GC Green Cross and Hanmi Pharmaceutical have licensed their next-generation Fabry disease treatment candidate, LA-GLA (HM15421·GC1134A), to the U.S. rare disease specialist BioMarin Pharmaceutical.
The companies announced on October 30 that they have signed an exclusive licensing agreement with BioMarin for LA-GLA. The deal is valued at up to $475 million (approximately 634.7 billion won), including upfront payments and milestone payments tied to development and commercialization stages.
Under the agreement, the companies will receive a non-refundable upfront payment of $70 million (approximately 935 billion won). They can also earn up to $405 million (approximately 541.2 billion won) in milestone payments based on the success of clinical development and regulatory approval. Additionally, they will secure separate royalties linked to sales after the product launch.
BioMarin will lead the development and commercialization of LA-GLA in markets outside of South Korea, while GC Green Cross and Hanmi Pharmaceutical will handle product approval and commercialization in South Korea.
LA-GLA is a next-generation enzyme replacement therapy (ERT) candidate for treating Fabry disease, a rare genetic disorder caused by a deficiency of the enzyme alpha-galactosidase A, leading to the accumulation of certain lipids in cells. The disease affects multiple organs, including the kidneys, heart, and nervous system, and can result in kidney failure or cardiovascular complications as it progresses.
Unlike existing ERTs that require intravenous infusions every two weeks, LA-GLA is designed for subcutaneous administration, with an extended half-life and improved stability. This is expected to reduce the treatment burden on patients and enhance administration convenience.
Preclinical studies have reportedly shown differentiated efficacy in key indicators related to kidney function, vascular health, and peripheral nervous system.
LA-GLA is a collaborative research outcome developed by combining Hanmi Pharmaceutical's proprietary drug development platform technology with GC Green Cross's capabilities in enzyme replacement therapy production and clinical development. The two companies have been collaborating on rare disease drug development since 2020 and have been advancing global joint clinical trials for LA-GLA.
LA-GLA received orphan drug designation from the U.S. Food and Drug Administration (FDA) in 2024 and is currently undergoing global Phase 1 and 2 trials. BioMarin will lead future global development.
BioMarin is a company specialized in the development and commercialization of treatments for rare genetic diseases. Recently, it strengthened its capabilities in the Fabry disease area by acquiring Amicus Therapeutics.
Im Joo-hyun, Vice Chairman of Hanmi Pharmaceutical Group, stated, "LA-GLA is an open innovation achievement that enhances the potential for global new drug development through collaboration among leading domestic pharmaceutical companies. We aim to accelerate global development through this partnership and provide new treatment options for domestic patients."
Heo Eun-cheol, CEO of GC Green Cross, remarked, "We will expand global partnering and commercialization based on our competitive pipeline."
The companies announced on October 30 that they have signed an exclusive licensing agreement with BioMarin for LA-GLA. The deal is valued at up to $475 million (approximately 634.7 billion won), including upfront payments and milestone payments tied to development and commercialization stages.
Under the agreement, the companies will receive a non-refundable upfront payment of $70 million (approximately 935 billion won). They can also earn up to $405 million (approximately 541.2 billion won) in milestone payments based on the success of clinical development and regulatory approval. Additionally, they will secure separate royalties linked to sales after the product launch.
BioMarin will lead the development and commercialization of LA-GLA in markets outside of South Korea, while GC Green Cross and Hanmi Pharmaceutical will handle product approval and commercialization in South Korea.
LA-GLA is a next-generation enzyme replacement therapy (ERT) candidate for treating Fabry disease, a rare genetic disorder caused by a deficiency of the enzyme alpha-galactosidase A, leading to the accumulation of certain lipids in cells. The disease affects multiple organs, including the kidneys, heart, and nervous system, and can result in kidney failure or cardiovascular complications as it progresses.
Unlike existing ERTs that require intravenous infusions every two weeks, LA-GLA is designed for subcutaneous administration, with an extended half-life and improved stability. This is expected to reduce the treatment burden on patients and enhance administration convenience.
Preclinical studies have reportedly shown differentiated efficacy in key indicators related to kidney function, vascular health, and peripheral nervous system.
LA-GLA is a collaborative research outcome developed by combining Hanmi Pharmaceutical's proprietary drug development platform technology with GC Green Cross's capabilities in enzyme replacement therapy production and clinical development. The two companies have been collaborating on rare disease drug development since 2020 and have been advancing global joint clinical trials for LA-GLA.
LA-GLA received orphan drug designation from the U.S. Food and Drug Administration (FDA) in 2024 and is currently undergoing global Phase 1 and 2 trials. BioMarin will lead future global development.
BioMarin is a company specialized in the development and commercialization of treatments for rare genetic diseases. Recently, it strengthened its capabilities in the Fabry disease area by acquiring Amicus Therapeutics.
Im Joo-hyun, Vice Chairman of Hanmi Pharmaceutical Group, stated, "LA-GLA is an open innovation achievement that enhances the potential for global new drug development through collaboration among leading domestic pharmaceutical companies. We aim to accelerate global development through this partnership and provide new treatment options for domestic patients."
Heo Eun-cheol, CEO of GC Green Cross, remarked, "We will expand global partnering and commercialization based on our competitive pipeline."
* This article has been translated by AI.
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