Prestige Biologics (KOSDAQ: 334970), a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) led by CEO Hyun Duk Hoon, announced on the 24th that its cumulative order backlog has surpassed KRW 32 billion. This marks the first time since the company’s establishment that its annual cumulative order value has exceeded KRW 30 billion. The order volume alone represents growth of more than 1,500% compared to the previous year’s revenue of KRW 2.1 billion.In particular, the KRW 3.9 billion contract announced last week carries special significance as it is the company’s first order this year that is not centered on its parent company. While the customer’s name and product details remain confidential at the client’s request, the contract is expected to significantly support Prestige Biologics’ business expansion, reflecting the strong trust the company has built with its customers. The company secured the contract by leveraging its extensive experience in contract manufacturing of biopharmaceuticals, having successfully completed more than 100 production batches.As a result, utilization rates across the company’s four manufacturing facilities with a combined capacity of 154,000 liters are steadily increasing. Plant 1 has already exceeded a 70% utilization rate based on maximum batch production capacity, while production for contracted orders is also underway at Plants 2 and 4. The company expects further expansion of its manufacturing operations this year, driven by production of its parent company Prestige Biopharma’s pipeline products and growing interest from global pharmaceutical and biotechnology companies. In particular, large-scale production of Tuznue is being carried out at Campus 1, which has already obtained EU GMP certification. In addition, preparations for U.S. FDA cGMP certification are actively underway at Plant 4 through HD204, which is currently being prepared for regulatory approval.With an order backlog of KRW 32 billion, the company plans to capitalize on its momentum by focusing its organization-wide capabilities on securing large-scale supply contracts. To support this strategy, Prestige Biologics is pursuing a two-track management approach that combines the recruitment of specialized personnel with the establishment of a rigorous quality management system. Having built a strong track record through a wide range of CDMO projects, the company continues to receive inquiries from both domestic and international markets, further raising expectations for additional contract wins.A company representative stated, “A virtuous cycle is being established in which stable new orders and a solid order backlog are increasing plant utilization rates and expanding our business footprint. Through our differentiated strategy based on single-use bioreactor technology, which reduces the risk of cross-contamination while enhancing cost competitiveness and manufacturing flexibility, we will continue to strengthen our efforts to secure new customers.”

Prestige Biologics has commenced preparations for large-scale production of the biosimilar Tuznue.Prestige Biologics (KOSDAQ: 334970), a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) led by CEO Hyun Duk Hoon, announced on the 5th that it has secured a KRW 12.3 billion contract from Prestige Biopharma for the supply of Drug Substance (DS) for Tuznue. The contract runs through September 17, 2025, and represents approximately 567% of the company’s revenue from the previous year. With this latest order, the total value of Tuznue manufacturing contracts awarded this year has reached KRW 19 billion.Tuznue, a biosimilar to Herceptin, received final marketing authorization from the European Commission (EC) in September and is scheduled for commercial launch in Europe next year. Following European approval, Prestige Biopharma initially placed orders for engineering and validation batches, as well as materials required for stability studies, to confirm manufacturing processes and prepare for large-scale production. The company has now placed an additional large-volume order to support commercial readiness.Drug Substance (DS) refers to the antibody protein that has undergone cell culture and purification processes and is subsequently formulated with stabilizing buffers. It is later converted into Drug Product (DP) through formulation, labeling, and packaging operations. As Prestige Biopharma prepares to finalize agreements with commercial partners in Europe, securing sufficient quantities of DS for supply to distributors and commercialization partners has become increasingly important.This contract is expected to serve as a significant global track record for Prestige Biologics. As its parent company accelerates commercial expansion into the European market, the opportunity exists not only for large-scale DS production but also for future Drug Product manufacturing, potentially driving substantial growth across the group. Supported by its parent company’s pipeline products—including Tuznue, biosimilar candidate PBP1601, and pancreatic cancer antibody therapeutic PBP1510—as well as previously secured orders, the company’s order backlog has now exceeded KRW 22 billion.Hyun Duk Hoon, CEO of Prestige Biologics, stated, “Our two-track strategy of manufacturing products for our parent company while simultaneously expanding our customer base is gaining momentum, allowing us to steadily establish ourselves as a global CDMO company. As the U.S. Senate is expected to decide this month on the Biosecure Act, we will also continue our efforts to secure final purchase orders from global pharmaceutical companies through our business development activities.”

The first international symposium of Prestige Biopharma IDC was a meaningful event that shared advanced biopharmaceutical technologies and platform development achievements while discussing the possibilities of collaboration and innovation.On the first day, presentations covered topics such as disease modulation, new drug development strategies, and immune-modulating virus therapies, offering insights into the future of advanced biotechnologies.On the second day, discussions focused on global biopharma collaboration and innovation cases, strategies for supporting biotech startups, and R&D cooperation achievements, with panel discussions presenting growth directions and collaboration strategies for the biopharma industry.This symposium served as an opportunity to foster networking and information exchange among experts, solidifying Prestige Biopharma IDC's vision to become a global innovation hub in the biopharma industry.

Prestige Biopharma Group has taken its first step toward becoming a global innovation hub in the biopharma industry with the opening ceremony of its R&D control tower, the Innovation Drug Center (IDC).With its cutting-edge research platform and global network, IDC is dedicated to the development of antibody therapeutics and biosimilars for the treatment of intractable diseases, embodying the vision of "Innovation for Life."The international symposium held alongside the opening ceremony provided an opportunity to share achievements in biopharmaceutical technologies and platform development, while exploring the possibilities of collaboration and innovation.Moving forward, IDC aims to lead the global biopharma industry and establish itself as a world-class biopharma cluster.We kindly ask for your continued interest and support in the journey of the Innovation Drug Center.

Prestige Biologics has been named ‘Best Biologics CMO in South Korea’ at the Biologics Contract Manufacturing Asia 2024!With expertise in single-use and scale-out biomanufacturing, we continue to deliver top-quality CDMO services.   

BIO USA 2024 has opened today in the United States.Prestige Biopharma Group is continuing with over 30 meetings on the first day.All employees are committed to doing their best to achieve successful outcomes.