sustained year–over–year growth in treatment numbers. In parallel, a global Phase 3 clinical trial is underway in the United States, Taiwan region and Japan, with plans to start treatment in Ukraine and Poland soon.

Rakuten Medical also plans to initiate a Phase 1 clinical trial in Japan for other solid tumors beyond head and neck cancer this year. These clinical and commercial dynamics are driving increased demand for Rakuten Medical's bioconjugates.

LOTTE Biologics has been expanding its capabilities as a global contract development and manufacturing organization (CDMO), particularly in the field of monoclonal and multispecific antibodies, antibody-drug conjugates (ADCs), and advanced bioconjugation services. LOTTE Biologics will support the production of monoclonal antibody intermediates and their conjugates for Rakuten Medical's programs, through its specialized ADC manufacturing facility at the Syracuse Bio Campus in New York. The facility is equipped with dedicated ADC production capabilities and advanced bioconjugation technologies, enabling the company to deliver high-quality manufacturing services while meeting global regulatory requirements and ensuring stable supply for customers worldwide.

About LOTTE Biologics

Founded in 2022 and headquartered in Seoul, South Korea, LOTTE Biologics operates integrated biologics facilities in the United States and South Korea. Through a unified Dual Hub Service model, LOTTE Biologics enhances supply security, supports manufacturing scalability, and maintains consistent quality standards across regions. LOTTE Biologics provides modular, phase-appropriate manufacturing solutions spanning preclinical through commercial stages, with proven capability in producing mammalian-cell-based biologics, including monoclonal antibodies, fusion proteins, and multispecific modalities.

At the Syracuse Bio Campus in New York, LOTTE Biologics delivers high-quality GMP drug substance manufacturing supported by more than 62 global regulatory approvals. The site offers 40,000 L of total capacity across eight 5,000 L stainless steel bioreactors and includes analytical and warehouse infrastructure. In addition, the company has expanded into Antibody-Drug Conjugates (ADCs) through strategic investment in onsite conjugation suites, enabling a streamlined, end-to-end pathway from biologic drug substance production to ADC manufacturing within a single campus.

In South Korea, LOTTE Biologics is constructing three advanced bio plants at the Songdo Bio Campus. With the first facility already underway and scheduled for operation in 2027, each plant will include eight 15,000 L stainless steel bioreactors for commercial production, supported by multiple 3,000 L bioreactors for clinical-scale needs. Collectively, these plants will provide a manufacturing volume exceeding 360,000L in bioreactor capacity.

Guided by the vision "Possibilities Beyond Limits," LOTTE Biologics is committed to serving as a long-term, trusted partner, supporting efficient scale-up, dependable manufacturing execution, and the continuous advancement of clients' therapeutic programs. More information about LOTTE Biologics, please visit: www.lottebiologics.com 

About Rakuten Medical, Inc.

Rakuten Medical, Inc. is a global biotechnology company developing and commercializing its Alluminox® platform-based photoimmunotherapy, which has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in five countries/regions, including the United States, where it is headquartered, Japan, Taiwan region, Switzerland and India. For more information, visit www.rakuten-med.com.

About the Alluminox® Platform

The Alluminox® platform is Rakuten Medical's investigational technology that combines pharmaceuticals, medical devices, medical technology and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration, and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690 nm) to transiently activate the drug. Rakuten Medical's preclinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational.

Source: LOTTE BIOLOGICS