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Prestige Biologics News
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Prestige BioLogics Achieves Record Quarterly Results(Aug. 19, '26) Prestige BioLogics surpassed KRW 10 billion in quarterly revenue for the first time.According to Prestige BioLogics on the 19th, the Company recorded revenue of KRW 11.47 billion in Q4 of FY2026 (April–June 2026).This represents an increase of more than five-fold compared to the previous quarter's revenue of KRW 2.27 billion.Throughout FY2026, Prestige BioLogics continued to expand its order base, signing a total of six new CDMO (contract development and manufacturing) contracts with domestic and international clients, worth approximately KRW 41.2 billion.As these new contracts were sequentially converted into production and revenue, they had a positive impact on this quarter's results.Kim Jin-woo, CEO of Prestige BioLogics, said, "The widened loss despite revenue growth was mainly due to items such as inventory assets, convertible bonds (CBs), and impairment of certain production equipment, with limited impact on actual cash flow."He added, "Surpassing KRW 10 billion in Q4 revenue is a clear sign that the order base we've been building is now materializing into results."| Source: Asia Economy (아시아경제) | https://www.asiae.co.kr/article/2026081908554428168 This English version is a translation provided by the Company for reference purposes. The original article was written and published in Korean by Asia Economy.
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Prestige Biopharma Enters Strategic MOU with Charles River , a Global Contract Research Organization(July 02, 2026) Prestige Biopharma Enters Strategic MOU with Charles River , a Global Contract Research Organization● Collaborating to Accelerate Development and Commercialization of Biosimilars and Novel Antibody Therapeutics● Integrating a Full-Coverage Value Chain: From Discovery, Preclinical, and Safety Testing to Process Development and GMP Manufacturing● Driving Global Business Expansion and CDMO Pipeline Growth through Strategic Networking and Joint MarketingSINGAPORE/SEOUL — June 22, 2026 — Prestige Biopharma Limited (KRX: 950210), a global biopharmaceutical company, announced today that it has signed a strategic Memorandum of Understanding (MOU) with Charles River Laboratories International, Inc. (NYSE: CRL), a premier global life sciences company headquartered in Massachusetts, U.S., to collaborate on the development, testing, analysis, and manufacturing of biopharmaceuticals.The collaboration leverages the unique strengths of both organizations: Charles River’s world-class expertise in preclinical and analytical services and Prestige Biopharma Group’s robust capabilities in antibody therapeutic development and Contract Development and Manufacturing Organization (CDMO) services. Together, the companies aim to streamline and accelerate the path to commercialization for biosimilars and novel biologics.The collaboration integrates specialized services across the entire drug development lifecycle, ranging from discovery and preclinical safety assessments to analytical testing, process development, and GMP manufacturing. Key areas of cooperation include:☉ Analytical method development and validation☉ Quality control (QC) and batch release testing☉ Biosafety, viral safety, and cell line characterization☉ GLP-compliant toxicology studies☉ Pharmacokinetic (PK) and pharmacodynamic (PD) researchCharles River, having supported the development of over 80% of all drugs approved by the U.S. Food and Drug Administration (FDA) over the past five years, brings unparalleled expertise to this collaboration. By utilizing Charles River’s comprehensive testing and analytical solutions with Prestige Biopharma Group’s antibody manufacturing expertise, the companies intend to offer enhanced support for clients seeking entry into major regulated markets, including the U.S. and Europe.The collaboration also initiates a joint business development strategy utilizing the companies' respective global networks. Charles River will refer clients requiring biopharmaceutical process development and GMP manufacturing to Prestige Biopharma Group, while Prestige Biopharma Group will connect clients in need of early-stage discovery, preclinical toxicology, and bioanalytical services to Charles River. With Charles River’s core focus on preclinical drug development and analytical testing services, this collaboration creates a highly synergistic model that optimizes both companies’ capabilities to expand their respective project pipelines and capitalize on new business opportunities.Furthermore, the companies plan to increase their global presence through joint marketing initiatives, including participation in major industry conferences, joint seminars, and the collaborative development of white papers and technical marketing materials detailing scientific breakthroughs."This collaboration with Charles River, a global leader in preclinical and testing services, marks a pivotal milestone in directly connecting our antibody development and manufacturing expertise with a broader global client network," said a spokesperson for Prestige Biopharma. "By combining our specialized skill sets, we will significantly enhance the efficiency of biopharmaceutical development while aggressively expanding our global CDMO order pipeline and long-term business development opportunities."Prestige Biopharma Group continues to solidify its global footprint by focusing on its core businesses: biosimilars, novel drug development, and CDMO services. Building on recent successful collaborations with global pharmaceutical leaders, the group remains committed to strengthening its foundation for sustained growth in the biopharmaceutical development and manufacturing sector.
