GC Biopharma

 

[Alpha Biz= Reporter Kim Jisun] On the 8th, GC Biopharma announced the commencement of shipments for its product 'Alyglo' in the United States. Alyglo, an intravenous immune globulin 10% blood product used for primary immunodeficiency disorders, received FDA approval at the end of last year. The initial shipment has been completed and will be delivered through U.S. logistics warehouses and distribution channels to specialized pharmacies. It is expected that actual prescriptions will be possible from mid-month.

Alyglo marks the first domestically produced blood product to enter the U.S. market and the eighth new drug approved by the FDA. GC Biopharma achieved FDA approval after three previous unsuccessful attempts.

GC Biopharma has been preparing for commercialization centered around its local subsidiary, GC Biopharma USA, established in 2018 for Alyglo sales. They are preparing for inclusion in prescription drug formularies through contracts with pharmacy benefit management (PBM) companies and securing partnerships with specialized pharmacies.

The company aims to generate $50 million in revenue this year and achieve over 50% annual growth thereafter.

 

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