Lutetium-177 (Lu-177) has been selected as the first commercialized item for the government's "industrialization of radioactive isotopes using nuclear power plants."
Lu-177 is the most widely used therapeutic isotope in the current global radiopharmaceuticals market, and Korea has relied entirely on imports. It is still in the early stage, but if carried out as planned, the first domestic commercial production of Lu-177 will be achieved.
Korea Hydro & Nuclear Power Co. (KHNP) said to ChosunBiz on the 6th, "It may vary depending on the timelines for technology development and regulatory approval, but our goal is to commercialize Lu-177 first," adding, "We then plan to expand the lineup to cobalt-60 (Co-60), tritium (H-3), and helium-3 (He-3)."
H-3 is a substance that naturally occurs in heavy-water reactors and is already being captured, and the plan is to increase production going forward. According to Pocheon Business Insight, the Lu-177 market is projected to grow at an average annual rate of 19.9%, from $3.43 billion this year to $14.7 billion in 2034.
KHNP is currently promoting the commercialization of radioactive isotopes through a special purpose company (SPC) in the form of a subsidiary. The overall production scale, investment amount, and the composition of private corporations to participate in the SPC have not yet been finalized. The government plans to establish the corporation by next year after interagency consultations this year and begin pilot production in 2028.
Full-scale commercial production is targeted for 2031. An official at the Ministry of Climate, Energy and Environment said, "We are reviewing one more radioactive isotope that can be commercialized," noting, "We plan to make a decision on the candidate substance and its application by comprehensively weighing technical feasibility and marketability."
The Wolseong Nuclear Power Plant's heavy-water reactor will be used for production. KHNP explained, "When you irradiate elements with neutrons generated in a reactor, the atoms change and radioactive isotopes are produced."
Unlike standard light-water reactors, heavy-water reactors allow raw materials to be inserted and removed from inside the reactor even while the plant is operating. Because it is easy to control the timing and volume of production, countries such as Canada are already using them to produce medical radioactive isotopes.
◇ Full imports for Lu-177… domestic supply chain starts up
Lu-177 is also used in Novartis' prostate cancer therapy "Pluvicto" and the neuroendocrine tumor therapy "Lutathera." With a half-life of only about 6.6 days, everything from production and transport to drug manufacturing and patient dosing must take place in a short time.
The corporations that use Lu-177 the most in Korea include CellBion(308430) and FutureChem(220100). Both companies are developing Lu-177-based prostate cancer therapies targeting prostate-specific membrane antigen (PSMA) and are competing to launch the first radiopharmaceutical therapy in Korea.
CellBion has applied to the Ministery of Food and Drug Safety for conditional approval of "177Lu-Pocuvotide." Recently, it also submitted a phase 3 clinical trial plan. FutureChem is conducting a domestic phase 3 trial of "FC705," and in May it completed dosing of the last patient in a U.S. phase 2a trial.
The full-import structure is a burden for domestic radiopharmaceutical corporations. That is why the government is pushing to localize Lu-177.
A FutureChem official said, "Even after a patient dosing schedule is confirmed, it takes about two weeks from ordering the raw material to receiving it," adding, "It is also difficult to cancel orders midway, so the expense burden is not small."
The official added, "Because Lu-177 relies entirely on imports, prices do not come down easily," noting, "The current raw material price itself is quite high."
A CellBion official said, "We have secured multiple supply sources in the United States, Europe, and the Middle East, so there are no disruptions to clinical and production schedules for now," but added, "Once commercial supply begins domestically, there will be positive effects in terms of diversifying the supply chain and shortening transport times." The explanation is that reducing transport time cuts losses from radioactive decay and improves utilization efficiency.
As global demand grows rapidly, competition to secure raw materials is also intensifying. An industry official said, "Some corporations find it difficult to enter the market at all because they cannot secure Lu-177 stably."
A FutureChem official also said, "There is no problem now because we have secured multiple supply sources, but in the early clinical stages there were difficulties with supply," adding, "When bringing it in from conflict regions, there were also flight delay issues."
The industry believes this project will be a starting point for building a domestic raw material supply chain ahead of the commercialization of Lu-177-based therapies.
A FutureChem official said, "If we can produce raw materials domestically, it will help secure price competitiveness for therapies," adding, "In overseas exports, the domestic production infrastructure itself can be a competitive edge."
However, the industry expects that even if domestic Lu-177 is produced, it will be difficult to immediately replace existing overseas supply chains. The position is that they will decide whether to adopt it after comprehensively verifying quality and compliance with GMP (Good Manufacturing Practice), regulatory requirements, and supply stability.
A CellBion official explained, "Because supply price, quality, and supply capacity have not yet been determined, it is difficult at this stage to calculate the economic effect."
On quality, KHNP said, "We will secure quality that meets relevant domestic and international regulations."
◇ Raw materials alone are not enough… market competition is just beginning
Some note that stabilizing raw material supply does not immediately translate into market competitiveness.
Novartis last month signed a memorandum of understanding (MOU) with the Ministry of Health and Welfare to build a radioligand therapy (RLT) ecosystem and decided to invest 140 billion won in domestic manufacturing facilities, cold-chain logistics networks, expansion of administering hospitals, and training research personnel.
Currently, about 10 hospitals in Korea can administer Lu-177 therapies, equipped with radiation shielding facilities and nuclear medicine specialists, but the agreement is expected to expand that to 30. If hospital infrastructure is established first, Pluvicto is likely to capture the early market.
Novartis is also likely to lead in health insurance coverage. Pluvicto is currently seeking to be listed for national health insurance benefits, and if reimbursement applies, the out-of-pocket rate for patients will fall to around 5% through the special case for cancer patients.
Against this backdrop, the industry is watching whether KHNP will expand its future production lineup to include actinium-225 (Ac-225).
Ac-225 is considered a next-generation radioactive isotope to follow Lu-177. Early clinical results indicate it has greater cancer cell-killing power than Lu-177 and relatively less damage to normal tissue. CellBion and FutureChem are also pursuing development of Ac-225-based therapies.
A FutureChem official said, "Ac-225 is an isotope with ample potential," adding, "There are still challenges to resolve, including supply stability, price, and side effects, but if they are overcome, it could offer patients a new treatment option."
A CellBion official explained, "Lu-177 is a radionuclide with a global track record of approvals and commercialization, and it will remain the center of the market for the time being," adding, "We see Ac-225 not as a replacement, but as a next-generation radionuclide that offers a new option for patients who do not respond to existing treatments."