NEWS | Innovation for Life

- Following approval by the European Commission, Prestige Biopharma's Herceptin biosimilar would become the first biosimilar from a Singaporean company to be authorized in the European Union.Singapore, July 26, 2024 — Prestige Biopharma, a pioneer in biopharmaceuticals, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Tuznue®, a Herceptin (trastuzumab) biosimilar. This milestone positions Prestige Biopharma to become the first Singaporean firm to commercialize its biosimilar in the European Union.The CHMP’s positive opinion is based on clinical evidence from Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Tuznue® to Herceptin®. The Phase 1 clinical PK study in healthy volunteers demonstrated PK equivalence, as well as similarity in safety and immunogenicity. Finally, the global Phase 3 confirmatory efficacy and similarity study met its primary endpoint and demonstrated similarity in efficacy, PK, safety, and immunogenicity in HER2-positive patients with early breast cancer. This favourable decision is a crucial step toward final approval from the European Commission (EC). Once approved, Tuznue® will be commercialized across Europe.Prestige Biopharma has already established licensing agreements with major pharmaceutical partners such as Dr. Reddy’s, Tabuk, Cipla, and Pharmapark for global marketing and sales. These agreements are set to generate immediate milestone payments and provide early revenue for the company. Negotiations are also underway to ensure a strong market entry for Tuznue® in Europe."Receiving a positive CHMP opinion for Tuznue® marks a major milestone for Prestige Biopharma, significantly advancing our revenue generation strategy and accelerating future pipeline approvals,” said Lisa Park, the CEO of Prestige Biopharma. “This recognition solidifies our position as a leading biosimilar developer. We are committed to leveraging this achievement to enhance our market presence and drive continued success."About TUZNUE® (HD201, biosimilar trastuzumab)Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC).About Prestige Biopharma:Established in 2015 in Singapore, Prestige Biopharma is a biopharmaceutical company with a diversified portfolio. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class, PAUF-based antibody drug, ulenistamab, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) in Korea, as well as Fast Track Designation by the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. Prestige Biopharma is also part of the Cancer Moonshot initiatives in pursuit of accelerating scientific discovery and innovation.

Event Dates:  Oct 8 ( Mon ) - Oct 10 (wed), 2024 개최 장소 : Fiera MilanoCity/Country  : Milan / ItalyWebsite : www.cphi.com/europeRESERVATIONThank you for your interest in exploring potential opportunities with us.Please indicate your preferred timeslot for an in-person meeting and specify the topic you would like to discuss.Once we receive your request, we will reach out to you to confirm the suitable timeslot andthe company delegate who will be attending. [ameliastepbooking service=2]INQUIRET. +65 6924 6535   E. info@prestigebio.com

BIO USA 2024 has opened today in the United States. Prestige Biopharma Group is continuing with over 30 meetings on the first day.All employees are committed to doing their best to achieve successful outcomes.

BIO USA 2024 has opened today in the United States. Prestige Biopharma Group is continuing with over 30 meetings on the first day.All employees are committed to doing their best to achieve successful outcomes.

BIO International Convention 2024 - Prestige Biopharma IDCEvent Dates:  June 3 to 6, 2024Venue: San Diego Convention Center, CaliforniaWebsite: www.convention.bio.orgPartnering Schedule:June 3: 1:00pm to 6:00pmJune 4: 10:30am to 5:00pmJune 5: 10:30am to 6:00pmJune 6: 10:30am to 4:30pmRESERVATIONThank you for your interest in exploring potential opportunities with us.Please indicate your preferred timeslot for an in-person meeting and specify the topic you would like to discuss.Once we receive your request, we will reach out to you to confirm the suitable timeslot andthe company delegate who will be attending. [wpforms id="5217" title="false"]INQUIRET. +65 6924 6535   E. info@prestigebio.com

BIO International Convention 2024 - Prestige BiopharmaEvent Dates:  June 3 to 6, 2024Venue: San Diego Convention Center, CaliforniaWebsite: www.convention.bio.orgPartnering Schedule:June 3: 1:00pm to 6:00pmJune 4: 10:30am to 5:00pmJune 5: 10:30am to 6:00pmJune 6: 10:30am to 4:30pmRESERVATIONThank you for your interest in exploring potential opportunities with us.Please indicate your preferred timeslot for an in-person meeting and specify the topic you would like to discuss.Once we receive your request, we will reach out to you to confirm the suitable timeslot andthe company delegate who will be attending.  [wpforms id="5153" title="false"] INQUIRET. +65 6924 6535   E. info@prestigebio.com