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Prestige Biologics Secures Follow-On Contract for Biosimilar Clinical Trial Material Production(June 10, 2026) Cumulative order backlog surpasses KRW 65 billion as of March 2026; pursuing commercial manufacturing partnerships through its “Scale-Bridge CDMO” strategyPrestige Biologics is accelerating the expansion of its CDMO (Contract Development and Manufacturing Organization) business by securing an additional contract to manufacture biosimilar clinical trial materials for a domestic biopharmaceutical company with experience in commercializing biosimilars in global markets.The company announced on June 10 that it had been awarded a contract by a Korean biotechnology company to manufacture biosimilar clinical trial materials required for pre-commercialization activities. The contract will remain in effect through the end of March 2027. The identity of the client and the product involved were not disclosed due to confidentiality obligations.The new agreement follows a recently signed CDMO contract with a major pharmaceutical company in Asia and is regarded as part of the company’s broader strategy to expand its order pipeline. As of the end of March 2026, Prestige Biologics had secured a cumulative order backlog of approximately KRW 65 billion and has now entered a phase in which these contracts are being translated into actual production activities and revenue generation.The product covered under the agreement is reported to be a biosimilar of a global blockbuster biologic. Given that the project is approaching the commercialization stage, the company expects the possibility of securing future commercial manufacturing contracts. Prestige Biologics plans to further strengthen its relationship with the client through this clinical trial material production project and pursue additional manufacturing opportunities.The company stated that it has established strong quality competitiveness through its experience in obtaining Good Manufacturing Practice (GMP) certifications from both the Korean Ministry of Food and Drug Safety (MFDS) and the European Medicines Agency (EMA), as well as through its successful preparation for inspections by global regulatory authorities. Based on these capabilities, Prestige Biologics has developed a manufacturing and quality management system that meets global standards.The company has also been strengthening its “Scale-Bridge CDMO” strategy, which is designed to ensure continuity from clinical development through commercial manufacturing. The strategy focuses on leveraging manufacturing experience gained during early-stage development to support subsequent clinical and commercial production, thereby reducing technology transfer burdens and manufacturing risks for customers.In parallel, Prestige Biologics continues to focus on improving profitability. The company has enhanced cost management efficiency by addressing a previous accounting structure under which raw material costs were recognized before corresponding revenue. As a result, management expects improvements in operating profit. The company intends to pursue both top-line growth and profitability through repeat orders and increasingly sophisticated cost management systems.A company representative commented:“This follow-on contract demonstrates that a customer with proven experience in commercializing biosimilars globally has once again selected Prestige Biologics based on our validated CDMO capabilities.”The representative added:“We intend to leverage our experience in producing pre-commercialization clinical trial materials to secure future commercial manufacturing opportunities. Through repeat business and strengthened cost management capabilities, we will continue to enhance both the growth potential and profitability of our CDMO business.”
