Rakuten Medical taps Lotte Biologics for antibody manufacturing support

Rakuten Medical, a clinical-stage biotechnology company headquartered in San Diego, and Lotte Biologics, a contract development and manufacturing organization (CDMO) based in South Korea, have signed a biopharmaceutical contract manufacturing agreement to support the production of monoclonal antibody intermediates and conjugates for Rakuten Medical’s oncology programs.

Under the agreement, Lotte Biologics will provide manufacturing services for antibody intermediates and their conjugates to support Rakuten Medical’s global clinical development and potential commercialization of its Alluminox platform-based photoimmunotherapy, according to the announcement. The agreement was signed during this week’s J.P. Morgan Healthcare Conference in San Francisco.

Rakuten Medical said its proprietary photoimmunotherapy technology combines cell-targeting molecules, such as antibodies, with light-activatable agents to enable selective destruction of solid tumor cells following light exposure. In Japan, the therapy has been approved for recurrent head and neck cancer and treatment adoption has expanded with continued year-over-year growth.

The company is also conducting a global Phase III clinical trial in the United States, Taiwan, and Japan, with plans to initiate treatment in Ukraine and Poland, according to Rakuten Medical. In addition, the company said it plans to begin a Phase I clinical trial in Japan this year for other solid tumor indications beyond head and neck cancer. These clinical and commercial activities are increasing demand for Rakuten Medical’s bioconjugates, according to the announcement.

Lotte Biologics will support Rakuten Medical’s programs through its antibody-drug conjugate (ADC) manufacturing facility in Syracuse, New York. The company said the site provides specialized bioconjugation and manufacturing capabilities designed to meet global regulatory requirements and support stable supply.

Lotte Biologics began full-scale operations at its Syracuse ADC manufacturing facility in 2025 following a $100 million investment, according to the company. The site marked the launch of Lotte Biologics’ ADC CDMO services and secured its first commercial order covering a clinical-stage ADC candidate. 

The facility includes a single-use manufacturing system and a 1,000-liter conjugation reactor, which are designed to support programs from clinical development through commercial-scale production, the company said.