Newsroom
Prestige Biologics News
-
Prestige Biopharma Group Highlights Integrated Value Chain Strategy and Expands Global Collaboration at JPMHC 2026(Jan. 16, 2026) Prestige Biopharma Group Highlights Integrated Value Chain Strategy and Expands Global Collaboration at JPMHC 2026[Anchor]Prestige Biopharma Group participated in the J.P. Morgan Healthcare Conference (JPMHC) for the first time this year. Leveraging its integrated value chain that spans research, clinical development, manufacturing, and commercialization, the Group aims to accelerate business development by engaging global partners from the earliest stages of product development.Reporter Kim Hyo-sun reports.[Reporter] Prestige Biopharma Group attended JPMHC 2026 and advanced discussions on global collaboration opportunities.The company emphasized that active discussions took place regarding partnerships related to its biosimilar pipeline and antibody-based therapeutic candidates.Kim Jin-woo, Vice Chairman of Prestige Biopharma Group“This year’s J.P. Morgan Healthcare Conference served as a key platform for advancing global collaboration. We held in-depth meetings with numerous global pharmaceutical companies regarding our biosimilar pipeline and antibody-based novel drug candidates. The biosimilar business remains a core pillar supporting the overall stability of the Group’s business operations.”The company is currently expanding the global commercialization of Tuznue®, its trastuzumab biosimilar, across Europe and other international markets.With the number of biologic products approaching patent expiration expected to increase significantly in the coming years, the biosimilar market is projected to grow rapidly. Prestige Biopharma intends to proactively capitalize on these market opportunities and strengthen its competitive position.Meaningful discussions also continued in the innovative therapeutics segment.The company reported strong interest in PBP1510, its pancreatic cancer treatment candidate, particularly regarding potential co-development opportunities and technology licensing partnerships.Kim Jin-woo, Vice Chairman of Prestige Biopharma Group“Based on the results from our ongoing Phase I clinical study, we are currently undertaking the necessary procedures to determine the recommended dose for use in Phase II trials. We are targeting entry into Phase II clinical development by the end of 2026.”Meanwhile, Prestige Biologics, which has surpassed KRW 100 billion in cumulative contract awards, stated that it conducted a series of business meetings focused on specialized manufacturing capabilities and flexible process strategies amid strong demand for antibody drug substance (DS) production services.The company emphasized that JPMHC 2026 provided an important opportunity to assess both the competitiveness of its pipeline and its potential for future business expansion.Reporter Kim Hyo-sun, Pax Economy TV
-
Prestige Biopharma Targets Growth Through Dual Strategy of Novel Drugs and CDMO(Jan. 13, 2026) Focusing on Revenue Growth Backed by KRW 38 Billion in CDMO OrdersThree Key Goals for 2026: Accelerating Pipeline Development, Expanding Global Markets, and Driving Revenue GrowthPrestige Biopharma Group highlighted both its CDMO-based revenue generation strategy and innovative drug pipeline at JPMHC 2026, strengthening its presence on the global stage. Building on KRW 38 billion in contract wins secured during the second half of last year, the company aims to expand its product portfolio and establish a clear commercialization roadmap that converts its pipeline into tangible revenue.Speaking with Hit News during the J.P. Morgan Healthcare Conference (JPMHC 2026), which opened on January 12 in San Francisco, USA, Prestige Biopharma CEO Soyeon Park outlined the Group’s mid- to long-term vision based on an “execution-focused commercialization strategy.”Park shared updates on the global commercialization strategy for Tuznue®, the trastuzumab biosimilar that received approval from the European Medicines Agency (EMA), as well as the clinical progress of PBP1510, the company’s pancreatic cancer therapeutic candidate. She emphasized the company’s ambition to evolve into a global biopharmaceutical company driven by technological innovation and integrated manufacturing capabilities.| Growing Interest in Korean Biopharma: Simultaneous Expansion of Biosimilars and Oncology Assets“The enactment of the Biosecure Act has significantly increased global interest in Korean biopharmaceutical companies,” said Park. “Unlike previous years, discussions now extend beyond pipeline introductions to include clinical progress, regulatory strategies, and manufacturing capabilities, reflecting a greater focus on execution and commercialization.”She added that despite ongoing market volatility and global interest rate uncertainties, companies with meaningful clinical achievements and clear commercialization potential are attracting stronger interest. In this environment, Prestige Biopharma’s oncology pipeline, biosimilar business, and CDMO services have received considerable attention.At this year’s conference, the company prioritized discussions regarding the clinical development of its innovative oncology candidates, including its pancreatic cancer antibody therapy, as well as market expansion strategies for Tuznue®, which has already entered the commercialization stage. The company also conducted meetings aimed at expanding its product portfolio and securing new partnerships based on contract wins achieved during the second half of last year.