Pangen to complete production processes for 3 new biosimilars this year

Biopharmaceutical company Pangen, led by CEO Yoon Jae-seung, is developing three blockbuster-class biosimilars and plans to complete their production processes by year-end.

The company has built its growth on the production and sale of an erythropoietin (EPO) biosimilar — a red blood cell-stimulating hormone used to treat anemia in chronic kidney disease patients — marketed in South Korea and abroad. Its EPO biosimilar is the world's second product based on the erythropoietin-alpha compound.

EPO product sales rose 21 percent year-on-year in the first quarter, driving the company's overall growth. The compound annual sales growth rate for EPO over the past three years stood at 28.6 percent. As of end-March, EPO accounted for 4.8 billion won of the company's total order backlog of 5.2 billion won ($3.38 million).

As a biopharmaceutical affiliate of Huons Group, Pangen operates two core businesses: EPO-centered biosimilars and biopharmaceutical contract development and manufacturing organization (CDMO) services. First-quarter sales reached 3.73 billion won, up 8.4 percent from the same period a year earlier.

Pangen runs its CDMO business on the strength of Good Manufacturing Practice-compliant facilities and proprietary technology. The company holds Pangen CHO-TECH, a core technology essential to biopharmaceutical development, and operates a factory certified under PIC/S GMP standards in line with European guidelines, offering customers one-stop CDMO services.

Pangen CHO-TECH is a protein-expression technology specialized for Chinese Hamster Ovary (CHO) cells, the animal cells used to produce biopharmaceuticals. It encompasses cell line development and process development technologies, both foundational to biopharmaceutical development.

The company currently holds regulatory approvals to sell its EPO biosimilar in eight markets: South Korea, Malaysia, the Philippines, Saudi Arabia, Turkey, Thailand, Brunei and Myanmar. It plans to expand further into Taiwan, Paraguay, Iraq and other Middle Eastern markets.

Pangen is also pursuing new biosimilar development, using its CHO cell technology to develop biosimilars of three biopharmaceuticals sold by multinational companies: Bristol Myers Squibb's immuno-oncology drug Yervoy (ipilimumab), Johnson & Johnson's autoimmune disease treatment Tremfya (guselkumab) for conditions including psoriasis, and Amgen's osteoporosis treatment Evenity (romosozumab).

The company has begun developing cell lines for production of all three biosimilars and expects to complete cell line development and establish production processes by year-end. Going forward, it plans to expand its CDMO business by developing biosimilars for biotech companies and pharmaceutical companies using CHO cell technology.

"We are strengthening growth and research and development through our CDMO business and the expansion of EPO biosimilar sales," CEO Yoon said. "We will also deepen cooperation with group affiliates to generate synergies."

Pangen recently won a 2.75 billion won contract from the Korea Disease Control and Prevention Agency's National Institute of Health to develop therapeutic antibodies for severe fever with thrombocytopenia syndrome (SFTS), a disease with a high fatality rate. Under the project, the company will carry out preclinical sample production and evaluation through 2028, with the goal of domestically producing an SFTS treatment. The company expects the contract to open a new growth avenue in next-generation biopharmaceutical development, beyond its existing biosimilar and CDMO businesses.