PanGen Biotech is gearing up to enter the European market with its erythropoietin (EPO) biosimilar. The company aims to leverage its experience in regulatory approvals and sales from emerging markets, along with its robust manufacturing and quality control capabilities, to explore new business opportunities in Europe and expand its contract development and manufacturing organization (CDMO) operations.
Huons Group subsidiary PanGen announced on Tuesday that it will participate in Bio Europe 2026, scheduled from November 9 to 11 in Cologne, Germany.
At this event, PanGen plans to pursue international partnerships to facilitate its EPO biosimilar’s entry into the European market and to expand its CDMO business. The company intends to broaden its reach into advanced markets like Europe, building on its track record of securing drug approvals and sales, particularly in emerging economies.
To achieve this goal, PanGen has been methodically upgrading its manufacturing and quality management standard (GMP) facilities and quality systems. In 2025, the company implemented an electronic document management system (EDMS) for quality control. It was also selected for the Ministry of SMEs and Startups’ smart factory construction support project, leading to the completion of its laboratory information management system (LIMS) and quality management system (QMS) in March of this year.
The company has also undergone quality inspections by external experts. PanGen reports completing two mock inspections with U.S. consulting firm Jeff Yuen & Associates and InterPro QRA.
In April, PanGen was chosen for the Korean Health Industry Promotion Agency’s initiative to support EPO biosimilar entry into advanced markets. Subsequently, the company analyzed differences in European regulatory requirements and verified qualifications related to the European Qualified Person (QP) through consultations with UK-based SCENDEA. An EU QP audit was also completed through SIFREI in Portugal.
PanGen is pursuing a dual-pronged business model in its EPO operations, combining the export of finished pharmaceuticals with the supply of active pharmaceutical ingredients (APIs). The company plans to boost finished pharmaceutical exports while offering APIs to overseas firms seeking local production. Additionally, PanGen will propose technology transfer methods to enable local companies to manufacture finished pharmaceuticals.
Chief Executive Officer (CEO) Yoon Jae-seung stated that it’s expanding the biopharmaceutical business from emerging markets to advanced countries, leveraging the proprietary technology. The participation in Bio Europe is a strategic move to enhance the competitiveness in the global market.
PanGen’s EPO business demonstrated strong growth last year. In 2025, EPO sales reached 7.5 billion KRW (5.6 million USD), marking a 33% increase from the previous year and accounting for over half of the company’s total sales.
Looking ahead, PanGen aims to maintain its revenue growth trajectory through new CDMO contracts and expanded EPO exports in the latter half of the year.
