SK Biopharmaceuticals Seals 1st Actinium-225-Based Collaborative Research Agreement with Korea Institute of Radiological and Medical Sciences as Steps Toward Becoming Global Radiopharmaceutical Therapy Player

SK Biopharmaceuticals,Korea Institute of Radiological and Medical Sciences collaborate on discovering and developing radiopharmaceutical drug candidates usingan alpha-particleemittingradioisotope,actinium-225,for potential cancer treatments

The two sides aim to submit an Investigational New Drug application by 2027,in line with SK Biopharmaceuticals' roadmap to strengthen its radiopharmaceutical therapy business

SK Biopharmaceuticals further accelerates the expansion of its radiopharmaceutical therapy pipeline and capability,via strengthened internal resources and partnerships

SEOUL,South Korea,Nov. 19,2024 -- SK Biopharmaceuticals,a biotech company,announced that it has entered into an agreement with the Korea Institute of Radiological and Medical Sciences (KIRAMS),Korea's premier research institution dedicated to the study and advancement of radiological and medical sciences,to collaborate on discovering and developing preclinical radiopharmaceutical drug candidates.

This marks the first collaborative research agreement in which both sides will aim to discover radiopharmaceutical compounds and investigate novel oncological treatments,using actinium-225(225Ac),an alpha-particleemittingradioisotope that selectively kills cancer cells. The research for radiopharmaceutical therapy (RPT) focuses on this application that has been gaining attention for its high potential in nuclear medicine.

SK Biopharmaceuticals has already initiated its 225Ac-based research as it secured a supply of the radioisotope from TerraPower Isotopes,a subsidiary of TerraPower,a nuclear innovation company whose investors include SK Biopharmaceuticals' parent SK Inc. and Bill Gates.

SK Biopharmaceuticals and KIRAMS will seek to submit an Investigational New Drug application by 2027,as they leverage each other's resources to optimize their drug discovery efforts. SK Biopharmaceuticals said it could significantly reduce the time and cost of new drug development,with KIRAMS' researchers,facilities and equipment using the radioisotope,enabling the company to further accelerate in securing and expanding its RPT pipeline and capability.

The agreement is in line with SK Biopharmaceuticals' so-called "RPT Roadmap" recently introduced to become a global leading RPT player by 2027,as the company will fortify its RPT business by discovering new drug compounds,extending supply and production capacities,and developing a tech platform,via strengthened internal assets and strategic partnerships.

In addition to the 225Ac supply agreement aligned with its roadmap,the company has in-licensed SKL35501 (FL-091) radiopharmaceutical compound targeting neurotensin receptor 1 (NTSR1) solid tumors.

Jinkyung Lee,President of KIRAMS,stated,"Through this joint research agreement,we aim to take a leading role in developing innovative radiopharmaceutical therapeutics,in alignment with the Ministry of Science and ICT's strategic initiative to drive advancements in Radiation Biology. We look forward to contributing to the growth of the domestic radiopharmaceutical industry in close collaboration with SK Biopharmaceuticals."

Donghoon Lee,CEO and President of SK Biopharmaceuticals,said "This agreement is one of key steps in enhancing SK Biopharmaceuticals' research capabilities. We will seek to spur SK Biopharmaceuticals to become a leading global RPT player through strengthened ties."

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.

About Korea Institute of Radiological and Medical Sciences

As a premier institution dedicated to the intersection of science,technology,and healthcare,the Korea Institute of Radiological and Medical Sciences (KIRAMS) is at the forefront of radiation medicine innovation.

Ever since KIRAMS opened its doors as a radiation medicine research center in 1963,we have been contributing to the national development of science and technology,and to the promotion of the health of the people,based on our research in medical uses of radiation.

By bringing the very first Cobalt-60 radiotherapy machine for cancer treatment to Korea in 1963,we were able to greatly increase the number of completely cured cancer patients. Following the restructuring of a cancer hospital in 1973,KIRAMS was leading domestic cancer treatment until the 1990s,by introducing diagnostic and treatment technologies that incorporated advanced science. In 2007,we became an independent institution,directly under the Ministry of Science and ICT,and since then we have established "Radiation Medicine" as a separate field of research and distinguished ourselves from other medical institutes by expanding the National Radiation Emergency Medical Center.

And now,going beyond our original mission of defeating cancer,KIRAMS is evolving into a public institution committed to solving new problems for the country and for society,as well as for the benefit of the people. In other words,we are opening new horizons in radiation medicine by supporting specialized,research-centric hospitals engaged in advanced biomedical R&D,by consolidating research and detection of radiation in everyday life,which has recently become a social issue,and by establishing and operating the new Radioisotope Center for Pharmaceuticals to promote the research and use of radioisotopes for medical purposes.

Leveraging our extensive experience and our accomplishments,we here at the Korea Institute of Radiological and Medical Sciences will not rest but continually develop into the number one specialist institute for radiotherapy trusted by the people.

For more information,visit https://www.kirams.re.kr/keng/.