- Business
- Prestige BioPharma Limited (950210.KS) develops biosimilars, first-in-class antibody drugs and vaccines for infectious diseases. The Singapore-headquartered biopharmaceutical company, founded in 2015, operates R&D campuses in Singapore and Korea, including the Innovation Discovery Center in Busan and a CDMO facility through Prestige Biologics in Osong, Korea; it targets oncology, autoimmune disorders and unmet needs such as pancreatic cancer across global markets. Core products and pipeline include biosimilars Tuznue (HD201, trastuzumab biosimilar for HER2-positive breast and gastric cancers, Phase III complete), HD204 (bevacizumab biosimilar for solid tumors, Phase III), PBP1502 (adalimumab biosimilar for arthritis, Phase I) and over 12 additional candidates; first-in-class antibodies such as ulenistamab (PBP1510, PAUF-targeted for pancreatic cancer with FDA/EMA Orphan Drug and Fast Track designations, Phase 1/2a ongoing globally); next-generation vaccines including COVID-19 candidates; and diagnostics like the PAUF Pancreatic Cancer Detection Kit. Recent developments encompass European Commission marketing authorization for Tuznue in September 2024, marking the first biosimilar approval for a Singaporean firm in the EU following positive CHMP opinion in July 2024; licensing and supply agreements with Teva for European commercialization in October 2025, Dr. Reddy’s, Tabuk, Cipla and Pharmapark for global markets generating milestone payments, and Biosidus for Latin America in November 2025; opening of the Innovation Drug Center as an R&D hub; and participation in BIO USA 2025 to expand CDMO partnerships.