{"id":7932,"date":"2026-01-13T15:00:04","date_gmt":"2026-01-13T23:00:04","guid":{"rendered":"https:\/\/rakuten-med.com\/us\/?post_type=press_releases&p=7932"},"modified":"2026-01-13T15:00:00","modified_gmt":"2026-01-13T23:00:00","slug":"rakuten-medical-and-lotte-biologics-sign-manufacturing-agreement-to-support-biopharmaceuticals-in-global-oncology-program","status":"publish","type":"press_releases","link":"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2026\/01\/13\/7932\/","title":{"rendered":"Rakuten Medical and LOTTE Biologics Sign Manufacturing Agreement to Support Biopharmaceuticals in Global Oncology Program"},"content":{"rendered":"
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Signing ceremony held during the J.P. Morgan Healthcare Conference<\/h3><\/div><\/div><\/div><\/div>
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San Diego, CA and Seoul, South Korea \u2014 Rakuten Medical, Inc. and LOTTE Biologics today announced that they have signed a biopharmaceutical manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco to strengthen Rakuten Medical\u2019s production capabilities for its innovative oncology therapy, Alluminox\u00ae platform-based photoimmunotherapy.<\/p>\n

Under the agreement, LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical\u2019s global clinical development and future commercialization.<\/p>\n

Rakuten Medical\u2019s 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.
\nIn Japan, the therapy is approved for recurrent head and neck cancer, and its footprint has expanded steadily, through broader site adoption and sustained year\u2011over\u2011year growth in treatment numbers. In parallel, a global Phase 3 clinical trial is underway in the United States, Taiwan and Japan, with plans to start treatment in Ukraine and Poland soon.
\nRakuten 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\u2019s bioconjugates.<\/p>\n

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\u2019s 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.<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div>

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About Rakuten Medical, Inc.<\/strong>
\nRakuten Medical, Inc. is a global biotechnology company developing and commercializing its Alluminox\u00ae platform-based photoimmunotherapy, which has been shown to induce rapid and selective cell killing. Rakuten Medical\u2019s 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, Switzerland and India. For more information, visit www.rakuten-med.com<\/a>.<\/p>\n

About the Alluminox\u00ae Platform<\/strong>
\nThe Alluminox\u00ae platform is Rakuten Medical\u2019s 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\u00ae 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\u2019s 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\u2019s Alluminox platform-based photoimmunotherapy is investigational.<\/p>\n

About LOTTE BIOLOGICS<\/strong>
\nHeadquartered in Seoul, South Korea, LOTTE BIOLOGICS was founded in 2022 with a mission to deliver therapies that contribute to a healthier world.
\nAt 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. With over $100 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.
\nLooking ahead, 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 to meet production needs. Collectively, these plants will provide a manufacturing volume exceeding 360,000L in bioreactor capacity.
\nMore information about LOTTE BIOLOGICS, please visit: www.lottebiologics.com<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>

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