SK Biopharmaceuticals Unveils Next-Generation Pipeline Strategy Centered on TPD at R&D Session

On May 7, SK Biopharmaceuticals unveiled its next-generation pipeline and research and development (R&D) strategy centered on Targeted Protein Degradation (TPD) and proprietary platform technologies during its R&D session, held in conjunction with the announcement of its first-quarter results for 2026.

This R&D session was organized to complete the roadmap for the company's three core areas—including TPD—following last quarter's announcement of its central nervous system (CNS) and radiopharmaceutical therapy (RPT) strategies. SK Biopharmaceuticals is pursuing concrete research directions for its transition to a 'Big Biotech,' leveraging free cash flow generated from its flagship product Cenobamate to: ▲ strengthen disease-modifying therapy (DMT) capabilities for CNS disorders beyond symptom relief; ▲ establish a sustainable RPT platform value chain; and ▲ discover new pipelines through its TPD platform.

This session featured Jongkil Choi, Head of Investment Company Management, who outlined the company's R&D strategy for the TPD field, as well as the key competitive advantages of its major pipelines and platform technologies.

Selective Degradation-Based Anticancer Strategy: Targeting p300 with 'SKT-18416'

In terms of the pipeline, the preclinical results of 'SKT-18416,' a p300-targeted degrader, were discussed in detail. p300 is a core protein within the transcriptional complex and is essential for cancer cell growth; however, due to its high structural similarity with the homologous CBP protein, existing inhibitors have faced limitations such as hematological toxicity. Homology refers to the degree of similarity in protein sequences; p300 and CBP are highly similar structurally, necessitating precise and selective degradation.

SKT-18416 demonstrated excellent safety in preclinical studies by selectively degrading p300 without affecting CBP. In efficacy assessments, it exhibited strong tumor growth inhibition in models of prostate cancer, multiple myeloma, and CBP mutant (Loss of Function, LoF) cancers, and showed antitumor effects in cancers highly dependent on tumor-specific factors. Notably, in cancers where CBP function is lost, the removal of p300 induces cancer cell death via 'synthetic lethality,' highlighting the potential for precision medicine. LOF refers to mutations that result in loss of gene function. In CBP mutant (LoF) cancers, selectively removing p300 leads to cancer cell death. Synthetic lethality describes a phenomenon where a cell survives when only one of two genes is defective, but dies when both genes lose function.

Based on these mechanistic data and its oral bioavailability, SKT-18416 has secured the potential to become a first-in-class development candidate in its target area. The project is currently under research with the aim of submitting an Investigational New Drug (IND) application, with the target submission set for the first half of 2027.

'MOPED™' Molecular Glue Platform: Expanding Target Reach

The company also introduced its proprietary platform 'MOPED™ (MOlecular Proximity Enabled Detection).' MOPED™ is a technology that induces protein-protein proximity to discover molecules that selectively degrade specific proteins, featuring the ability to target 'undruggable' proteins previously considered out of reach by conventional approaches. Molecular glues discovered via MOPED™ exhibit superior drug-like properties and blood-brain barrier (BBB) permeability compared to traditional heterobifunctional TPD technologies, while also demonstrating high scalability and differentiated competitive advantages. Heterobifunctional TPD refers to a technique that combines two different functional parts within a single molecule to selectively eliminate disease-related proteins.

SK Biopharmaceuticals has expanded its access to new targets and identified optimal combinations by leveraging a proprietary E3 ligase library of over 30 types, applying high-sensitivity screening technology to detect even subtle protein-protein interactions and thereby securing platform scalability. Additionally, the company has integrated AI-based predictive modeling to estimate the probability of ternary complex formation and target degradation activity, thereby increasing the efficiency of candidate discovery.

Revenue-Based R&D Expansion: Accelerating the 'Balanced Big Biotech' Strategy

SK Biopharmaceuticals is expanding its R&D portfolio by building proprietary platforms and pursuing external collaborations in next-generation modality areas such as TPD and RPT, leveraging stable revenue from Cenobamate. Through these efforts, the company aims to continuously generate new drug candidates with in-house capabilities and expand its global competitiveness.

An SK Biopharmaceuticals official stated, "SK Biopharmaceuticals is the only company in Korea possessing a small-molecule CNS drug platform that has discovered two FDA-approved innovative new drugs. We have reinvested the sustainable and growing revenue generated from new drugs into next-generation pipelines and platforms such as TPD and RPT, and will continue to communicate tangible achievements closely with the market going forward."

More detailed information on the R&D strategies and key pipelines discussed in this session will be provided in separate reference materials. Conference call materials, including the content of the R&D session, are available on the SK Biopharmaceuticals website.

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