News
NEWS | Innovation for Life
-
Prestige Biopharma Announces Grand Opening of Global-Scale Vaccine Center in South KoreaSINGAPORE, December 1, 2021 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, is pleased to announce the grand opening of its global-scale Vaccine Center in Osong, South Korea.The opening ceremony was held on December 01, 2021 at the Vaccine Center in Osong Campus. The ceremony was attended by many distinguished guests including Minister for Government Policy Coordination Mr. Yun-cheol Koo, Deputy Governor Mr. Il-hong Seong of Chungbuk Province, Mayor of Cheongju City Mr. Beom-deok Han, Representatives from Octava Fund Limited Mr. Joseph Tey and Mr. Sze Khai Pang.PBP commenced construction of its Vaccine Center April this year and completed the global-scale manufacturing facility with a total area of 10,342.88 m2 and a total capacity of 104,000 litres (52 units of 2,000 liter bioreactors) in only eight months by employing Prestige Biologics (334970: KOSDAQ)’ proprietary engineering technology, ALITA Smart BioFactoryTM. With the ALITA system which provides combined advantages of Stainless Steel & Single-Use system, different types of vaccines can be produced in versatile custom manufacturing suites. The Vaccine Center’s Single-Use bioreactors also enhance operational efficiency and productivity while minimizing the risk of cross contamination.PBP is currently focusing on two COVID19 vaccine projects to produce Sputink V and Sputink Light vaccines. PBP’s global-scale Vaccine Center is capable of producing around 2.6 billion doses of the first dose of Sputnik V vaccine (Ad26 adenovirus vector) per year.The center will soon be prepared to produce other types of vaccines including mRNA vaccines to actively respond to the growing demands of COVID19 vaccines.The company ultimately aims to develop its own vaccine products to combat potential future pandemics and PBP Vaccine Center will be the basecamp for this journey.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented, “We are very pleased to complete the Prestige Biopharma Vaccine Center as planned this year with our Group’s unique and unmatched engineering technology, ALITA Smart BioFactory” and “this Vaccine Center will be playing a significant role in our fight against Covid-19 and possible future pandemics.”NEWS
-
Prestige Biopharma Participates in CPhI Worldwide 2021 Milan, ItalySINGAPORE, November 10, 2021 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with global presence, announced that the company will take part in CPhI Worldwide 2021 Milan, Italy.CPhI is the world’s largest biopharmaceutical conference. This year’s event will be held on- and offline for the first time since the Covid-19 outbreak.Prestige Biopharma has set up a separate booth at the convention and prepared various brochures that allow visitors to see the company’s innovative biosimilar and new antibody drug pipelines and global-scale vaccine manufacturing capabilities. A lot of participants have submitted meeting requests on Prestige Biopharma’s Herceptin® biosimilar, HD201. The company is also planning to actively promote its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “We have been receiving a lot of inquiries on our antibody drug R&D and vaccine manufacturing capabilities. Prestige Biopharma will actively cooperate with the global pharmaceutical companies and organisations which can generate synergy in antibody drug and vaccine business.”NEWS
-
Prestige Biopharma Signs Technology Transfer Agreement with Human Vaccine & Enso for Sputnik Light COVID-19 vaccineSINGAPORE, November 8, 2021 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with global presence, announced that the company signed a technology transfer agreement with Human Vaccine LLC (HV), a wholly owned subsidiary of the Russian Direct Investment Fund (RDIF) and ENSO Healthcare DMCC(ENSO) on November 5, 2021 for the production of ‘Sputnik Light’ COVID-19 vaccine.The single-component Sputnik Light vaccine that PBP will be producing, after the technical transfer, is designed as a single-dose vaccine consisting of the first dose of Sputnik V vaccine, using one type of vector (Ad26 adenovirus). Sputnik Light is currently being approved for use in the growing number of countries where Sputnik V has been approved.HV holds a license for undertaking the manufacture and sale of Sputnik vaccine and ENSO is RDIF’s coordination partner for sourcing and distribution of Sputnik vaccine. In order to respond to the growing demands of Sputnik Light, HV and ENSO have entered into this technical transfer agreement with Prestige Biopharma for manufacturing of Sputnik Light. The technical transfer agreement includes DS (Drug Substance) and DP (Drug Product) production technology transfer and validation.Prestige Biopharma Group recently completed its Osong Campus 1 Annex in South Korea and its commercial vaccine production unit has been installed in the building. Prestige Biopharma’s global-scale Vaccine Center, being built with its affiliate, Prestige Biologics’ proprietary technology ALITA Smart BioFactoryTM in Osong Campus 2, will be equipped with a total of 104,000 litres of production capacity, and this capacity will be allocated to the HV-ENSO contract and Huons Global Consortium.Prestige Biopharma is actively establishing a drug product (DP) production capacity (filling and packaging) for a smooth global vaccine supply. Such efforts include recent purchase of a state-of-the-art aseptic filling machine from Cytiva for DP manufacturing.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “Prestige Biopharma international scale Vaccine Centre is designed to enable mass-production of various vaccines in short period of time. Our first project with Huons Global Consortium is showing visible progress and results. Through this technical transfer agreement with HV and ENSO, we will also be preparing to produce Sputnik Light vaccine and the company feels a tremendous responsibility” and “we will keep contributing to the growing global demands for COVID-19 vaccine production with the company’s unmatched production facility and technologies.”NEWS
-
Prestige Biopharma Group Completes its Campus 1 Annex in Osong, South KoreaSINGAPORE, October 29, 2021 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with global presence, is pleased to announce the completion of Prestige Biopharma Group’s Campus 1 Annex in Osong, South Korea.Prestige Biopharma Group commenced construction of its Osong Campus 1 Annex in May this year and completed the multi-purpose building with a total area of 10,014m² in only six months by using Prestige Biologics’ proprietary engineering technology, ALITA Smart BioFactoryTM. PBP’s commercial vaccine production unit in the Campus 1 Annex is currently under validation and Prestige Biopharma Group’s R&D and other manufacturing facility will be installed in this building as well.Prestige Biopharma began the process of pilot production of Sputnik V COVID19 vaccine in last August and the newly installed vaccine unit in the Campus 1 Annex is for commercial production.Apart from this, Prestige Biopharma’s main vaccine centre with a total area of 10,342m² is being built in Osong Campus 2 site and it is on target to complete the construction by the end of this year.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “The Campus 1 Annex has been completed and the Campus 2’s vaccine centre and antibody drug manufacturing facility are on the verge of completion as planned earlier this year” and “we will complete a production system validation and procure necessary equipment to establish a reliable manufacturing facility for vaccine and antibody drug.”NEWS
-
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
-
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
-
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
-
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
-
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