Samsung Bioepis

Biosimilar to Soliris (eculizumab) used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS); approved by Brazil's ANVISA in December 2024.

Denosumab biosimilar; the European Commission approved OBODENCE (60 mg) and XBRYK (120 mg) in February 2025.

Keytruda (pembrolizumab) biosimilar candidate; interim results of a randomized, double-blind phase 1 study in 163 patients with completely resected stage II–IIIA non-small cell lung cancer showed pharmacokinetic equivalence to the reference product and are being presented at ESMO 2026.

Nectin-4-targeting antibody-drug conjugate (ADC) candidate and the company's first in-house novel drug program; a global phase 1 trial began in March 2026.

Head office on Songdo-gyoyuk-ro, Yeonsu-gu, Incheon, home to R&D roles (cell line, culture, purification, analytical method development, clinical and regulatory) and manufacturing and quality functions.

The Nectin-4-targeting ADC candidate SBE303 received U.S. FDA Fast Track designation for locally advanced or metastatic urothelial cancer in patients previously treated with Nectin-4-targeted therapy.

Signed a 10-year agreement, under Brazil's Productive Development Partnership (PDP) framework with local partners Bahiafarma and Bionovis, to supply the eculizumab biosimilar SB12 to Brazil's public health system (SUS); finished-product supply starts in 2027.

Announced that interim phase 1 results for the Keytruda biosimilar candidate SB27, showing pharmacokinetic equivalence to the reference product, will be presented as a poster at ESMO 2026.

Started a global phase 1 trial of SBE303, its first in-house novel drug candidate, and presented preclinical results at AACR in April 2026.