| Diversifying Biosimilar Portfolio to Target Opportunities Beyond Blockbuster ProductsAccording to Park, global pharmaceutical companies showed particular interest in the company’s commercialization achievements and product differentiation.“Many companies asked detailed questions regarding Tuznue®, the progress of our biosimilar development programs, and the differentiation of our oncology pipeline,” she said. “The successful EMA approval of Tuznue® and our experience in global supply, combined with our novel oncology candidates, appear to be receiving positive evaluations.”As a result, Prestige Biopharma is actively strengthening its biosimilar portfolio, including HD204 and PBP1502, while engaging potential partners in discussions regarding commercialization, collaborative research, and strategic partnerships.The company’s current revenue-generation roadmap is centered on Tuznue®, next-generation biosimilars, and CDMO operations.Tuznue® is currently entering the European market through a partnership with Teva Pharmaceuticals and has also expanded into Latin America and selected Southeast Asian markets through an agreement with Dr. Reddy’s Laboratories.“We plan to continue obtaining regulatory approvals and establishing reliable supply chains through local partnerships in China, Japan, the Middle East, and other emerging markets,” Park explained. “Rather than pursuing direct sales, we intend to work with regional partners to ensure faster and more stable market penetration.”Development of follow-on biosimilars is also progressing steadily. HD204, an Avastin® biosimilar candidate, is currently in Phase III global clinical trials and is being advanced toward the U.S. and European markets through partnerships including Intas Pharmaceuticals. Meanwhile, PBP1502, a Humira® biosimilar candidate, has received IND approval for a Phase I clinical study in Hungary and is proceeding with clinical development aimed at demonstrating biosimilarity and enabling efficient market entry.| Reinforcing CDMO Identity Through Fully Integrated Development-to-Commercialization CapabilitiesCDMO operations remain another key pillar of the Group’s business strategy.Following manufacturing agreements signed with global pharmaceutical company Teva and additional contracts secured during the second half of last year, the company accumulated approximately KRW 38 billion in CDMO orders.“JPMHC 2026 serves as an important opportunity to reinforce our identity as a specialized CDMO provider,” Park stated. “We intend to highlight our unique ability to maintain process continuity while flexibly managing process changes and scheduling risks.”She emphasized that the company’s objectives extend beyond candidate development.“Our focus is not limited to discovering drug candidates. We place significant importance on a comprehensive strategy that covers clinical development, regulatory approval, and commercialization.”Based on this strategy, Prestige Biopharma plans to explore various business models with global partners, including co-development agreements, licensing transactions, and supply contracts. Ultimately, the company aims to establish a stable revenue base capable of supporting continued investment in innovative drug development.Park noted that future competitiveness in the biosimilar market will depend on pricing advantages, next-generation formulation technologies that improve patient convenience, and manufacturing efficiency. The company therefore plans to further strengthen its existing strategies, including enhanced cell-line productivity and optimized manufacturing processes.| Building a Sustainable Growth Structure Through Group SynergiesPark identified three primary business objectives for 2026:- Accelerating pipeline development- Expanding global market presence- Achieving revenue growthKey priorities include advancing the clinical development of PBP1510 and pursuing regulatory approvals for HD204. The company also plans to accelerate Tuznue® commercialization discussions and GMP certification activities during the first half of the year to generate tangible business results.In addition, Prestige Biopharma expects to achieve visible milestones throughout the year, including product approvals, commercial shipments, and further expansion of its CDMO portfolio.“Prestige Biopharma Group places greater importance on generating continuous results through close collaboration among affiliated companies than on short-term events,” Park concluded. “JPMHC 2026 will serve as a catalyst for accelerating this momentum. By strengthening an integrated business structure that connects R&D, manufacturing, and commercialization, we aim to become a globally competitive biopharmaceutical company driven by innovation and supported by a strong international partnership network.”
