NEWS | Innovation for Life

SINGAPORE, September 16, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that the company has withdrawn the Marketing Authorization Application (MAA) for the company’s Herceptin Biosimilar, HD201(Tuznue®), submitted to the European Medicines Agency (EMA). The company will reapply to EMA for the MAA with supplementation of data and analysis.On May 23, the company requested re-examination on the MAA for the HD201, after receiving a negative opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on May 19. Despite the evidence of the analytical comparability and biological similarity proven through clinical trials of HD201, CHMP delivered a negative opinion due to disparity in the range of acceptance for the criteria of analytical comparability between the clinical testing batch and commercial production batch of HD201.During re-examination, it was reported that the newly assigned main rapporteur suggested a positive opinion. Nonetheless, it couldn’t overturn CHMP’s range of acceptance for the criteria of analytical comparability. Based on long-term marketing strategy, the company decided to voluntarily withdraw its application and plans to reapply after supplementing data through additional tests and analysis to meet CHMP’s criteria of analytical comparability.Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin® (trastuzumab) 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.Currently, the MAA for HD201 is under review by Health Canada and Korea Ministry of Food and Drug Safety and will be submitted to the US Food and Drug Administration (FDA) by the end of this year. At the same time, Prestige Biopharma plans to focus on the reapplication process of the MAA to EMA for HD201 and prepare for the global market entry based on partnerships with global biopharmaceuticals.The internal and external expert advisory panel of Prestige Biopharma stated: “The company’s confidence is based on the excellent pharmaceutical quality of HD201 proven through clinical studies and multiple analysis. Through the re-examination, we received positive opinion by the main rapporteur, which is encouraging. We will do our best to obtain approval for HD201 in US and Europe without any doubt and provide patients with better access to treatments.”

SINGAPORE, August 29, 2022 – Prestige Biopharma Limited announced that the company will become the largest shareholder of Prestige Biologics by acquiring new shares to secure a total of 24.88% of the CDMO company.On August 26, the board of directors of Prestige Biopharma approved subscription in Prestige Biologics’ capital increase through third party allotment of 13,787,830 new shares amounting to approximately KRW 59.8 billion. As result, the Company will have management control over Prestige Biologics which will be accounted for as a subsidiary of Prestige Biopharma.The new structure allows the two companies to maximize synergy and the group to establish a full value chain. Prestige Biopharma can secure a global-scale production facility with 154,000 litres of capability and core bioprocessing technologies on top of its R&D expertise. Prestige Biologics can leverage Prestige Biopharma’s marketing capabilities to obtain more consignment contracts and raise its position as global CDMO. Hence, the group can improve its revenue and continue its robust investment in R&D of new biologics, contributing to long-term financial stability and prosperity.In addition, the new structure enables integrated business management by operating integrated organization and digital management system. Thus, it is expected to facilitate strategic and efficient management, streamline decision-making process, and strengthen cooperation.Meanwhile, Prestige Biologics announced the appointment of Duk-Hoon Hyun as new CEO on August 26 and held an inauguration ceremony on August 29. Duk-Hoon Hyun has led Prestige Biologics’ digital transformation project since last year and has successfully introduced the SAP system into the entire organization. Previously, he was a senior executive of SAP, a global ERP company.Duk-Hoon Hyun, new CEO of Prestige Biologics mentioned: “I feel heavy responsibility to expedite the innovation in production process and produce results as a global CDMO. I will do my utmost to strengthen ICT technology capabilities, which are essential for data management and factory automation, and create new synergy under the reorganized group structure.”Lisa Park, CEO of Prestige Biopharma, mentioned: “The new integral organizational structure of the group will be the foundation of becoming a global comprehensive biopharmaceutical by enhancing the group’s profitability and stability for growth. Welcoming the new CEO of Prestige Biologics, we look forward to building a future together in discovering, developing, and producing biomedicines.”

