Huonslab Announces Successful Enrollment and Administration of First Patient in Phase 1 Pivotal Study for Hydizyme™ (rHuPH20)
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등록 2024-12-11 10:33
Huonslab ( a subsidiary of Huons Global ( (KOSDAQ: 084110), announced on December 10th the successful enrollment and administration of the first patient in its pivotal Phase 1 clinical study of Hydizyme™ (recombinant human natural hyaluronidase PH20) in South Korea.
This milestone represents a major step in Huonslab’s commitment to introducing Hydizyme™ to Korea and the U.S. market in a timely and strategic way.
Hydizyme™ (rHuPH20) is a highly purified recombinant human natural hyaluronidase PH20 designed to enhance the dispersion and absorption of other co-administered drugs and fluids.
The ongoing Phase 1 clinical study is a multicenter, double-blind, randomized, and placebo-controlled study aiming to evaluate the safety and potential allergic reactions associated with Hydizyme™ (HLB3-002) in 243 healthy volunteers.
“We are delighted to announce the enrollment and administration of our first patient, marking a significant milestone in our unwavering commitment to securing approval and ensuring the timely launch of Hydizyme™ in both South Korea and the United States. Hydizyme™ is poised to revolutionize the global market with its recombinant human natural hyaluronidase PH20-based approach, manufactured by our proprietary process-patented SC drug delivery technology, HyDIFFUZE™,” said Dr. Young Sun Lee, Chief Business Officer of Huonslab.
Hyaluronidases are extensively utilized in various medical applications, including enhancing subcutaneous drug delivery, facilitating fluid administration in emergency care, improving outcomes in ophthalmology, aesthetics, and dermatology, and reducing pain associated with co-administered local anesthetics.
For further information on Huonslab, a process patented antibody SC delivery technology, HyDIFFUZE™ and Hydizyme™(rHuPH20), please visit www.huonslab.com
About Huonslab
Huonslab, a subsidiary of Huons Global in South Korea, is a leader in biologics research and development, specializing in its proprietary antibody subcutaneous (SC) delivery platform, HyDIFFUZE™.
HyDIFFUZE™ is a highly purified recombinant human natural hyaluronidase (PH20), a glycoprotein with a molecular weight of 61 kDa. When co-formulated with partner antibodies, it facilitates the delivery of high-dose, high-volume antibodies via subcutaneous injection, providing a more patient-friendly and cost-effective alternative to traditional intravenous administration.
Huonslab holds a registered process patent for both upstream and downstream manufacturing processes of HyDIFFUZE™ (rHuPH20).
This ensures exceptionally high purity, superior purification yields, and high specific enzyme activity, setting a new standard in rHUPH20 based SC antibody delivery.
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