[Paek Jongmin's Shockwave]Radiopharmaceutical Cancer Drug 'Game Changer': Path to Domestic Production Opens

Korea Institute of Radiological & Medical Sciences Obtains Approval for Cyclotron-Based Production of Actinium-225
Breaking Free from Complete Import Dependence, Stabilizing Supply Expected
Alpha Particle Emission Enables Precision Targeting of

The era of domestic production of Actinium-225 (Ac-225), a key raw material for next-generation radiopharmaceuticals, is just around the corner.

The establishment of a domestic production base for Ac-225 is expected to serve as a crucial cornerstone not only for securing advanced technology, but also for providing new treatment opportunities to patients with intractable cancers and enabling Korea to emerge as a global leader in the field of radiopharmaceuticals.

The Ministry of Science and ICT announced on May 22 that the Korea Institute of Radiological & Medical Sciences (hereinafter referred to as the Institute) has obtained approval from the Nuclear Safety and Security Commission for cyclotron (particle accelerator)-based production of Ac-225, establishing the nation’s first production base. Until now, Korea has relied entirely on imports for Ac-225, suffering from unstable supply. Domestic production is expected to stabilize local supply and serve as a turning point for the development of innovative new drugs and cancer treatment.

Ac-225, a radioisotope that saves lives, is currently the most sought-after therapeutic radioisotope in the medical field. It has a relatively short half-life of about 10 days (9.92 days) and emits a total of four powerful alpha (α) particles during its decay process. Alpha particles have hundreds of times more energy than beta (β) or gamma (γ) radiation, but their penetration distance in human tissue is extremely short?only a few dozen micrometers (μm), about the thickness of a human hair.

Thanks to these unique physical properties, Ac-225 is in the spotlight as a core component of Targeted Alpha Therapy (TAT). When Ac-225 is attached to a targeting ligand?a substance that binds specifically to the surface of cancer cells?and administered into the body, the drug precisely reaches the cancer cells and emits alpha particles. The high-energy alpha particles released at this point act like a “precision-guided bomb,” selectively destroying only cancer cells while leaving surrounding healthy cells virtually unaffected. This innovative approach maximizes therapeutic efficacy while minimizing the side effects of conventional cancer treatments, offering new hope especially for refractory cancers or micro-metastatic cancers that do not respond to existing therapies.

Ac-225 is actively being researched and utilized in the development of neuroendocrine tumor treatments (such as Ac-225 DOTATATE) and prostate cancer treatments (such as Ac-225 PSMA-617). In particular, a series of clinical studies have reported remarkable therapeutic responses when Ac-225-PSMA-617 was administered to patients with advanced castration-resistant prostate cancer, drawing global attention.

◇ Domestic production enables timely treatment for cancer patients = Despite the great therapeutic potential of Ac-225, there is a major issue: severe supply shortages. According to the Institute, the global annual production of Ac-225 is only about 67 GBq (gigabecquerels), while demand is estimated to exceed 1,850 GBq. Only a handful of countries possess the necessary production facilities and technology. This is a classic case of supply failing to meet demand.

Until now, Korea has relied entirely on imports for Ac-225. As a result, unstable supply and high costs have persisted for years, and except for some clinical trial participation, patients have had no choice but to travel abroad for treatment. Kim Yongkyun, Vice President of the Korea Association for Radiation Application, stated, “There have been several instances in 2009, 2016, and 2022 where domestic patients were affected by the shutdown of foreign reactors,” emphasizing, “Ultimately, localization is the solution.”

Against this backdrop, the Institute’s acquisition of Ac-225 production approval is seen as a pivotal turning point for the self-sufficiency of domestic radiopharmaceuticals. The Institute plans to use a cyclotron to irradiate a radioactive radium (Ra-226) target with a proton beam to produce Ac-225, followed by chemical separation and purification processes to obtain high-purity Ac-225. Kim Kyungmin, Director of the Institute’s Radiation Medicine Research Center, stated, “We are currently modifying our facilities after receiving production approval, and aim to begin first production in December when inspections are completed.” The initial production scale will be 12 millicuries (mCi) per batch, enough to treat 34 patients at a time, with plans to develop technology to increase production by 10 to 15 times in the long term.

◇ Rapid moves by industry and government support = The competition to secure Ac-225 is fierce among domestic companies. SK Biopharm recently announced a supply agreement for Ac-225 with Pantera, a Belgian company. Pantera is a joint venture between particle accelerator specialist IBA and the Belgian Nuclear Research Center, aiming for large-scale Ac-225 production. Previously, SK Biopharm also secured an initial supply by signing Korea’s first Ac-225 supply contract with U.S. company TerraPower.

Companies are striving to secure Ac-225 because establishing a stable supply system for new radioisotopes is essential for developing new radiopharmaceuticals.

Kim Kwon, CEO of Cellbion, stated, “Last year, a temporary disruption in actinium supply forced Bristol Myers Squibb (BMS) to halt its clinical trials. If the (domestic production) system enables timely supply, it will be a great help for new drug development.” Ji Daeyoon, CEO of FutureChem, also emphasized, “The choice of radioisotope for new drug development depends on the supply situation, and (stable supply) is a key factor in determining the economic feasibility of clinical trials.” Hwang Seongwan, Vice President of SK Biopharm, added, “Even basic R&D cannot proceed actively without actinium, so even a small domestic supply is highly meaningful.”

Exterior view of the Korea Institute of Radiological & Medical Sciences.

The government has also pledged active support. On May 22, the Ministry of Science and ICT held an on-site meeting at the Institute to promote self-sufficiency in medical isotopes and the development of radiopharmaceuticals, with First Vice Minister Lee Changyun presiding over discussions with radiopharmaceutical companies and nuclear medicine experts on establishing a domestic supply system. At the meeting, Vice Minister Lee stated, “Through the National Bio Committee, radiopharmaceuticals have been designated as one of the top 10 bio R&D investment areas,” and announced plans for increased budget allocation.

He also urged, “Please make efforts to supply actinium and iodine (I-131 for thyroid cancer treatment, with GMP approval obtained by the Korea Atomic Energy Research Institute) domestically within this year,” and added, “The government will actively support the establishment of isotope production infrastructure and the expansion of R&D support for radiopharmaceuticals to achieve 100% self-sufficiency in key isotopes.”

After the meeting, the Institute signed a memorandum of understanding (MOU) with four companies?SK Biopharm, Saehan Industry, Cellbion, and FutureChem?to form an “Alpha New Drug Research Council.” The council will jointly promote the development of therapeutics using alpha-emitting isotopes such as Ac-225 and Astatine-211 (At-211), regulatory improvements, and the discovery of national R&D projects. This is expected to serve as an important foundation for the localization and commercialization of therapeutics in the future.

Challenges remain. Industry stakeholders have pointed out that dual regulations by the Nuclear Safety and Security Commission and the Ministry of Food and Drug Safety slow down new drug development, and have suggested that parallel regulatory procedures could help shorten the timeline. In addition, the Institute has raised the need to introduce two dedicated cyclotrons for these radioisotopes to ensure stable and expanded supply.