-
Prestige Biologics Receives ‘$2 million Export Tower’ AwardPrestige Biologics announced on Dec. 4 that it received the “$2 Million Export Tower” award at the 62nd Trade Day ceremony held at COEX in Seoul, marking a milestone for the company’s expanding global contract development and manufacturing organization (CDMO) business.The award recognizes companies that surpass designated export thresholds and is regarded as a benchmark of international commercial performance in South Korea’s export-driven industries. Prestige Biologics said its actual export volume in 2025 reached $2.6 million, significantly exceeding the official benchmark tied to the award.The company said the recognition serves as formal validation of its technological capabilities and manufacturing quality in overseas markets. Built around its antibody drug contract manufacturing business, Prestige Biologics has been expanding exports of active pharmaceutical ingredients (APIs), gaining traction among international clients seeking biopharmaceutical production partners.While South Korea hosts numerous contract manufacturing organizations, many remain focused primarily on domestic production contracts. Industry observers noted that Prestige Biologics’ success in identifying overseas customers, signing international manufacturing agreements, and completing product deliveries represents a meaningful achievement for a mid-sized Korean CDMO company.Prestige Biologics also stated that it received strong interest from global pharmaceutical companies during CPHI Frankfurt 2025 in Germany, where its platform technologies and digitally driven manufacturing capabilities were highlighted. The company said those discussions helped secure additional overseas supply agreements and expand its global footprint.The company described the Export Tower award as historically significant, arguing that it represents one of the first concrete examples of a Korean CDMO establishing a meaningful commercial presence in global markets through export-driven manufacturing revenue. Exceeding the $2 million benchmark with actual exports of $2.6 million is also expected to strengthen the company’s credibility with prospective international clients and support future contract wins.Following the award, Prestige Biologics said it plans to accelerate several initiatives, including diversification of export markets, expansion of global CDMO contracts, and further investment in artificial intelligence-based manufacturing automation and process innovation.Kim Jin-woo said the company continues to strengthen its export competitiveness through expanded global quality certifications and strategic technology collaboration programs with overseas customers. “We will continue pursuing dynamic export growth through increasingly differentiated strategies,” Kim said. “Our goal is to enhance the global standing of K-Bio and play an even more significant role in the worldwide biopharmaceutical supply chain.”
-
Prestige Biologics Hosts Korean Intellectual Property Office Commissioner, Gains Recognition for Global IP Strategy and Smart FPrestige Biologics, a biopharmaceutical contract development and manufacturing organization (CDMO), announced on May 8 that Kim Wan-ki visited the company’s headquarters in Osong, North Chungcheong Province, on May 4 to review its intellectual property (IP) strategy and smart factory operations during a roundtable discussion.The visit was organized as part of the Korean Intellectual Property Office’s effort to assess the on-site results of its “Global IP Star Company Development Program” and discuss future policy directions. The initiative provides customized IP support services over a three-year period — including patent strategy development, overseas rights acquisition, and brand development — to help small and medium-sized enterprises expand steadily into global markets.Through participation in the program, Prestige Biologics has implemented artificial intelligence (AI) and smart factory technologies across its entire production, quality control, and logistics operations, establishing what the company describes as a world-class bio smart factory. Strengthening its global IP strategy has also translated into measurable business results, including a 568 percent increase in revenue and the creation of more than 90 new jobs.In particular, the company has leveraged AI technology to predict and resolve potential issues in process development and manufacturing before they occur, further enhancing its competitiveness in the CDMO sector. Industry observers view this capability as extending beyond simple manufacturing efficiency, enabling the company to meet global partners’ demands simultaneously for quality, reliability, and on-time delivery.Speaking at the meeting, Commissioner Kim said, “Intellectual property is a critical factor for small and mid-sized companies seeking to successfully expand exports in the global marketplace.” He added, “The Korean Intellectual Property Office will continue to expand IP-based support so that Korean biotech companies, including Prestige Biologics, can grow on the global stage.”Kim Jin-woo said the commissioner’s visit represented “meaningful recognition” of the company’s smart factory-based production system and global IP strategy. “Going forward, we will continue contributing to the elevation of K-Bio’s global standing through stronger intellectual property competitiveness and advanced smart factory technologies,” he said.
