NEWS | Innovation for Life

SINGAPORE, August 12, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, announced its unaudited results for FY2021 (from July 2020 to June 2021) on August 12, 2021. Consolidated operating loss was KRW 18.78 billion, mainly due to an increase in operating expenses relating to research and development activities which will be the future growth engine of Prestige Biopharma. The net loss of KRW 7.69 billion for FY2021 declined by 48.7% from the previous fiscal year due primarily to the valuation gains on investment in equity securities of its affiliate, Prestige Biologics Co., Ltd.

PBP has been laying a solid foundation for future growth for the past six years since its establishment in 2015, and the company was listed on the Korean stock exchange last February.

PBP is currently participating in the CMO consortium to produce Russia’s Sputnik COVID-19 vaccines. Its vaccine centre with 100,000 litres of final production capacity has started a test operation this month. The commercial production of Sputnik vaccine is scheduled in the fourth quarter of 2021 and a strong increase in sales and earnings is expected from the vaccine CMO business.

The company expects a commercialisation of its biosimilar pipelines next year. PBP’s Herceptin® biosimilar, HD201 has secured global distribution partnerships in major regions of the world, and it is currently under EU EMA’s review. The FDA bridging study of HD201 was published in the international journal of Pharmacology Research & Perspectives last July and the US submission to FDA is on target to be completed this year. Prestige Biopharma’s biosimilar to Avastin®, HD204 is in the process of the global Phase 3 clinical trial and PBP1502, biosimilar to Humira® is in the preparation of its Phase 1 clinical trial.

The initiation of Phase 1/2a clinical trial of Prestige Biopharma’s first-in-class antibody treatment of pancreatic cancer, PBP1510 was approved in France in June this year. The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and Korean Ministry of Food and Drug Safety (MFDS) granted Orphan Drug Designation (ODD) to PBP1510 last year and ODD products’ marketing authorisation application can be reviewed before Phase 3 clinical trial depending on the result of Phase 2 study.

Based on this fundamental strength, Prestige Biopharma will see a solid growth momentum from the fourth quarter this year.