SAMSUNG BIOLOGICS CO., LTD.

Samsung Biologics launched Samsung Organoids, an advanced drug screening service utilizing three-dimensional cell culture systems that closely mimic human organs to provide clinically relevant insights for drug discovery and development.

The US Small Molecule Innovator API CDMO Market is valued at $8.78 billion in 2024 and expected to reach $12.49 billion by 2030, growing at a 6.03% CAGR.

Samsung is restructuring its biopharmaceutical business governance by making Samsung Bioepis a wholly-owned subsidiary of Samsung Biologics, streamlining operations and decision-making processes.

Samsung Biologics announced plans to establish Samsung Epis Holdings, which will incorporate Samsung Bioepis as a wholly owned subsidiary, separating its biosimilar development from CDMO operations.

Samsung Biologics has secured over 3 trillion won ($2.2 billion) in cumulative contract orders for 2025 within just five months, representing more than 60 percent of its total 2024 contract value.

GSK received FDA approval for Benlysta's 200 mg/mL autoinjector for subcutaneous injection in patients five years and older with active lupus nephritis, marking the first FDA-approved treatment specifically for this severe kidney complication.

Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases.

• Samsung entities have collectively invested $10 million in C2N Diagnostics to scale their clinical laboratory services and advanced diagnostic solutions for brain health. • C2N's PrecivityAD2 blood test algorithm has demonstrated over 90% accuracy in diagnosing Alzheimer's disease in primary care settings, comparable to results from cerebrospinal fluid or amyloid PET analysis. • The strategic partnership aims to accelerate global access to C2N's blood biomarker testing technologies for Alzheimer's disease while expanding their biomarker pipeline for tau pathology and Parkinson's disease.

• Samsung Bioepis is developing SB16, a biosimilar version of denosumab, targeting multiple indications including post-menopausal osteoporosis and skeletal-related events in advanced malignancies. • The investigational monoclonal antibody works by targeting RANK ligand (RANKL) and is administered subcutaneously, aiming to provide a more accessible treatment option. • Samsung Bioepis continues to expand its biosimilar portfolio across multiple therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology.

• Major pharmaceutical research trends in 2024 highlight the growing integration of artificial intelligence in R&D, with significant discussions at the 42nd JP Morgan Health Conference shaping industry perspectives. • CRISPR technology continues its revolutionary trajectory in genetic medicine, marking crucial milestones in its evolution from discovery to practical therapeutic applications. • Alexion and other industry leaders are accelerating rare disease research, while clinical trials undergo transformation through decentralization, increased diversity initiatives, and digital tool implementation.