[JPM 2026] Lotte Biologics Signs Biopharmaceutical Contract with Rakuten Medical

Production of Head and Neck Cancer Treatment Based on Photoimmunotherapy

Lotte Biologics and Rakuten Medical announced on January 14 that they have signed a biopharmaceutical contract manufacturing (CMO) agreement in San Francisco, California, where the J.P. Morgan Healthcare Conference is being held.

The contract covers Rakuten Medical's flagship pipeline, a head and neck cancer treatment based on photoimmunotherapy. Photoimmunotherapy is an innovative therapeutic mechanism that enhances efficacy and safety by binding a light-reactive substance to a targeted antibody, then irradiating the tumor area with red light to selectively destroy targeted cells.

At the contract signing ceremony for the biopharmaceutical contract manufacturing agreement between Lotte Biologics and Rakuten Medical, Abhijit Bhatia, Chief Operating Officer of Rakuten Medical (photo left), Minami Maeda, President of Rakuten Medical, James Park, CEO of Lotte Biologics, and Yooyul Shin, CEO of Lotte Biologics, are taking a commemorative photo. Lotte Biologics

This treatment from Rakuten Medical has already received regulatory approval under a conditional early approval system in Japan and has accumulated commercial use experience. Currently, global Phase 3 clinical trials are underway in several countries, including the United States and Taiwan, and clinical trials are also set to begin in Ukraine and Poland.

Lotte Biologics plans to support production through its Syracuse Bio Campus in New York State. The company stated that it will actively support global clinical and commercialization services based on its high-quality manufacturing systems, stable supply capabilities, and global regulatory compliance expertise required for global clinical development and commercialization.

In particular, the Syracuse Bio Campus recently began full-scale operation of its antibody-drug conjugate (ADC) production facility, continuously strengthening its advanced bioconjugation service capabilities. Additionally, the first plant at the Songdo Bio Campus is scheduled for completion in August this year. Through these developments, the company aims to accelerate the establishment of a dual-site global production infrastructure in 2026 and further solidify its position as a global ADC CDMO.

With this contract, the two companies plan to gradually establish a supply chain that extends from the clinical stage to commercialization. As the long-term partnership for monoclonal antibody (mAb) and ADC manufacturing collaboration has now materialized into an actual contract, Lotte Biologics plans to leverage this to enhance brand recognition and actively pursue new contracts in global markets such as the United States and Japan.