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Prestige Biopharma Participates in Korea-EU Global Vaccine Partnership Business Forum in BrusselsSINGAPORE, October 12, 2021 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with global presence, announced that PBP took part in a Korea-EU Global Vaccine Partnership Business Forum in Brussels, on October 08, 2021. Those attending included the South Korean Minister of Health and Welfare Kwon Deok-cheol, the South Korean Trade Minister Yeo Han-Koo, officials of the EU commission, Coalition for Epidemic Preparedness Innovations (CEPI), EU’s Bio Supply Management Alliance (BSMA) and the representatives of Korea-EU vaccine companies.At the partnership forum, Vice Chairman of Prestige Biopharma Group Michael Jinwoo Kim gave a presentation on Prestige Biopharma’s business plan and vaccine production capacity to the Korea-EU government officials, and Prestige Biopharma discussed cooperation with the EU pharmaceuticals who have proprietary self-amplifying mRNA vaccine technology and cancer vaccine platform. There is potential to generate synergy between Prestige Biopharma vaccine business and these EU vaccine companies as Prestige Biopharma ultimately aims to develop its own vaccine products.EU’s biomanufacturing equipment suppliers also attended the forum and showed interest in Korea’s vision for hosting an Asian vaccine production hub. Prestige Biopharma had a discussion with the manufacturing equipment supplier specialising in Drug Product (DP) bioprocessing equipment to secure a reliable supply chain for its vaccine business.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented, “We incorporated Innovative Discovery Center (IDC) in Busan, Korea this year and its global-scale R&D center will be completed next year. Prestige Biopharma will ultimately develop our own vaccine products and novel antibody therapeutics in the IDC Busan through innovative cooperation with global vaccine companies and organizations.”NEWS
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Prestige Biopharma participates in Korea-U.S. Global Vaccine Partnership Signing Ceremony in New YorkSINGAPORE, September 23, 2021 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with global presence, announced that it took part in a Korea-U.S. global vaccine partnership signing ceremony in New York, on September 21, 2021.Vice Chairman of Prestige Biopharma Group Michael Jinwoo Kim and Managing Director of Prestige Biopharma USA Deborah Moshinsky attended the ceremony on behalf of the company, and discussed cooperation with the US pharmaceuticals who are developing vaccines against coronavirus variants.At the partnership ceremony, South Korea and the US signed several memorandums of understanding (MOUs) between their companies, all of which are small-and medium-sized, and other MOUs between research institutes.Cytiva, a US producer of vaccine materials, has decided to invest in South Korea beginning next year. Cytiva announced plans to build a production facility to produce disposable cell culture bags in Korea and this will be providing a reliable supply chain for Prestige Biopharma Group who also use disposable bioreactor bags for vaccine production.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “The world is combating the fast-spreading Coronavirus variants and now is the time for global pharmaceuticals to work together in solidarity to stop this pandemic,” and “We will keep contributing to the growing global demands for COVID-19 vaccine production based on the solid partnership with the global pharma companies.”NEWS
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RDIF (Russian Direct Investment Fund) Conducted On-Site Inspection for CMO ContractSINGAPORE, August 17, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, announced that RDIF (Russian Direct Investment Fund)’s executive team in charge of CMO contract, Director Vladimir Svintsov and Senior Analyst Svetlana Baeva visited Prestige Biopharma’s Vaccine Center in South Korea for on-site inspection.The RDIF team’s visit was planned for pre-inspection before finalising the CMO contract to produce Sputnik COVID-19 vaccine and they checked the progress of technical transfer and examined the quality of pilot production.Prestige Biopharma has started test operation of its pilot vaccine unit and RDIF’s technical transfer is ongoing according to the initial plan. With the recent progress of the project, this on-site inspection has provided a positive signal ahead of the formal CMO contract.NEWS
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Prestige Biopharma Korea Signs Business Cooperation Agreement with LH and BJFEZ for its IDC DevelopmentSINGAPORE, August 13, 2021 – Prestige Biopharma Limited, specializing in the development of antibody therapeutics, announced that Prestige Biopharma Korea entered into a business cooperation agreement with Korea Land & Housing Corporation (LH) and Busan-Jinhae Free Economic Zone Authority (BJFEZ) for the construction of Innovative Discovery Centre (IDC) on August 11, 2021. Prestige Biopharma and Busan City Government signed an MOU for the establishment of IDC in May this year.According to this business cooperation agreement, LH provides land for the IDC building construction and BJFEZ will provide the necessary regulatory supports. Prestige Biopharma Korea and LH will be signing a land purchase agreement based on this three-parties cooperation agreement.Prestige Biopharma is planning to build a global-scale R&D centre with a total area of approximately 34,000 square meters. The development will have a large-scale conference hall with 300 seats and specialised laboratories for antibody research. With state-of-the-art facilities, IDC will be focusing on new antibody biologics discovery, dual-antibody development based on proprietary First-in-Class biologics and next generation vaccine development.The company will start the IDC construction this year and is scheduled for completion by the end of next year. IDC will be hiring more than 200 of PhD and highly qualified R&D personnel over the next five years and fifty percent of its R&D resources will be sourced from local universities and community. Prestige Biopharma’s IDC will serve as a bio-cluster that supports the local economy and drives mutual growth in academia and industry.Dr. Lisa S. Park, CEO of Prestige Biopharma commented: “I am very pleased to enter into the business cooperation agreement with LH and BJFEZ. With this partnership and the global-scale R&D centre, Prestige Biopharma Group 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 leading PBP Group’s innovative drug R&D area.”NEWS
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Prestige Biopharma expects Solid Growth from COVID-19 Vaccine CMO businessSINGAPORE, 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.NEWS
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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