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[{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Grants Orphan Drug Designation (ODD) for Prestige BioPharma\u2019s PBP1510 Anti-PAUF Monoclonal Antibody","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"SINGAPORE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prestige Biopharma Receives Positive EMA Opinion on Orphan Designation for PBP1510 for Treatment of Pancreatic Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"SINGAPORE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Teva Pharmaceutical Industries","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Prestige Biopharma and Teva Israel Announce License and Supply Agreement to Commercialize Prestige's Trastuzumab Biosimilar in Israel","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SINGAPORE","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Pharmapark","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Prestige Biopharma and Pharmapark Announce License and Supply Agreement to Commercialize Prestige's Bevacizumab Biosimilar in Russia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SINGAPORE","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prestige Biopharma\u2019s PBP1510, Receives Approval for Clinical Trial in France","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SINGAPORE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prestige Bio Receives French Ansm Approval for Phase 1\/2a Trial of PBP1510","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"SINGAPORE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Dr. Reddy's Laboratories","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Prestige BioPharma and Dr. Reddy\u2019s Announce Partnership to Commercialize Trastuzumab Biosimilar in Select Countries in Latin America and Southeast Asia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SINGAPORE","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Preclinical Data of Prestige Biopharma\u2019s First-in-Class Pancreatic Cancer Treatment, PBP1510, Presented in ESMO TAT 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SINGAPORE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The Result of the Phase 3 Study for Prestige BioPharma\u2019s Herceptin Biosimilar, HD201(Tuznue\u00ae), Published in JAMA Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SINGAPORE","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Vaxine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Prestige Biopharma Enters MOU with Vaxine for Supply of COVID-19 Vaccine and Co-development of COVID-19\/Influenza Combo Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"SINGAPORE","productType":"Vaccine","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Approves Prestige Biopharma\u2019s IND for Phase 1\/2a trial of First-in-Class Pancreatic Cancer Treatment, PBP1510","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SINGAPORE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Intas Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Prestige Biopharma and Intas Pharmaceuticals Announce Partnership to Commercialize Bevacizumab Biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, CIS and the SEA Countries","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SINGAPORE","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SINGAPORE","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Prestige BioPharma Pte Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SINGAPORE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]

Find Clinical Drug Pipeline Developments & Deals by Prestige BioPharma Pte Ltd

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            PBP1510 (ulenistamab) targets pancreatic adenocarcinoma upregulated factor, a tumour-specific protein, found to be overexpressed in majority of pancreatic cancer cases. It represents a promising therapeutic strategy for addressing the unmet medical needs of pancreatic cancer patients.

            Lead Product(s): Ulenistamab,Gemcitabine

            Therapeutic Area: Oncology Product Name: PBP1510

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 21, 2023

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            Tuznue (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.

            Lead Product(s): Trastuzumab

            Therapeutic Area: Oncology Product Name: Tuznue

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 13, 2022

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            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.

            Lead Product(s): Bevacizumab

            Therapeutic Area: Oncology Product Name: HD20

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Intas Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership July 26, 2022

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            PBP1510 (ulenistamab), a first-in-class anti-PAUF monoclonal antibody,is envisioned to provide significant benefit to all patients affected by PAUF-positive pancreatic cancer.

            Lead Product(s): PBP1510,Gemcitabine

            Therapeutic Area: Oncology Product Name: PBP1510

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 27, 2022

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            Through MOU, Prestige and Vaxine will be building a partnership, initially focused on manufacturing and commercialization of Vaxine’s Covid-19 vaccine, Covax-19® and then as Covid-19 enters an endemic phase development of a next generation Covid19/influenza combo vaccine.

            Lead Product(s): Covax-19

            Therapeutic Area: Infections and Infectious Diseases Product Name: Spikogen

            Highest Development Status: Approved Product Type: Vaccine

            Partner/Sponsor/Collaborator: Vaxine

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 30, 2022

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            The study met its primary endpoint (tpCR) and showed equivalent efficacy and comparable safety profile for Troika (HD201), a biosimilar to Herceptin® (trastuzumab), for the treatment of HER2 positive breast and metastatic gastric cancer.

            Lead Product(s): Trastuzumab,Docetaxel,Epirubicin Hydrochloride

            Therapeutic Area: Oncology Product Name: Troika

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 14, 2022

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            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.

            Lead Product(s): PBP1510,Gemcitabine

            Therapeutic Area: Oncology Product Name: PBP1510

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 08, 2022

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            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.

            Lead Product(s): Trastuzumab,Docetaxel

            Therapeutic Area: Oncology Product Name: HD201

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Dr. Reddy\'s Laboratories

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership December 09, 2021

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            French National Agency for the Safety of Medicines and Health Products (L'Agence nationale de sécurité du medicament, ANSM) has approved a phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer.

            Lead Product(s): PBP1510

            Therapeutic Area: Oncology Product Name: PBP1510

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 22, 2021

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            French National Agency for the Safety of Medicines and Health Products has approved a Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer.

            Lead Product(s): PBP1510

            Therapeutic Area: Oncology Product Name: PBP1510

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 21, 2021

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