SK Biopharm said it posted its best-ever first-quarter results, driven by strong sales of its epilepsy drug cenobamate, sold in the U.S. as Xcopri. The company said it plans to use the momentum and cash flow to speed research and development centered on targeted protein degradation, or TPD, along with next-generation pipeline and proprietary platform technologies.
In a regulatory filing on 7일, SK Biopharm said its consolidated operating profit for the first quarter was 89.8 billion won, up 249.7% from a year earlier on a preliminary basis. Revenue rose 57.8% to 227.9 billion won. U.S. sales of cenobamate, the company’s main profit driver, increased 48.4% to 197.7 billion won.
To expand cenobamate’s indications, the company said it submitted a U.S. Food and Drug Administration new drug application in March for an oral suspension formulation. It is also pursuing filings within the year to expand indications to primary generalized tonic-clonic seizures, or PGTC, and pediatric patients. In China, it began commercialization in March through partner Ignis Therapeutics. Approval procedures are also underway in Japan within the year, it said.
SK Biopharm said it is stepping up R&D investment based on cash flow from cenobamate. Building on its central nervous system focus, it is expanding pipelines in radiopharmaceutical therapeutics, or RPT, and TPD. The company has previously identified RPT, TPD and cell and gene therapy, or CGT, as three new growth platforms.
On a post-earnings conference call, SK Biopharm detailed development of SKT-18416, a p300 selective degrader candidate. The TPD candidate is designed to selectively degrade the p300 protein, which is involved in cancer cell growth and survival.
Choi Jong-gil, head of strategy at SK Biopharm, said SKT-18416 is a first-in-class candidate that selectively degrades p300. He said the company has confirmed in preclinical work that a p300 selective degrader can reduce the risk of hematologic toxicity and is advancing development based on those findings.
The company said it confirmed tumor growth inhibition in preclinical models of prostate cancer and CBP-mutant cancers. It is preparing a preclinical package for an investigational new drug application, targeting submission in the first half of next year. Indications under review include cancers with high p300 dependency, with prostate cancer and multiple myeloma prioritized, it said.
The conference call also introduced the company’s proprietary platform, MOPED, a technology for discovering compounds that selectively degrade specific proteins by inducing protein-protein interactions.
SK Biopharm said molecular glues discovered through MOPED show improved drug-like properties and blood-brain barrier penetration compared with conventional heterobifunctional TPD approaches, and have demonstrated scalability, supporting differentiated technological competitiveness.
* This article has been translated by AI.
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