NEWS | Innovation for Life

SINGAPORE, March 8, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the preclinical data of their First-in-Class pancreatic cancer treatment, PBP1510 (INN-Ulenistamab), has been shared in a poster presentation at the European Society for Medical Oncology (ESMO) Targeted Anticancer Therapies (TAT) Congress 2022 held virtually from March 7 to 8, 2022.ESMO is one of the leading professional organisations for medical oncology, together with American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO).Preclinical data of PBP1510 presented in the poster shows notable regression in tumour volume and weight in subcutaneous as well as orthotopic patient derived cancer xenograft (PDX) mouse models treated with PBP1510 compared to gemcitabine and IgG controls. In the orthotopic PDX model, tumour cells derived from pancreatic cancer patients are surgically implanted into the pancreas of mice. Such models are of high clinical relevance as they aid in establishing organ-specific tumour microenvironment with great accuracy.In repeated dose toxicity studies, no notable systemic or local toxicity was observed for up to 40 mg/kg of PBP1510. Absence of anti-drug antibodies was noted in all animals receiving PBP1510 indicating low immunogenic potential.Based on the efficacy and safety demonstrated in the preclinical study, PBP1510 is currently in Phase 1/2a clinical trial in France and Spain.The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. 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 and the U.S. for certain years.Prestige has strong pipeline portfolio comprising innovative antibody drugs and biosimilars including the frontrunning Herceptin biosimilar HD201 (Tuznue®) filed to EMA, Health Canada and MFDS, an Avastin biosimilar HD204 (Vasforda®) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe. The company’s second First-in-Class antibody PBP1710 targeting CTHRC1, a ubiquitous protein overexpressed in many types of cancer, is currently in preclinical stage.Lisa S. Park, CEO of Prestige Biopharma, commented: “We will identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy,” and “Prestige will accelerate the development of PBP1510 that has demonstrated solid evidence and potential as the new cure for pancreatic cancer.”

SINGAPORE, April 1, 2022 – Prestige Biopharma Limited a Singapore-based leading biopharmaceutical with operations in USA and South Korea, announced that the company has been recognized as the grand winner of the Bioprocessing Excellence in SEA (South-East Asia).The Awards Ceremony was held in conjunction with the 9th Biologics Manufacturing Asia and 6th Biologistics World Asia 2022 hybrid Conference, which was streamed live on 29 – 30 March 2022.Asia Pacific Bioprocessing Excellence Awards recognizes exceptional bioprocessing experts, organizations and technologies that facilitate biomanufacturing excellence at enhanced speed, reduced cost, and superior quality. The panel of expert judges include key opinion leaders with more than 20 years of experience from all the key players in Asia and globally.“We are very proud to receive this award and thank you for recognizing Prestige’s passion for driving innovation and change in bioprocessing,” said Dr. Deborah Moshinsky, Head of Global R&D of Prestige in her acceptance speech. “Prestige Group has undergone a significant expansion to our manufacturing capabilities. Our EU-GMP certified facility with global compliance recognition is currently expanding its capacity up to 234,000 liters through its 2nd Campus developments.”Prestige has developed biosimilars and first-in-class antibody drugs of high quality and strong cost competitiveness in expedited development programmes, with its proprietary bioprocessing technology.Prestige’s leading pipeline HD201 trastuzumab (Tuzune®) is currently under EU EMA’s MAA review and its manufacturing facility has received European Union Good Manufacturing Practices (GMP) certification last February.The company’s robust pipeline in clinical stage also includes an innovative therapy for pancreatic cancer, PBP1510 (INN: Ulenistamab) in Phase 1/2a clinical trial in Europe, an Avastin biosimilar HD204 (Vasforda®) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe.

SINGAPORE, February 21, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the manufacturing facility for its Herceptin® biosimilar, Tuznue®, in Prestige Biologics Co., Ltd., has received European Union Good Manufacturing Practices (GMP) certification. EU-GMP certification is one of the highest standards of pharmaceutical production in the world, and it provides pharmaceuticals with the foundation to start selling their products into European markets.Tuznue, HD201, is a proposed biosimilar to Roche’s Herceptin and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Tuznue’s equivalence to the originator has been demonstrated in 2 Phase 1 trials conducted in Europe and Australia and a global Phase 3 trial, which has been published in scientific journals and conferences. Tuznue has secured global distribution partnerships in major markets, and is currently under Marketing Authorization Application (MAA) review in EU EMA, Canada and South Korea.CEO Mr. Jay Yang, Prestige BiologicsPrestige Biopharma has strong pipeline portfolio comprising biosimilars and first-in-class antibody drugs. Following the frontrunning Tuznue, a biosimilar to Avastin®, HD204 (Vasforda®) is wrapping up the global Phase 3 clinical trial targeting filing to FDA and EMA this year. PBP1510 (Ulenistamab), first-in-class antibody drug for pancreatic cancer, and PBP1502, a biosimilar to Humira® are currently in Phase 1/2a and Phase 1 clinical trial in Europe, respectively.Lisa S. Park, CEO of Prestige Biopharma, commented: “EU GMP certification of our manufacturing arm in Korea demonstrated our global standard biomanufacturing facility and system that are applied to all of our products. By achieving one of the key requirements for product registration, we are one step closer to global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need.”

