NEWS | Innovation for Life

SINGAPORE, December 21, 2021 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, commences construction of Innovative Discovery Center (IDC) in Busan, South Korea. The construction of IDC is scheduled for completion by February 2023.Prestige Biopharma holds a groundbreaking ceremony on December 21, 2021 with Korean government officials and guests including Deputy Mayor of Busan City Mr. Yoon-il Kim, Director General for Investment Policy of the Ministry of Trade, Industry and Energy Mr. Jong-young Jung and Head of Development Administration Division in Busan-Jinhae Free Economic Zone Authority (BJFEZ) Mr. Seokho Cha.The company is on target to build the global-scale R&D centre with a total area of approximately 34,000 square meters and facilities sufficient for 800 researchers. Earlier in May this year, PBP and Busan City Government had signed an MOU for the establishment of IDC in which the company’s plan to invest over US$200 million by 2030 was announced.IDC will be focusing on diverse first-in-class antibody biologics discovery starting from 8 bispecific antibody projects based on PBP’s proprietary oncology therapeutic targets, PAUF and CTHRC1. Next generation vaccines using mRNA technologies and bioinformatics will be developed in IDC for current and potential future pandemics.IDC also will be hiring more than 250 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.As the first global scale R&D center in Busan, IDC is expected to lead the growth of Busan’s bioindustry and to lay a foundation to make the region into a viable bio-cluster that supports the local economy and drives mutual growth in academia and industry. IDC is planning to implement an open innovation platform that provides the local biomedical society a ‘one stop’ R&D solution for full cycle of new drug development targeting global markets.Dr Lisa S. Park, CEO of Prestige Biopharma commented: “IDC will be leading PBP Group’s innovative drug discovery R&D in connection with our research centers in Singapore and US and creating a global open innovation hub for industry-academic collaboration” and “we envision IDC where Prestige Biopharma’s innovation realizes and the start of a new world-class bio-cluster here in Busan.”Hyeong-joon Park, Mayor of Busan City, commented: “We are very excited to have a global scale bio-R&D center in Busan and work with a global leading bio-pharmaceutical company, Prestige Biopharma. Busan City will fully support PBP’s IDC so this novel partnership can lead a local bio-industry’s growth and contribute to local economic development and high-quality job creation.”

SINGAPORE, December 9, 2021 – Prestige Biopharma Ltd. and Dr. Reddy’s Laboratories Ltd. (hereafter referred to as “Dr. Reddy’s”) today announced that the two companies have entered into a binding agreement for an exclusive partnership for the supply and commercialization of Prestige Biopharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.Prestige Biopharma’s trastuzumab (HD201) is a proposed biosimilar to Roche’s Herceptin® and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Trastuzumab targets human epidermal growth factor 2 (HER2). In some types of cancer cells, HER2 is overexpressed and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.The license agreement grants Dr. Reddy’s the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia. Under this partnership, Prestige Biopharma will be responsible for sustainable commercial supply of HD201 from its manufacturing facilities in Osong, South Korea, while Dr. Reddy’s will be responsible for local registrations, marketing and sales in the licensed territories.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are delighted to establish a partnership with Dr. Reddy’s for key Latin American and Southeast Asian markets. Dr. Reddy’s is the ideal partner to commercialize our lead biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets.”M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s, said: “In keeping with our purpose of accelerating access to affordable and innovative medicines, we are happy to bring this life-saving drug to patients in need. Our partnership with Prestige Biopharma will help us combine their established expertise in the area of biosimilars with our commercial strengths and growth ambition in these markets. This is in line with our stated intention to create a portfolio of oncology products and expand our biosimilar offerings in Emerging Markets.”About Prestige Biopharma Limited:PRESTIGE BIOPHARMA LTD (PBP) is a Singapore-based biopharmaceutical company with operations in USA and Korea, specialising in the discovery and development of biosimilars, novel antibodies and vaccines. PBP strives to become a global innovator through the development of first-in-class mAbs including PBP1510 anti-PAUF mAb for pancreatic cancer that recently obtained orphan designation from FDA, EMA and MFDS. PBP’s rich portfolio of biosimilars in various stages including HD204 bevacizumab in global Phase 3, PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. PBP’s business also includes alliance vaccine development and production, starting with the partnered commercial production of COVID-19 vaccines. For more information, please visit www.prestigebio.com.About Dr. Reddy’s:About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.

SINGAPORE, December 7, 2021 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the company’s Adalimumab biosimilar, PBP1502’s phase 1 study has been registered at US National Institutes of Health (NIH)’s ClinicalTrials.gov.PBP filed a phase 1 clinical trial application of PBP1502 in Spain. Once the application is approved, the clinical trial will be conducted in Hospital Universitario La Paz based in Madrid, Spain, in 324 of healthy volunteers. PBP’s affiliate, Prestige Biologics will be providing drugs for the clinical trial.Biosimilars are usually not required to conduct phase 2 trials as their administration and dosage have already been established by their reference drugs. PBP is also planning to conduct PBP1502’s phase 3 study mid-next year once its safety has been proved through the phase 1 study. PBP1502’s phase 3 clinical trail will be conducted in approximately 600 of psoriasis patients and the company plans to file Marketing Authorisation Application (MAA) in EU and US in 2023.The world’s top selling drug, Humira® is used to treat autoimmune diseases such as rheumatoid arthritis and psoriasis and it brought in close to U$20 billion for AbbVie in 2020. In response to Humira®’s US patent protection expiring in 2023, PBP is on target to launch PBP1502 in EU and US.Lisa S. Park, CEO of Prestige Biopharma, commented: “Our Humira Biosimilar, PBP1502 will be launched with its strong price competitiveness resulting from PBP’s proprietary ‘non-protein A antibody purification’ technology” and “PBP will accelerate the development of PBP1502 to provide better treatment for more patients with autoimmune disease.”

SINGAPORE, 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.”

SINGAPORE, 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.”

SINGAPORE, 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.”

SINGAPORE, 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.”

SINGAPORE, 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.”

SINGAPORE, 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.”