The Ochang Plant in Ochang-eup, Cheongju-si, Chungcheongbuk-do, 130 kilometers from Seoul. It is the manufacturing site of GC Green Cross's blood product 'Alyglo'.

It is the largest facility in Asia that processes 1.3 million liters of raw plasma per year on 130,000 ㎡ land in the Ochang Science and Industrial Complex. Alyglo is produced here for export to the United States.

The Green Cross plans to launch Alyglo in the U.S. in July, aiming to generate sales of $50 million (ca 66 billion won) and growing 50% annually to reach $300 million (ca 400 billion won) in sales by 2028.

Alyglo, which is a liquid immunoglobulin purified from plasma fractions, was approved by the U.S. Food and Drug Administration (FDA) December 2023. On February 27th, Wikileaks Korea visited the Alyglo production site of the Green Cross and took a look at its status in the United States.

At the plasma storage center RP2, plasma collected from donors is stored. This is where plasma is inspected for whether it is damaged, contains harmful plasma, and matches the registered information.

10,000 liters (12,500 units) of plasma per container on a truck is delivered once a week, of which only about 10 units are determined to be unsuitable. The remaining good plasma is transported to an automated warehouse at -20 degrees Celsius, where it is processed.

The transferred plasma is then sedimented to separate various proteins, which are purified, and treated to inactivate virus.

A representative from Green Cross explained, "Alyglo, having made a successful entry into the U.S. market, plays a crucial role in eliminating impurities like blood coagulation factors, the primary contributors to thromboembolism. This is achieved through the implementation of our proprietary CEX chromatography technology in the immunoglobulin purification process."

Moving on to the third floor of the Warehouse & Filling and Finish (W&FF), the sterile vials (bottles) containing the final solution are undergoing inspection for any foreign substances.

W&FF has a filling and packaging facility, sterile filling equipment, and a single-use system. These state-of-the-art facilities automate the entire process, from receiving raw materials to production and shipment.

The automated foreign substance inspection employs 11 cameras to detect foreign substances both on the outside and inside, along with two high-voltage leak detectors to check for leaks. Additionally, a manual vial inspection process involves researchers holding the bottles up to a light to identify any foreign substances.

Following these inspections, the reagents are labeled and packaged, completing the process to become finished products.

With its successful entry into the U.S. market, the Green Cross Ochang Plant is set to achieve the status of a trillion-won cGMP plant.

Commonly referred to as cGMP (Current Good Manufacturing Practice), the highest level of GMP, Green Cross (GC) received FDA approval in December of last year to be recognized as a cGMP manufacturing facility, meeting U.S. Current Good Manufacturing Practice standards.

In July, Green Cross will launch Alyglo in the U.S. market through its U.S. subsidiary, GC Biopharma.

The U.S. immunoglobulin market, valued at approximately 13 trillion won, stands as the world's largest and the average price is about 6.5 times that of the Korean market, making it the highest price. 

The company aims to achieve $50 million in sales during this year of Alyglo launch and targets approximately $300 million in sales by 2028, anticipating a growth rate exceeding 50% annually.

To achieve this, the company has a three-pronged strategy involving high-margin pricing, enhanced patient access, and contract optimization. Alyglo is distributed through specialty pharmacies, which account for approximately 50% of the immunoglobulin distribution channel.

The specialty pharmacy channel presents the advantage of not requiring a large sales force, making it favorable for new entrants, particularly due to the high rate of generic prescribing. The company aims to increase its market share by capitalizing on specialty pharmacies that specialize in carrying high-priced specialty drugs.

Mr. Woojin Lee, Head of Global Business at Green Cross, stated, "With a high-margin strategy rooted in Alyglo's unique quality competitiveness, we aim to make Alyglo accessible to around 75% of U.S. private insurers in July. This will be achieved through vertically integrated channel agreements with insurers, prescription drug benefit managers, specialty pharmacies, and distributors.“

[WIKI KOREA=Cho Eun, Reporter(cheongju)]

choeun@wikileaks-kr.org

Cho Eun, Reporter(cheongju) 다른기사 보기

• facebook
• 트위터
• 카카오톡
• 네이버블로그
• 유튜브