GC Biopharma and Hanmi Pharm license Fabry disease therapy to BioMarin

GC Biopharma and Hanmi Pharm have signed an exclusive worldwide licensing agreement with BioMarin Pharmaceutical for LA-GLA (HM15421/GC1134A), a next-generation enzyme replacement therapy candidate for Fabry disease.

The deal is valued at up to $475 million, including a $70 million upfront payment and up to $405 million in development and commercial milestones, plus tiered royalties. BioMarin will lead the global clinical development, manufacturing, and commercialization of the candidate outside of South Korea. GC Biopharma and Hanmi Pharm will retain rights for licensing and commercialization within South Korea.

LA-GLA is designed to improve patient convenience by utilizing a long-acting platform to enable subcutaneous injection, whereas current enzyme replacement therapies typically require intravenous administration every two weeks. The candidate, which has received Orphan Drug Designation from the US FDA, is currently undergoing Phase 1/2 clinical trials. The development combines Hanmi Pharm’s long-acting drug delivery platform with GC Biopharma’s expertise in enzyme replacement therapy production.