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RDIF (Russian Direct Investment Fund) Visited Prestige Biopharma’s Vaccine Centre in KoreaSINGAPORE, August 9, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, announced that RDIF (Russian Direct Investment Fund)’s delegation, Professor Dmitry Kulish and the technical advisors, visited Prestige Biopharma’s Vaccine Centre in Osong, South Korea.The RDIF delegation will be staying in Korea for the next two months and the technical transfer of Sputnik COVID-19 vaccine will be completed during this time. Prestige Biopharma’s technical team is also slated to visit Russia next month.Prestige Biopharma completed installing two units of 200-litre bioreactors in the pilot production facility in July this year. The company begins the process of pilot production this month with the Russian team and the commercial production is scheduled in September. The final production capacity of Prestige Biopharma Vaccine Centre will be 100,000 litres which is designed on a global-scale.Amid a global vaccine shortage, Prestige Biopharma is receiving several inquiries from various global vaccine developers on contract manufacturing. The company is expecting that Prestige Biopharma will be able to produce ‘mRNA’ based vaccines from Pfizer and Moderna in the long term.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “The company is excited to start our first vaccine CMO project. Prestige Biopharma will work closely with the Korean government’s global vaccine hub project and the COVAX project co-led by WHO (World Health Organisation) and CEPI (Coalition for Epidemic Preparedness Innovations) to defeat the pandemic.”NEWS
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Prestige Biopharma’s Biosimilar HD201’s FDA Bridging Study Demonstrated an Equivalent Pharmacokinetic Profile to Herceptin®SINGAPORE, July 28, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, announced that its Herceptin® biosimilar, HD201’s FDA bridging study demonstrated an equivalent pharmacokinetic and safety profile to US-Herceptin®. The study was published in the international journal of Pharmacology Research & Perspectives on July 26, 2021.The bridging study was completed last year and a French authority on breast cancer, Professor Xavier Pivot participated in this study.The FDA accepts clinical and other comparative data previously submitted to European regulators, supplemented by ‘bridging studies’ in the FDA approval process. Prestige Biopharma ’s HD201 bridging study was conducted on 105 healthy male volunteers in Australia. The study showed HD201’s equivalent pharmacokinetic and safety profile to both US-Herceptin® and EU- Herceptin®.Prestige Biopharma submitted HD201’s Marketing Authorisation Application (MAA) to EU EMA in 2019 and the US submission to FDA is on target to complete this year. The estimated market size of US- Herceptin® is approximately 2.6 billion US dollars per year.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “We are very pleased to demonstrate HD201’s excellence and its commercial value through this FDA bridging study,” and “Prestige Biopharma will accelerate the US market expansion to provide more access to more patients for our Herceptin® Biosimilar, HD201.”NEWS
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Prestige Biopharma Group Accelerates its Vaccine & Antibody Drug BusinessSINGAPORE, July 5, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, and its dedicated CDMO, Prestige Biologics speed up their vaccine and antibody drug business.Prestige Biopharma announced that Sputnik Light COVID19 vaccine’s cell lines and viruses have been successfully imported from Russia for pilot production. Prestige Biopharma’s global-scale vaccine production facility in Osong, South Korea with a total production capacity of 100,000 litres is on target to meet surging global demands for COVID 19 vaccine.The company is slated to start pilot production with 200-litre bioreactors in August, and as planned, its full production using 2,000-litre bioreactors will be processed from September.The analyst of Samsung Securities, Dr. Keunhee Seo published a note on June 30 that Prestige Biopharma will exhibit rapid growth once its COVID 19 vaccine CMO business commences full production.Prestige Biologics also successfully received approval on 50 billion won in long-term loans for the construction of its Campus 2 production facility from the Korea Development Bank.Dr. Lisa S. Park, Group Chairman of Prestige Biopharma Group, commented: “Our group value chain includes from R&D to production and this full value chain capability enables us to be responsive to market needs,” and “This year’s momentum will lead our business to its high-growth stage.”NEWS