SINGAPORE, January 27, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical group with operations in USA and South Korea, announced that the company’s first-in-class anti-PAUF monoclonal antibody, PBP1510 has obtained a patent in Japan.Given that Japan is one of the biggest markets in the global biologics industry together with USA and Europe, PBP1510’s patent registration in Japan has significant impact in terms of its global reputation and marketability.PBP1510 has thus far been patented in the seven major countries in the world including USA, Japan, Australia, South Korea, Russia, Taiwan and South Africa, and currently around twenty countries such as Canada and New Zealand are reviewing PBP1510 for patent registration.The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. French National Agency for the Safety of Medicines and Health Products has approved a Phase 1/2a clinical trial of PBP1510 in June last year. The Spanish regulatory authority is also reviewing the Phase 1/2a IND of PBP1510 and the company is preparing for a FDA submission as well.PBP1510, a first-in-class anti-PAUF treatment, acts by neutralizing PAUF to dismiss its cellular effects. Rapid progression of pancreatic cancer can be partly explained by PAUF and its important role in disease progression. Currently, no targeted molecular therapy against PAUF exists. PBP1510 effectively counteracts the effects induced by PAUF, thus creating a more responsive environment for antitumor immunotherapy and PBP1510 is expected to be a promising alternative to chemotherapy.Prestige Biopharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit in all patients affected by PAUF-positive pancreatic cancer.The company is planning to complete the clinical studies of PBP1510 by 2023 and its marketing authorisation application can be reviewed before Phase 3 clinical trial depending on the result of Phase 2 study. The New Drug Application (NDA) submission to FDA and EMA is planned in 2024.

SINGAPORE, January 12, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the company’s Sputnik Light CMO project is going along as initially planned, amid Omicron spread.PBP signed a contract manufacturing agreement to produce Russia’s Sputnik Light COVID19 vaccine in November last year. The demands of Sputnik Light are expected to grow rapidly as both Sputink V (Ad26/Ad5 vector) and Sputink Light (Ad26 vector) use Sputink Light as a booster shot.According to the recent study of Russia’s Gamaleya National Research Center of Epidemiology and Microbiology, the expected efficacy of Sputnik V with Sputnik Light booster against Omicron infection could be more than 80%. Russia also mentioned that the study of reputed Harvard team demonstrated that boosting of Pfizer vaсcine with Ad26 vector produces optimal durable protection against Omicron.Currently, Sputnik V and Sputnik Light have been approved in more than 70 countries and in around 30 countries respectively, and PBP’s commercial production of both vaccines are planned to be commenced soon.PBP’s global-scale vaccine center in Korea with 104,000 liters of production capacity has been designed with multi-purpose production lines using Prestige Biologics (334970: KOSDAQ)’ proprietary technology, ALITA Smart BioFactoryTM, so the production facility can anytime be used for PBP’s other pipeline production such as antibody therapeutics.PBP’s CEO, Dr Lisa S. Park commented: “Currently, a considerable number of reputed studies are demonstrating the efficacy of Sputnik Light as a booster shot against Omicron infection and our production volume is also expected to increase due to its high demand” and “in 2022, PBP will prove our true potential and value to the market with visible performance and revenue from the existing pipeline and vaccine business.”

SINGAPORE, December 23, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the company has joined COVID-19 Vaccines Global Access (COVAX) Marketplace launched by the Coalition for Epidemic Preparedness Innovations (CEPI).The scheme, called the COVAX Marketplace, is designed to address bottlenecks by facilitating access to supplies needed to produce COVID-19 vaccines. This secure platform enables global vaccine manufacturers and raw-material suppliers to share critical inputs to confidentially indicate their needs or available supplies to CEPI.PBP takes part in the COVAX Marketplace as a vaccine manufacturer and the company will be having more chances to discuss with global vaccine developers for its vaccine CMO business and securing a reliable supply chain network. The company ultimately aims to develop its own vaccine products in PBP’s global R&D center, Innovative Discovery Center (IDC) in Korea.PBP’s CEO, Dr Lisa S. Park commented: “With PBP’s global scale vaccine center with 104,000 liters of total production capacity in Korea and this COVAX partnership, the company will keep contributing to the growing global demands for COVID-19 vaccine production” and “the COVAX Marketplace will play a crucial role in combating the fast-spreading Coronavirus variants, now is the time for global pharmaceuticals to work together in solidarity to stop this pandemic.”

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.”