SINGAPORE, August 24, 2022 – Prestige BioPharma Limited, a Singapore-based biopharmaceutical company with operations in U.S. and South Korea, announced that the company has obtained a patent in Singapore for PBP1510 (INN-ulenistamab), the company’s first-in-class anti-PAUF monoclonal antibody.PBP1510 has thus far been patented in eight countries including Singapore, Korea, United States, Japan, Australia, Taiwan. Russia, and South Africa. In addition, it is currently under review for patent registration in 16 countries such as Canada and New Zealand.Being a first-in-class anti-PAUF treatment, PBP1510 helps preventing the progression and metastasis of the cancer induced by PAUF (Pancreatic Adenocarcinoma Up-regulated Factor) and creating a more responsive environment for antitumor immunotherapy. Thus, it is expected to provide significant benefit to patients suffering from PAUF-positive pancreatic cancer.In 2020, PBP1510 was granted Orphan Drug Designation by the European Medicines Agency, the U.S. Food and Drug Administration, and Korea Ministry of Food and Drug Safety MFDS. Currently, it is undergoing phase 1/2a clinical trial in Europe and U.S.To bring the new promising drug to patients as early as possible, Prestige Biopharma is planning to apply for FDA’s Fast Track program, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

SINGAPORE, July 26, 2022 – Prestige Biopharma Limited (hereafter referred to as “Prestige”) and Intas Pharmaceuticals Limited (hereafter referred to as “Intas”) today announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige Biopharma´s bevacizumab biosimilar, in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.Prestige´s bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin®, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer including metastatic colorectal cancer, advanced non-small-cell lung cancer, advanced kidney cancer, certain types of epithelial cancers and cancers of the cervix. HD204 is currently in Phase III clinical development (SAMSON-II) and the US and EU filing is planned next year. Positive results were previously reported from the Phase I clinical trial (SAMSON-I) which evaluated the pharmacokinetics, safety and immunogenicity of HD204 to Avastin®.The partnership arrangement includes the exclusive rights for Intas and its affiliate Accord Healthcare that will commercialize the bevacizumab biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan, leveraging their strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. As one of the key players in the global biosimilar market, Accord has a longstanding commitment to oncology with proven commercial capabilities and it currently supplies around one in three injectable oncology medicines in Europe.This collaboration represents the successful execution of the company’s strategy to expand its market reach in Europe and Canada leveraging Accord’s strong global footprint and deep commercial expertise. The global sales of bevacizumab including its biosimilars were recorded at USD 6.4 billion1) last year and the market is expected to continue growing. Prestige’s HD204 with excellent cost competitiveness based on the company’s proprietary bevacizumab production technology will be providing affordable access to more patients in need.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are delighted to establish a partnership with Intas for the key markets, the US and Europe. Accord is the ideal partner to commercialize our bevacizumab biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets.”Binish Chudgar, Vice Chairman & Managing Director of Intas Pharmaceuticals, commented: “We are pleased to announce the collaboration with Prestige Biopharma. This collaboration is in line with our long-term strategy and reinforces our commitment to improving access to high-quality biosimilar drugs for cancer patients globally.” About Intas Pharmaceuticals Limited: Intas Pharmaceuticals Ltd. is a leading vertically integrated pharmaceutical company based in Ahmedabad, India, having end-to-end capabilities of formulation development, manufacturing and marketing along with backward integration of APIs. The organisation has more than 18,000 employees and 14 manufacturing sites worldwide and sells products in more than 85 countries. The Intas Group’s revenue amounted to USD 2.3 bn in FY 2020-21 and the compounded annual growth rate of revenue has been 19% in the past 5 years. For more information, please visit www.intaspharma.com. 1) Source: IQVIA