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Prestige Biopharma’s First-in-Class Pancreatic Cancer Treatment PBP1510 Receives Approval for Clinical Trial in FranceSINGAPORE, June 21, 2021 – Prestige BioPharma Limited, specializing in the development of antibody therapeutics, announced that French National Agency for the Safety of Medicines and Health Products (L’Agence nationale de sécurité du medicament, ANSM) has approved a Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer.The clinical trial will be conducted in the Research Institute against Digestive Cancer (IRCAD) based in Strasbourg, France, in pancreatic cancer patients who have an overexpression of a gene called Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in majority of pancreatic cancers. PBP’s affiliate, Prestige Biologics will be providing drugs for the clinical trial.Prestige BioPharma is also in the process of preparing for the conduct of this trial in other countries such as the U.S., Australia and Belgium. Korea’s Ministry of Food and Drug Safety (MFDS) is currently reviewing Prestige BioPharma’s application for conduct of this clinical trial in Korea as well.Pancreatic cancer is a highly aggressive malignancy originating in the exocrine or endocrine pancreatic cells suspected to be caused by poor diet, smoking, and genetic factors. It contributes to high morbidity and mortality with a survival rate of 9% at five years in the U.S. Currently, the only curative options are limited to surgical resection in combination with adjuvant chemotherapy. However, only 10 to 15% of patients are candidates as the diagnosis occurs in advanced or metastatic stages that are surgically inoperable. Limited efficacy of treatment modalities and rapid progression of pancreatic cancer can be partly explained by PAUF and it plays an important role in disease progression, but no targeted molecular therapy against PAUF currently exists. Prestige BioPharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit in all patients affected by PAUF-positive pancreatic cancer.The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 last year. ODD is granted to investigational drugs intended for the safe and effective treatment of rare diseases with an unmet medical need that affect very few individuals but cause great suffering. This designation provides companies with certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for health technology assessments in certain countries, and if approved, marketing exclusivity in the EU for 10 years, in the U.S. for 7 years.Dr. Lisa S. Park, CEO of Prestige BioPharma, commented: “We are very pleased to initiate the Phase 1/2a clinical trial of PBP1510 in France,” and “Prestige BioPharma will accelerate the development of PBP1510 to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments.”NEWS
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Prestige Biopharma enters MOU with Busan City for establishment of its R&D centre in Busan, South KoreaSINGAPORE, May 18, 2021 – Prestige Biopharma Limited and Busan City Government today announced that the two organisations have entered into a memorandum of understanding (MOU) for the establishment of Research and Development (R&D) centre in Busan, South Korea. The signing of this MOU is meaningful for Busan City to have its first local biopharmaceutical R&D centre.The signing ceremony was held at Busan City hall in Busan, South Korea. Those attending included Mayor of Busan City Hyeong-joon Park, Vice President of Korea Land & Housing Corporation Choong-mo Jang, Group Chairman and CEO of Prestige Biopharma Group Lisa Soyeon Park, Group Vice Chairman and COO of Prestige Biopharma Group Michael Jinwoo Kim, Director of Alliance Management Chris Davie and CEO of Prestige Biopharma Korea Lai Wat Tay.Prestige Biopharma is on target to build a global-scale R&D centre with a total area of approximately 45,000 square meters and will be investing US$152 million, including hiring 209 of PhD and highly qualified R&D personnel, for the next five years.Through this MOU, Prestige Biopharma and Busan City will cooperate in creating a bio-cluster that supports a local economy and drives mutual growth in academia and industry. The fifty percent of its R&D resources will be sourced from local universities and community.Prestige Biopharma is the first Singapore-based company to be listed on the Korea Composite Stock Price Index (KOSPI). The first pipeline of Prestige Biopharma, Herceptin® biosimilar has successfully completed its Phase III clinical trial and is currently under EMA review. Prestige Biopharma’s pipeline also includes its proprietary First-in-Class antibody for pancreatic cancer targeting PAUF, PBP1510, and it has been designated as an Orphan Drug by FDA, EMA and Korean MFDS (Ministry of Food and Drug Safety). The company has recently expanded its business to vaccine development and production and participated in a consortium in the production of Russia’s Sputnik V COVID-19 vaccine as the Drug Substance (DS) manufacturing organisation.