K-Bio Under Pressure as Novartis Invests KRW 140 Billion

Number of Hospitals Expanding from 10 to 30... Infrastructure Grows
Cellbion and FutureChem Set for Direct Competition with Pluvicto

With the decision by global pharmaceutical company Novartis to invest 140 billion won in South Korea’s radiopharmaceutical (RPT) treatment infrastructure, domestic companies developing RPT drugs are feeling increased urgency. Although the number of hospitals capable of administering this therapy will triple, Novartis’s “Pluvicto”—which has virtually dominated the domestic market—will be used first at these expanded locations.

According to the pharmaceutical, biotechnology, and hospital sectors on July 30, the Korean RPT industry is now facing a mismatch between the speed at which the market is forming and the timeline for the emergence of domestically developed drugs. The main catalyst for this situation is the memorandum of understanding (MOU) signed on July 21 by the Ministry of Health and Welfare and Novartis, aimed at creating an ecosystem for radioligand therapy (RLT). Novartis plans to invest 140 billion won in domestic manufacturing facilities, cold chain pharmaceutical logistics networks, the expansion of hospitals providing treatment, and the training of research professionals.

RPT is a treatment that kills cancer cells using radioactive isotopes. Several methods exist, among which RLT works by attaching a radioactive isotope to a “ligand” that binds to proteins on the surface of cancer cells, thereby attacking only the targeted cells. The isotopes used are divided into beta emitters and alpha emitters, depending on the type of radiation they emit. Both Pluvicto and the domestic drug candidates use lutetium-177 (Lu-177), a beta emitter with a 6.6-day half-life, meaning it must be administered shortly after production and can only be used in hospitals with radiation-shielded rooms and nuclear medicine specialists. Even if domestic drugs receive approval, there are currently only ten hospitals where they can be sold, but the new agreement expands this number to 30.

The concern for domestic companies is that Novartis will fill the newly available hospitals first. The therapies under development by Cellbion and FutureChem operate by the same mechanism as Pluvicto. They target the same cancer cell proteins, use the same radioactive isotope, and are intended for the treatment of metastatic castration-resistant prostate cancer. In December of last year, Cellbion applied for conditional approval of “177Lu-Poqybotide,” and FutureChem’s “FC705” is currently in phase 3 clinical trials in Korea. In this context, if hospitals start using Pluvicto first, domestic companies will end up as latecomers who must convince doctors to switch prescriptions at a later stage.

Novartis is also expected to take the lead in insurance reimbursement, a decisive factor for price competitiveness. Pluvicto, priced at about 200 million won for six doses, is currently not covered by insurance but is in the application process for national health insurance listing. If it becomes reimbursable, cancer patient special status benefits would lower the copayment to 5%. In contrast, domestic drugs are targeting conditional approval based only on phase 2 clinical data, which could put them at a disadvantage in cost-effectiveness assessments. As a result, they may launch earlier but be slower to gain insurance coverage.

"The Decisive Battleground Is 'Alpha Emitters'... Infrastructure Expansion Brings Opportunity"

This trend is prompting domestic companies to turn their attention to the next-generation “alpha emitter” technology.

Alpha rays are more powerful than beta rays at killing cancer cells but travel only a few cell distances, greatly reducing damage to healthy tissues and targeting micro-metastasis not visible to the eye. Most importantly, alpha emitter therapies are still in very early clinical stages worldwide, meaning Korean firms have a real chance to compete globally.

Domestic companies are already accelerating the development of next-generation alpha emitter treatments. Last year, Cellbion’s preclinical project for an actinium-225 (Ac-225)-based prostate cancer therapy was selected for the National New Drug Development Project. FutureChem has secured an Ac-225 compound patent and is preparing for phase 1 clinical trials, while SK Biopharmaceuticals has received phase 1 trial approval in both the U.S. and Korea for its Ac-225 therapy, “SKL35501.” In May last year, the Korea Institute of Radiological & Medical Sciences formed the “Alpha New Drug Research Consortium” with four companies—including the above—and received approval for domestic production of Ac-225, opening the door to sourcing this raw material within Korea.

The hospital infrastructure being built by Novartis can later be used for domestic alpha emitter therapies as well. Radiation-shielded rooms and nuclear medicine specialists are relevant regardless of the type of isotope employed. An executive at a domestic biotech commented, “The true competition in RPT will ultimately be decided with alpha emitters. Since the hospitals and professionals being established now are not limited by isotope type, domestic companies have gained extra time to prepare next-generation therapies.”

The medical community expects the radiopharmaceutical market to continue its expansion. With advances in pre-diagnosis to identify patients likely to benefit, “theranostics” treatments—using radiopharmaceuticals that target cancer cells—are converging with the trend toward precision medicine. As research expands the range from terminally ill patients to early-stage treatments and various cancer types globally, Professor Seungkyun Ha of the Department of Nuclear Medicine at Seoul St. Mary’s Hospital stated, “As robust clinical evidence and multidisciplinary care systems develop together, the value of theranostics will only grow.”

This content was produced with the assistance of AI translation services.