[Report] Green Cross "Aliglo Sales to Reach 400 Billion Won by 2028"

FDA Approval After 13 Years, Targeting 65 Billion KRW Sales This Year
Chungbuk Ochang Plant to Complete Automated Processes Within 2-3 Years

On the 27th, the GC Green Cross Ochang Plant in Cheongju, Chungbuk, was bustling with the movements of employees dedicated to producing blood products. In the plasma storage area, inspections were swiftly conducted to check for any damaged plasma, while in the vial inspection room, workers used sharp eyes to detect foreign substances. After all inspections were completed, the medicine bottles were labeled and packed into boxes, quickly becoming finished products.

Overview of GC Green Cross Ochang Plant Integrated Control Building
Photo by Lee Chunhee

The Ochang Plant is the production base for Green Cross's intravenous immunoglobulin 10% formulation, Aliglo, which received approval from the U.S. Food and Drug Administration (FDA) last December. Sales will begin in July through the local subsidiary GC Biopharma USA. Immunoglobulin is an immune antibody that circulates in the blood to protect our bodies. However, patients with congenital immunodeficiency, who inherently lack immunoglobulin, must continuously receive immunoglobulin antibody drugs extracted from blood donated by healthy individuals.

The FDA approval of Aliglo is the result of a 13-year project that began in 2011. Green Cross first attempted approval in 2015 with a 5% immunoglobulin concentration product but failed due to insufficient data. In 2021, they reattempted with the 10% product Aliglo. However, due to COVID-19, only remote video evaluations were conducted, and a decision was made that an on-site inspection was necessary, causing the approval to be denied at that time. Finally, in April of last year, an on-site inspection of the Ochang Plant was conducted, leading to successful approval. Park Hyung-jun, the Ochang Plant manager, explained, "We received only about four minor comments," and added, "After that, we reapplied for approval and received the good news."

At the GC Green Cross Ochang Plant, the inspection process is underway to filter foreign substances from medicine bottles.
[Photo by Lee Chun-hee]

Since medicines are administered to humans, quality is paramount. Introducing an automated system that minimizes human intervention can reduce contamination caused by people. However, some processes in Aliglo production are still performed manually. Instead, visitors could experience the smart factory concept at the integrated finished product facility, where influenza vaccine production is underway. Unlike previous processes where people had to inspect bottles and intervene in packaging, 11 cameras quickly take 12 photos to check for moving foreign substances, and all packaging is done automatically. A Green Cross official explained, "Since the production volume of Aliglo is not large, manual work is currently more efficient," adding, "We plan to introduce an automated system within 2 to 3 years."

Aliglo is considered one of Green Cross's key weapons to overcome its recent performance slump caused by reduced benefits from COVID-19. The company expects Aliglo to generate $50 million (about 65 billion KRW) in sales in the second half of the year following its July launch and to grow to annual sales of $300 million (about 400 billion KRW) by 2028. Lee Woo-jin, head of the Global Strategy Division, expressed confidence, saying, "Considering the growth of the U.S. immunoglobulin market, $300 million is a conservative figure," and added, "Sales will definitely grow beyond that."

GC Green Cross's 10% Immunoglobulin Preparation Aliglo Sample
Photo by Lee Chunhee

Aliglo's greatest strength is its quality. On this day, Green Cross repeatedly emphasized that Aliglo poses no risk of thromboembolism, a condition where blood clots block blood vessels. The FDA requires all immunoglobulin product labels to include warnings about thromboembolism side effects after several incidents of recalls due to thromboembolism in patients receiving immunoglobulin treatments. However, Green Cross introduced its proprietary cation exchange chromatography (CEX chromatography) technology to remove impurities such as coagulation factor 11a, a major cause of thromboembolism. As the only FDA-approved product without thromboembolism concerns, Green Cross plans to use this as a key selling point to target the market. They are also developing a subcutaneous injection formulation to improve patient convenience.