-
[GBC 2025 On Site] Prestige Biologics Says Plant 1 Fully Booked Through Next Year, Focuses on ‘Customer Partnerships’Prestige Biologics outlined the latest trends shaping the contract development and manufacturing organization (CDMO) industry at the 2025 Global Bio Conference, emphasizing a customer-focused partnership strategy as demand grows for tailored biopharmaceutical manufacturing solutions. As the global biopharmaceutical market expands rapidly, customized production and end-to-end manufacturing services are becoming increasingly important across the industry. Speaking at the conference, Yang Jae-young presented the company’s outlook on the CDMO sector and its long-term growth strategy.“The share of biopharmaceuticals in the overall pharmaceutical market accounted for only about 3 percent in 1999,” Yang said. “That figure rose to roughly 10 percent in 2000, 18 percent in 2010, and approximately 30 percent by 2020. Growth has accelerated sharply since 2010, and we expect this trend to continue going forward.” As demand for biopharmaceuticals increases, CDMO companies are moving aggressively to diversify manufacturing technologies and production capabilities. Prestige Biologics highlighted its strengths in animal cell-based manufacturing, capable of producing monoclonal antibodies, recombinant proteins, and viral vaccines.“Products obtained through animal cell culture include antibodies, monoclonal antibodies, and recombinant proteins,” Yang said. “For example, erythropoietin (EPO) is produced using CHO cells, and we are capable of manufacturing those products as well. We also have the capability to produce viral vaccines, including the type considered during the COVID-19 response. In that sense, there is room to expand production into other categories of animal cell-based products.”The company said the industry is shifting beyond simple contract manufacturing toward a “one-stop CDMO” model that integrates manufacturing, quality control, and commercialization services under a single platform. Prestige Biologics stated that it is strengthening its competitiveness by enhancing customer-tailored quality management and service capabilities. “Our primary direction at this stage is ensuring customer satisfaction not only in production, but also in quality and overall service,” Yang said.Prestige Biologics added that commercial manufacturing at its first production plant is currently operating at full pace. According to the company, Plant 1 is already fully booked by the end of next year, while preparations are underway to obtain GMP certification for its fourth production facility.“Plant 1 is currently manufacturing approved commercial products, and additional production schedules have already been secured,” Yang said. “As a result, the facility is fully booked through the end of next year. Plant 4 is a new facility, and GMP certification will be required there as well. We plan to apply for CDMO GMP certification with the Ministry of Food and Drug Safety, undergo inspections early next year, and expect to receive GMP certification during the first half of next year.”The company also disclosed that it is currently in discussions with domestic firms regarding project-based manufacturing partnerships and intends to strengthen its order-winning competitiveness through customized production services.
-
[BIO USA 2025] Prestige Biologics CEO Kim Jin-woo Declares ‘First Full Year of Plant Operations,’ Pledges Push Toward Market-FrAt the 2025 BIO International Convention, Kim Jin-woo signaled a new phase of growth for Prestige Biologics, marking his first official appearance since assuming leadership of the company. Backed by what the company described as global business expertise and strong commercial capabilities, Kim declared this year the “first year of full-scale growth,” driven by expanding orders and production operations.Kim expressed confidence that 2025 would become the foundational year for full-scale operation across the company’s manufacturing network, with a strategy centered on maximizing production capacity, increasing contract orders, and transforming Prestige Biologics into a more market-oriented CDMO player.Q. How do you view your appointment as CEO of Prestige Biologics, and what are your goals?“The biopharmaceutical manufacturing business requires massive facilities, significant investment, and long-term commitment to building a quality-first operation,” Kim said. “My predecessors created excellent facilities by dedicating substantial expertise and value to these efforts, and as a result, we have received strong interest from pharmaceutical companies both in Korea and abroad.”He continued, “My responsibility and goal moving forward are to fully utilize these assets to generate revenue, improve profitability in a customer-friendly manner, and deliver returns that meet investor expectations.”Q. What business synergies do you expect from recruiting industry experts?Kim highlighted the recruitment of globally recognized industry professionals, including Julien Raes, Michael Rupert, and SP Tan.“We were able to bring in renowned experts in this industry, and together with them, I aim to deliver the kind of performance stakeholders can consistently expect,” Kim said. “Through these efforts, we intend to build the momentum necessary for the company’s continued growth.”He added that the company is also seeing increased opportunities for co-development projects with traditional pharmaceutical firms and multinational drugmakers. To capitalize on those opportunities and strengthen Korea’s biomanufacturing ecosystem, Prestige Biologics plans to launch a new drug product (DP) manufacturing facility.According to Kim, the new DP plant is expected to expand the company’s service portfolio, improve customer satisfaction, and become a major driver of future revenue growth.Q. What is Prestige Biologics’ strategy at BIO USA?“Through on-site meetings and networking, we are creating more strategic collaboration opportunities with leading global companies,” Kim said. “Our goal is not only to secure manufacturing contracts, but also to collaborate with a wide range of partners to ensure stable manufacturing operations and supply high-quality products through more advanced services.”Kim emphasized that Prestige Biologics now operates multiple manufacturing facilities spanning Plants 1 through 4. He noted that Plant 1 is already fully booked, while Plants 2 and 4 are scheduled to begin production operations next month.“These developments represent a major milestone,” he said. “I believe this year will mark the first full year in which we fully realize and operate our intended production capacity. Through this, we expect to become a more market-friendly company and earn continued support and confidence from shareholders going forward.”