GC Biopharma's Alyglo blood product headed to U.S.

Industry

Published: 28 Feb. 2024, 18:13

GC Biopharma's Alyglo blood product headed to U.S.

GC Biopharma's plasma plant in Ochang, North Chungcheong [SARAH CHEA]

OCHANG, North Chungcheong — Workers scan barcodes of bottles full of orange liquid to double-check that the plasma enclosed matches with donors.

In another room, workers sit in a dark room to inspect the liquid one by one to filter out disapproved units. The completed blood products are sent to a labeling room for the packaging process.

"The whole process is currently done by workers manually as the demand for blood products remains low at the time," said Park Hyeong-joon, head manager of the plant in Ochang, North Chungcheong, during a media tour on Tuesday.

"But with demand likely to increase with the launch of Alyglo in the U.S. market, we aim to shift to automation in two or three years."

The Ochang plant is where GC Biopharma's Alyglo blood product is made. Alyglo, a 10 percent intravenous immune globulin, is a treatment for primary humoral immunodeficiency, also known as PI, which encompasses a number of different conditions that impact immunity.

A GC Biopharma worker packs Alyglo blood products at its plant in Ochang, North Chungcheong, on Tuesday. [GC BIOPHARMA]

The Alyglo blood product developed by GC Biopharma. It will be released in the U.S. market in July. [GC BIOPHARMA]

Alyglo won approval from the U.S. Food and Drug Administration (FDA) in December, becoming the first Korean pharmaceutical blood product to do so.

GC Biopharma's plasma factory in Ochang receives 10,000 liters (2,642 gallons) of plasma every week. Some 90 percent of plasma is water while 7 percent is protein. A blood product is any therapeutic substance prepared from human blood.

"A container carries up to 12,500 units of plasma, and we go through a thorough evaluation process and an average of 10 units are disqualified in the quality test," said Park.

"Around seven tanks with 10,000 liters of ethanol are used in the fractionation process to filter out protein from the plasma," Park added. "The clean plasma has to be preserved at 20 degrees Celsius [68 degrees Fahrenheit] or below, for up to two years."

The green light from the FDA comes after 13 years since GC Biopharma started the Alyglo project in 2011. The U.S. agency has rejected GC Biopharma twice since 2015, when the company initially submitted a blood product with a lower level of immune globulin than Alyglo's.

"We will finally introduce the product in the U.S. market in July and will start the production at the Ochang plant in March," said Lee Woo-jin, CEO of GC Biopharma USA.

"We aim to log $50 million in Alyglo sales this year, and expect growth at an annual rate of 50 percent every year to reach $300 million in 2028," Lee said.

GC Biopharma workers conduct quality tests of plasma for the production of Alyglo at its plant in Ochang, North Chungcheong, on Tuesday. [GC BIOPHARMA]

Fractionation equipment that filters out protein from plasma at GC Biopharma's plant in Ochang, North Chungcheong, on Tuesday. [GC BIOPHARMA]

GC Biopharma is currently in talks with 10 specialty pharmacies that have contracts with private insurers.

"We expect to ink a contract for Alyglo with at least one special pharmacy by the end of July," Lee said.

The U.S. immune globulin market was valued at a total of $10.4 billion, with the price of the product remaining the highest at around 6.5 times more than in Korea.

GC's Ochang plant has the capacity to deal with 1.3 million liters of plasma every year, the largest in Asia.

Lee Woo-jin, CEO of GC Biopharma USA, speaks during a press conference before the media tour of the company's plasma factory in Ochang, North Chungcheong, on Tuesday. [GC BIOPHARMA]

It currently produces Albumin, which is for burns and hemorrhagic shock, and Hunterase, a treatment option for skeletal, tissue, neurological and multi-organ complications resulting from a lack of certain enzymes.

Blood products manufactured at the plant are exported to 32 countries across the globe.

BY SARAH CHEA [chea.sarah@joongang.co.kr]