GC Biopharma and Hanmi sign $475m deal with BioMarin — Korea Herald
South Korea’s GC Biopharma and Hanmi Pharmaceutical have signed an exclusive licensing agreement with U.S. biotechnology company BioMarin Pharmaceutical for an experimental drug to treat Fabry disease. The total value of the agreement could reach $475 million, Korea Herald reports.
BioMarin will be responsible for the global development and commercialization of the LA-GLA drug candidate. Meanwhile, GC Biopharma and Hanmi Pharmaceutical will retain responsibility for regulatory approval and commercialization of the drug in South Korea.
Terms of the licensing agreement
The agreement provides for an upfront payment of $70 million. The Korean companies may also receive up to $405 million in additional payments tied to development and commercialization milestones. In addition, they will be entitled to tiered royalties from future sales of the drug.
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LA-GLA is also known as HM15421 and GC1134A. It is a next-generation enzyme replacement therapy for the treatment of Fabry disease, a rare inherited lysosomal storage disorder.
Development is undergoing clinical trials
Unlike conventional enzyme replacement therapies, which are usually administered intravenously once every two weeks, LA-GLA is being developed as a long-acting drug for subcutaneous administration. According to the Korean pharmaceutical companies, the candidate was designed to extend its half-life and improve stability, potentially reducing the treatment burden for patients.
Preclinical studies, according to the companies, demonstrated improvements in indicators related to kidney function, blood vessels, and the peripheral nervous system. LA-GLA combines Hanmi Pharmaceutical’s long-acting drug development technology and GC Biopharma’s expertise in enzyme replacement therapy. In 2024, the drug received orphan drug designation from the U.S. Food and Drug Administration and is currently undergoing a global Phase I/II clinical trial.