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “We are very pleased to enter into an MOU with the international city, Busan. With this partnership and the global-scale R&D centre, Prestige Biopharma will be able to accelerate the development of innovative antibody drugs and at the same time contribute to the growing global demands of vaccines in response to COVID-19 and potential future pandemics. We strongly believe that this Busan R&D centre will be a landmark of Busan City and will boost the local economy.”Hyeong-joon Park, Mayor of Busan City, commented: “Busan City is very excited to work with a global leading bio-pharmaceutical company, Prestige Biopharma, and hopefully this novel partnership will lead a local bio-industry’s growth and promote establishment of bio-ventures.”NEWS
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Prestige Biopharma Appoints Internationally known Virus Expert Dr. Wang Sik Ryu as Executive Science AdvisorSINGAPORE, May 6, 2021 – Prestige Biopharma Limited, specializing in the development of new antibody therapeutics, is pleased to announce the appointment of the former managing director of Institute Pasteur Korea, Dr. Wang Sik Ryu as its executive science advisor for the Group. Dr. Ryu will lead in essential research areas of new generation vaccine development for future infectious diseases like mutated COVID-19 virus variants.Dr. Ryu is a virus expert with a doctoral degree from Wisconsin-Madison and has thirty-five years of R&D, academic and industry experience in global institutions such as Fox Chase Cancer Center, LG Life Sciences and Yonsei University. He has been contributing to the Korean government’s COVID-19 vaccine development initiative as a scientific advisor since the last year.Prestige Biopharma Vaccine Centre initiated construction in March this year and is projected to start operations from August 2021 utilizing Prestige Biologics’ unmatched engineering service for expedited establishment with cutting-edge technology. The vaccine center’s test operation is expected to commence in August, and aims to start full production of Sputnik V COVID-19 vaccine from September this year. Prestige Biopharma has recently entered into a strategic partnership with Cytiva, a global leading bioprocessing supplies provider.Dr. Ryu commented: “I am delighted to be joining Prestige Biopharma group and take charge of its new vaccine business. As a virus expert, I feel a tremendous responsibility to help defeat the ongoing pandemic. I will contribute to the growing global demands for vaccine development and production in response to the current and future viral pandemics through cooperation with domestic and international organisations.”NEWS
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Prestige Biopharma Group enters strategic partnership with CytivaSINGAPORE, April 27, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, announced a strategic partnership with Cytiva on April 27, 2021. The signing ceremony was held at its affiliated company, Prestige Biologics in Osong, South Korea. Those attending included President and CEO of Cytiva Emmanuel Ligner, Vice President Commercial, Asia-Pacific of Cytiva Francis Van Parys, General Manager of Cytiva Korea Joon Ho Choi, Group Chairman and CEO of Prestige Biopharma Group Lisa Soyeon Park and Group Vice Chairman and COO of Prestige Biopharma Group Michael Jinwoo Kim.Through this partnership, Cytiva will supply bioprocessing equipment for cell culture and purification that will be used for vaccine and biologics production. Cytiva will also be providing technologies and solutions for bio-manufacturing to help Prestige Biopharma to rapidly produce multiple vaccines and biologics.Prestige Biopharma will be procuring a variety of bioprocessing equipment including 50 units of 2,000 litre single-use bioreactors and will be using them to produce Russia’s Sputnik V COVID-19 vaccine. Prestige Biopharma vaccine center’s test operation is expected to commence in August and aims to start full production of 100 million doses of vaccine DS (Drug Substance) per month from September this year.Cytiva Korea’s General Manager, Mr. Joon Ho Choi commented, “we are very excited to enter into this partnership that will build a global-scale supply chain” and “hopefully our partnership will enable Prestige Biopharma with further production capabilities to assist in defeating the pandemic”. “Cytiva will also support PBP’s antibody therapeutics business as well” added Mr. Choi.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “Despite the current vaccine distribution, most of the global population unfortunately still lacks access to life-saving, essential COVID-19 vaccines and global vaccine developers are facing increasing challenges in rapidly building supply chains to meet the high demand,” and “with this novel partnership and our global-scale vaccine centre, PBP Group will contribute to the growing global demands of vaccine development and production in response to the current situation, and also for potential, viral pandemics of the future.”NEWS
