License-out agreement includes $70 million upfront payment
GC Biopharma and Hanmi Pharmaceutical announced on Friday that they have signed an exclusive licensing-out agreement with US biotech company BioMarin Pharmaceutical for their jointly developed experimental treatment for Fabry disease in a deal worth up to $475 million.
Under the agreement, BioMarin will oversee the candidate's global development and commercialization while GC Biopharma and Hanmi Pharm will retain responsibility for regulatory approval and commercialization in Korea.
The deal includes an upfront payment of $70 million, with the two Korean companies eligible to receive up to an additional $405 million in development and commercialization milestone payments. They will also receive tiered royalties on future product sales.
The candidate, LA-GLA, also known as HM15421 or GC1134A, is a next-generation enzyme replacement therapy designed to treat Fabry disease, a rare inherited lysosomal storage disorder.
Unlike conventional enzyme replacement therapies, which typically require intravenous administration every two weeks, LA-GLA is being developed as a long-acting treatment that can be administered through subcutaneous injections.
The Korean drugmakers said the candidate was engineered to extend its half-life and improve stability, potentially reducing treatment burdens and improving convenience for patients.
Preclinical studies showed improved efficacy across several key indicators associated with kidney function, blood vessels and the peripheral nervous system.
LA-GLA combines Hanmi Pharm's proprietary long-acting drug platform technology with GC Biopharma's expertise in enzyme replacement therapies, including the development and commercialization of Hunterase, a treatment for Hunter syndrome.
The candidate received orphan drug designation from the US Food and Drug Administration in 2024 and is currently undergoing a global Phase 1/2 clinical trial. BioMarin will lead subsequent global development.
Hanmi Group Vice Chair Lim Ju-hyun said the deal demonstrates how collaboration between major Korean pharmaceutical companies could help advance the development of novel medicines across the world.
"Through this partnership, we will further accelerate the global development of LA-GLA while doing our utmost to provide a new treatment option for patients in Korea," she said.
GC Biopharma CEO Huh Eun-chul described the licensing agreement as the outcome of close research and development cooperation between the two companies, adding that the company would continue expanding global partnerships and commercialization opportunities based on its pipeline.
hwkan@heraldcorp.com
