Aprogen Conducts Global Phase 3 Clinical Trials of Trastuzumab Biosimilar in 19 Countries

Aprogen announced on the 27th that it will conduct the global Phase 3 clinical trial of the trastuzumab biosimilar AP063 at 147 hospitals across 19 countries. The regions include 7 countries in Europe, 4 in Asia, 6 in the Americas, and 2 in the Middle East and Africa, with a total of 720 patients participating in the clinical trial.

The clinical trial is managed by Syneos, one of the world's top three CROs. Sample analysis for the trial is performed by Genuity, a specialized sample analysis company based in Tennessee, USA. Pharmacokinetics (PK), anti-drug antibody (ADA), and neutralizing antibody analyses are conducted by Syneos affiliate Syneos BioA. To ensure blinding, the administering medical staff cannot distinguish between the investigational drug and the comparator drug, and drug management is handled by Catalant in Germany. Aprogen produced and completed analysis of the AP063 investigational drug for the Phase 3 trial last year at Aprogen Biologics Osong Plant before sending it to Catalant in Germany this year.

At the Aprogen Biologics Osong Plant, a single 2000-liter bioreactor can produce 92 kg of AP063 per batch, and with 8 batches per year, it can produce 736 kg annually. This amount is equivalent to what competitors would need to produce by operating a 15,000-liter bioreactor more than 30 times.

According to global medical statistics and CRO company IQVIA, as of the first quarter of last year, the average global sales price of trastuzumab was $2,893 per gram. The annual production volume from one 2000-liter bioreactor at Aprogen Biologics Osong Plant corresponds to approximately KRW 2.1 trillion in final sales value. Even applying Aprogen’s targeted 50% discount rate compared to competitors, this still corresponds to an amount exceeding KRW 1 trillion.

Based on high productivity and low manufacturing costs, Aprogen is actively discussing strategic cooperation plans with multiple pharmaceutical companies in Europe and the United States for the European and U.S. markets, respectively, and expects to achieve its targeted results within this year.

A company representative stated, “The European and U.S. biosimilar distribution specialist pharmaceutical companies we previously met evaluated that our AP063, with its absolute price competitiveness, could become a leading trastuzumab biosimilar product in the European market within a short period.” They added, “We are confident in expanding overseas market entry and supply regions upon completion of the global Phase 3 clinical trial.”

This content was produced with the assistance of AI translation services.