[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 (JPMHC) is being held.

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

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

This Rakuten Medical therapy has already gained commercial use experience in Japan, having received regulatory approval under a conditional early approval system. 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, leveraging its high-quality manufacturing systems, stable supply capabilities, and global regulatory compliance required for global clinical trials and commercialization.

In particular, the Syracuse Bio Campus has recently begun 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 intends to leverage this to enhance brand recognition and actively pursue new contracts in global markets such as the United States and Japan.