- 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.Sizgapore, 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