Korea Begins Local Supply of Critical Medical Radioisotopes (Image supported by ChatGPT)
SEOUL, May 23 (Korea Bizwire) – South Korea has taken a major step toward medical self-sufficiency by launching domestic production of key cancer-fighting radioisotopes, Actinium-225 (Ac-225) and Iodine-131 (I-131), which had previously been entirely imported, creating frequent supply shortages for patients and drug developers.
The Ministry of Science and ICT announced Thursday that the Korea Institute of Radiological & Medical Sciences (KIRAMS) received regulatory approval on May 12 from the Nuclear Safety and Security Commission to begin producing Actinium using a cyclotron, a particle accelerator. This marks the first time the isotope will be manufactured domestically.
Actinium is a powerful alpha-emitting isotope used in targeted cancer therapies, particularly for neuroendocrine and prostate cancers. It is combined with ligands that direct it to tumor cells, delivering radiation precisely. Until now, Korean patients had to travel abroad or join limited clinical trials to access such treatment due to global supply constraints.
KIRAMS said it will produce Actinium by bombarding Radium-226 with proton beams and chemically extracting the isotope. While global demand for Actinium exceeds 1,850 gigabecquerels annually, only 67 gigabecquerels are currently produced worldwide.
A conceptual diagram of radiopharmaceuticals. (Image courtesy of the Ministry of Science and ICT)
The institute expects to start small-scale production by December 2025, with initial quantities sufficient to treat three to four patients per batch. Long-term plans include scaling up production ten- to fifteenfold.
South Korea is also working to stabilize domestic supply of Iodine-131, a standard treatment for thyroid cancer. Following disruptions in international supply last year, the Korea Atomic Energy Research Institute (KAERI) obtained GMP certification from the Ministry of Food and Drug Safety and has begun producing Iodine using the HANARO research reactor.
Annual output is projected to reach 2,000 curies, enough to meet national demand, estimated at 1,537 curies.
However, further steps are required to register HANARO-derived isotopes as ingredients in approved pharmaceuticals, as no drugmakers have yet filed the necessary paperwork to amend their product licenses.
On Thursday, the government convened a high-level roundtable at KIRAMS in northern Seoul to discuss strategies for boosting domestic production and regulatory streamlining.
Attendees included executives from leading radiopharmaceutical companies such as Cellbion, FutureChem, SK Biopharmaceuticals, and Saehan Industry, as well as nuclear medicine experts.
Yong-Kyun Kim, Vice President of the Korea Radiation Industry Association, stressed the urgent need for a national supply management framework, citing multiple instances—in 2009, 2016, and 2022—when foreign reactor shutdowns left Korean patients without treatment.
A radioisotope is a substance that emits radiation and can be used for therapeutic or diagnostic purposes. When combined with a targeting ligand—a compound that guides the isotope to bind with cancer cells or other specific sites—it can be utilized as a radiopharmaceutical. (Image courtesy of PxHere/CCL)
Industry leaders echoed the call. “Last year’s temporary Actinium shortage forced Bristol Myers Squibb to halt clinical trials,” said Kwon Kim, CEO of Cellbion. “A stable domestic supply will be a game changer for drug development.” Jae-Yoon Ji, CEO of FutureChem, added, “We can only pursue new therapies based on what isotopes are reliably available. That’s why this shift is critical.”
SK Biopharmaceuticals Vice President Sun-Kwan Hwang noted that even small quantities of Actinium are vital for early-stage research. “The short half-life of imported isotopes puts us at a competitive disadvantage,” he said. “We need centralized, government-backed logistics to make this viable.”
The current dual regulatory system—requiring approvals from both the Nuclear Safety and Security Commission and the Ministry of Food and Drug Safety—was also flagged as a bottleneck. Experts called for parallel reviews to expedite approvals.
Vice Minister of Science and ICT Chang-Yoon Lee confirmed that the government is prioritizing radiopharmaceuticals as one of 10 strategic bio-R&D investment areas and pledged expanded funding.
Following the forum, KIRAMS signed a memorandum of understanding with four companies to launch a new “Alpha Drug Development Consortium.” The group will jointly pursue treatments using alpha-emitting isotopes like Actinium-225 and Astatine-211, while also collaborating on regulatory reform and national R&D projects.
To support this effort, KIRAMS has proposed introducing a dedicated cyclotron for alpha isotope production.
Vice Minister Lee concluded by urging that domestic supply of Actinium and Iodine begin within the year, pledging full government support for infrastructure development and 100% localization of core medical isotopes.
M. H. Lee (mhlee@koreabizwire.com)
