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GC Green Cross to Raise 170 Billion Won Through National Growth Fund… Expands U.S. Immunoglobulin Business

GC Green Cross to Raise 170 Billion Won Through National Growth Fund… Expands U.S. Immunoglobulin Business

Invests in Clinical Trials and Production Facilities for 20% High-Concentration Subcutaneous Injection Formulation… Aims to Submit Phase 3 IND to FDA Next Year
Develops Follow-on Products Following Aliglo… Pushes to Build Intravenous and Subcutaneous Injection Portfolio

GC Green Cross will raise 170 billion won in development funds through the National Growth Fund. The company plans to invest the funds in clinical trials and production facilities for a high-concentration subcutaneous immunoglobulin (SCIG) therapy targeting the U.S. market, aiming to secure a follow-up growth driver after its existing intravenous product, "Aliglo."

GC Green Cross announced on the 3rd that it was selected as a recipient of the National Growth Fund last month on the 29th, securing a total of 170 billion won. The National Growth Fund is a policy finance program in which the government and private financial sector jointly raise funds to make long-term investments in advanced strategic industries such as semiconductors, artificial intelligence (AI), biotechnology, and secondary batteries.

GC Green Cross plans to use the raised funds for global Phase 3 clinical trials and production facility investments for its 20% high-concentration SCIG therapy. The company aims to submit an Investigational New Drug (IND) application for Phase 3 trials to the U.S. Food and Drug Administration (FDA) next year.

SCIG is a formulation that administers immunoglobulin subcutaneously, characterized by allowing patients to self-administer, unlike intravenous immunoglobulin (IVIG). The 20% SCIG being developed by GC Green Cross is a product with increased immunoglobulin concentration; according to the company, there are currently three SCIG products of the same concentration launched in the U.S. market.

GC Green Cross is pursuing a strategy to sell its existing Aliglo and follow-on SCIG products together in the U.S. immunoglobulin market. The size of the U.S. immunoglobulin market presented by the company is approximately 14.4 billion dollars (approximately 20 trillion won).

Aliglo is an intravenous immunoglobulin therapy developed by GC Green Cross that received product approval from the U.S. FDA in 2023. According to the company, Aliglo's U.S. export value exceeded 100 million dollars last year. GC Green Cross envisions expanding its immunoglobulin business by leveraging the U.S. market foundation of its existing product while also securing subcutaneous injection products.

Heo Eun-cheol, CEO of GC Green Cross, stated, "Being selected as a supported company by the National Growth Fund is the result of our global business capabilities being recognized," adding, "Following Aliglo, we will secure 20% SCIG to complete an immunoglobulin portfolio covering both intravenous and subcutaneous injections."

This year, GC Green Cross secured contract payments through the sale of Curevo and the technology export of a Fabry disease treatment. Based on this, the company plans to continue investing in core new drug development projects, including SCIG.

"This article was translated using AI and may differ slightly from the original."