GC Biopharma Builds Up Cash, Goes 'All-In' on SCIG

A string of stake sales and technology exports this year
Secures at least 400 billion won in cash
"Most funds to be invested in SCIG development"
Safety management remains a key variable

GC Biopharma will invest most of the funds it has raised this year in developing subcutaneous immunoglobulin (SCIG). Following Aliglo, its intravenous immunoglobulin (IVIG) product that has established a foothold in the United States, the company aims to gain an early lead in the still-nascent U.S. market for high-concentration SCIG.

Image of GC Biopharma's Aliglo product. GC Biopharma

According to industry sources on November 5, GC Biopharma is estimated to have secured at least 400 billion won in cash this year through the sale of equity stakes and technology exports. In March, it transferred a 22.1% stake in GC Wellbeing to its holding company, GC Holdings, for 50.5 billion won. In May, it sold its U.S. affiliate Qurevo to Eli Lilly, securing an upfront payment of about 308.7 billion won. Last month, it licensed to U.S. company BioMarin a Fabry disease treatment jointly developed with Hanmi Pharmaceutical, receiving an upfront payment of about 46.8 billion won.

The funds will go toward the U.S. SCIG market. GC Biopharma plans to spend most of the money it has secured on SCIG development and expanding production facilities. The 170 billion won it recently raised through the National Growth Fund will also be used for the Phase 3 clinical trial of its "20% concentration SCIG" and investment in production facilities. A GC Biopharma official said, "Our first priority is to invest in SCIG development for the U.S. market and expand our Ochang plant," adding, "We plan to use the remaining funds for research and development of treatments for rare diseases."

GC Biopharma will invest 530 billion won in its Ochang plant in Cheongju, North Chungcheong Province, by 2033 to establish a commercial SCIG production system. Of that amount, 140 billion won will go toward building a production line dedicated to 20% concentration SCIG. Once the new line is completed in 2029, the plant's annual plasma processing capacity will increase to 3.5 times its current level. The company plans to submit an application to the U.S. Food and Drug Administration (FDA) next year for a Phase 3 clinical trial of its SCIG candidate, "GC5136B," and apply for product approval in 2031.

SCIG is a treatment that directly replenishes antibodies that are deficient in patients with weakened immune systems. Unlike intravenous injections, it is administered under the skin, allowing patients to give themselves the treatment at home without visiting a hospital. Thanks to this convenience, patients in the U.S. immunoglobulin market, estimated at about $14.4 billion (approximately 20 trillion won) a year, are rapidly shifting from IVIG to SCIG. Supply, however, remains limited. Only three high-concentration 20% SCIG products have been launched in the United States. This is why GC Biopharma has identified its 20% SCIG candidate as the top development priority among its five key pipeline assets.

Hypersensitivity reactions, a known side effect of immunoglobulin products, remain a challenge to manage. To prevent a possible increase in the incidence of hypersensitivity reactions, GC Biopharma voluntarily recalled certain batches of Aliglo from the U.S. market twice, in December last year and July this year. The European Medicines Agency (EMA) has also recently acknowledged related adverse effects and is broadening its safety review of hypersensitivity reactions to cover immunoglobulin products as a whole, including SCIG. Analysts say regulatory responses could therefore become a key variable going forward.

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