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SINGAPORE, 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.

SINGAPORE, 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.”

SINGAPORE, 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.

SINGAPORE, 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.”

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.”

SINGAPORE, 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.”

SINGAPORE, 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.”

SINGAPORE, 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.”

SINGAPORE, 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.”