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Prestige Biopharma’s new vaccine production center for infectious diseases including COVID-19SINGAPORE, April 20, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, announces that the company will be introducing a vaccine development and production center into its core business. Prestige Biopharma has been preparing for a business expansion into the development of vaccine-based therapeutics since the start of the ongoing COVID-19 outbreak as a response to the current, and potential future, viral pandemics. The design, development and implementation of the vaccine center has resulted from that plan.Prestige Biopharma is on target to complete the construction of its global-scale vaccine production facility in Osong, South Korea with a total area of approximately 8,500 m2 inside the Campus 2 facility of its affiliated company Prestige Biologics. The vaccine center initiated construction last month (March 2021) and is projected to start operations from August 2021 utilizing Prestige Biologics’ unmatched engineering service for expedited establishment with cutting-edge technology.Prestige Biopharma will be utilising Prestige Biologics’ proprietary ALITA Smart BioFactory™, the world’s first smart factory system in biomanufacturing designed based on digital artificial intelligence, which will contribute to reducing human or process related errors. The system will also enable fast and convenient change-over to maximize efficiency when catering for multiple products and manufacturing processes. This smart factory’s ‘single-use’ system will enable mass production of vaccine in the short-term.The total production capacity of the vaccine center is 100,000 litres, comprised of 50 units of 2,000 litre single-use bioreactors with accompanying seed train and down-stream purification capacities. With this global-scale production capacity, the center will contribute to the growing global demands of vaccine development and production in response to infectious diseases such as COVID-19.Prestige Biopharma will participate in a consortium led by Huons Global in the production of Russia’s Sputnik V COVID-19 vaccine as the Drug Substance (DS) manufacturing center.Dr. Lisa S. Park, CEO of Prestige BioPharma, commented: “The prolonged fight against the COVID-19 pandemic has led to growing concerns surrounding infectious viral disease and the increased necessity for production capability for vaccine-based therapeutics,” and “Hopefully our global-scale vaccine center will assist in defeating the pandemic and we will ultimately aim to develop our own vaccine products to combat potential future pandemics.”NEWS
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Prestige Biopharma joins consortium to produce Russia's Sputnik V vaccineSINGAPORE, April 16, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, announced on April 16, 2021 that it has participated in a consortium that will be producing Russia’s Sputnik V COVID-19 vaccine. South Korean biotech firm Huons Global will lead the consortium and Prestige Biopharma will be participating as a drug substance (DS) manufacturer.The Sputnik V vaccine was developed at the Gamaleya National Research Centre for Epidemiology and Microbiology in Russia and it has been authorized in approximately 60 countries.Prestige Biopharma vaccine center commenced construction last month with the aim of producing vaccines and therapeutics for COVID-19 and to prepare for future pandemics. The vaccine center’s test operation is expected to commence in August, and aims to start full production of 2,000 liters of vaccine DS per batch from September this year with the consortium’s technology transfer.Prestige Biopharma will be using Prestige Biologics’ ALITA, the world’s first smart factory system designed based on digital artificial intelligence, which will contribute to reducing process error and human error. This smart factory’s ‘single-use bag’ system will enable mass production of vaccine in the short-term.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “We are pleased to contribute to defeating the pandemic and also feel a heavy responsibility of joining the world’s first approved COVID-19 vaccine, Sputnik V’s manufacturing consortium,” and “With the start of this project, we will ultimately aim to develop our own vaccine products to meet the demands of vaccines for future pandemics.”NEWS