Prestige Bio Begins Analysis of HD204 Phase 3 Clinical Data... "Results to be Announced Within the Year"

Prestige BioPharma, a pharmaceutical company specializing in antibody biopharmaceuticals, announced on the 2nd that it has begun analyzing the results of the Phase 3 clinical trial of HD204 (product name Vasforda®), which is nearing completion.

The global Phase 3 clinical trial was conducted on 650 patients across 17 countries worldwide. The interim analysis will start with 642 patients who can be observed for a long period after dosing. The remaining 8 patients are expected to complete dosing by June, with the interim result analysis to be completed within the year. This two-track strategy was decided in collaboration with Accord Healthcare, which is responsible for the marketing authorization of HD204, to ensure rapid commercialization.

The Phase 3 clinical trial of HD204 proceeded smoothly, as the review of efficacy and safety data showed no concerns related to the drug’s safety or effectiveness. In particular, since marketing authorization application is possible based on the interim clinical results alone, close cooperation with Accord Healthcare will continue. Accord Healthcare, a biosimilar specialist subsidiary of the multinational pharmaceutical company Intas, plans to apply for marketing authorization starting from the UK, where its headquarters are located.

Prestige BioPharma has signed a supply agreement for HD204 with Intas, a global pharmaceutical company with annual sales of 2 trillion KRW, covering major global markets including Europe, the United States, the UK, Canada, Brazil, Mexico, the Middle East and North Africa, and Southeast Asian countries. Once the marketing authorization for HD204 is granted, milestone payments will be received according to the supply contract terms, enabling immediate revenue realization.

The original drug, Roche’s Avastin, is a blockbuster anticancer drug with annual sales of 9 trillion KRW, indicated for several solid tumors including colorectal cancer and glioblastoma. The company is focusing on enhancing cost competitiveness through a full value chain approach, with production handled by its affiliate Prestige BioLogics. Additionally, the company has improved production process efficiency by obtaining three patents related to antibody production processes: ‘Optimized method for bevacizumab formulation,’ ‘Antibody purification method,’ and ‘Bicistronic expression vector for antibody expression and antibody production method using the same,’ along with process development.

A representative of Prestige BioPharma stated, “We will announce the results as soon as the Phase 3 analysis is completed and proceed with marketing authorization procedures in the UK, Europe, and the US in sequence without delay,” adding, “We will also make every effort to prepare for the sales of HD204 based on price competitiveness that is not inferior even when compared to other companies’ biosimilars, including the original drug.”