Huonslab applies for clinical trial of hyaluronidase drug
Published: 29 Apr. 2024, 15:59
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- SARAH CHEA
- chea.sarah@joongang.co.kr
Huonslab said on Monday that it filed an investigational new drug (IND) application for HLB3-002, a human genetic recombinant hyaluronidase candidate, with Korea's Ministry of Food and Drug Safety.
It completed all essential nonclinical toxicity studies for the candidate, going by the name Hydiffuze, ensuring safety across all criteria.
Hyaluronidase is used as a drug diffusion agent that directly decomposes hyaluronic acid in the subcutaneous tissue of the human body to help with pain and swelling. It is also used to convert intravenous injection drugs into subcutaneous injections.
Compared to another subcutaneous drug containing the hyaluronidase enzyme that was manufactured under the same conditions, HLB3-002 was confirmed to possess a similar drug diffusion effect and efficacy equivalent to the original drug Hylenex from San Diego-based Halozyme Therapeutics.
"The expiration of the patent for Hylenex in Korea and Europe in March this year, with the U.S. patent set to expire in September 2027, marks a significant milestone," said Lim Chae-young, the executive director of Bio Research at Huonslab.
The global market for hyaluronidase drugs is expected to grow at an annual rate of 8.6 percent to reach $1.4 billion in 2026 from $700 million in 2018.
Meanwhile, Huonslab is also developing of the world's first biosimilar of Hylenex, a genetically designed protein used as an aid in helping the body absorb other injected medications.
BY SARAH CHEA [chea.sarah@joongang.co.kr]
with the Korea JoongAng Daily
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