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FDA Pre-BLA Meeting for Prestige Biopharma’s Herceptin Biosimilar Scheduled for December 14SINGAPORE, November 02, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that the request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting for Herceptin Biosimilar, HD201(Tuznue®) has been accepted and the meeting has been scheduled for 14th of December this year.The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a Biologics License Application (BLA) in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues.The company has been preparing for FDA BLA for HD201 since 2019 when the company had the Biosimilar Initial Advisory Meeting with the FDA. The FDA bridging study was completed in 2020 and the study result was published in the international journal of Pharmacology Research & Perspectives in July 2021. The study showed HD201’s equivalent pharmacokinetic and safety profile to both US-Herceptin® and EU- Herceptin®.Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin® (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Switzerland.NEWS
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Prestige Biopharma Korea Receives 2022 Foreign Company Day AwardSINGAPORE, [01 November 2022] / Prestige Biopharma Limited, a Singapore-based leading biopharmaceutical company, announced that the CEO of its subsidiary, Prestige Biopharma Korea, received 2022 Foreign Company Day award in South Korea.The ceremony was held on 1st of November 2022 at Intercontinental Hotel Seoul to award 44 companies’ representatives orders and merits of honor for their contribution to boosting Foreign Direct Investment (FDI) to South Korea.The CEO of Prestige Biopharma Korea, Tay Lai Wat, was awarded the commendation of the Ministry of Trade, Industry and Energy (MOTIE) minister for his commitment to FDI to South Korea.NEWS
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Prestige Biopharma Submitted Pre-BLA Meeting Request to FDA for Herceptin BiosimilarSINGAPORE, October 14, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company’s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue®).The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a BLA in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues. The meeting is expected to take place around November, and the BLA submission by the end of the year.Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin® (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Singapore.Lisa Park, CEO of Prestige Biopharma, commented: “This Type 4 Meeting will be the final gate of BLA for HD201. In addition to the Bridging Study on biosimilarity of HD201 to US-Herceptin® and the Biosimilar Initial Advisory Meeting with FDA in 2019, we have been through a series of meetings with the FDA on each step of the development to prepare the launch of HD201 in US to help more patients in need. We will take this final step to thoroughly review and finalise the application for FDA’s approval.”NEWS
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Prestige Biopharma attends 2022 Biosimilar Medicines ConferenceSINGAPORE, October 6, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that the company is attending the 2022 Biosimilar Medicines Conference which takes place in Brussels, Belgium, on October 6 and 7.The Biosimilar Medicines Conference by Medicines for Europe (MfE) aims to facilitate discussion on existing challenges and future opportunities for biosimilar medicine policy and pharmaceutical legislation. The MfE represents the pharmaceutical companies supplying the largest share of medicines across Europe. According to the association, its members currently supply over 67% of all medicines in Europe.This year’s conference is held in person after three years since COVID-19 pandemic. Speakers and panellists will explore how to turn the Pharmaceutical Strategy aim to ensure better access and affordability into concrete biosimilar medicine policy measures.At the conference, many former and current members of European Medicines Agency (EMA) will be speakers and address biosimilar medicine policies. Prestige Biopharma plans to actively engage in discussions on regulations and build network, while seeking opportunities for collaboration with major biopharmaceuticals in Europe.Dr. Susanne Schmidt, Director of Alliance & Portfolio Management in Prestige Biopharma, will participate in the conference. Dr. Schmidt had served as Senior Director of Global/International Business Development at Pfizer and has 25 years of experience in the biopharmaceutical industry, working for multiple leading pharmaceuticals.Dr. Schmidt commented: “The healthcare systems and policies in the European market vary from country to country. This conference, which brings together pharmaceutical experts from different countries in Europe, provides a good opportunity for in-depth study and understanding on the European market. We also plan to strengthen our presence in the European market by participating in more conferences held in individual European countries and introducing our pipeline portfolio and R&D results.”NEWS
