South Korea is taking a major step toward securing its radiopharmaceutical future.
Korea Hydro & Nuclear Power (KHNP) has unveiled plans to establish the country's first domestic commercial production of lutetium-177 (Lu-177), the therapeutic radioisotope used in Novartis' blockbuster radioligand therapies Pluvicto and Lutathera. If successful, the initiative would end South Korea's complete dependence on imported Lu-177 while laying the foundation for future production of additional medical isotopes, including actinium-225.
The government-backed program calls for the creation of a special-purpose company next year, pilot production beginning in 2028, and full commercial production by 2031.
"While the timeline may vary depending on technology development and licensing schedules, the goal is to commercialize Lu-177 first," KHNP said. "The plan is to subsequently expand the product lineup to include Cobalt-60, Tritium, and Helium-3."
Unlike many existing Lu-177 production facilities that rely on research reactors, KHNP intends to utilize the heavy water reactor at the Wolsong Nuclear Power Plant. Heavy water reactors offer a unique operational advantage because target materials can be inserted into and removed from the reactor while it remains online, allowing greater flexibility in scheduling isotope production.
"When neutrons generated in the reactor bombard an element, the atom transforms, creating a radioisotope," KHNP explained, noting that Canada has long used heavy water reactors for medical isotope production.
For South Korea, the project represents more than simply adding another isotope producer. It is part of a broader national strategy to develop a domestic radiopharmaceutical supply chain as local biotechnology companies move closer to commercializing Lu-177-based therapies.
South Korean companies including Cellbion and FutureChem are among the country's largest Lu-177 users, with both advancing PSMA-targeted radiopharmaceutical therapies for prostate cancer. Today, every shipment of Lu-177 must be imported. Because the isotope has a physical half-life of only about 6.6 days, delays in manufacturing or transportation directly reduce usable activity while increasing costs.
A FutureChem official described the logistical challenges.
"Even after a patient dosing schedule is confirmed, it takes about two weeks to order and receive the raw material," the company said. "It is difficult to cancel orders midway, so the cost burden is considerable."
The official added that "since Lu-177 is entirely dependent on imports, prices do not come down easily," noting that the current cost of raw material remains high.
FutureChem also acknowledged that securing isotope supply has become easier than during its early clinical programs but said international logistics have previously created challenges.
"Currently, we have secured multiple suppliers, so there are no issues, but in the early stages of clinical trials, there were supply difficulties," the company said. "In cases where materials were brought in from conflict zones, there were also air freight delay issues."
Industry leaders caution that domestic production will not immediately replace established international suppliers. Instead, they see KHNP's project as adding resilience to an increasingly complex isotope supply chain.
A Cellbion official said the company currently maintains suppliers across the United States, Europe and the Middle East.
"Currently, we have secured multiple supply sources in the U.S., Europe, and the Middle East, so there are no disruptions to clinical and production schedules," the company said. However, "if commercial supply begins domestically, it will have a positive effect in terms of supply chain diversification and reduced transport time."
Shorter transportation times mean less radioactive decay before manufacturing, improving both production efficiency and available patient doses.
Still, Cellbion emphasized that adoption will ultimately depend on product quality and commercial performance.
"Since the supply price, quality, and supply capacity have not yet been determined, it is difficult to estimate the economic effect at this stage."
KHNP has stated it intends to produce isotope material that meets both domestic and international quality standards.
Even if South Korea successfully establishes domestic Lu-177 production, winning market share will require much more than securing isotope supply. Last month, Novartis announced plans to invest approximately 140 billion won (about $98.5 million) to expand South Korea's radioligand therapy ecosystem through domestic manufacturing, cold-chain logistics, physician training and hospital infrastructure.
The initiative is expected to increase the number of South Korean hospitals capable of administering Lu-177 therapies from roughly 10 today to approximately 30. Pluvicto is also pursuing national reimbursement, a move that could significantly lower patient out-of-pocket costs and strengthen Novartis' early commercial position.
While Lu-177 remains today's dominant therapeutic isotope, KHNP is already looking toward the next generation. The company has identified actinium-225 among the isotopes it hopes to eventually produce. That roadmap aligns with growing industry interest as developers increasingly expand pipelines beyond beta-emitting therapies into targeted alpha therapies.
Cellbion views the transition as evolutionary rather than disruptive.
"Lu-177 is a nuclide with accumulated global approval and commercialization cases and will remain the center of the market for the time being," a Cellbion official said. "We view Ac-225 not as a replacement but as a next-generation nuclide that offers a new option for patients who do not respond to existing treatments."
FutureChem echoed that perspective.
"Ac-225 is also an isotope with sufficient potential," the company said. "While challenges such as supply stability, price, and side effects remain to be solved, if overcome, it could become a new treatment option for patients."
South Korea's Lu-177 initiative reflects a broader shift taking place across the global nuclear medicine industry. Countries are increasingly treating medical isotope production as strategic national infrastructure, recognizing that reliable domestic supply can support not only patient care but also pharmaceutical innovation, manufacturing investment and healthcare resilience. As more governments seek to localize isotope production, competition may increasingly be defined not by who develops the next radiopharmaceutical, but by who controls the critical isotopes that power them.
