- Marking a cornerstone of serial success in confirming the biological equivalence to the marketed rHuPH20 co-formulations with blockbuster antibodies including Rituximab/HyDIFFUZETM
- Huonslab in a significant stride in Antibody SC delivery with HyDIFFUZETM, powered by process patent, confirmed In Vivo PK comparability and Dispersion efficacy
Huonslab, Co. Ltd.("Huonslab"), a subsidiary of Huons Global (KOSDAQ: 084110) today announced the positive study results of the confirmed biological equivalence from In Vivo comparative PK study between trastuzumab/HYDIFFUZE and trastuzumab/Enhanze.
Huonslab previously confirmed comparable non clinical efficacy of HYDIFFUZE to Enhanze as locally acting and transiently active permeation enhancer through dye dispersion assay in mouse model and biological equivalence between rituximab/HYDIFFUZE and rituximab/Enhanze through In Vivo comparative PK study in rats.
Dr. Young Sun Lee, the CBO at Huonslab, stated, "Substance patent on Enhanze is already expired in Europe and S. Korea and will be expired in the US in 2027 based on the confirmation of the external patent law firm."
"Having cleared IP issues with a robust FTO analysis and Huonslab own process patent, we bring unmatched excellence and scientifically sound documents to become a global one point of contact for HCAF, high concentration antibody formulation for SC delivery".
Lee finished by saying, "We are accelerating pivotal P1 of Hydizyme, stand-alone human hyaluronidase drug product in S. Korea with a goal to receive the BLA with MFDS in 2026 and recently uploaded expert webinar on HYDIFFUZE on the home page www.huonslab.com for partnering candidates."
Huonslab is presenting during the company presentation session at the upcoming BIO Europe 2024 in Stockholm, Sweden.
About Huonslab Co., Ltd.
Huonslab is a subsidiary of Huons Global Co., Ltd., S. Korea, a fast-paced Bio, Pharmaceuticals Healthcare business holding company with more than 2,200 employees, worldwide.
Huonslab was established in 2018 as a dedicated biologics R&D organization and with a mission to innovate in the human hyaluronidase-based biologics SC delivery field with its proprietary drug delivery platform, HYDIFFUZE.
Huonslab has a well-balanced and patient-centric pipeline including HLB3-002 as a lead candidate in P1, and followed by other non-clinical developments in Alzheimer's, Obesity and Diabetes.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240906941418/en/
Contacts:
Huonslab, Co. Ltd.
Dr. Young Sun Lee, RPh.
Chief Business Officer
yslee68@huonslab.com