Prestige Biologics enters into MoU with Aurigene Pharmaceutical Services Limited to explore collaboration in the global biologics CDMO marketPrestige Biologics, a Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceuticals, announced the establishment of a strategic partnership with Aurigene Pharmaceutical Services Limited (APSL), a wholly owned step-down subsidiary company of Dr. Reddy’s Laboratories Limited, through the signing of a non-binding Memorandum of Understanding (MoU). The MoU, which is subject to a Definitive Agreement, will oversee collaborative efforts between Prestige Biologics and APSL to bring in a comprehensive set of services and capabilities towards meeting the CDMO needs of biologics-focused companies. “We are delighted to announce our strategic partnership with Aurigene Pharmaceutical Services Limited,” stated Duk Hoon Hyun, CEO of Prestige Biologics. “Prestige Biologics’ global prominence in the CDMO market, coupled with Aurigene’s pharmaceutical expertise in R&D services, will create an end-to-end service capability in the Biologics CRDMO segment through this collaboration, offering cell line development to large-scale manufacturing services for global Biologics customers.”Aurigene Pharmaceutical Services Limited is a Contract Research, Development and Manufacturing Organization (CRDMO) with end-to-end capabilities across drug discovery, development, and manufacturing of small and large molecules. Dr. Reddy’s Laboratories Limited, the parent company of APSL, is a global pharmaceutical company, founded in 1984, with four decades of expertise in pharmaceutical development, and a global commercial network. Prestige Biologics operates production facilities based in South Korea, with a manufacturing capacity of 154,000 litres, making Prestige Biologics one of the top 10 global CDMO companies working with animal cell culture.

CPhI Worldwide 2023 in EuropeEvent Dates: October 24th (Tuesday) - October 26th (Thursday), 2023Venue: Fira de Barcelona - Recinto Gran ViaCity/Country: Barcelona / SpainWebsite: www.europe.cphi.comSchedule:October 24th: 09:00* - 18:30October 25th: 09:00* - 18:30October 26th: 09:00* - 16:00   *The start time is the same for all days.RESERVATIONWe hope to meet with you to explore potential opportunities.Please let us know your desired date and time in the table below, and we will get in touch with you. Thank you.[ameliastepbooking service=1]INQUIRET. +8210 - 4401 - 9913   E. bd@prestigebio.com

Prestige Biopharma IDC, a leading figure in antibody drug research, stood prominently as it participated in the '2023 Global Healthcare Week.'August 22, 2023 -  The event took place at BEXCO in Busan for three days starting from the 17th, featuring an opening ceremony with ribbon-cutting and participation in exhibition booths. During the event, Prestige Biopharma IDC, represented by CEO Seok Jae SEO, revealed its cutting-edge advancements in antibody drug research and development. The event, characterized as an integrated healthcare exhibition, was organized based on active support for the life care industry, one of Busan Metropolitan City's seven major strategic industries. The company also explained that it engaged in numerous meetings with industry stakeholders and domestic institutions to foster strategic partnerships.This event is the 6th edition held this year, with participation from 148 healthcare-related institutions. 29% increase compared to the previous year's participation of 115 institutions. With comprehensive support from Busan Metropolitan City, the event has grown significantly into a global bio event. Prestige Biopharma IDC, actively engaged in developing antibody pharmaceuticals, including for pancreatic cancer, shared that it utilized this event to discuss and formulate practical business strategies with various stakeholders in the healthcare industry, including medical experts.Especially noteworthy was the opening ceremony on the 17th, where Prestige Biopharma IDC's CEO, Seokjae SEO, joined key figures such as Economic Deputy Mayor Seongkwon Lee, Future Industries Director Gyeongdeok Lee, Director of Eunseong Medical Foundation, Namgyeongchan, President of the Korea Medical Devices Distribution Association, Buyeolkwang Branch, Gangbyeongsu of KOTRA Busan, Secretary General Kim Byeonggun of Busan Healthcare Industry Association, Director of the Innovative Health Convergence College at Dong-eui University, Gyeongtae Jeong, and Director of Industrial Promotion Support at Busan Economic Promotion Agency, Jihwan Oh, in cutting the opening ceremony ribbon. Subsequently, the company actively promoted various bio healthcare research activities, ranging from antibody drugs, biosimilars, vaccines to diagnostics, through its dedicated exhibition booth. Of particular significance was the opportunity to discuss the promotion of industrial growth at the Busan level and the establishment of a healthcare cluster.CEO Seokjae SEO of Prestige Biopharma IDC commented, "This event in Busan, where the significance of a healthy life has been highlighted even more after the post-COVID-19 era, was a meaningful occasion to promote various new drug research efforts that the company is undertaking for the sake of 'innovation for life.' Through this event, along with the cooperation of newly established relationships within the medical industry and comprehensive support from Busan Metropolitan City, we will solidify our position as a company that contributes to improving national health and promoting global healthcare in the post-pandemic era."Meanwhile, at Prestige Biopharma Group's Innovative Discovery Center (IDC), responsible for antibody drug development, core projects including the development of antibody drug PBP1510 for pancreatic cancer and a diagnostic kit for the same disease are being actively pursued. With Prestige Biopharma recently joining the 'Cancer Moonshot' project, a cancer conquest initiative led by U.S. President Joe Biden, related research is advancing vigorously.<picture : Seok Jae SEO, CEO of Prestige Biopharma IDC (fifth from the right), participating in the ribbon-cutting ceremony of the '2023 Global Healthcare Week,' held at BEXCO in Busan from the 18th to the 3rd for three days.><picture :  View of the Prestige Biopharma IDC booth participating in the '2023 Global Healthcare Week,' held at BEXCO in Busan from the 18th to the 3rd for three days.>