Lotte Biologics has won a contract manufacturing (CMO) deal with Japan's Rakuten Medical for biopharmaceuticals. The contract size was not disclosed.
The company said on the 13th (local time) in San Francisco, where the "J.P. Morgan Healthcare Conference" is being held, that it signed a contract manufacturing (CMO) agreement for biopharmaceuticals.
The contracted item is a head and neck cancer treatment based on Rakuten Medical's flagship pipeline "photoimmunotherapy." Photoimmunotherapy is a novel treatment that enhances efficacy and safety by attaching a light-reactive substance to a targeted antibody and then irradiating the tumor site with red light to selectively destroy target cells.
Rakuten Medical's therapy has already received conditional early approval in Japan and secured commercial use experience. A global phase 3 trial is underway in multiple 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 the Syracuse Bio Campus in New York state. The company said, "Based on high-quality manufacturing systems required for global clinical development and commercialization, stable supply capabilities, and global regulatory response competencies, we will actively support global clinical and commercialization services."
With this order contract, the two companies plan to gradually build a supply chain that extends from the clinical stage to commercialization.
The company said, "A mid- to long-term partnership for cooperation in manufacturing monoclonal antibodies (mAb) and Antibody-Drug Conjugate (ADC) has led to an actual contract," adding, "Leveraging this, we plan to raise brand recognition in global markets including the United States and Japan and continue proactive order-winning activities."
Lotte Biologics' Syracuse plant in the United States has recently begun full-scale operation of an antibody-drug conjugate (ADC) production facility and has continued to strengthen its capabilities to provide bio conjugation services. Bio conjugation is a technology that chemically links biomolecules such as proteins or antibodies with other molecules.
The first plant in Songdo, Incheon, is also set to be completed in Aug. this year. The company's strategy is to build a global production infrastructure based on its U.S. and domestic hubs and strengthen its position as a global ADC CDMO.
Shin Yoo-yeol, the eldest son of Shin Dong-bin, chairman of Lotte Group, and CEO of Lotte Biologics, attended the event, held meetings with global pharmaceutical companies, and checked market trends.
Shin Yoo-yeol said, "The core purpose of this event is to closely analyze global market trends and broaden contact points with potential customers," adding, "We will present the dual-site production strategy of the Syracuse campus, led by ADC capabilities, and the state-of-the-art Songdo campus to be completed in the second half as a business competitiveness, and secure meaningful business momentum that goes beyond networking to lead to the signing of substantive contracts."