An ADC is a targeted therapeutic modality that combines a monoclonal antibody, which delivers therapeutic agents to target cells such as cancer cells, with a cytotoxic drug. The global ADC market has experienced rapid growth in recent years, with development expanding across a broad range of therapeutic indications.
Currently approved ADC products are all administered via intravenous (IV) infusion, driving growing interest in SC formulation technologies that may improve patient convenience and healthcare efficiency. Because ADCs are structurally complex biologics, the development of SC formulations requires advanced formulation technologies capable of simultaneously ensuring stability at high concentrations and efficient subcutaneous drug delivery.
The newly granted patent covers SC formulation technology for ADCs utilizing the HyDIFFUZE™ platform, including formulation technologies designed to enable the development of SC formulations for ADC therapeutics.
Through formulation studies, Huonslab confirmed that HyDIFFUZETM-enabled ADC SC formulations maintained excellent physicochemical stability even under high-concentration conditions. In nonclinical pharmacokinetic (PK) evaluations, the formulations showed a more rapid inintial increase in plasma concentrations following SC administration. Compared with SC formulations without HyDIFFUZETM, systemic drug exposure (AUC) and peak plasma concentration (Cmax) increased by up to 126% and 149%, respectively.
Based on these study, Huonslab expects that HyDIFFUZE™-enabled ADC SC formulations will improve early absorption following subcutaneous administration and enhance systemic drug exposure.
The study findings were presented at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting in March. With the patent registration, Huonslab has also secured intellectual property rights covering core technologies for ADC SC formulations.
“This patent is meaningful in that it demonstrates the applicability of the HyDIFFUZE™ platform to ADCs while expanding the platform’s potential applications,” a Huonslab official said. “Going forward, we will continue to advance the HyDIFFUZE™ platform technology, broaden its application to a wide range of next-generation biopharmaceuticals, and further strengthen the platform’s competitiveness through global business development.”
Meanwhile, Huonslab is currently undergoing regulatory review with the goal of obtaining marketing authorization from Korea’s Ministry of Food and Drug Safety (MFDS) within this year for HYDIZYME Injection, its standalone recombinant hyaluronidase product. In addition, the HyDIFFUZE™ platform continues to expand its application across a variety of next-generation biopharmaceuticals, including ADCs.
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