[Reporter’s View] Time to verify K-radiopharmaceuticals

Radiopharmaceuticals are special preparations that combine drugs with radioactive isotopes for diagnostic or therapeutic use.

 

In particular, radioligand therapy (RLT), which delivers radiation directly to tumor cells, is known for its high precision, being referred to as "moving radiation surgery." As beta particle-based radioligand therapy enters the commercialization stage, the global industry is shifting its focus to alpha particle-based therapies, which offer higher energy, shorter range, and more precise killing power.

 

Leading candidates include actinium-225 and astatine-211.

 

These agents, which have a shorter range and higher linear energy transfer (LET) than the existing beta-particle-based lutetium-177, are gaining attention as next-generation targeted therapies for their ability to precisely target cancer cells while minimizing damage to surrounding tissues.

 

Multinational pharmaceutical companies are also making bold investments.

 

Novartis, which developed Lutathera and Pluvicto, acquired a radioligand therapy developer Mariana Oncology last year.

 

AstraZeneca has begun joint development with Actinium Pharmaceuticals.

 

The United States, Canada, and Europe have already incorporated the development of actinium production and purification infrastructure into their national strategies.

 

In contrast, Korea is still in its early stages.

 

Although the Korea Atomic Energy Research Institute (KAERI) and the Korea Institute of Radiological & Medical Sciences (KIRAMS) have isotope production and some research platforms, vertical integration encompassing isotope purification, labeling technology, ligand design, and clinical development has not yet been achieved.

 

Above all, the connection between hospitals, nuclear power, and pharmaceutical companies remains weak.

 

While platforms exist, they rarely lead to the development of pharmaceuticals.

 

Radiopharmaceuticals for diagnostic use have been commercialized, but the development of therapeutic agents is still lagging behind.

 

Nevertheless, companies in Korea have also begun to explore this field.

 

Currently, Cellbion is completing Phase II clinical trials for prostate cancer and is expected to apply for approval.

 

They expect therapeutic effects comparable to or better than those of the already commercialized Pluvicto.

 

FutureChem has completed a Phase II clinical trial for prostate cancer and plans to proceed with Phase III trials.

 

The company plans to apply for conditional approval as soon as it receives authorization for the Phase 3 Investigational New Drug (IND) application.

 

In this sense, the rumored development of K-radiopharmaceuticals is finally beginning to show some tangible results.

 

However, the companies’ pipelines still have gaps in key technological elements such as target protein design, clinical strategy, and formulation optimization compared to global standards.

 

Therefore, structural government support is necessary to secure independent competitiveness.

 

Radiopharmaceuticals are a complex technology with a high barrier to development.

 

However, as the entry barriers become extremely high, some experts believe that successful localization could enable market dominance even beyond that of antibody-drug conjugates (ADCs) once a company enters the field.

 

The solution for domestic production of radiopharmaceuticals lies not in isolated technologies but in “strategic integration.” It is now time to establish a “Korean RLT Alliance” that encompasses everything from target proteins to hospital networks, clinical design, and isotope supply.

 

Otherwise, domestically produced radiopharmaceuticals will remain mere objects of technology transfer rather than becoming market leaders.