PanGen Biotech, a biopharmaceutical subsidiary under Huons Group, is maintaining its growth trajectory this year after achieving profitability in 2024. The company said it plans to accelerate earnings expansion by leveraging its biosimilar portfolio and contract development and manufacturing (CDMO) services.

Developing CDMO biz backed by GMP facilities, platform technology

Founded in 1999 and listed on the Kosdaq market in 2016, PanGen Biotech is expanding its CDMO business, building on its GMP-certified biopharmaceutical production capabilities and platform technology.

The company established its GMP facility in 2011 and successfully developed an erythropoietin (EPO) biosimilar for anemia treatment. It was the first in Korea to demonstrate non-inferiority to the originator drug, Eprex, through comparative clinical trials. The biosimilar received marketing approval from the Ministry of Food and Drug Safety (MFDS) in 2019.

PanGen now operates its biopharmaceutical CDMO business with GMP certifications from both the MFDS and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

PanGen Biotech is bolstering its CDMO business with its proprietary source technology platform, PANGEN CHO-TECH™, a protein expression system specialized for Chinese hamster ovary (CHO) cells -- widely used in biopharmaceutical production. The platform encompasses core technologies for cell line development and production process optimization, which are essential for biopharmaceutical development and manufacturing. PanGen has signed multiple technology transfer agreements based on this platform, enabling partner companies to utilize CHO-TECH™ in their own production pipelines. As part of these agreements, PanGen receives annual technology fees, which are expected to grow in tandem with the commercial success of the licensees’ products. 

The contract development organization (CDO) service is a business that builds high-performance recombinant CHO production cell lines based on platform technology and transfers production process technology required for biopharmaceutical development. The contract manufacturing organization (CMO) service outsources the production of non-clinical or clinical trial samples and commercial biopharmaceuticals.

As of last year, PanGen’s CDMO revenue, which includes CMO and CDO combined, increased 144 percent year-on-year to 6.27 billion won. This accounted for 42.7 percent of PanGen's total revenue, with a significant portion of the revenue coming from the production and research of human-derived hyaluronidase, which is being developed by Huonslab.

In 2024, PanGen reported revenue of 14.67 billion won, a 101 percent year-over-year increase, according to the company's standalone financial statements. The company turned profitable with operating income recorded at 1.02 billion won. In the first quarter of this year, the company reported 3.44 billion won in revenue and 700 million won in operating profit.

EPO biosimilar wins local approval, expands export

PanGen's EPO biosimilar sales have been growing steadily and accounted for 38.5 percent of total sales by 2024. In the same year, exports of the EPO biosimilar to Association of Southeast Asian Nations (ASEAN) countries, including Malaysia and the Philippines, increased, while full-scale exports to Saudi Arabia and Turkiye commenced.

PanGen produces and sells an EPO biosimilar, a treatment for anemia in patients with chronic kidney failure, both in Korea and abroad. 

In February 2019, the company received approval for its EPO biosimilar from the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia. It is currently marketed in Malaysia under the brand name Erysaa.

In Korea, the product was approved by the Ministry of Food and Drug Safety (MFDS) in November 2019 under the brand name Panpotin and has been on sale since February 2020. In 2023, the company secured approval for high-dose EPO products (6000 IU, 10000 IU). 

PanGen is steadily expanding shipments to additional countries, receiving regulatory approval in the Philippines in 2022, Saudi Arabia in 2023, and Thailand in September 2024.

In 2021, PanGen signed a $3 million technology transfer agreement for its EPO biosimilar with VEM, a pharmaceutical company in Turkiye, and has been supplying VEM with the final drug substance (FDS) since November 2024. To date, PanGen has licensed its EPO biosimilar products in six countries and is selling them in five.

As of the first quarter of 2025, EPO biosimilar exports increased 57 percent year-on-year. PanGen expects its EPO biosimilar to continue expanding export markets, including the Middle East and Africa, and to achieve sustained revenue growth.

PanGen expected to create synergies with other Huons family firms

PanGen joined Huons Group as an affiliate in December 2024. In April, Huons acquired additional shares in PanGen, raising its stake to 36.7 percent. PanGen aims to enhance synergies within the Huons family of companies.

In April, PanGen signed a 1.9 billion won agreement with CHA Vaccine Institute, which appointed PanGen as its CMO for vaccine projects. In March, the company also secured an 800 million won contract with Huonslab for process characterization services to support biopharmaceutical product approval. PanGen plans to continue maximizing synergies within the Huons Group.

PanGen serves as the production site for the human-derived hyaluronidase being developed by Huonslab, having fully produced and supplied clinical samples and three batches of raw materials for regulatory approval. Going forward, Huonslab will focus solely on R&D without operating its own raw material drug manufacturing facilities. Instead, bio-raw materials will be produced at PanGen, while bio-finished drugs will be manufactured at Humedix to support global expansion in partnership with international pharmaceutical companies. In May, Huonslab completed dosing the last patient in its human-derived hyaluronidase phase 1 clinical trial in Korea.

“PanGen expects to expand its earnings growth by revitalizing its main business,” said Yoon Jae-seung, CEO of PanGen. “We will contribute to the revitalization of Huons Group's biopharmaceutical R&D and CDMO businesses and enhance synergies among the group's family companies to become a key pillar leading the global healthcare market.”