At a Glance
- Companies: Rakuten Medical, Inc.; LOTTE Biologics
- Location: San Diego, California (Rakuten); Seoul, South Korea/New York (LOTTE)
- Deal value: Undisclosed; multi‑year CMO for clinical/commercial supply
- Focus area: Monoclonal antibody intermediates and conjugates for Alluminox photoimmunotherapy
- Next steps: Scale production at LOTTE’s Syracuse ADC facility for global phase 3 trials
What happened?
Rakuten Medical and LOTTE Biologics signed a biopharmaceutical contract manufacturing agreement at the J.P. Morgan Healthcare Conference to support Rakuten’s Alluminox platform‑based photoimmunotherapy for oncology. LOTTE will provide GMP manufacturing for monoclonal antibody intermediates and conjugates at its Syracuse Bio Campus in New York.
Why does it matter?
Rakuten’s photoimmunotherapy—approved in Japan as ASP‑1929 for recurrent head and neck cancer—is in global phase 3 trials (US, Taiwan, Japan; planned Ukraine/Poland), with steady adoption in Japan. The deal de‑risks scaling for commercialisation by tapping LOTTE’s ADC/bioconjugation expertise, ensuring stable supply amid growing demand for targeted light‑activated therapies.
Who’s behind it?
Rakuten Medical develops Alluminox, which combines tumour‑targeting antibodies with light‑activatable agents for selective solid tumour cell destruction. LOTTE Biologics operates integrated facilities in the US/South Korea, with Syracuse offering 40,000L capacity, ADC suites and 62+ global approvals.
How was it achieved?
LOTTE’s Syracuse site—acquired from BMS in 2023—handles mAb/ADC production with end‑to‑end capabilities, supporting Rakuten’s phased supply from clinical to commercial stages while meeting regulatory standards.
What’s next?
The partnership establishes a robust supply chain for Rakuten’s expanding global footprint, with LOTTE leveraging the deal to boost US/Japan market recognition. Phase 3 readouts could enable broader approvals.
What are people saying?
Rakuten Medical highlighted LOTTE’s “high‑quality manufacturing” for global scaling. LOTTE Biologics called it a milestone showcasing ADC/bioconjugation prowess.