PanGen Biotech to Renew its GMP Certification in Turkiye “Accelerating Global EPO Biosimilar Bus...

EPO registration complete in 6 global countries

[Shin-Min Joon, Edaily Reporter] PanGen Biotech of Huons Group is continuing to make progress on erythropoietin (EPO) biosimilar (biological medical product) in the overseas market.

PanGen Biotech CI. (Image=PanGen Biotech)

PanGen Biotech Inc. announced on September 25 that the company has recently renewed its Good Manufacturing Practice (GMP) certification from Turkiye for manufacturing equipment and the system in facility in Korea, for EPO biosimilar- its key export product.

EPO biosimilar is used for acute anemia treatment which can occur during kidney dialysis. PanGen Biotech was the second in the world to develop EPO biosimilar.

In 2021 PanGen Biotech signed a production technology transfer agreement for its EPO biosimilar with VEM, a pharmaceutical company in Turkiye. The agreement is worth 3 million US dollars including upfront and milestone payments. PanGen Biotech has completed milestone phase 1 and received 1.5 million US dollars. When phase 2 is complete, the company will receive additional 1.5 million US dollars.

VEM has been supplied with the final drug substance (FDS) of EPO biosimilar made by PanGen Biotech in Korea, and plans to sell EPO biosimilar in Turkiye within this year.

Accordingly PanGen Biotech has acquired GMP certification from Turkish Medicines and Medical Devices Agency (TMMDA) in 2022. Since the certification required renewal in every 3 years, the company renewed it this year.

According to the agreement when milestone phase 2 is completed, VEM will manufacture Active Pharmaceutical Ingredients (APIs) in house and PanGen Biotech will collect running royalty for the next 10 years.

To date, PanGen Biotech has received approval for its EPO biosimilar products in six countries, including Korea, Malaysia, Philippines, Saudi Arabia, Turkiye and Thailand, and is selling them in five except for Thailand. The company has recently received a purchase order from Thailand and plans to begin market launch within the year.

PanGen Biotech’s revenue on EPO biosimilar exports recorded 4.35 billion won in the first half of this year, marking a 79% increase compared to the same period last year. The company reported its revenue of 6.93 billion won up 20.6% year over year. EPO exports accounted for 63% of PanGen Biotech’s total revenue.

CEO of PanGen Biotech Jaeseung Yoon said “PanGen Biotech is expanding its presence in the global market by strengthening global marketing to promote EPO biosimilar exports. We will further expand overseas market and actively develop new biosimilar products.”

Yoon added “We expect that the development cost will soon be lowered as the approval process for biosimilar becomes simplified. PanGen Biotech is bolstering its development on biosimilars to take advantage of the impending patent expiration for major antibody drugs based on its proprietary technology PANGEN CHO TECH™.”

신민준 (adonis@edaily.co.kr)