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Prestige Biologics Accelerates Growth as CDMO Orders Move into Full-Scale Production(May 8, 2026) Revenue in the first half alone exceeds 80% of the previous year's annual revenue; expanded global CDMO opportunities expected through Osong manufacturing infrastructurePrestige Biologics is accelerating its growth trajectory as CDMO (Contract Development and Manufacturing Organization) orders secured in recent years transition into full-scale production. On May 8, the company announced that it has entered a new phase of growth as orders obtained since 2024 are increasingly being reflected in actual manufacturing activities and recognized revenue.According to the company, following a 3.7-fold increase in revenue in 2025 compared to the previous year, Prestige Biologics has continued its strong performance in 2026, generating more than 80% of its total 2025 annual revenue during the first half of the year alone. The growth is attributed to previously secured projects advancing into the production stage, resulting in the commencement of revenue recognition.Prestige Biologics reported cumulative order intake of approximately KRW 58 billion as of 2025. The company has also continued to secure new business opportunities, including a KRW 4.3 billion biopharmaceutical contract manufacturing agreement signed with a global pharmaceutical company earlier this year. The company plans to strengthen its CDMO competitiveness by simultaneously executing existing projects and expanding its customer base through new client acquisitions.The company is developing a large-scale biopharmaceutical manufacturing infrastructure in Osong, Chungcheongbuk-do, with a total production capacity of 154,000 liters. Leveraging this infrastructure, Prestige Biologics operates a one-stop CDMO platform capable of supporting projects from early-stage development through commercial manufacturing.The company also noted that business discussions with overseas clients have become increasingly active amid the ongoing restructuring of global biopharmaceutical supply chains and rising demand for outsourced manufacturing services.Industry observers expect the global CDMO market to continue expanding alongside the growth of the worldwide biopharmaceutical sector. As demand for supply chain diversification increases across the United States and Europe, Korean CDMO companies with proven manufacturing capabilities and quality management systems are expected to benefit significantly from these market trends.Prestige Biologics is also viewed as strengthening its long-term growth foundation through its large-scale manufacturing facilities and quality-focused operational capabilities.A company representative stated:“Having completed the initial investment and manufacturing infrastructure build-out phase, we have now entered a period in which secured orders are being converted into actual revenue. Leveraging our Osong manufacturing facilities and global-standard quality management capabilities, we will continue to accelerate the growth of our CDMO business.”The representative added:“As global biopharmaceutical supply chains continue to evolve and demand for CDMO services increases, inquiries and follow-up discussions related to contract manufacturing are steadily growing. While ensuring the successful execution of existing projects, we will continue expanding our customer base and further strengthen the foundation for sustainable long-term revenue growth.”
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Prestige Biopharma Moves Closer to Approval and Commercialization of Avastin Biosimilar ‘HD204’Prestige Biopharma is accelerating commercialization efforts for its second major biosimilar product, targeting a global market valued at more than 10 trillion won. If successful, the drug is expected to emerge as a major cash-generating asset alongside the company’s Herceptin biosimilar, Tuznue, which received marketing authorization from the European Commission in September 2024.According to industry sources on May 23, Prestige Biopharma recently secured topline results from a global Phase 3 clinical trial of HD204, marketed under the brand name Vaspoda, a biosimilar referencing Avastin. The Phase 3 study was conducted in patients with advanced non-squamous non-small cell lung cancer (NSCLC). A total of 625 patients across 91 institutions in 15 countries participated in the randomized, double-blind trial, which was designed to compare the efficacy and safety of HD204 with the original Avastin product.According to the topline results, HD204 achieved strong outcomes on the primary endpoint. Analysis of the objective response rate (ORR) at 18 weeks showed that the HD204 treatment group recorded a response rate of 48.7 percent, compared with 46.5 percent for the reference Avastin group, successfully meeting the predefined equivalence criteria.Safety data also drew attention. The incidence of treatment-related serious adverse events (SAEs) was reported at 5.2 percent in the HD204 group, significantly lower than the 8.3 percent observed in the control group. The results suggest that HD204 demonstrated not only analytical similarity to the original product, but also favorable tolerability and safety in clinical practice. Xavier Pivot described the trial as a success, saying, “The clinical data fully satisfied the predefined equivalence range and successfully demonstrated the clinical similarity of HD204.”The global bevacizumab market targeted by HD204 is continuing to expand rapidly. According to market research firm Data Bridge Market Research, the global bevacizumab market reached approximately $5.65 billion in 2023. With biosimilar penetration accelerating, the market is projected to grow at a compound annual rate of 9.8 percent, surpassing $8.56 billion by 2030. In developed markets such as Europe, biosimilars have already captured more than 60 to 70 percent market share, rapidly replacing originator products.Prestige Biopharma said it aims to secure at least an 8 percent share of the bevacizumab market through HD204. If achieved, the company expects the product to generate stable annual revenue worth hundreds of billions of won. Analysts note that the company’s vertically integrated manufacturing structure — supported by affiliate Prestige Biologics — could provide a meaningful pricing advantage over competitors.The company has also established a detailed commercialization strategy. Prestige Biopharma has already signed a supply agreement with Intas Pharmaceuticals and is preparing regulatory filings for the United States and Europe in partnership with Accord Healthcare, an Intassubsidiary. Regulatory submissions to major health authorities are planned for the second half of this year.Earlier, Prestige Biopharma eased marketskepticism after signing a licensing and supply agreement with Teva Pharmaceutical Industries covering 31 European countries for Tuznue. Industry observers believe Teva’s endorsement of Prestige Biopharma’s technology could accelerate the global expansion of HD204 and other follow-on pipeline assets.Beyond biosimilars, the company is also strengthening its innovative drug pipeline. Its pancreatic cancer antibody therapy candidate, PBP1510, has received orphan drug designation from both the U.S. Food and Drug Administration and the European Medicines Agency, in addition to Fast Track designation. Early Phase 1/2a clinical studies reportedly demonstrated favorable safety data, improving the therapy’s commercialization prospects.Prestige Biopharma is also conducting Phase 1 clinical trials for PBP1502, a biosimilar candidate referencing Humira. The company said it plans to pursue a “Fast to Market” strategy focused on countries where Phase 3 clinical trials may be waived under evolving global regulatory trends.A company spokesperson said, “Following Tuznue, the successful clinical outcome of HD204 demonstrates that we possess sufficient competitiveness in the global biosimilar market.” The spokesperson added, “Toward our goal of achieving a market capitalization of 30 trillion won by 2030, we will fully leverage our technological capabilities, cost competitiveness, and strategic partnerships.”
