Overview
- The companies finalized the contract at the J.P. Morgan Healthcare Conference in San Francisco, with financial terms not disclosed.
- Lotte Biologics will make monoclonal antibody intermediates and antibody–dye conjugates at its Syracuse, New York ADC facility to support clinical development and potential commercialization.
- Rakuten’s therapy, marketed as Akalux in Japan, holds conditional early approval there for recurrent head and neck cancer and remains investigational elsewhere.
- Phase 3 studies are underway in the United States, Taiwan and Japan, with additional trials planned in Ukraine and Poland, and a Phase 1 in Japan targeting other solid tumors expected this year.
- Lotte is building out a dual U.S.–Korea supply model, including new capacity under construction at its Songdo Bio Campus in Incheon to bolster long-term manufacturing security.