SINGAPORE, July 14, 2022 – Major shareholders of Prestige Biopharma Group were actively defending their stock prices, while the local stock market has recently fluctuated and fallen sharply due to concerns over an economic slowdown.According to the Data Analysis Retrieval and Transfer System by Korean Financial Supervisory Service on July 14, Octava Fund Limited, a major institutional shareholder, recently purchased KRW 1.3 billion of Prestige Biopharma stock and KRW 400 million of Prestige Biologics stock, amounting to a total of KRW 1.7 billion.Chairman Lisa S. Park and Vice Chairman Michael J. Kim of Prestige Biopharma Group, the largest shareholders of the two companies, have also bought a total of KRW 7.5 billion worth of stock through Mason Partners, a joint investment company established by Chairman Park and Vice Chairman Kim. As a result, the investment that major shareholders have put in defending the stock price of Prestige Biopharma and Prestige Biologics amounts to nearly KRW 10 billion since EMA.According to the company, Octava Fund has provided support in defending the stock price to show trust and confidence as a long-term investment partner. Previously, the major institutional shareholder had purchased KRW 6.9 billion stock in December 2021.Meanwhile, Prestige BioPharma is focusing on preparing for the re-examination of Marketing Authorisation Application (MAA) for the company’s Herceptin® biosimilar HD201 that it requested European Medicines Agency (EMA) in May. The company decided to seek approval through re-examination by setting up with a global expert team, instead of choosing withdrawal and reapplication which will take more than a year. Prestige Biologics is strengthening its business with signing new contracts as a global CDMO utilizing its global-scale facilities and state-of-the-art patented technologies.

SINGAPORE, June 27, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company with operations in USA and South Korea, announced that the U.S. Food and Drug Administration (FDA) has approved the Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510 (INN-Ulenistamab), for the treatment of pancreatic cancer.The clinical trial will be conducted on patients with advanced/metastatic pancreatic cancer in the Massachusetts General Hospital and the Ronald Reagan UCLA Medical Center by Principal Investigators (PI) comprised of leading authorities at Harvard Medical School and UCLA School of Medicine. The study aims to identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy.Pancreatic cancer is a highly aggressive malignancy which contributes to high morbidity and mortality with an overall survival rate in the U.S. of around 11%1) at five years. Currently, the only curative options are surgical resection in combination with adjuvant chemotherapy. However, only 10 to 15%2) 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 Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in majority of pancreatic cancer patients. PAUF 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 to all patients affected by PAUF-positive pancreatic cancer.The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) 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 few individuals but cause great suffering. This designation provides 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.PBP1510 is also expected to be eligible for FDA’s accelerated approval program if certain conditions are met. This program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. The company believes that PBP1510 will be able to apply for the accelerated approval program with the validated surrogate endpoint from its Phase 2 study.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are very pleased to initiate the Phase 1/2a clinical trial of PBP1510 in the world-class medical institutions in the US,” and “the company will accelerate the Phase 1/2a study of PBP1510 to demonstrate the solid evidence to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments.” 1) American Cancer Society 2022, Survival Rates for Pancreatic Cancer, accessed 27 June 2022, https://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html>2) Srustidhar D. and Surinder K. B. (2015). Pancreatic Cancer Metastasis: Are we being Pre-EMTed?. Current Pharmaceutical Design, Volume 21, Issue 10, 1249 – 1255