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Prestige Biopharma Scientists Publish New Findings on PAUF-induced Cancer Cell Migration and Its PathwaySINGAPORE, October 5, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that a team of scientists at Prestige Biopharma Innovative Discovery Centre (IDC) published a study titled ‘PAUF Induces Migration of Human Pancreatic Cancer Cells Exclusively via the TLR4/MyD88/NF‐κB Signalling Pathway’ in the International Journal of Molecular Sciences.PAUF (pancreatic adenocarcinoma up‐regulated factor) is a novel secreted protein which is substantially expressed in pancreatic cancer cells. It is known to induce pancreatic cancer progression and metastasis. According to this study, PAUF binds directly to TLR4 (Toll‐like receptor 4), which is identified as a receptor for PAUF, on pancreatic cancer cell surfaces and promote cell migration exclusively through the TLR4/MyD88/NF‐κB pathway.In addition, the study demonstrated that the knockout of TLR4 led to a marked decrease in the expression of PD‐L1 (Programmed Death‐Ligand 1), an immune checkpoint contributing to cancer immune escape. Accordingly, the scientists are conducting a follow-up study to confirm if combining anti-PAUF treatment with TLR4 inhibitor can enhance treatment efficacy.The results of this study enhanced the understanding of the mechanism of PAUF‐induced tumour‐promoting effects. Furthermore, it suggests that TLR4 expression on cancer cells may be a critical biomarker for anti‐PAUF treatment, implying a potential clinical application in later phase clinical trials.Prestige Biopharma has been developing PBP1510 (INN: Ulenistamab), a first-in-class anti-PAUF monoclonal antibody for pancreatic cancer treatment. PBP1510 been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Korean MFDS. Currently, it is on Phase 1/2a clinical trial in France, Spain, and US.Sangseok Koh, President of Prestige Biopharma IDC commented: “Through this study, we found a potential therapeutic biomarker and target for the development of effective pancreatic cancer treatment. We will keep up our research to discover and develop methods to control TLR4 expression and further improve PBP1510’s treatment effect.”Meanwhile, Prestige Biopharma IDC is also undergoing research on technology for diagnosis of pancreatic cancer by detecting PAUF in the body. IDC aims to continue its efforts to enable early diagnosis of fatal diseases as well as effective treatment through innovative drugs.NEWS
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Major Shareholder of Prestige Biopharma Group Shows Trust with Additional Stock PurchaseSINGAPORE, September 28, 2022 – Prestige Biopharma announced on September 27 through a public disclosure that Octava Fund Limited, the company’s major institutional shareholder, has purchased 57,000 KDR of Prestige Biopharma stock. Tay Lai Wat, Executive Director of Prestige Biopharma, also purchased 5,000 KDR Group to help defend the stock price.The company explained that the additional investment from its major institutional shareholder confirmed their steady partnership and trust based on the fundamental and intrinsic value of the company as well as the potential growth of the business.Recently, Prestige Biopharma withdrew its Marketing Authorisation Application (MAA) for HD201 submitted to the European Medicines Agency (EMA). The company plans to file a new MAA for HD201 to the EMA with supplementation of data and analysis.Since EMA informed a negative opinion on the Marketing Authorisation Application for the company’s Herceptin Biosimilar in May, major shareholders have been concerned about the sharp drop in stock price and showing support and confidence by purchasing the company’s stock.In May, Chairman Lisa S. Park and Vice Chairman Michael J. Kim of Prestige Biopharma Group, the largest shareholders of the two companies, 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. In July, Octava Fund had 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.Tay Lai Wat, Executive Director of Prestige Biopharma, commented: “The recent withdrawal of MAA submitted to the EMA is nothing more than a temporary delay in the company’s plan. The company has no issue with its fundamental value, business competence, and liquidity.”According to the company, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a MAA by the Korea Ministry of Food and Drug Safety. At the same time, the company is on track with the phase 3 clinical trial of its Avastin biosimilar HD204, phase 1 clinical trial of its Humira biosimilar PBP1502 in Europe, and phase 1/2a clinical trial of its first-in-class antibody PBP1510 in Europe and US.NEWS
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Prestige Biopharma Withdraws Marketing Authorization Application for Herceptin Biosimilar in EuropeSINGAPORE, 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.”NEWS
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Prestige Biopharma to Acquire More Shares of Prestige Biologics to Consolidate Group CompetitivenessSINGAPORE, 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.”NEWS
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Prestige Biopharma Obtains PBP1510 Patent in SingaporeSINGAPORE, 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.NEWS