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Prestige Biologics Reports KRW 10 Billion in Cumulative First-Half Revenue, Up 199% Year-over-Year(Feb. 20, 2026) Prestige Biologics announced on February 20 that it recorded approximately KRW 10 billion in cumulative revenue for the first half of the fiscal year. This represents a 199% increase compared to the same period last year and approaches the company’s total annual revenue recorded in the previous year.The company stated that its business operations are gradually reaching a stable growth trajectory as previously secured contracts begin to transition into actual production activities and recognized revenue.Although the first-half performance corresponds to approximately KRW 20 billion in annualized revenue, the company noted that its growing order backlog demonstrates the strengthening of its medium- and long-term growth foundation.Prestige Biologics explained that, due to the nature of CDMO business contracts and accounting standards, revenue recognition generally occurs later than the actual production activities. CDMO projects typically involve customer-specific manufacturing, technology transfer, and process establishment. In addition, quality stability testing and regulatory compliance procedures remain necessary even after production is completed. As a result, a time gap may arise between substantial manufacturing and supply activities and the point at which revenue can be formally recognized under accounting standards.The company is also diversifying its customer portfolio beyond its historical dependence on affiliated companies by expanding contract manufacturing services for global pharmaceutical and biotechnology companies. High contract renewal rates among existing customers, combined with new project wins from global clients, are contributing not only to revenue growth but also to improvements in the quality of earnings.Given the inherent characteristics of the CDMO industry, where revenue recognition follows technology transfer and process establishment after contract execution, the company believes its first-half performance serves as a leading indicator of future growth momentum.Prestige Biologics is gradually expanding its long-term revenue base by flexibly managing production and supply schedules in accordance with the business plans of global distribution partners and customers. For certain early-stage commercialization projects, production and shipment timing may be adjusted based on customers’ market entry strategies and supply schedules. The company emphasized that such adjustments are a normal part of operations supported by confirmed order volumes. Commercial production and product shipments are currently proceeding as planned while maintaining a stable supply chain.The company further noted that individual project performance may vary from quarter to quarter due to customer schedules and the simultaneous execution of multiple projects. However, these fluctuations remain within the normal scope of operational adjustments and do not affect overall manufacturing capacity, order backlog, medium- to long-term revenue prospects, or business outlook.Regarding the relatively high cost ratio reported during the first half, the company explained that the increase was primarily attributable to temporary investments, including the advance procurement of raw materials to support new projects and the establishment of global-standard data integrity systems and autonomous quality management infrastructure as part of its cGMP readiness initiatives.Prestige Biologics expects profitability to improve gradually through higher facility utilization rates and the benefits of fixed-cost leverage.Looking ahead to the second half of the year, the company anticipates continued growth in both revenue and profitability through additional contract wins, operational efficiency improvements, and further system enhancements. Prestige Biologics stated that its goal is to evolve beyond a simple manufacturing partner and become a sustainable CDMO company trusted by global customers and the broader biopharmaceutical market.A company representative commented: “Our first-half results represent a meaningful achievement demonstrating that contract wins are now being translated into actual production and recognized revenue, creating a virtuous cycle of growth. Supported by our secured order pipeline and increasing facility utilization, we intend to sustain growth momentum throughout the second half of the year while accelerating profitability improvements.”Source: Pax Economy TV