SINGAPORE, June 14, 2022 – Prestige Biopharma Group, comprising Singapore-based biopharmaceutical company Prestige Biopharma Limited. and biopharmaceutical CDMO company Prestige Biologics Co., Ltd., announced that the Group is participating in the BIO International Convention 2022, taking place in San Diego from June 13 to 16, 2022.The Group aims to partner with global players for its core pipelines and secure clients for its CDEMO business at the world’s largest event for the biotechnology and pharmaceutical industries. After 2 years of online conventions, this year’s event is back in-person, thus expected to gather a high number of participants including around 3,000 companies from all over the world.At booth #1421 in Bioprocess Zone, Hall B2, Prestige Biopharma Group showcases its technological platform for bioprocessing value chain, ranging from drug discovery to commercialization, which enhances productivity and cost-effectiveness. In particular, Prestige Biopharma introduces its biosimilar and antibody portfolio and share current progress on each pipeline to discusses partnership in development or commercialization. Prestige Biologics concentrates on securing clients and business contracts of its CDEMO services that provide customized manufacturing suites as well as development and engineering solutions.Michael Ruppert, Director of International Business Development at Prestige Biopharma, said: “Our goal here is to build global network and partnership to enter the global market. In addition to biosimilars and first-in-class antibody drugs, we also look forward to discussing collaborations in research and development of vaccines against next-generation infectious diseases.”Jae-young Yang, CEO of Prestige Biologics, said: “In the competitive CDMO market, we have armed ourselves with state-of-the-art biomanufacturing facilities and patent technologies that ensures high quality and productivity. We will seize this opportunity to raise Prestige Biologics’ profile worldwide and secure new clients for CDEMO business.”

SINGAPORE, June 2, 2022 – CEO Lisa S. Park and COO Michael J. Kim have purchased additional shares in Prestige Biopharma and Prestige Biologics to stabilize stock prices of the two companies. Through Mason Partners, a joint investment company established by CEO Park and COO Kim, the two executive directors bought 137,420 shares of Prestige Biopharma’s stock. In addition, CEO Park and COO Kim bought 19,337 shares and 19,301 shares of Prestige Biologics’ stock respectively. Including the KRW 2 billion stock purchase previously announced on May 23, the two executive directors have purchased KRW 4 billion stock in total so far, and will consider further action to protect the market value of their companies.picture: Vice Chairman, Mr. Michael Kim“We are confident with the value of our business and have been putting strenuous efforts towards the development and commercialization of our pipelines. The recent fall in stock price doesn’t reflect the potential value of our companies. We hope the in-house purchase would be a positive signal to the shareholders and help recover our market value. Prestige Biopharma and Prestige Biologics will continue to do the utmost to enhance future values,” said Dr. Lisa S. Park, CEO of Prestige Biopharma.Prestige Biopharma has requested European Medicines Agency (EMA) for re-examination of Marketing Authorisation Application (MAA) for the company’s Herceptin® biosimilar HD201. The result is expected to be announced after 120 days. Prestige Biologics is strengthening its business as a global CDMO utilizing its state-of-the-art facilities and patented technologies.

SINGAPORE, May 31, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company with operations in USA and South Korea, announced that its first-in-class antibody PBP1510 has acquired an International Nonproprietary Name (INN) of ‘Ulenistamab’ and was placed on the INN Recommended List by the World Health Organization (WHO).“With its INN- Ulenistamab, PBP1510 is one step closer to commercialization. Not to mention pancreatic cancer has the highest mortality rate of all major cancers, we will try our utmost with PBP1510 so that it could provide significant benefit in all patients affected by PAUF-positive pancreatic cancer,” said Lisa S. Park, CEO of Prestige Biopharma.INN-Ulenistamab, which is also known as a generic name, facilitates the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. The name is given through a thorough examination and discussion on the drug by the WHO and INN experts.PBP1510 (INN-Ulenistamab) is an anti-PAUF monoclonal antibody for pancreatic cancer treatment. It effectively counteracts the effects induced by PAUF (Pancreatic Adenocarcinoma Up-regulated Factor) which is known to play an important role in tumor growth and to be involved in the rapid progression of pancreatic cancer.In 2020, PBP1510 (INN-Ulenistamab) has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Korean MFDS. Currently, it is on Phase 1/2a clinical trial in France and Spain.Meanwhile, Prestige Biopharma has recently published a research paper on Frontiers in Pharmacology revealing that PBP1510 may potentially treat ovarian cancer as well. The study showed that PAUF independently promotes tumor growth and metastasis in ovarian cancer cells, in a baseline PAUF dependent and saturable manner, thus an anti-PAUF antibody may sensitize and synchronize the anti-tumor effects of cytotoxic agents and prolong survival time for patients with ovarian cancer.