FL-091 NTSR1-targeting RDC (Full-Life Technologies/SK Biopharmaceuticals)

	Next higher product group	radionuclide-drug conjugate (RDC)
	Status	2024-07-17 development existent
	Organisation	SK Biopharmaceuticals Co., Ltd. (326030.KS)
	Group	SK Group (Group)
	Organisation 2	Full-Life Technologies Ltd., Heidelberg
	Group	Full-Life Technologies (Group)

Full-Life Technologies. (7/17/24). "Press Release: Full-Life Technologies, SK Biopharmaceuticals Enter Licensing Agreement for Novel Therapeutic Targeting Multiple Solid Tumors". Heidelberg & Seoul.

Full-Life Technologies seals $571.5 million agreement with SK Biopharmaceuticals to license and further develop Full-Life's 'FL-091' radiopharmaceutical compound into an innovative anti-cancer treatment for worldwide markets

Full-Life Technologies ("Full-Life"), a fully integrated global radiotherapeutics company, announced today that it has entered into a license agreement with SK Biopharmaceuticals, a global biotech company, for exclusive worldwide clinical research, development, manufacturing, and commercialization rights to Full-Life's "FL-091" radiopharmaceutical compound targeting neurotensin receptor 1 (NTSR1) positive cancers.

This licensing deal worth $571.5 million includes an upfront payment, and development and commercial milestones, separate from royalties. Under the terms of the agreement, SK Biopharmaceuticals will in-license the NTSR1-targeting Radionuclide Drug Conjugate (RDC) program FL-091 – as well as its back-up compounds – aimed at developing and commercializing it as an innovative anti-cancer drug.

FL-091 is a small-molecule radioligand vector designed to deliver targeted radiation therapy to cancer cells by binding specifically to NTSR1, a receptor protein, which is selectively overexpressed in various types of solid tumors, including colorectal cancer, prostate cancer, and pancreatic cancer.

SK Biopharmaceuticals also has a right of first negotiation to license other pre-selected RDC programs of Full-Life.

Lanny Sun, Chief Executive Officer of Full-Life, said, "This agreement with SK Biopharmaceuticals highlights the potential of FL-091 in advancing cancer treatment and demonstrates SK Biopharmaceuticals' unwavering commitment to building an oncology business around medical innovation. We look forward to future collaborations with SK Biopharmaceuticals, and to leveraging its expertise and resources to advance radiopharmaceutical therapy. The agreement is aligned with our strategic vision of fostering global partnerships and making a meaningful impact on patients worldwide."

Donghoon Lee, Chief Executive Officer and President of SK Biopharmaceuticals, said, "The licensing agreement with Full-Life not only brings the two companies closer together for future collaborations in the fastest rising biotech sector, but also most importantly, pushes SK Biopharmaceuticals forward to become a 'Big Biotech'. Since the introduction of the company's strategy roadmap to venture into radiopharmaceuticals last year, we have been on track toward our envisioned goal. We expect to further unveil and implement business plans for RPT (radiopharmaceutical therapy) this year, and actively pursue clinical development and commercialization in the near future to provide treatment options and create new value worldwide."

About FL-091

FL-091 is a novel small-molecule radioligand vector targeting NTSR1 positive solid tumors. Overexpression of NTSR1 has been associated with disease progression of multiple types of cancers, including colorectal, breast, pancreatic, and head and neck cancers. FL-091 radioligands have demonstrated favorable biodistribution profiles and enhanced binding affinity to NTSR1, as well as encouraging anti-tumor activities in preclinical studies. The development of the alpha-emitter therapy candidate 225Ac-FL-091 targeting NTSR1-positive tumors is currently in progress.

About Full-Life Technologies

Full-Life Technologies ("Full-Life") is a fully integrated global radiotherapeutics company with operations in Belgium, Germany, and China. We aim to own the entire value chain for radiopharmaceutical research & development, production & commercialization to deliver clinical impact for patients. The Company endeavors to tackle fundamental challenges affecting radiopharmaceuticals today by pioneering innovative research that will shape the treatments of tomorrow. We are comprised of a team of fast-moving entrepreneurs and seasoned scientists with a proven history of success in the life sciences, alongside radioisotope research and clinical development. For more information, visit Full-Life's website at www.full-life.com.

About SK Biopharmaceuticals

SK Biopharmaceuticals focuses on the research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin its expansion into oncology through research and development efforts.

SK Biopharmaceuticals is the first and only Korean company to independently develop and commercialize an antiseizure medication, cenobamate (brand name: XCOPRI®) in the U.S. More than 100,000 patients have been treated globally with cenobamate, developed by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, Inc., since its launch in the U.S. in 2020. Cenobamate has successfully entered five major regions: North America, Europe, Asia, Central and South America, and the Middle East and North Africa.

The company also has a pipeline of eight compounds in development in both CNS disorders and oncology. Additionally, SK Biopharmaceuticals is focused on the discovery of new treatments in oncology. For more information, visit SK Biopharmaceuticals' website at www.SKBP.com/eng, and SK Life Science's website at www.SKLifeScienceInc.com.