SK Biopharmaceuticals Expands into Radiopharmaceuticals After Epilepsy Drug Success

SK Biopharmaceuticals (326030) is broadening its business portfolio by reinvesting cash generated from its epilepsy drug into next-generation cancer technologies, including radiopharmaceuticals. Analysts say the company has established a virtuous R&D cycle based on profitable direct sales of its proprietary drug in the United States.

According to industry sources on May 26, SK Biopharmaceuticals posted revenue of 706.7 billion won and operating profit of 203.9 billion won last year, marking record-high performance since the company's founding. The results exceeded market expectations. Operating profit surged 111.7% year-on-year, more than doubling in just one year. The company has resolved the chronic profitability issues plaguing domestic biotech firms and secured self-sustaining R&D investment funds.

The improved performance is attributed to strong sales of cenobamate, the company's internally developed epilepsy treatment. U.S. sales of cenobamate reached 630.3 billion won during the same period, up more than 40% year-on-year, with total prescriptions reaching 477,412.

Cenobamate's competitive edge lies in its high "seizure freedom rate"—the proportion of patients who experience no seizures for a defined period after taking the medication. Rather than simply reducing seizure frequency, this metric shows how many patients achieve complete seizure cessation. It is considered a key criterion in epilepsy treatment, directly linked to patients' return to daily life. Based on this clinical data, the company is expanding market share by strengthening direct sales and marketing operations in the U.S. With Phase 3 trials progressing smoothly for indication expansion into pediatric epilepsy and generalized seizures, global royalty revenues are expected to increase substantially.

The company is channeling this cash flow into radiopharmaceutical therapeutics (RPT), a next-generation oncology field. Radiopharmaceuticals combine radioactive materials with cancer-targeting molecules to precisely attack only cancer cells. The goal is to enhance therapeutic efficacy while minimizing damage to normal tissue.

In January, the company's alpha-emitting radiopharmaceutical candidate "SKL35501" received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration for Phase 1 clinical trials. This marks the first time a Korean company has obtained FDA approval for an alpha-emitting radiopharmaceutical.

SK Biopharmaceuticals is particularly focused on securing chelator platform technology. Chelators are structures that stably link radioactive materials to cancer-targeting molecules. This technology enables application across various cancer targets, facilitating pipeline expansion. The company aims to submit an IND for its second RPT pipeline by next year.

SK Biopharmaceuticals is also advancing targeted protein degradation (TPD) technology. This approach induces the degradation of disease-causing proteins within cells, rather than merely inhibiting their function. It is considered a next-generation technology for its potential to extend treatment to diseases previously difficult to address with conventional drugs.

Research continues in the central nervous system (CNS) field. SK Biopharmaceuticals is pursuing development of disease-modifying treatments (DMT) that slow the progression of Parkinson's disease itself. While most current Parkinson's treatments focus on alleviating symptoms such as tremors, DMTs aim to slow disease progression or address root causes. The strategy is to secure treatments that influence disease course beyond symptom management.

"We will strengthen our mid-to-long-term growth foundation by reinvesting cash generated from our proprietary drugs into new technologies," an SK Biopharmaceuticals official said.